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https://zephyrnet.com/NCT03800407
2019-01-28
https://zephyrnet.com/?p=NCT03800407
NCT03800407https://www.clinicaltrials.gov/study/NCT03800407?tab=tableOluwayemisi Ojewale, MBChB, MPHOluwayemisi.Ojewale@medicine.ufl.edu3522739446Efavirenz (EFV)-based antiretroviral therapy (ART) remains the preferred regimen in human immunodeficiency virus (HIV)-infected children aged 3 years or older on rifampin-containing antituberculosis (anti-TB) therapy. This is because drug interactions between first-line anti-TB therapy with protease inhibitors (PIs) are more severe to adjust for, and interactions with integrase strand transfer inhibitors (INSTIs) are not well studied in that age group. Although, current weight-based EFV dosing recommendation is not optimal in some children, pharmacokinetic-treatment response (PK-PD) data to guide optimal dosing of EFV during concurrent rifampin-containing therapy in children is very limited. The study team propose that EFV concentrations outside the optimal therapeutic range in children will be associated with virologic failure due to lack of efficacy because of low concentrations or increased central nervous system (CNS) toxicities from high concentrations leading to poor medication adherence. The study will determine virological suppression rates in HIV-infected children with and without TB coinfection treated with standard efavirenz-based therapy and examine the factors contributing to poor virologic response.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2023-05-16 |
Start Month Year | January 28, 2019 |
Primary Completion Month Year | May 31, 2024 |
Verification Month Year | May 2023 |
Verification Date | 2023-05-31 |
Last Update Posted Date | 2023-05-16 |
Detailed Descriptions
Sequence: | 20619572 |
Description | In a previous study, the study team found that first-line anti-TB therapy had minimal effect on EFV pharmacokinetics (PK) at the population level, but children with TB/HIV coinfection on anti-TB therapy had a trend towards worse virologic outcome compared to those with only HIV infection. Due to the small sample size, the study team were unable to examined the patient factors contributing to the poor virologic response. The study team hypothesized that virologic suppression rates on EFV-based therapy is significantly lower in children with TB/HIV coinfection compared to those with HIV alone. In addition, virologic response will be dependent EFV plasma concentrations, CYP2B6 516 G>T genotype and/or adherence level. This hypothesis is based on the premise that extremes (low and high EFV concentration, respectively) could lead to virologic failure because of lack of efficacy or intolerable side effects leading to poor adherence. The current study will investigate the effect of anti-TB therapy, CYP2B6 genotype and pharmacokinetically determined adherence level on virologic response in children with TB/HIV coinfection treated with EFV-based ART. |
Facilities
Sequence: | 199057015 |
Status | Recruiting |
Name | Kwame Nkrumah University of Science and Technology |
City | Kumasi |
Country | Ghana |
Facility Contacts
Sequence: | 27991441 | Sequence: | 27991442 |
Facility Id | 199057015 | Facility Id | 199057015 |
Contact Type | primary | Contact Type | backup |
Name | Sampson Antwi, MBChB | Name | Anthony Enimil, MBChB |
kantwi@gmail.com | tenimil@live.com | ||
Phone | +233265812061 | Phone | +233208164433 |
Conditions
Sequence: | 51910347 | Sequence: | 51910348 | Sequence: | 51910349 |
Name | Tuberculosis | Name | Human Immunodeficiency Virus | Name | Coinfection |
Downcase Name | tuberculosis | Downcase Name | human immunodeficiency virus | Downcase Name | coinfection |
Id Information
Sequence: | 39954130 | Sequence: | 39954131 | Sequence: | 39954132 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | IRB201801820 TB/HIV – N | Id Value | 2R01HD071779 | Id Value | 5R01HD071779-10 |
Id Type | U.S. NIH Grant/Contract | Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/2R01HD071779 | Id Link | https://reporter.nih.gov/quickSearch/5R01HD071779-10 |
Countries
Sequence: | 42346744 |
Name | Ghana |
Removed | False |
Design Groups
Sequence: | 55317746 | Sequence: | 55317747 |
Title | EFV-based ART | Title | Concurrent EFV-based ART plus anti-TB therapy |
Description | ART-naïve HIV-infected children aged 3 – 14 years who initiate EFV-based ART | Description | ART-naïve HIV-infected children aged 3 – 14 years with TB coinfection who initiate EFV-based ART while receiving first-line anti-TB therapy |
Interventions
Sequence: | 52224949 |
Intervention Type | Other |
Name | Observational study |
Description | Outcome of EFV-based ART in children with TB/HIV coinfection compared to those with HIV only on EFV-based ART |
Keywords
Sequence: | 79454238 | Sequence: | 79454239 | Sequence: | 79454240 | Sequence: | 79454241 | Sequence: | 79454242 |
Name | Pharmacokinetic | Name | Concurrent antituberculosis therapy | Name | Efavirenz | Name | Virologic response | Name | Children |
Downcase Name | pharmacokinetic | Downcase Name | concurrent antituberculosis therapy | Downcase Name | efavirenz | Downcase Name | virologic response | Downcase Name | children |
Design Outcomes
Sequence: | 176482908 | Sequence: | 176482909 | Sequence: | 176482910 | Sequence: | 176482911 | Sequence: | 176482912 | Sequence: | 176482913 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | TB coinfection status and HIV RNA < 200 copies/mL on EFV-based ART in HIV-infected children. | Measure | Efavirenz plasma mid-dose concentration and HIV RNA suppression < 200 copies/mL. | Measure | Random efavirenz concentration below the limit of detection (poor ART adherence) and HIV RNA suppression rate. | Measure | CYP2B6 516G>T genotype status and random efavirenz concentration below the limit of detection (poor ART adherence). | Measure | CYP2B6 516G>T genotype status and HIV RNA suppression < 200 copies/mL. | Measure | TB coinfection status and risk of virological failure on EFV-based ART. |
Time Frame | At week 24 of HIV therapy. | Time Frame | Up to week 24 of HIV therapy. | Time Frame | Up to week 24 of HIV therapy. | Time Frame | Up to week 24 of HIV therapy. | Time Frame | Up to week 24 of HIV therapy. | Time Frame | Up to week 48 of HIV therapy. |
Description | The proportion of children with TB/HIV coinfection with virological suppression (HIV RNA < 200 copies/mL) on EFV-based ART and anti-TB therapy compared to that in children with only HIV infection on EFV-based therapy. | Description | Relationship between EFV mid-dose concentration and HIV RNA suppression rate in the combined population of HIV-infected children with and without TB coinfection. | Description | Relationship poor ART adherence and EFV-based ART response in the combined population of HIV-infected children with and without TB coinfection. | Description | Relationship between CYP2B6 516G>T genotype status and likelihood of poor EFV-based ART adherence. | Description | Relationship between CYP2B6 516G>T genotype status and likelihood of HIV RNA suppression. | Description | Proportion of children with TB/HIV coinfection compared to those with only HIV infection with virological failure (HIV RNA > 1000 copies/mL) at 12 months of EFV-based ART. |
Browse Conditions
Sequence: | 192438313 | Sequence: | 192438314 | Sequence: | 192438315 | Sequence: | 192438316 | Sequence: | 192438317 | Sequence: | 192438318 | Sequence: | 192438319 | Sequence: | 192438320 | Sequence: | 192438321 | Sequence: | 192438322 | Sequence: | 192438323 | Sequence: | 192438324 | Sequence: | 192438325 | Sequence: | 192438326 | Sequence: | 192438327 | Sequence: | 192438328 | Sequence: | 192438329 | Sequence: | 192438330 | Sequence: | 192438331 | Sequence: | 192438332 | Sequence: | 192438333 | Sequence: | 192438334 | Sequence: | 192438335 |
Mesh Term | Tuberculosis | Mesh Term | Acquired Immunodeficiency Syndrome | Mesh Term | HIV Infections | Mesh Term | Coinfection | Mesh Term | Mycobacterium Infections | Mesh Term | Actinomycetales Infections | Mesh Term | Gram-Positive Bacterial Infections | Mesh Term | Bacterial Infections | Mesh Term | Bacterial Infections and Mycoses | Mesh Term | Infections | Mesh Term | Immunologic Deficiency Syndromes | Mesh Term | Immune System Diseases | Mesh Term | Blood-Borne Infections | Mesh Term | Communicable Diseases | Mesh Term | Sexually Transmitted Diseases, Viral | Mesh Term | Sexually Transmitted Diseases | Mesh Term | Lentivirus Infections | Mesh Term | Retroviridae Infections | Mesh Term | RNA Virus Infections | Mesh Term | Virus Diseases | Mesh Term | Slow Virus Diseases | Mesh Term | Genital Diseases | Mesh Term | Urogenital Diseases |
Downcase Mesh Term | tuberculosis | Downcase Mesh Term | acquired immunodeficiency syndrome | Downcase Mesh Term | hiv infections | Downcase Mesh Term | coinfection | Downcase Mesh Term | mycobacterium infections | Downcase Mesh Term | actinomycetales infections | Downcase Mesh Term | gram-positive bacterial infections | Downcase Mesh Term | bacterial infections | Downcase Mesh Term | bacterial infections and mycoses | Downcase Mesh Term | infections | Downcase Mesh Term | immunologic deficiency syndromes | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | blood-borne infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | sexually transmitted diseases, viral | Downcase Mesh Term | sexually transmitted diseases | Downcase Mesh Term | lentivirus infections | Downcase Mesh Term | retroviridae infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | slow virus diseases | Downcase Mesh Term | genital diseases | Downcase Mesh Term | urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48073444 | Sequence: | 48073445 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Florida | Name | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Overall Officials
Sequence: | 29131986 |
Role | Principal Investigator |
Name | Awewura Kwara, MD |
Affiliation | University of Florida |
Central Contacts
Sequence: | 11951906 | Sequence: | 11951907 |
Contact Type | primary | Contact Type | backup |
Name | Awewura Kwara, MD | Name | Oluwayemisi Ojewale, MBChB, MPH |
Phone | 3522739501 | Phone | 3522739446 |
awewura.kwara@medicine.ufl.edu | Oluwayemisi.Ojewale@medicine.ufl.edu | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 67816448 | Sequence: | 67816449 |
Design Group Id | 55317747 | Design Group Id | 55317746 |
Intervention Id | 52224949 | Intervention Id | 52224949 |
Eligibilities
Sequence: | 30610335 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 3 Years |
Maximum Age | 14 Years |
Healthy Volunteers | No |
Population | Children aged 3 to 14 years old with HIV infection with or without active TB |
Criteria | Inclusion Criteria:
HIV seropositive children with or without active TB Exclusion Criteria: Unable to obtain informed signed consent parent(s) or legal guardian |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253951421 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 3 |
Maximum Age Num | 14 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30357579 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28729448 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800394
2019-01-28
https://zephyrnet.com/?p=NCT03800394
NCT03800394https://www.clinicaltrials.gov/study/NCT03800394?tab=tableOluwayemisi Ojewale, MBChB, MPHoawoyemi@ufl.edu3522739446Tenofovir (TFV) disoproxil fumarate (TDF) plus emtricitabine (FTC) or lamivudine (3TC) is the preferred nucleoside backbone of first-line antiretroviral therapy (ART) for adolescents in sub-Saharan Africa. In addition, TDF/FTC is recommended for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection in adolescents at substantial risk of acquisition of HIV infection, as well as for hepatitis B virus (HBV) treatment in those with HBV/HIV coinfection. The efficacy TDF and FTC are dependent on intracellular concentrations of the active phosphate anabolites, called TFV diphosphate (TFV-DP) and FTC triphosphate (FTC-TP). However, the intracellular pharmacokinetics of TFV-DP and FTC-TP to examine the adequacy of current dosages in African adolescents has not been previously studied. Thus, examining the pharmacokinetics (PK) of these widely used antiretrovirals in African adolescents is important as ART outcomes remain poor and the recommended dosages of these drugs for children and adolescent were extrapolated from drug approval clinical trials in adult in the United States and Europe.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2023-06-15 |
Start Month Year | January 28, 2019 |
Primary Completion Month Year | October 5, 2023 |
Verification Month Year | June 2023 |
Verification Date | 2023-06-30 |
Last Update Posted Date | 2023-06-15 |
Detailed Descriptions
Sequence: | 20672540 |
Description | This study will evaluate the intracellular PK of TFV-DP and FTC-TP in Ghanaian HIV-infected adolescents with and without TB coinfection. As the clinical effects of TDF and FTC are related to the intracellular concentrations of the phosphate anabolites, called TFV-DP and FTC-TP, there is a need to understand the cellular pharmacology of TDF interactions in African HIV-infected adolescents with and without TB, as the study team cannot extrapolate from US patients not on antituberculosis (anti-TB) drugs. This study will enroll HIV-infected adolescents aged 10 to 18 years old with and without TB coinfection who are already established on ART. The study team hypothesize that younger age, adenosine triphosphate (ATP)-binding cassette subfamily C (ABCC) single nucleotide polymorphisms (SNPs) and anti-TB therapy may influence the intracellular TFV-DP and FTC-TP concentrations in adolescents. |
Facilities
Sequence: | 199554958 |
Status | Recruiting |
Name | Kwame Nkrumah University of Science and Technology |
City | Kumasi |
Country | Ghana |
Facility Contacts
Sequence: | 28053624 | Sequence: | 28053625 |
Facility Id | 199554958 | Facility Id | 199554958 |
Contact Type | primary | Contact Type | backup |
Name | Sampson Antwi, MBChB | Name | Anthony Enimil, MBChB |
Kantwi@gmail.com | Tenimil@live.com | ||
Phone | +233265812061 | Phone | +233208164433 |
Facility Investigators
Sequence: | 18299636 | Sequence: | 18299637 |
Facility Id | 199554958 | Facility Id | 199554958 |
Role | Principal Investigator | Role | Sub-Investigator |
Name | Sampson Antwi, MBChB | Name | Anthony Enimil, MBChB |
Conditions
Sequence: | 52043113 | Sequence: | 52043114 | Sequence: | 52043115 |
Name | Human Immunodeficiency Virus (HIV) | Name | Tuberculosis | Name | Coinfection |
Downcase Name | human immunodeficiency virus (hiv) | Downcase Name | tuberculosis | Downcase Name | coinfection |
Id Information
Sequence: | 40057537 | Sequence: | 40057538 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | IRB201801820 – PKAdol | Id Value | 2R01HD071779 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/2R01HD071779 |
Countries
Sequence: | 42455772 |
Name | Ghana |
Removed | False |
Design Groups
Sequence: | 55451566 | Sequence: | 55451567 |
Title | HIV only | Title | HIV/TB |
Description | Adolescents aged 10-19 years with HIV infection | Description | Adolescents aged 10-19 years with HIV and TB coinfection |
Interventions
Sequence: | 52354694 |
Intervention Type | Other |
Name | Observational PK study |
Description | Effect of antituberculosis treatment, age and genetic factors on intracellular TFV-DP and FTC-TP concentrations |
Keywords
Sequence: | 79659601 | Sequence: | 79659602 | Sequence: | 79659603 | Sequence: | 79659604 | Sequence: | 79659605 |
Name | Pharmacokinetic | Name | Pharmacogenomic | Name | Tenofovir diphosphate | Name | Emtricitabine triphosphate | Name | Adolescents |
Downcase Name | pharmacokinetic | Downcase Name | pharmacogenomic | Downcase Name | tenofovir diphosphate | Downcase Name | emtricitabine triphosphate | Downcase Name | adolescents |
Design Outcomes
Sequence: | 176935749 | Sequence: | 176935750 | Sequence: | 176935751 | Sequence: | 176935752 | Sequence: | 176935753 | Sequence: | 176935754 | Sequence: | 176935755 | Sequence: | 176935756 | Sequence: | 176935757 | Sequence: | 176935758 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Average concentration (Cav) of intracellular TFV-DP and FTC-TP in Ghanaian HIV-infected adolescents. | Measure | Area under the time-concentration curve 0-24 hours (AUC0-24h) of intracellular TFV-DP and FTC-TP in Ghanaian HIV-infected adolescents. | Measure | Cav of TFV-DP and FTC-TP PK in HIV-infected adolescents with and without TB coinfection. | Measure | AUC0-24h of TFV-DP and FTC-TP PK in HIV-infected adolescents with and without TB coinfection. | Measure | Effect of age on TFV-DP and FTC-TP Cav. | Measure | Effect of age on TFV-DP and FTC-TP AUC0-24h . | Measure | Intracellular TFV-DP and FTC-TP Cav in adolescents compared to that in historical adult controls. | Measure | Intracellular TFV-DP and FTC-TP AUC0-24h in adolescents compared to that in historical adult controls. | Measure | Relationship between Adenosine triphosphate (ATP)-binding cassette subfamily C, member 2 (ABCC2), member 4 (ABCC4) and member 10 (ABCC10) SNPs and TFV-DP and FTC-TP AUC0-24h. | Measure | Prevalence and covariates of intracellular TFV-DP Cav < 95 fmol/106 cells in adolescents. |
Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. | Time Frame | After at least 8 weeks of HIV therapy. |
Description | Mean and median Cav of intracellular TFV-DP and FTC-TP in Ghanaian HIV-infected adolescents. | Description | Mean and median AUC0-24h of intracellular TFV-DP and FTC-TP in Ghanaian HIV-infected adolescents. | Description | Geometric mean intracellular TFV-DP and FTC-TP Cav in adolescents with TB/HIV coinfection compared to those only HIV infection. | Description | Geometric mean of intracellular TFV-DP and FTC-TP AUC0-24h in adolescents with TB/HIV coinfection compared to those with only HIV infection. | Description | Geometric mean of intracellular TFV-DP and FTC-TP Cav in adolescents aged 10 – 14 years old compared to that in adolescents aged 15 – 19 years old. | Description | Geometric mean of intracellular TFV-DP and FTC-TP AUC0-24h in adolescents aged 10 – 14 years old compared to that in adolescents aged 15 – 19 years old. | Description | Geometric mean of intracellular TFV-DP and FTC-TP Cav in Ghanaian HIV-infected adolescent compared to published values in adults treated with similar dosage. | Description | Geometric mean of intracellular TFV-DP and FTC-TP AUC0-24h in Ghanaian HIV-infected adolescent compared to published values in adults treated with similar dosage. | Description | Relationship between ABCC2, ABCC4 and ABCC10 SNPs and intracellular TFV-DP and FTC-TP AUC0-24h. | Description | Proportion of Ghanaian adolescents and factors associated with intracellular TFV-DP average concentration < 95 fmol/106 cells. |
Browse Conditions
Sequence: | 192975167 | Sequence: | 192975168 | Sequence: | 192975169 | Sequence: | 192975174 | Sequence: | 192975175 | Sequence: | 192975176 | Sequence: | 192975177 | Sequence: | 192975178 | Sequence: | 192975179 | Sequence: | 192975180 | Sequence: | 192975181 | Sequence: | 192975182 | Sequence: | 192975183 | Sequence: | 192975184 | Sequence: | 192975185 | Sequence: | 192975186 | Sequence: | 192975187 | Sequence: | 192975188 | Sequence: | 192975189 | Sequence: | 192975170 | Sequence: | 192975171 | Sequence: | 192975172 | Sequence: | 192975173 |
Mesh Term | Tuberculosis | Mesh Term | Acquired Immunodeficiency Syndrome | Mesh Term | HIV Infections | Mesh Term | Bacterial Infections | Mesh Term | Bacterial Infections and Mycoses | Mesh Term | Infections | Mesh Term | Immunologic Deficiency Syndromes | Mesh Term | Immune System Diseases | Mesh Term | Blood-Borne Infections | Mesh Term | Communicable Diseases | Mesh Term | Sexually Transmitted Diseases, Viral | Mesh Term | Sexually Transmitted Diseases | Mesh Term | Lentivirus Infections | Mesh Term | Retroviridae Infections | Mesh Term | RNA Virus Infections | Mesh Term | Virus Diseases | Mesh Term | Slow Virus Diseases | Mesh Term | Genital Diseases | Mesh Term | Urogenital Diseases | Mesh Term | Coinfection | Mesh Term | Mycobacterium Infections | Mesh Term | Actinomycetales Infections | Mesh Term | Gram-Positive Bacterial Infections |
Downcase Mesh Term | tuberculosis | Downcase Mesh Term | acquired immunodeficiency syndrome | Downcase Mesh Term | hiv infections | Downcase Mesh Term | bacterial infections | Downcase Mesh Term | bacterial infections and mycoses | Downcase Mesh Term | infections | Downcase Mesh Term | immunologic deficiency syndromes | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | blood-borne infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | sexually transmitted diseases, viral | Downcase Mesh Term | sexually transmitted diseases | Downcase Mesh Term | lentivirus infections | Downcase Mesh Term | retroviridae infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | slow virus diseases | Downcase Mesh Term | genital diseases | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | coinfection | Downcase Mesh Term | mycobacterium infections | Downcase Mesh Term | actinomycetales infections | Downcase Mesh Term | gram-positive bacterial infections |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48198941 | Sequence: | 48198942 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Florida | Name | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Overall Officials
Sequence: | 29210382 |
Role | Principal Investigator |
Name | Awewura Kwara, MD |
Affiliation | University of Florida |
Central Contacts
Sequence: | 11981812 | Sequence: | 11981813 |
Contact Type | primary | Contact Type | backup |
Name | Awewura Kwara, MD | Name | Oluwayemisi Ojewale, MBChB, MPH |
Phone | 352-273-9501 | Phone | 3522739446 |
awewura.kwara@medicine.ufl.edu | oawoyemi@ufl.edu | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 67977861 | Sequence: | 67977862 |
Design Group Id | 55451566 | Design Group Id | 55451567 |
Intervention Id | 52354694 | Intervention Id | 52354694 |
Eligibilities
Sequence: | 30689779 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 10 Years |
Maximum Age | 19 Years |
Healthy Volunteers | No |
Population | Adolescents aged 10-19 years with HIV with or without TB co-infection. |
Criteria | Inclusion Criteria:
HIV-infected adolescents aged 10 to 19 years old who are stable on antiretroviral regimen containing TDF/FTC (300/200 mg daily) for at least 8 weeks. Exclusion Criteria: Unable to obtain informed signed consent from parent(s) or legal guardian. |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253898317 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 10 |
Maximum Age Num | 19 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30436474 |
Observational Model | Cohort |
Time Perspective | Cross-Sectional |
Responsible Parties
Sequence: | 28802995 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800381
2019-01-28
https://zephyrnet.com/?p=NCT03800381
NCT03800381https://www.clinicaltrials.gov/study/NCT03800381?tab=tableOluwayemisi Ojewale, MBChB, MPHOluwayemisi.Ojewale@medicine.ufl.edu3522739446Lack of quality-assured pediatric formulations of the first-line antituberculosis (anti-TB) drugs is barrier to optimized tuberculosis (TB) treatment outcome in children. In 2010 and subsequently modified in 2014, the World Health Organization (WHO) recommended increased dosages of the first-line anti-TB drugs for children, but there were no child-friendly fixed-dose combination (FDC) formulations based on the guidelines. A large proportion of children treated with the new guidelines using old formulations did not achieve the desired rifampin peak concentration (Cmax) > 8 mg/L and pyrazinamide Cmax > 35 mg/L. The TB Alliance and the WHO led the development of a new child-appropriate isoniazid/rifampin/pyrazinamide (HRZ) and isoniazid/rifampin (HR) FDC formulation in line with current WHO recommended dosing guidelines. The new formulations dissolve quickly in liquid, have palatable fruit flavors, and are expected to improved daily adherence but no studies have evaluated the pharmacokinetics (PK) of the FDC formulation in children. The study team hypothesize that the new dispersible HRZ FDC tablet, dosed according to current WHO weight-band dosing recommendations will result in better PK parameters for each drug component than that achieved by the old formulation.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2022-12-22 |
Start Month Year | January 28, 2019 |
Primary Completion Month Year | August 31, 2023 |
Verification Month Year | December 2022 |
Verification Date | 2022-12-31 |
Last Update Posted Date | 2022-12-22 |
Detailed Descriptions
Sequence: | 20680678 |
Description | This study will evaluate the PK of the new pediatric HRZ FDC tablet in Ghanaian children with TB with and without HIV coinfection. The new HRZ FDC dispersible tablet was designed to be child-friendly and to achieve recommended dosages for each weight-band. The formulation has been rolled out in Africa without PK studies in the target population to verify that the tablets achieves adequate drug concentrations. The current study will evaluate the adequacy of the formulation by examining the PK of the component drugs as well as the effect of HIV coinfection. The direct PK data will be used in a population PK model and stimulations to define optimal weight-band dosages and proportions of the components of the pediatric FDC tablets. |
Facilities
Sequence: | 199609468 |
Status | Recruiting |
Name | Kwame Nkrumah University of Science and Technology |
City | Kumasi |
Country | Ghana |
Facility Contacts
Sequence: | 28059603 | Sequence: | 28059604 |
Facility Id | 199609468 | Facility Id | 199609468 |
Contact Type | primary | Contact Type | backup |
Name | Sampson Antwi, MBChB | Name | Anthony Enimil, MBchB |
antwisampson@yahoo.com | tenimil@live.com | ||
Phone | +233265812061 | Phone | +233208164433 |
Browse Interventions
Sequence: | 95831526 | Sequence: | 95831527 | Sequence: | 95831528 | Sequence: | 95831529 | Sequence: | 95831530 | Sequence: | 95831531 | Sequence: | 95831532 | Sequence: | 95831533 | Sequence: | 95831534 | Sequence: | 95831535 | Sequence: | 95831536 | Sequence: | 95831537 | Sequence: | 95831538 | Sequence: | 95831539 | Sequence: | 95831540 | Sequence: | 95831541 | Sequence: | 95831542 | Sequence: | 95831543 | Sequence: | 95831544 | Sequence: | 95831545 | Sequence: | 95831546 |
Mesh Term | Rifampin | Mesh Term | Isoniazid | Mesh Term | Pyrazinamide | Mesh Term | Antibiotics, Antitubercular | Mesh Term | Antitubercular Agents | Mesh Term | Anti-Bacterial Agents | Mesh Term | Anti-Infective Agents | Mesh Term | Leprostatic Agents | Mesh Term | Nucleic Acid Synthesis Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Cytochrome P-450 CYP2B6 Inducers | Mesh Term | Cytochrome P-450 Enzyme Inducers | Mesh Term | Cytochrome P-450 CYP2C8 Inducers | Mesh Term | Cytochrome P-450 CYP2C19 Inducers | Mesh Term | Cytochrome P-450 CYP2C9 Inducers | Mesh Term | Cytochrome P-450 CYP3A Inducers | Mesh Term | Fatty Acid Synthesis Inhibitors | Mesh Term | Hypolipidemic Agents | Mesh Term | Antimetabolites | Mesh Term | Lipid Regulating Agents |
Downcase Mesh Term | rifampin | Downcase Mesh Term | isoniazid | Downcase Mesh Term | pyrazinamide | Downcase Mesh Term | antibiotics, antitubercular | Downcase Mesh Term | antitubercular agents | Downcase Mesh Term | anti-bacterial agents | Downcase Mesh Term | anti-infective agents | Downcase Mesh Term | leprostatic agents | Downcase Mesh Term | nucleic acid synthesis inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | cytochrome p-450 cyp2b6 inducers | Downcase Mesh Term | cytochrome p-450 enzyme inducers | Downcase Mesh Term | cytochrome p-450 cyp2c8 inducers | Downcase Mesh Term | cytochrome p-450 cyp2c19 inducers | Downcase Mesh Term | cytochrome p-450 cyp2c9 inducers | Downcase Mesh Term | cytochrome p-450 cyp3a inducers | Downcase Mesh Term | fatty acid synthesis inhibitors | Downcase Mesh Term | hypolipidemic agents | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | lipid regulating agents |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52062679 | Sequence: | 52062680 | Sequence: | 52062681 |
Name | Tuberculosis | Name | Human Immunodeficiency Virus | Name | Coinfection |
Downcase Name | tuberculosis | Downcase Name | human immunodeficiency virus | Downcase Name | coinfection |
Id Information
Sequence: | 40072582 | Sequence: | 40072583 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | IRB201801820 – HRZ PK -N | Id Value | 5R01HD071779-11 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/5R01HD071779-11 |
Countries
Sequence: | 42470297 |
Name | Ghana |
Removed | False |
Design Groups
Sequence: | 55474109 | Sequence: | 55474110 |
Title | Active TB only | Title | Active TB with HIV Co-infection |
Description | Children with clinical diagnosis or acid-fast bacilli (AFB) smear positive TB disease | Description | Children with clinical diagnosis or AFB smear positive TB disease who test positive for HIV infection |
Interventions
Sequence: | 52375069 |
Intervention Type | Other |
Name | Observational PK study |
Description | The study team will examine the PK and tolerability of the new HRZ 50/75/150 mg dispersible tablet in children with TB with and without HIV coinfection. Intensive PK testing will be performed after at least 4 weeks of treatment in children on first-line anti-TB therapy using the new pediatric HRZ FDC tablet. |
Keywords
Sequence: | 79690399 | Sequence: | 79690400 | Sequence: | 79690401 | Sequence: | 79690403 | Sequence: | 79690404 | Sequence: | 79690402 |
Name | Pharmacokinetic | Name | Pharmacogenomic | Name | Antituberculosis drugs | Name | Tuberculosis | Name | TB/HIV coinfection | Name | Children |
Downcase Name | pharmacokinetic | Downcase Name | pharmacogenomic | Downcase Name | antituberculosis drugs | Downcase Name | tuberculosis | Downcase Name | tb/hiv coinfection | Downcase Name | children |
Design Outcomes
Sequence: | 177004598 | Sequence: | 177004599 | Sequence: | 177004600 | Sequence: | 177004601 | Sequence: | 177004602 | Sequence: | 177004603 | Sequence: | 177004604 | Sequence: | 177004605 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Peak concentration (Cmax) of isoniazid, rifampin and pyrazinamide in the new pediatric HRZ FDC tablet. | Measure | Area under the time-concentration curve from 0-8 hours (AUC0-8h) of isoniazid, rifampin and pyrazinamide in the new pediatric HRZ FDC tablet. | Measure | Cmax of isoniazid, rifampin and pyrazinamide in children with TB with and without HIV coinfection | Measure | AUC0-8h of isoniazid, rifampin and pyrazinamide in children with TB with and without HIV coinfection. | Measure | AUC0-8h of isoniazid, rifampin and pyrazinamide in the new versus old pediatric HRZ FDC tablet. | Measure | Cmax of isoniazid, rifampin and pyrazinamide in the new versus old pediatric HRZ FDC tablet. | Measure | Proportion of children treated with new pediatric HRZ FDC tablet who develop with liver enzymes elevations. | Measure | Identify optimal weight-band dosages of the new HRZ FDC tablet |
Time Frame | After at least 4 weeks of anti-TB therapy | Time Frame | After at least 4 weeks of anti-TB therapy | Time Frame | After at least 4 weeks of anti-TB therapy | Time Frame | After at least 4 weeks of anti-TB therapy | Time Frame | After at least 4 weeks of anti-TB therapy | Time Frame | After at least 4 weeks of anti-TB therapy | Time Frame | After at least 4 weeks of anti-TB therapy | Time Frame | After at least 4 weeks of anti-TB therapy |
Description | Mean and median Cmax of rifampin, isoniazid and pyrazinamide in children with TB treated with the new HRZ FDC tablet. | Description | Mean and median AUC0-8h of rifampin, isoniazid and pyrazinamide in children with TB treated with the new HRZ FDC tablet. | Description | Geometric mean values of Cmax of rifampin, isoniazid and pyrazinamide in children with HIV/TB coinfection compared to those with TB alone. | Description | Geometric mean values of AUC0-8h of rifampin, isoniazid and pyrazinamide in children with HIV/TB coinfection compared to those with TB alone. | Description | Geometric mean values of AUC0-8h of rifampin, isoniazid, and pyrazinamide in children with TB treated with the new FDC tablet compared to those treated with the old formulation in our previous study (historical controls). | Description | Geometric mean values of Cmax of rifampin, isoniazid, and pyrazinamide in children with TB treated with the new FDC tablet compared to those treated with the old formulation in our previous study (historical controls). | Description | Frequency of liver enzymes elevations compared to baseline requiring treatment modification in children with TB with and without HIV coinfection. | Description | Use a population PK model that incorporates demographic, clinical and genetic factors and stimulations to identify the optimal weight-band dosing of the new FDC formulation. |
Browse Conditions
Sequence: | 193053677 | Sequence: | 193053678 | Sequence: | 193053679 | Sequence: | 193053680 | Sequence: | 193053681 | Sequence: | 193053682 | Sequence: | 193053683 | Sequence: | 193053684 | Sequence: | 193053685 | Sequence: | 193053686 | Sequence: | 193053687 | Sequence: | 193053688 | Sequence: | 193053689 | Sequence: | 193053690 | Sequence: | 193053691 | Sequence: | 193053692 | Sequence: | 193053693 | Sequence: | 193053694 | Sequence: | 193053695 | Sequence: | 193053696 | Sequence: | 193053697 | Sequence: | 193053698 | Sequence: | 193053699 |
Mesh Term | Tuberculosis | Mesh Term | Acquired Immunodeficiency Syndrome | Mesh Term | HIV Infections | Mesh Term | Coinfection | Mesh Term | Mycobacterium Infections | Mesh Term | Actinomycetales Infections | Mesh Term | Gram-Positive Bacterial Infections | Mesh Term | Bacterial Infections | Mesh Term | Bacterial Infections and Mycoses | Mesh Term | Infections | Mesh Term | Immunologic Deficiency Syndromes | Mesh Term | Immune System Diseases | Mesh Term | Blood-Borne Infections | Mesh Term | Communicable Diseases | Mesh Term | Sexually Transmitted Diseases, Viral | Mesh Term | Sexually Transmitted Diseases | Mesh Term | Lentivirus Infections | Mesh Term | Retroviridae Infections | Mesh Term | RNA Virus Infections | Mesh Term | Virus Diseases | Mesh Term | Slow Virus Diseases | Mesh Term | Genital Diseases | Mesh Term | Urogenital Diseases |
Downcase Mesh Term | tuberculosis | Downcase Mesh Term | acquired immunodeficiency syndrome | Downcase Mesh Term | hiv infections | Downcase Mesh Term | coinfection | Downcase Mesh Term | mycobacterium infections | Downcase Mesh Term | actinomycetales infections | Downcase Mesh Term | gram-positive bacterial infections | Downcase Mesh Term | bacterial infections | Downcase Mesh Term | bacterial infections and mycoses | Downcase Mesh Term | infections | Downcase Mesh Term | immunologic deficiency syndromes | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | blood-borne infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | sexually transmitted diseases, viral | Downcase Mesh Term | sexually transmitted diseases | Downcase Mesh Term | lentivirus infections | Downcase Mesh Term | retroviridae infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | slow virus diseases | Downcase Mesh Term | genital diseases | Downcase Mesh Term | urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48218542 | Sequence: | 48218543 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Florida | Name | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Overall Officials
Sequence: | 29221985 |
Role | Principal Investigator |
Name | Awewura Kwara, MD |
Affiliation | University of Florida |
Central Contacts
Sequence: | 11986021 | Sequence: | 11986022 |
Contact Type | primary | Contact Type | backup |
Name | Awewura Kwara, MD | Name | Oluwayemisi Ojewale, MBChB, MPH |
Phone | 3522739501 | Phone | 3522739446 |
awewura.kwara@medicine.ufl.edu | Oluwayemisi.Ojewale@medicine.ufl.edu | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68004346 | Sequence: | 68004347 |
Design Group Id | 55474109 | Design Group Id | 55474110 |
Intervention Id | 52375069 | Intervention Id | 52375069 |
Eligibilities
Sequence: | 30701978 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 3 Months |
Maximum Age | 14 Years |
Healthy Volunteers | No |
Population | Children aged 3 months to14 years with active TB with or without HIV co-infection |
Criteria | Inclusion Criteria:
Children with active TB with or without HIV coinfection. Active TB diagnosis defined by clinical criteria consistent with active TB and/or a positive AFB smear. Exclusion Criteria: Children with concurrent conditions other than HIV, have acute hepatitis within 30 days of study entry, persistent vomiting, and diarrhea will be excluded from the study. |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253918682 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 3 |
Maximum Age Num | 14 |
Minimum Age Unit | Months |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30448615 |
Observational Model | Cohort |
Time Perspective | Prospective |
Intervention Other Names
Sequence: | 26612909 |
Intervention Id | 52375069 |
Name | New pediatric isoniazid/rifampin/pyrazinamide (HRZ) FDC tablet |
Responsible Parties
Sequence: | 28815095 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800368
2016-12-21
https://zephyrnet.com/?p=NCT03800368
NCT03800368https://www.clinicaltrials.gov/study/NCT03800368?tab=tableNANANAThe objective of this randomized controlled trial (RCT) is to compare the changes of the sleep-related memory functions in patients with psychosis after they have completed the 12-week high-intensity exercise intervention, the 12-week low-intensity exercise intervention, or the 12-week controlled non-exercise intervention respectively. Fifty-one patients with psychosis, patients who received either the high-intensity exercise or low-intensity exercise as intervention shown a significant improvement to their impaired sleep-related memory function, while those who received non-exercise intervention has no such improvement. Moreover, high-intensity exercise may have a more prominent effect compare to low-intensity exercise.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2019-01-11 |
Start Month Year | December 21, 2016 |
Primary Completion Month Year | September 1, 2017 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-11 |
Conditions
Sequence: | 52440219 | Sequence: | 52440220 |
Name | Schizophrenia and Related Disorders | Name | Psychotic Disorders |
Downcase Name | schizophrenia and related disorders | Downcase Name | psychotic disorders |
Id Information
Sequence: | 40350605 |
Id Source | org_study_id |
Id Value | HKU_Psych |
Design Groups
Sequence: | 55891618 | Sequence: | 55891619 | Sequence: | 55891620 |
Group Type | Experimental | Group Type | Experimental | Group Type | Active Comparator |
Title | High-endurance group | Title | Low-endurance group | Title | Psycho-education |
Description | This group of subjects will receive 2-3 sessions of high-intensity cycling exercise training per week, for a total of 12 weeks. The exercise the subjects received will interchange between the aerobic and anaerobic state. | Description | This group of subjects will receive 2-3 sessions of low-intensity cycling exercise training per week, for a total of 12 weeks. The exercise the subjects received will maintain at an aerobic level. | Description | This group of subjects will receive 2-3 sessions of psycho-education class per week, for a total of 12 weeks. The content of the class includes non-exercise related psycho-education content to participants (e.g., food hygiene, psychological well being, food nutrition, etc). |
Interventions
Sequence: | 52749920 | Sequence: | 52749921 |
Intervention Type | Other | Intervention Type | Other |
Name | Exercise | Name | Non-exercise |
Description | Indoor cycling exercise intervention | Description | Psycho-education |
Keywords
Sequence: | 80233147 | Sequence: | 80233148 | Sequence: | 80233149 | Sequence: | 80233150 |
Name | Exercise | Name | Sleep-dependent memory consolidation | Name | Aerobic | Name | Anaerobic |
Downcase Name | exercise | Downcase Name | sleep-dependent memory consolidation | Downcase Name | aerobic | Downcase Name | anaerobic |
Design Outcomes
Sequence: | 178390685 | Sequence: | 178390686 | Sequence: | 178390687 | Sequence: | 178390688 | Sequence: | 178390689 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The sleep-dependent procedural memory consolidation after 12 weeks of intervention | Measure | The verbal memory consolidation after 12 weeks of intervention | Measure | The attention performance after 12 weeks of intervention | Measure | The sleep quality after 12 weeks of intervention | Measure | The insomnia severity after 12 weeks of intervention |
Time Frame | 12-week Follow-up | Time Frame | 12-week Follow-up | Time Frame | 12-week Follow-up | Time Frame | 12-week Follow-up | Time Frame | 12-week Follow-up |
Description | Tested by comparing the finger-tapping motor sequence task performance between the three groups during the 12-week follow-up assessment. | Description | Tested by comparing the logical memory task performance between the three groups during the 12-week follow-up assessment | Description | Measured by using the cancellation task performance and compare between the three groups during the 12-week follow-up assessment | Description | Measured by using the Pittsburgh Sleep Quality Index (PSQI) and compare the differences between the three groups during the 12-week follow-up assessment | Description | Measured by using the Insomnia Severity Index (ISI) and compare the differences between the three groups during the 12-week follow-up assessment |
Browse Conditions
Sequence: | 194512303 | Sequence: | 194512304 | Sequence: | 194512305 | Sequence: | 194512306 |
Mesh Term | Schizophrenia | Mesh Term | Psychotic Disorders | Mesh Term | Schizophrenia Spectrum and Other Psychotic Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | schizophrenia | Downcase Mesh Term | psychotic disorders | Downcase Mesh Term | schizophrenia spectrum and other psychotic disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48568425 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | The University of Hong Kong |
Overall Officials
Sequence: | 29425466 |
Role | Principal Investigator |
Name | Lik Hang Lincoln Lo |
Affiliation | The University of Hong Kong |
Design Group Interventions
Sequence: | 68517368 | Sequence: | 68517369 | Sequence: | 68517370 |
Design Group Id | 55891618 | Design Group Id | 55891619 | Design Group Id | 55891620 |
Intervention Id | 52749920 | Intervention Id | 52749920 | Intervention Id | 52749921 |
Eligibilities
Sequence: | 30919508 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 55 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Aged from 18 to 55 Exclusion Criteria: Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise may be contraindicated), and seizure disorders |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254187921 |
Registered In Calendar Year | 2019 |
Actual Duration | 8 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 55 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30665184 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29031876 |
Responsible Party Type | Principal Investigator |
Name | Dr. Lincoln Lik-Hang Lo |
Title | Postdoctoral Fellow |
Affiliation | The University of Hong Kong |
]]>
https://zephyrnet.com/NCT03800355
2018-09-14
https://zephyrnet.com/?p=NCT03800355
NCT03800355https://www.clinicaltrials.gov/study/NCT03800355?tab=tableNANANAAn observational, Other Designs (OD) post-marketing, multicenter study, which will obtain retrospective data from male patients diagnosed with invasive breast cancer between 2000 and 2019 in the medical oncology departments of hospitals that are associated with Spanish Breast Cancer Research Group (GEICAM) (using information obtained from patient medical histories).
<![CDATA[
Studies
Study First Submitted Date | 2018-06-22 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2023-04-18 |
Start Month Year | September 14, 2018 |
Primary Completion Month Year | October 30, 2023 |
Verification Month Year | April 2023 |
Verification Date | 2023-04-30 |
Last Update Posted Date | 2023-04-18 |
Detailed Descriptions
Sequence: | 20764939 |
Description | One of the objectives of this project is to ensure representativeness of the cases referred to. Accordingly, participating sites agree to enroll in the study male patients who were diagnosed with breast cancer in the period between 2000 and 2019. |
Facilities
Sequence: | 200474328 | Sequence: | 200474310 | Sequence: | 200474311 | Sequence: | 200474312 | Sequence: | 200474313 | Sequence: | 200474314 | Sequence: | 200474315 | Sequence: | 200474316 | Sequence: | 200474317 | Sequence: | 200474318 | Sequence: | 200474319 | Sequence: | 200474320 | Sequence: | 200474321 | Sequence: | 200474322 | Sequence: | 200474323 | Sequence: | 200474324 | Sequence: | 200474325 | Sequence: | 200474326 | Sequence: | 200474327 | Sequence: | 200474329 | Sequence: | 200474330 | Sequence: | 200474331 | Sequence: | 200474332 | Sequence: | 200474333 | Sequence: | 200474334 | Sequence: | 200474335 | Sequence: | 200474336 | Sequence: | 200474337 | Sequence: | 200474338 | Sequence: | 200474339 | Sequence: | 200474340 | Sequence: | 200474341 | Sequence: | 200474342 | Sequence: | 200474343 | Sequence: | 200474344 | Sequence: | 200474345 | Sequence: | 200474346 | Sequence: | 200474347 | Sequence: | 200474348 | Sequence: | 200474349 | Sequence: | 200474350 | Sequence: | 200474351 | Sequence: | 200474352 | Sequence: | 200474353 | Sequence: | 200474354 | Sequence: | 200474355 | Sequence: | 200474356 | Sequence: | 200474357 | Sequence: | 200474358 | Sequence: | 200474359 | Sequence: | 200474360 | Sequence: | 200474361 | Sequence: | 200474362 | Sequence: | 200474363 |
Name | Clínica Universidad de Navarra | Name | Complejo Hospitalario Universitario de Ferrol | Name | Hospital Virgen de los Lirios | Name | Hospital Universitario San Agustín | Name | Hospital General de Granollers | Name | Instituto Catalán de Oncología de L'Hospitalet | Name | Consorci Corporació Sànitari Parc Taulí | Name | Consorci Sanitari de Terrassa | Name | Hospital Universitario Basurto | Name | Consorcio Hospitalario Provincial de Castellón | Name | Hospital General La Mancha Centro | Name | Hospital Universitario Donostia | Name | Onkologikoa | Name | Hospital Universitario de Fuenlabrada | Name | Hospital Universitario de Getafe | Name | Hospital Universitario Severo Ochoa | Name | Hospital Universitario de Móstoles | Name | Hospital Universitario Quirónsalud Madrid | Name | Hospital Clínico Universitario Virgen de la Arrixaca | Name | Hospital Álvaro Cunqueiro | Name | Hospital de Tortosa Verge de la Cinta | Name | Complejo Hospitalario Universitario A Coruña | Name | Hospital del Mar | Name | Hospital Universitari Dexeus-Grupo Quirónsalud-Instituto Oncológico Dr. Rosell | Name | Hospital Universitari Vall D´Hebrón | Name | IDOC Centre Médic | Name | Hospital Virgen de la Luz | Name | Instituto Catalán de Oncología de Girona | Name | Hospital Universitario Virgen de las Nieves | Name | Hospital Juan Ramón Jiménez | Name | Complejo Hospitalario de Jaén | Name | Complejo Hospitalario Universitario Insular-Materno Infantil | Name | Hospital Universitario Lucus Augusti | Name | GenesisCare Madrid Hospital La Milagrosa | Name | Hospital Central de la Defensa Gómez Ulla | Name | Hospital Universitario Infanta Leonor | Name | Hospital Universitario La Paz | Name | Hospital Universitario La Zarzuela | Name | Hospital Universitario Ramón y Cajal | Name | Hospital General Universitario Morales Meseguer | Name | Hospital Regional Universitario | Name | Hospital Universitari Son Espases | Name | Hospital Universitario Nuestra Señora De Candelaria | Name | Hospital de Sant Pau i Santa Tecla | Name | Hospital Universitario de Toledo | Name | Fundación Instituto Valenciano de Oncología | Name | Hospital Arnau de Vilanova | Name | Hospital Clínico Universitario de Valencia | Name | Hospital General Universitario de Valencia | Name | Hospital Universitario La Fe | Name | Hospital Universitario Río Hortega | Name | Hospital Clínico Universitario Lozano Blesa | Name | Hospital Quirón Zaragoza | Name | Hospital Universitario de Araba |
City | Pamplona | City | Ferrol | City | Alcoy | City | Avilés | City | Granollers | City | L'Hospitalet De Llobregat | City | Sabadell | City | Terrassa | City | Bilbao | City | Castellón De La Plana | City | Alcázar De San Juan | City | Donostia-San Sebastián | City | Donostia-San Sebastián | City | Fuenlabrada | City | Getafe | City | Leganés | City | Móstoles | City | Pozuelo De Alarcón | City | El Palmar | City | Vigo | City | Tortosa | City | A Coruña | City | Barcelona | City | Barcelona | City | Barcelona | City | Barcelona | City | Cuenca | City | Girona | City | Granada | City | Huelva | City | Jaén | City | Las Palmas De Gran Canaria | City | Lugo | City | Madrid | City | Madrid | City | Madrid | City | Madrid | City | Madrid | City | Madrid | City | Murcia | City | Málaga | City | Palma De Mallorca | City | Santa Cruz De Tenerife | City | Tarragona | City | Toledo | City | Valencia | City | Valencia | City | Valencia | City | Valencia | City | Valencia | City | Valladolid | City | Zaragoza | City | Zaragoza | City | Vitoria-Gasteiz |
State | Navarra | State | A Coruña | State | Alicante | State | Asturias | State | Barcelona | State | Barcelona | State | Barcelona | State | Barcelona | State | Bizcaia | State | Castellón | State | Ciudad Real | State | Guipúzcoa | State | Guipúzcoa | State | Madrid | State | Madrid | State | Madrid | State | Madrid | State | Madrid | State | Murcia | State | Pontevedra | State | Tarragona | State | Álava | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Zip | 45007 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain |
Conditions
Sequence: | 52282526 |
Name | Breast Cancer, Male |
Downcase Name | breast cancer, male |
Id Information
Sequence: | 40239022 |
Id Source | org_study_id |
Id Value | GEICAM/2016-04 |
Countries
Sequence: | 42657226 |
Name | Spain |
Removed | False |
Design Groups
Sequence: | 55717473 |
Title | Male breast cancer |
Description | The study target population is all cases of male breast cancer (MBC), diagnosed with invasive breast cancer between the years 2000 and 2019, and treated in the Medical Oncology Departments of participating sites. |
Keywords
Sequence: | 80025980 | Sequence: | 80025981 | Sequence: | 80025982 |
Name | Breast Cancer in males | Name | Observational | Name | Gene Sequencing |
Downcase Name | breast cancer in males | Downcase Name | observational | Downcase Name | gene sequencing |
Design Outcomes
Sequence: | 177788856 | Sequence: | 177788857 | Sequence: | 177788858 | Sequence: | 177788859 | Sequence: | 177788860 | Sequence: | 177788861 | Sequence: | 177788862 | Sequence: | 177788863 | Sequence: | 177788864 | Sequence: | 177788865 | Sequence: | 177788866 | Sequence: | 177788867 | Sequence: | 177788868 | Sequence: | 177788869 | Sequence: | 177788870 | Sequence: | 177788871 | Sequence: | 177788872 | Sequence: | 177788873 | Sequence: | 177788874 | Sequence: | 177788875 | Sequence: | 177788876 | Sequence: | 177788877 | Sequence: | 177788878 | Sequence: | 177788879 | Sequence: | 177788880 | Sequence: | 177788881 | Sequence: | 177788882 | Sequence: | 177788883 | Sequence: | 177788884 | Sequence: | 177788885 | Sequence: | 177788886 | Sequence: | 177788887 | Sequence: | 177788888 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | General condition: Age | Measure | General condition: performance status at diagnosis | Measure | General condition and history: substance abuse | Measure | Diagnosis of other primary tumors | Measure | Body mass index (BMI) | Measure | Primary comorbidities | Measure | Mutational status of BReast CAncer gene (BRCA) or other genes of genetic predisposition | Measure | Family history of cancer | Measure | Anatomopathological characteristics of the tumor: date of diagnosis | Measure | Anatomopathological characteristics of the tumor: histology | Measure | Anatomopathological characteristics of the tumor: clinical and/or pathological stage | Measure | Anatomopathological characteristics of the tumor: hormone-receptor expression | Measure | Anatomopathological characteristics of the tumor: Human Epidermal Growth Factor Receptor 2 (HER-2) expression | Measure | Anatomopathological characteristics of the tumor: histologic grade | Measure | Anatomopathological characteristics of the tumor: Ki-67 | Measure | Anatomopathological characteristics of the tumor: lymphovascular invasion | Measure | Treatment data: date of surgery | Measure | Treatment data: type of surgery | Measure | Treatment data: type of chemotherapy | Measure | Treatment data: adjuvant radiotherapy | Measure | Treatment data: adjuvant hormonotherapy | Measure | Treatment data: other type of anti-cancer treatment | Measure | Follow-up data: relapse type | Measure | Follow-up data: site of metastatic disease | Measure | Follow-up data: occurrence of other primary tumors | Measure | Follow-up data: current condition | Measure | Biological and molecular characteristics analyzed in primary tumors: tumor subtypes | Measure | Biological and molecular characteristics analyzed in primary tumors: risk groups | Measure | Date and cause of death | Measure | Disease-free survival (DFS). | Measure | Distant metastasis-free survival (DMFS). | Measure | Progression-free survival (PFS). | Measure | Overall survival (OS). |
Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2017. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. | Time Frame | From date of patient breast cancer diagnosis until 2019. |
Description | General condition age will be recorded. | Description | Performance status by Eastern Cooperative Oncology Group (ECOG) Scale | Description | Number of Participants With Substance abuse of tobacco and alcohol will be recorded. | Description | Diagnosis of other primary tumors synchronous or metachronous, will be recorded. | Description | BMI is a value derived from the mass (weight) and height. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres. | Description | Primary comorbidities will be recorded. | Description | Mutational status of BRCA or other genes of genetic predisposition will be recorded. | Description | Family history of cancer will be recorded. | Description | Date of diagnosis will be collected. | Description | The histology of the tumor will be collected | Description | Tumor clinical and/or pathological stage will be collected through the tumor-node-metastasis (TNM) staging system of the Union for International Cancer Control (UICC). | Description | Hormone-receptor expression will be collected | Description | Human Epidermal Growth Factor Receptor 2 (HER-2) expression will be collected | Description | Tumor histologic grade will be collected | Description | Tumor Ki-67 proliferation index will be collected | Description | Number of Participants With Presence of lymphovascular invasion will be collected | Description | Will be collected date of surgery | Description | Number of participants with each type of surgery: mastectomy or lumpectomy or quadrantectomy or lymphadenectomy or sentinel lymph node biopsy will be collected. | Description | Number of Participants With neoadjuvant chemotherapy and adjuvant chemotherapy. | Description | Number of Participants With adjuvant radiotherapy | Description | Number of Participants With hormonotherapy | Description | Number of Participants With other type of anti-cancer treatment. | Description | Number of Participants With each relapse type: local, regional or distant | Description | Number of Participants With site of metastatic disease | Description | Number of Participants With occurrence of other primary tumors whether or not of breast origin (in situ or invasive). | Description | The date of the last review and current clinical condition will be recorded. | Description | Number of Participants With tumor subtypes, luminal profiles (e.g., luminal subtypes M1/M2, intrinsic subtypes) | Description | Number of Participants With risk groups on the reference of breast cancer in women, including morphological analyses and description of the clinical profile (e.g., morphological type, differentiation (histologic grade), Estrogen Receptor (ER), Progesterone Receptor (PgR), Human Epidermal growth factor Receptor 2 (HER2), Androgen Receptor (AR), Ki-67). | Description | Date and cause of death, when applicable. | Description | DFS: it is defined as the time from date of initial breast cancer diagnosis to the date of the first documented relapse event (local, regional and/or distant) of the disease, second breast or non-breast primary tumor, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered. | Description | DMFS: it is defined as the time from date of initial breast cancer diagnosis to the date of the first documented distant relapse, second invasive non-breast primary tumor, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered. | Description | PFS: it is defined as the time from the start date of a specific treatment to the documentation of disease progression on such treatment, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered. | Description | OS: it is defined as the time from the date of initial breast cancer diagnosis to the date of death due to any cause. |
Browse Conditions
Sequence: | 193912576 | Sequence: | 193912577 | Sequence: | 193912578 | Sequence: | 193912579 | Sequence: | 193912580 | Sequence: | 193912581 |
Mesh Term | Breast Neoplasms | Mesh Term | Breast Neoplasms, Male | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Breast Diseases | Mesh Term | Skin Diseases |
Downcase Mesh Term | breast neoplasms | Downcase Mesh Term | breast neoplasms, male | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | breast diseases | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48423391 | Sequence: | 48423392 |
Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Spanish Breast Cancer Research Group | Name | Fundación ADEY |
Overall Officials
Sequence: | 29345366 | Sequence: | 29345367 |
Role | Study Director | Role | Study Director |
Name | Chief Medical Investigator | Name | Chief Medical Investigator |
Affiliation | Hospital Universitario Ramón y Cajal, Madrid, Spain | Affiliation | Fundación Onkologikoa, San Sebastián, Spain |
Eligibilities
Sequence: | 30830027 |
Sampling Method | Probability Sample |
Gender | Male |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | The study target population is all cases of male breast cancer (MBC), diagnosed with invasive breast cancer between the years 2000 and 2019, and treated in the Medical Oncology Departments of participating sites. |
Criteria | Inclusion Criteria:
Male patients diagnosed with primary invasive breast carcinoma between the years 2000-2019, and who have been treated and/or followed up in the Medical Oncology Departments of participating sites. Exclusion Criteria: Male patients who do not wish to participate in the study for any reason. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254131588 |
Number Of Facilities | 54 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 26 |
Number Of Secondary Outcomes To Measure | 7 |
Designs
Sequence: | 30575949 |
Observational Model | Case-Only |
Time Perspective | Retrospective |
Links
Sequence: | 4396862 |
Url | http://www.geicam.org |
Description | Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group |
Responsible Parties
Sequence: | 28942357 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800342
2019-01-22
https://zephyrnet.com/?p=NCT03800342
NCT03800342https://www.clinicaltrials.gov/study/NCT03800342?tab=tableNANANAThe purpose of this protocol is to investigate the role of expired non-metabolic carbon dioxide in the relationship between fatigability and recovery and the response to aerobic exercise training in healthy individuals. Both fatigability and recovery are profoundly influenced by mitochondrial energetics which can be inhibited by ionic by-product accumulation during exercise. Buffering mechanisms of these fatigue-inducing ions releases non-metabolic carbon dioxide (CO2) that can be measured as expired CO2 (VCO2) during cardiopulmonary exercise testing (CPET), however the role of non-metabolic VCO2 in the relationship between fatigability and recovery has yet to be investigated.
Furthermore, this study aims to identify the how the patterns of proteins in healthy individuals respond to aerobic exercise training (e.g. stationary cycling) over approximately one month. The underlying mechanisms of recovery after physical activity, including mechanisms or biological pathways that could be highlighted by analysis of proteins in urine, could add to scientific knowledge regarding physical activity tolerance and potential exercise interventions. This knowledge could eventually assist with designing precise and personalized exercise interventions to improve physical activity performance.
The investigators hypothesize that 1) non-metabolic CO2 will be at least moderately associated with the inverse relationship between fatigability and recovery; and 2) highly active adults, compared to sedentary individuals, will exhibit differential proteomic patterns in response to an initial acute bout and subsequent repeated bouts of aerobic exercise.
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Studies
Study First Submitted Date | 2018-12-18 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2019-05-16 |
Start Month Year | January 22, 2019 |
Primary Completion Month Year | April 24, 2019 |
Verification Month Year | May 2019 |
Verification Date | 2019-05-31 |
Last Update Posted Date | 2019-05-16 |
Detailed Descriptions
Sequence: | 20548778 |
Description | Subjects will be recruited from the greater Washington D.C. metro area by word of mouth, university classes, healthcare provider referral, social media posting, and by posted fliers. Healthy males and females as determined by the Physical Activity Readiness Questionnaire Plus (PARQ+) will qualify to participate, regardless of their fitness level. The study design and participation will be explained to those who are potentially interested in participating in the study. Individuals interested in participating as subjects will complete the PARQ+ and those answering "no" to all of the PARQ+ questions will qualify for inclusion. Those answering "yes" to one or more of the questions will be asked follow-up questions to determine if they meet inclusion/exclusion criteria. Subjects will then be consented and enrolled for participation.
Visit 1: Subjects meeting all inclusion criteria and no exclusion criterion will be consented and enrolled in the study. Subjects will then complete the International Physical Activity Questionnaire (IPAQ) to describe their current levels of physical activity. Height and weight measurements of the subject will also be taken. Subjects will then complete a standard peak cardiopulmonary exercise test (pkCPET) to volitional exhaustion with near infrared spectroscopy (NIRS) assessment of muscle oxygenation and microvascular reactivity, bioimpedance cardiographic (ZCG) assessment of cardiac output and stroke volume, and electrocardiographic (EKG) measurement of heart rate (HR) at rest and during exercise. After a 10-minute passive recovery period, subjects will perform an endurance based CPET (enCPET) at intensity of 70% of the peak wattage reached during the pkCPET, again to volitional exhaustion followed by a final 10-minute passive recovery period to conclude day one of testing. Visit 2: Subjects will complete a submaximal square-wave test (swCPET) for measurement of oxygen on-kinetics. After a 10-minute recovery period, subjects will complete the same enCPET they performed during Visit 1 testing. This testing will again be followed by a 10-minute recovery period. EKG measurements of HR will be taken during exercise and rest periods. Subjects will receive a urine collection cup to be used prior to visit 3. Subjects will be asked to collect approximately 75-90 mL of urine on the morning of Visit 3 to provide upon arrival. Subjects will be asked to log food intake using the form described below for 48 hours, starting 24 hours prior to Visit 3. Visits 3-19: On days 3-19, subjects will complete a continuous high intensity aerobic exercise training (AET) protocol. Subjects will warm up for approximately 5-minutes, exercise within their predetermined HR range for 45 minutes, followed by a 5-10 min recovery period. HR will be monitored using a Polar chest strap worn by the subject and a paired watch and the heart rate reading on the cycle ergometer monitored by the investigators. The entire training session will take approximately 60 minutes. Following Visit 3, subjects will be provided with a 2nd urine sample cup and asked to collect a "first-morning" urine sample (75-90mL) at home on the day after visit 3. Subjects will be asked to provide subsequent first-morning midstream urine samples at home on the morning of and the morning after visits 7, 11, 15, and 19 (10 total urine samples). Subjects will be provided with a copy of their initial food log and asked to repeat their nutritional intake for the same timeframe as the initial sample for each subsequent sample (24 hours prior to pre-exercise sample until post-exercise sample). Visit 20: Subjects will repeat the same procedures performed at Visit 1 including a pkCPET, 10-minute recovery, enCPET, 10-minute recovery, in that order. NIRS, ZCG, and EKG again will be collected throughout both the active and recovery portions of the testing. Visit 21: Subjects will repeat the same procedures performed on day two of testing including a swCPET, 10-minute recovery, enCPET, 10-minute recovery, in the order. EKG data will again be collected during the active and recovery portions of the testing. |
Facilities
Sequence: | 198402805 |
Name | George Mason University |
City | Fairfax |
State | Virginia |
Zip | 22030 |
Country | United States |
Conditions
Sequence: | 51727240 | Sequence: | 51727241 |
Name | Adult | Name | Fatigue |
Downcase Name | adult | Downcase Name | fatigue |
Id Information
Sequence: | 39805698 |
Id Source | org_study_id |
Id Value | VCO2-Proteomics |
Countries
Sequence: | 42204450 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55147116 |
Group Type | Experimental |
Title | Healthy |
Description | Healthy individuals will participate in two separate days of cardiopulmonary exercise testing (CPET) (separated by a minimum of two, maximum of 7 days apart) prior to starting the aerobic exercise training program (AET). Individuals will then complete a 4-5 week (4x/week x 17 sessions) continuous, high-intensity AET. Each training session will consist of cycling for 3-5 minutes to warm-up, 45 minutes at 70% of heart rate reserve (HRR-determined from pre-training CPET), and 5-10 minutes to cool down. Following the AET, individuals will repeat the two separate days of CPET performed pre-training. |
Interventions
Sequence: | 52048850 |
Intervention Type | Other |
Name | Aerobic Exercise Training |
Description | see arm/group description |
Keywords
Sequence: | 79145065 | Sequence: | 79145066 | Sequence: | 79145067 | Sequence: | 79145068 | Sequence: | 79145069 |
Name | recovery | Name | proteomics | Name | cardiorespiratory fitness | Name | exercise | Name | aerobic exercise training |
Downcase Name | recovery | Downcase Name | proteomics | Downcase Name | cardiorespiratory fitness | Downcase Name | exercise | Downcase Name | aerobic exercise training |
Design Outcomes
Sequence: | 175933172 | Sequence: | 175933171 |
Outcome Type | secondary | Outcome Type | primary |
Measure | Urinary proteome | Measure | Non-metabolic VCO2 |
Time Frame | This outcome will be assessed at 10 time points per participant: each morning of visits 3,4,7,8,11,12,15,16,19, and 20. Data will be collected during these 5 weeks and at post-testing occurring the week following the end of training. | Time Frame | pre and post 5 week (4 training sessions per week, 17 total sessions) aerobic exercise training protocol |
Description | Proteome of urine samples as measured by mass spectrometry | Description | Correlate measures of non-metabolic carbon dioxide (as measured by the contribution of total expired non-metabolic VCO2) with the correlative relationship between fatigability (as measured by total time during an endurance CPET and on-kinetics during a constant square-wave CPET) and recovery (as measured by VO2 and VCO2 following maximal and submaximal CPET). Compare changes in measures of non-metabolic carbon dioxide (as measured by the contribution of total expired non-metabolic VCO2) and changes in oxygen consumption (as measured by VO2) pre and post exercise training. |
Browse Conditions
Sequence: | 191700818 |
Mesh Term | Fatigue |
Downcase Mesh Term | fatigue |
Mesh Type | mesh-list |
Sponsors
Sequence: | 47907154 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | George Mason University |
Overall Officials
Sequence: | 29027134 |
Role | Principal Investigator |
Name | Andrew A Guccione, PT, PhD, DPT |
Affiliation | George Mason University |
Design Group Interventions
Sequence: | 67607873 |
Design Group Id | 55147116 |
Intervention Id | 52048850 |
Eligibilities
Sequence: | 30506618 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
age 18-60 Exclusion Criteria: diabetes mellitus |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254052888 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 3 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30255698 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | One arm, a single group of healthy individuals, will perform cardiopulmonary exercise testing pre and post an aerobic exercise training program. |
Responsible Parties
Sequence: | 28636188 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 51618354 | Sequence: | 51618355 | Sequence: | 51618356 | Sequence: | 51618357 | Sequence: | 51618358 | Sequence: | 51618359 | Sequence: | 51618360 | Sequence: | 51618361 | Sequence: | 51618362 | Sequence: | 51618363 | Sequence: | 51618364 | Sequence: | 51618365 | Sequence: | 51618366 | Sequence: | 51618367 | Sequence: | 51618369 | Sequence: | 51618368 | Sequence: | 51618370 | Sequence: | 51618371 | Sequence: | 51618372 | Sequence: | 51618373 | Sequence: | 51618374 | Sequence: | 51618375 | Sequence: | 51618399 | Sequence: | 51618376 | Sequence: | 51618377 | Sequence: | 51618378 | Sequence: | 51618379 | Sequence: | 51618380 | Sequence: | 51618381 | Sequence: | 51618382 | Sequence: | 51618383 | Sequence: | 51618384 | Sequence: | 51618385 | Sequence: | 51618386 | Sequence: | 51618387 | Sequence: | 51618388 | Sequence: | 51618389 | Sequence: | 51618390 | Sequence: | 51618391 | Sequence: | 51618392 | Sequence: | 51618393 | Sequence: | 51618394 | Sequence: | 51618395 | Sequence: | 51618396 | Sequence: | 51618397 | Sequence: | 51618398 |
Pmid | 23798298 | Pmid | 22818936 | Pmid | 26606383 | Pmid | 19958872 | Pmid | 17967770 | Pmid | 20345416 | Pmid | 30236049 | Pmid | 9784121 | Pmid | 26014593 | Pmid | 29893975 | Pmid | 23382011 | Pmid | 26542523 | Pmid | 25145492 | Pmid | 29320704 | Pmid | 25663672 | Pmid | 20930125 | Pmid | 26050974 | Pmid | 19268720 | Pmid | 17548726 | Pmid | 23851406 | Pmid | 19222236 | Pmid | 26791624 | Pmid | 25177766 | Pmid | 27461997 | Pmid | 23892338 | Pmid | 10081212 | Pmid | 20656622 | Pmid | 28666548 | Pmid | 25313451 | Pmid | 26565376 | Pmid | 20656616 | Pmid | 11738220 | Pmid | 9216958 | Pmid | 12871687 | Pmid | 9688429 | Pmid | 27701422 | Pmid | 27562396 | Pmid | 22964543 | Pmid | 19176328 | Pmid | 22860899 | Pmid | 20722821 | Pmid | 29368427 | Pmid | 8752810 | Pmid | 27979503 | Pmid | 3087938 | ||
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
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Hydrogel nanoparticle harvesting of plasma or urine for detecting low abundance proteins. J Vis Exp. 2014 Aug 7;(90):e51789. doi: 10.3791/51789. | Citation | Whitham M, Parker BL, Friedrichsen M, Hingst JR, Hjorth M, Hughes WE, Egan CL, Cron L, Watt KI, Kuchel RP, Jayasooriah N, Estevez E, Petzold T, Suter CM, Gregorevic P, Kiens B, Richter EA, James DE, Wojtaszewski JFP, Febbraio MA. Extracellular Vesicles Provide a Means for Tissue Crosstalk during Exercise. Cell Metab. 2018 Jan 9;27(1):237-251.e4. doi: 10.1016/j.cmet.2017.12.001. | Citation | Hecksteden A, Kraushaar J, Scharhag-Rosenberger F, Theisen D, Senn S, Meyer T. Individual response to exercise training – a statistical perspective. J Appl Physiol (1985). 2015 Jun 15;118(12):1450-9. doi: 10.1152/japplphysiol.00714.2014. Epub 2015 Feb 5. | Citation | Keller P, Vollaard NB, Gustafsson T, Gallagher IJ, Sundberg CJ, Rankinen T, Britton SL, Bouchard C, Koch LG, Timmons JA. A transcriptional map of the impact of endurance exercise training on skeletal muscle phenotype. J Appl Physiol (1985). 2011 Jan;110(1):46-59. doi: 10.1152/japplphysiol.00634.2010. Epub 2010 Oct 7. | Citation | Lane RK, Hilsabeck T, Rea SL. The role of mitochondrial dysfunction in age-related diseases. Biochim Biophys Acta. 2015 Nov;1847(11):1387-400. doi: 10.1016/j.bbabio.2015.05.021. Epub 2015 Jun 4. | Citation | Lombardi A, Silvestri E, Cioffi F, Senese R, Lanni A, Goglia F, de Lange P, Moreno M. Defining the transcriptomic and proteomic profiles of rat ageing skeletal muscle by the use of a cDNA array, 2D- and Blue native-PAGE approach. J Proteomics. 2009 May 2;72(4):708-21. doi: 10.1016/j.jprot.2009.02.007. Epub 2009 Mar 5. | Citation | Wisloff U, Stoylen A, Loennechen JP, Bruvold M, Rognmo O, Haram PM, Tjonna AE, Helgerud J, Slordahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen O, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007 Jun 19;115(24):3086-94. doi: 10.1161/CIRCULATIONAHA.106.675041. Epub 2007 Jun 4. | Citation | Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available. | Citation | Oberg AL, Vitek O. Statistical design of quantitative mass spectrometry-based proteomic experiments. J Proteome Res. 2009 May;8(5):2144-56. doi: 10.1021/pr8010099. | Citation | Gemperline DC, Scalf M, Smith LM, Vierstra RD. Morpheus Spectral Counter: A computational tool for label-free quantitative mass spectrometry using the Morpheus search engine. Proteomics. 2016 Mar;16(6):920-4. doi: 10.1002/pmic.201500420. | Citation | Brooks, G. A., Fahey, T. D. & Baldwin, K. M. Exercise physiology: human bioenergetics and its applications. (McGraw-Hill, 2005). | Citation | Lavallee-Adam M, Rauniyar N, McClatchy DB, Yates JR 3rd. PSEA-Quant: a protein set enrichment analysis on label-free and label-based protein quantification data. J Proteome Res. 2014 Dec 5;13(12):5496-509. doi: 10.1021/pr500473n. Epub 2014 Oct 16. | Citation | Pascovici D, Handler DC, Wu JX, Haynes PA. Multiple testing corrections in quantitative proteomics: A useful but blunt tool. Proteomics. 2016 Sep;16(18):2448-53. doi: 10.1002/pmic.201600044. | Citation | Finsterer J, Mahjoub SZ. Fatigue in healthy and diseased individuals. Am J Hosp Palliat Care. 2014 Aug;31(5):562-75. doi: 10.1177/1049909113494748. Epub 2013 Jul 26. | Citation | Aaronson LS, Teel CS, Cassmeyer V, Neuberger GB, Pallikkathayil L, Pierce J, Press AN, Williams PD, Wingate A. Defining and measuring fatigue. Image J Nurs Sch. 1999;31(1):45-50. doi: 10.1111/j.1547-5069.1999.tb00420.x. | Citation | Eldadah BA. Fatigue and fatigability in older adults. PM R. 2010 May;2(5):406-13. doi: 10.1016/j.pmrj.2010.03.022. | Citation | Kim I, Hacker E, Ferrans CE, Horswill C, Park C, Kapella M. Evaluation of fatigability measurement: Integrative review. Geriatr Nurs. 2018 Jan-Feb;39(1):39-47. doi: 10.1016/j.gerinurse.2017.05.014. Epub 2017 Jun 27. | Citation | Keyser RE, Woolstenhulme JG, Chin LM, Nathan SD, Weir NA, Connors G, Drinkard B, Lamberti J, Chan L. Cardiorespiratory function before and after aerobic exercise training in patients with interstitial lung disease. J Cardiopulm Rehabil Prev. 2015 Jan-Feb;35(1):47-55. doi: 10.1097/HCR.0000000000000083. | Citation | Barbosa JF, Bruno SS, Cruz NS, de Oliveira JS, Ruaro JA, Guerra RO. Perceived fatigability and metabolic and energetic responses to 6-minute walk test in older women. Physiotherapy. 2016 Sep;102(3):294-9. doi: 10.1016/j.physio.2015.08.008. Epub 2015 Sep 28. | Citation | Keyser RE. Peripheral fatigue: high-energy phosphates and hydrogen ions. PM R. 2010 May;2(5):347-58. doi: 10.1016/j.pmrj.2010.04.009. | Citation | Nanas S, Nanas J, Kassiotis C, Nikolaou C, Tsagalou E, Sakellariou D, Terovitis I, Papazachou O, Drakos S, Papamichalopoulos A, Roussos C. Early recovery of oxygen kinetics after submaximal exercise test predicts functional capacity in patients with chronic heart failure. Eur J Heart Fail. 2001 Dec;3(6):685-92. doi: 10.1016/s1388-9842(01)00187-8. | Citation | Short KR, Sedlock DA. Excess postexercise oxygen consumption and recovery rate in trained and untrained subjects. J Appl Physiol (1985). 1997 Jul;83(1):153-9. doi: 10.1152/jappl.1997.83.1.153. | Citation | Belardinelli R, Lacalaprice F, Carle F, Minnucci A, Cianci G, Perna G, D'Eusanio G. Exercise-induced myocardial ischaemia detected by cardiopulmonary exercise testing. Eur Heart J. 2003 Jul;24(14):1304-13. doi: 10.1016/s0195-668x(03)00210-0. | Citation | Scrutinio D, Passantino A, Lagioia R, Napoli F, Ricci A, Rizzon P. Percent achieved of predicted peak exercise oxygen uptake and kinetics of recovery of oxygen uptake after exercise for risk stratification in chronic heart failure. Int J Cardiol. 1998 Apr 1;64(2):117-24. doi: 10.1016/s0167-5273(98)00019-9. | Citation | Thompson RB, Pagano JJ, Mathewson KW, Paterson I, Dyck JR, Kitzman DW, Haykowsky MJ. Differential Responses of Post-Exercise Recovery of Leg Blood Flow and Oxygen Uptake Kinetics in HFpEF versus HFrEF. PLoS One. 2016 Oct 4;11(10):e0163513. doi: 10.1371/journal.pone.0163513. eCollection 2016. | Citation | Fiedler GB, Schmid AI, Goluch S, Schewzow K, Laistler E, Niess F, Unger E, Wolzt M, Mirzahosseini A, Kemp GJ, Moser E, Meyerspeer M. Skeletal muscle ATP synthesis and cellular H(+) handling measured by localized (31)P-MRS during exercise and recovery. Sci Rep. 2016 Aug 26;6:32037. doi: 10.1038/srep32037. | Citation | Bower JE. Fatigue, brain, behavior, and immunity: summary of the 2012 Named Series on fatigue. Brain Behav Immun. 2012 Nov;26(8):1220-3. doi: 10.1016/j.bbi.2012.08.009. Epub 2012 Aug 31. | Citation | Vestergaard S, Nayfield SG, Patel KV, Eldadah B, Cesari M, Ferrucci L, Ceresini G, Guralnik JM. Fatigue in a representative population of older persons and its association with functional impairment, functional limitation, and disability. J Gerontol A Biol Sci Med Sci. 2009 Jan;64(1):76-82. doi: 10.1093/gerona/gln017. Epub 2009 Jan 27. | Citation | Schnelle JF, Buchowski MS, Ikizler TA, Durkin DW, Beuscher L, Simmons SF. Evaluation of two fatigability severity measures in elderly adults. J Am Geriatr Soc. 2012 Aug;60(8):1527-33. doi: 10.1111/j.1532-5415.2012.04062.x. Epub 2012 Aug 2. | Citation | Alexander NB, Taffet GE, Horne FM, Eldadah BA, Ferrucci L, Nayfield S, Studenski S. Bedside-to-Bench conference: research agenda for idiopathic fatigue and aging. J Am Geriatr Soc. 2010 May;58(5):967-75. doi: 10.1111/j.1532-5415.2010.02811.x. | Citation | Distefano G, Standley RA, Zhang X, Carnero EA, Yi F, Cornnell HH, Coen PM. Physical activity unveils the relationship between mitochondrial energetics, muscle quality, and physical function in older adults. J Cachexia Sarcopenia Muscle. 2018 Apr;9(2):279-294. doi: 10.1002/jcsm.12272. Epub 2018 Jan 24. | Citation | de Groote P, Millaire A, Decoulx E, Nugue O, Guimier P, Ducloux. Kinetics of oxygen consumption during and after exercise in patients with dilated cardiomyopathy. New markers of exercise intolerance with clinical implications. J Am Coll Cardiol. 1996 Jul;28(1):168-75. doi: 10.1016/0735-1097(96)00126-x. | Citation | Garcia-Saldivia M, Ilarraza-Lomeli H, Myers J, Lara J, Bueno L. Effect of physical training on the recovery of acute exercise, among patients with cardiovascular disease. Arch Cardiol Mex. 2017 Jul-Sep;87(3):199-204. doi: 10.1016/j.acmx.2016.11.004. Epub 2016 Dec 13. | Citation | Beaver WL, Wasserman K, Whipp BJ. A new method for detecting anaerobic threshold by gas exchange. J Appl Physiol (1985). 1986 Jun;60(6):2020-7. doi: 10.1152/jappl.1986.60.6.2020. |
]]>
https://zephyrnet.com/NCT03800329
2018-03-07
https://zephyrnet.com/?p=NCT03800329
NCT03800329https://www.clinicaltrials.gov/study/NCT03800329?tab=tableNANANAThis study is designed to determine the perceived value of continuous remote monitoring to surgeons and surgical patients at Mayo Clinic in Rochester, MN, and determine whether algorithms can be generated to predict risk of readmission following discharge. This initial study will be conducted through the Department of Cardiovascular Surgery.
<![CDATA[
Studies
Study First Submitted Date | 2018-08-14 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2021-11-03 |
Start Month Year | March 7, 2018 |
Primary Completion Month Year | October 26, 2021 |
Verification Month Year | November 2021 |
Verification Date | 2021-11-30 |
Last Update Posted Date | 2021-11-03 |
Detailed Descriptions
Sequence: | 20810208 |
Description | The overall aim of this project is to determine the perceived utility and benefit to use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN. The investigators also aim to determine whether machine learning algorithms can predict readmission following cardiac surgery in these patients, which the investigators believe will benefit patients in future studies. |
Facilities
Sequence: | 200859409 |
Name | Mayo Clinic in Rochester |
City | Rochester |
State | Minnesota |
Zip | 55905 |
Country | United States |
Conditions
Sequence: | 52397221 |
Name | Remote Monitoring |
Downcase Name | remote monitoring |
Id Information
Sequence: | 40319156 |
Id Source | org_study_id |
Id Value | 17-008249 |
Countries
Sequence: | 42742492 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55844080 | Sequence: | 55844081 |
Group Type | Active Comparator | Group Type | Placebo Comparator |
Title | Snap40 Monitor | Title | No Monitor |
Description | Patients randomly assigned to wear the Snap40 monitor will wear the device for 48 hours following discharge from the hospital. | Description | Patients randomly assigned to not wear the Snap40 monitor will continue with their follow-up surgical care in the ordinary fashion. |
Interventions
Sequence: | 52706612 | Sequence: | 52706613 |
Intervention Type | Device | Intervention Type | Other |
Name | Snap40 Monitor | Name | No Monitor |
Description | Non-invasive, wearable armband device used to measure change in systolic blood pressure, respiratory rate, heart rate, body temperature, movement, and oxyhemoglobin saturation and streams this information to a cloud-based storage system. Patients will complete a questionnaire. | Description | Patients will be discharged in the ordinary manner, without the Snap40 monitor. Patients will complete a questionnaire. |
Design Outcomes
Sequence: | 178214853 | Sequence: | 178214854 | Sequence: | 178214855 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | other |
Measure | Physician satisfaction in the use of remote monitoring technology. | Measure | Patient satisfaction in the use of remote monitoring technology. | Measure | Algorithms useful in prediction of readmission following cardiac surgery |
Time Frame | 48 hours | Time Frame | 48 hours | Time Frame | 48 hours |
Description | Physician satisfaction survey measure the utility and benefit to the use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN. | Description | Patient satisfaction survey measures the utility and benefit to the use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN. | Description | Measure data collected via machine learning algorithms to predict readmission following cardiac surgery in patients. |
Sponsors
Sequence: | 48529606 | Sequence: | 48529607 |
Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Mayo Clinic | Name | Snap40 Ltd. |
Overall Officials
Sequence: | 29403396 |
Role | Principal Investigator |
Name | Jordan D Miller |
Affiliation | Mayo Clinic |
Design Group Interventions
Sequence: | 68456190 | Sequence: | 68456191 |
Design Group Id | 55844080 | Design Group Id | 55844081 |
Intervention Id | 52706612 | Intervention Id | 52706613 |
Eligibilities
Sequence: | 30895618 |
Gender | All |
Minimum Age | 40 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Target accrual: 100 patients
Subject population (children, adults, groups): adults undergoing coronary bypass surgery at Mayo Clinic in Rochester, MN Inclusion Criteria: Patients undergoing isolated coronary artery bypass graft (CABG) surgery Exclusion Criteria: Under 40 years of age |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254141736 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 44 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 40 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30641356 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Links
Sequence: | 4405050 |
Url | https://www.mayo.edu/research/clinical-trials |
Description | Mayo Clinic Clinical Trials |
Responsible Parties
Sequence: | 29007965 |
Responsible Party Type | Principal Investigator |
Name | Jordan D. Miller, Ph.D. |
Title | Principal Investigator |
Affiliation | Mayo Clinic |
]]>
https://zephyrnet.com/NCT03800316
2019-01-14
https://zephyrnet.com/?p=NCT03800316
NCT03800316https://www.clinicaltrials.gov/study/NCT03800316?tab=tableNANANAThe study team aims to test connectivity metrics and follow patient outcomes using a new, innovative synchronous video technology in the prehospital setting in three distinct areas:
– 911 Calls
– Pediatric Critical Care Transport
Currently, paramedics and pediatric transport teams seek advice from physicians using a telephone. This project replaces the phone with video consultation where the physicians can directly interact with patients, paramedics and transport teams when care advice is needed.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-10 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2020-05-04 |
Start Month Year | January 14, 2019 |
Primary Completion Month Year | March 31, 2020 |
Verification Month Year | May 2020 |
Verification Date | 2020-05-31 |
Last Update Posted Date | 2020-05-04 |
Facilities
Sequence: | 198643644 |
Name | Mayo Clinic in Rochester |
City | Rochester |
State | Minnesota |
Zip | 55905 |
Country | United States |
Conditions
Sequence: | 51793075 | Sequence: | 51793076 | Sequence: | 51793077 | Sequence: | 51793078 |
Name | Emergencies | Name | Prehospital | Name | Telemedicine | Name | Telehealth |
Downcase Name | emergencies | Downcase Name | prehospital | Downcase Name | telemedicine | Downcase Name | telehealth |
Id Information
Sequence: | 39858308 |
Id Source | org_study_id |
Id Value | 18-005054 |
Countries
Sequence: | 42256134 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55212457 |
Group Type | Experimental |
Title | Synchronous Video Consultation |
Description | Testing the feasibility of a synchronous video consultation in the field prior to emergency department arrival. |
Interventions
Sequence: | 52115640 |
Intervention Type | Device |
Name | Video Consultation |
Description | Video consultation with emergency medicine physicians for patients that are critically ill prior to arrival in the ED |
Design Outcomes
Sequence: | 176159115 | Sequence: | 176159112 | Sequence: | 176159113 | Sequence: | 176159114 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Emergency Room Length of Stay | Measure | Video Consultations Completed | Measure | Mortality | Measure | Hospital Length of Stay |
Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year |
Description | Total number of hours subjects were admitted to the emergency room | Description | Total number of video consultations completed | Description | Total number of subject deaths | Description | Total number of hours subjects were admitted to the hospital |
Browse Conditions
Sequence: | 191964291 | Sequence: | 191964292 | Sequence: | 191964293 |
Mesh Term | Emergencies | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | emergencies | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47966512 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mayo Clinic |
Overall Officials
Sequence: | 29062175 |
Role | Principal Investigator |
Name | Christopher S Russi |
Affiliation | Mayo Clinic |
Design Group Interventions
Sequence: | 67692190 |
Design Group Id | 55212457 |
Intervention Id | 52115640 |
Eligibilities
Sequence: | 30543314 |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Cardiac Arrest Exclusion Criteria: • All other patients not list above |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254212723 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 14 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30291726 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Health Services Research |
Time Perspective | |
Masking | None (Open Label) |
Links
Sequence: | 4355749 |
Url | https://www.mayo.edu/research/clinical-trials |
Description | Mayo Clinic Clinical Trials |
Responsible Parties
Sequence: | 28670274 |
Responsible Party Type | Principal Investigator |
Name | Christopher S. Russi |
Title | Prinipal Investigator |
Affiliation | Mayo Clinic |
]]>
https://zephyrnet.com/NCT03800303
2018-03-15
https://zephyrnet.com/?p=NCT03800303
NCT03800303https://www.clinicaltrials.gov/study/NCT03800303?tab=tableNANANAIn an effort to understand the effects of evidence-based interventions on children and adolescents, the aims of this study are to:
evaluate the feasibility of utilizing wearable devices to track health information (i.e., sleep, physical activity);
evaluate the effectiveness of evidence-based intervention components on mood and interpersonal functioning, family engagement, and sleep and physical activity level outcomes.
<![CDATA[
Studies
Study First Submitted Date | 2018-03-15 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2020-12-29 |
Start Month Year | March 15, 2018 |
Primary Completion Month Year | December 31, 2019 |
Verification Month Year | December 2020 |
Verification Date | 2020-12-31 |
Last Update Posted Date | 2020-12-29 |
Facilities
Sequence: | 201290099 | Sequence: | 201290100 | Sequence: | 201290101 |
Name | Mayo Clinic in Arizona | Name | Mayo Clinic in Florida | Name | Mayo Clinic in Rochester |
City | Scottsdale | City | Jacksonville | City | Rochester |
State | Arizona | State | Florida | State | Minnesota |
Zip | 85259 | Zip | 32224 | Zip | 55905 |
Country | United States | Country | United States | Country | United States |
Conditions
Sequence: | 52507864 |
Name | Mood Disorders in Children and Adolescents |
Downcase Name | mood disorders in children and adolescents |
Id Information
Sequence: | 40399424 |
Id Source | org_study_id |
Id Value | 17-010831 |
Countries
Sequence: | 42835751 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55964349 |
Group Type | Experimental |
Title | two-week family-based treatment |
Description | Active treatment includes a two-week family-based partial hospitalization treatment utilizing and integrated therapeutic design. |
Interventions
Sequence: | 52815812 |
Intervention Type | Behavioral |
Name | Family-based treatment |
Description | 2-week family-based treatment |
Keywords
Sequence: | 80325664 | Sequence: | 80325665 | Sequence: | 80325666 | Sequence: | 80325667 | Sequence: | 80325668 | Sequence: | 80325669 | Sequence: | 80325670 |
Name | depression | Name | bipolar | Name | caregivers | Name | children | Name | adolescents | Name | treatment | Name | parents |
Downcase Name | depression | Downcase Name | bipolar | Downcase Name | caregivers | Downcase Name | children | Downcase Name | adolescents | Downcase Name | treatment | Downcase Name | parents |
Design Outcomes
Sequence: | 178632258 |
Outcome Type | primary |
Measure | Conner's Comprehensive Behavior Rating Scales |
Time Frame | 12 months |
Description | Likert scale items measuring symptom presentation |
Browse Conditions
Sequence: | 194770858 | Sequence: | 194770859 |
Mesh Term | Mood Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | mood disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48630817 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mayo Clinic |
Overall Officials
Sequence: | 29461031 |
Role | Principal Investigator |
Name | Jarrod M Leffler |
Affiliation | Mayo Clinic |
Design Group Interventions
Sequence: | 68607730 |
Design Group Id | 55964349 |
Intervention Id | 52815812 |
Eligibilities
Sequence: | 30957213 |
Gender | All |
Minimum Age | 10 Years |
Maximum Age | 18 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Children and adolescents between the ages of 10 and 18 years; Exclusion Criteria: Individual's not eligible for admission to the Child and Adolescent Integrated Mood Program (CAIMP)at Mayo Clinic. |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253937766 |
Number Of Facilities | 3 |
Registered In Calendar Year | 2018 |
Actual Duration | 21 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 10 |
Maximum Age Num | 18 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30702789 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Links
Sequence: | 4413777 |
Url | https://www.mayo.edu/research/clinical-trials |
Description | Mayo Clinic Clinical Trials |
Responsible Parties
Sequence: | 29069551 |
Responsible Party Type | Principal Investigator |
Name | Jarrod M. Leffler, Ph.D., L.P. |
Title | Assistant Professor |
Affiliation | Mayo Clinic |
]]>
https://zephyrnet.com/NCT03800290
2019-06-01
https://zephyrnet.com/?p=NCT03800290
NCT03800290https://www.clinicaltrials.gov/study/NCT03800290?tab=tableNANANAThe purpose of this study is to investigate the effect of two weeks clenbuterol/placebo supplementation on skeletal muscle glucose disposal in healthy male volunteers.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-06 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2022-12-01 |
Start Month Year | June 1, 2019 |
Primary Completion Month Year | April 23, 2021 |
Verification Month Year | July 2020 |
Verification Date | 2020-07-31 |
Last Update Posted Date | 2022-12-01 |
Facilities
Sequence: | 201074330 |
Name | Maastricht University |
City | Maastricht |
State | Limburg |
Zip | 6229ER |
Country | Netherlands |
Browse Interventions
Sequence: | 96480844 | Sequence: | 96480845 | Sequence: | 96480846 | Sequence: | 96480847 | Sequence: | 96480848 | Sequence: | 96480849 | Sequence: | 96480850 | Sequence: | 96480851 | Sequence: | 96480852 | Sequence: | 96480853 | Sequence: | 96480854 | Sequence: | 96480855 | Sequence: | 96480856 |
Mesh Term | Clenbuterol | Mesh Term | Adrenergic beta-Agonists | Mesh Term | Adrenergic Agonists | Mesh Term | Adrenergic Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Physiological Effects of Drugs | Mesh Term | Bronchodilator Agents | Mesh Term | Autonomic Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Anti-Asthmatic Agents | Mesh Term | Respiratory System Agents | Mesh Term | Sympathomimetics |
Downcase Mesh Term | clenbuterol | Downcase Mesh Term | adrenergic beta-agonists | Downcase Mesh Term | adrenergic agonists | Downcase Mesh Term | adrenergic agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | bronchodilator agents | Downcase Mesh Term | autonomic agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | anti-asthmatic agents | Downcase Mesh Term | respiratory system agents | Downcase Mesh Term | sympathomimetics |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52440250 |
Name | Healthy |
Downcase Name | healthy |
Id Information
Sequence: | 40350629 |
Id Source | org_study_id |
Id Value | NL67646.068.18 |
Countries
Sequence: | 42784026 |
Name | Netherlands |
Removed | False |
Design Groups
Sequence: | 55891661 | Sequence: | 55891662 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Clenbuterol hydrochloride | Title | Placebos |
Description | Subjects will ingest clenbuterol hydrochloride capsules (20 microgram/each) twice daily (40 microgram/day) for a maximum of 14 days.
Subjects that received the clenbuterol hydrochloride capsules (at random) in the first study period will receive the placebo capsules during the second study period. |
Description | Subjects will ingest placebo capsules matching the clenbuterol hydrochloride capsules one time per day for a maximum of 14 days.
Subjects that received the placebo capsules (at random) in the first study period will receive the clenbuterol hydrochloride capsules during the second study period. |
Interventions
Sequence: | 52749963 | Sequence: | 52749964 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Clenbuterol Hydrochloride | Name | Placebos |
Description | Daily ingestion of clenbuterol hydrochloride capsules (40 microgram/day) for a total period of 14 days with a wash-out period of 4 weeks. | Description | Daily ingestion of placebo capsules for a total period of 14 days with a wash-out period of 4 weeks. |
Keywords
Sequence: | 80233182 | Sequence: | 80233183 | Sequence: | 80233184 | Sequence: | 80233185 |
Name | Beta-2 adrenergic agonist | Name | Glucose homeostasis | Name | Skeletal muscle | Name | Human |
Downcase Name | beta-2 adrenergic agonist | Downcase Name | glucose homeostasis | Downcase Name | skeletal muscle | Downcase Name | human |
Design Outcomes
Sequence: | 178390805 | Sequence: | 178390806 | Sequence: | 178390807 | Sequence: | 178390808 | Sequence: | 178390809 | Sequence: | 178390810 | Sequence: | 178390811 | Sequence: | 178390812 | Sequence: | 178390813 | Sequence: | 178390814 | Sequence: | 178390815 | Sequence: | 178390816 | Sequence: | 178390817 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Insulin-stimulated peripheral glucose disposal (Rd) | Measure | Skeletal muscle GLUT4 translocation | Measure | Body weight/composition | Measure | Plasma substrates | Measure | Heart rate | Measure | Blood pressure | Measure | Insulin-mediated suppression of hepatic glucose production | Measure | Energy expenditure and substrate oxidation | Measure | Sleeping energy expenditure and substrate oxidation | Measure | Skeletal muscle glycogen | Measure | Skeletal muscle lipid content using wide-field microscopie | Measure | Skeletal muscle gene expression | Measure | Skeletal muscle protein expression using western blotting |
Time Frame | 2 weeks | Time Frame | acute (4 hours) and long-term (2 weeks) | Time Frame | 2 weeks | Time Frame | Acute (4 hours) and long-term (1 and 2 weeks) | Time Frame | Acute (4 hours) and long-term (1 and 2 weeks) | Time Frame | Acute (4 hours) and long-term (1 and 2 weeks) | Time Frame | 2 weeks | Time Frame | Acute (4 hours) and long-term (2 weeks) | Time Frame | 2-weeks | Time Frame | 2 weeks | Time Frame | 2 weeks | Time Frame | Acute (4 hours) and long-term (1 and 2 weeks) | Time Frame | Acute (4 hours) and long-term (1 and 2 weeks) |
Description | Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on insulin-stimulated peripheral glucose disposal (Rd) during the high-insulin infusion step during the two-step hyperinsulinemic-euglycemic clamp. | Description | Comparison between acute (4h) and prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle GLUT4 translocation as assessed by means of wide-field microscopy in skeletal muscle biopsies | Description | Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on body weight and composition as assessed by means of a Bodpod measurement. | Description | Comparison between acute (4h) and prolonged (1 and 2 weeks) clenbuterol hydrochloride or placebo supplementation on plasma substrate concentrations, including insulin, glucose, free fatty acids and TAGs. | Description | Comparison between acute (4h) and prolonged (1 and 2 weeks) clenbuterol hydrochloride or placebo supplementation on heart rate as measured by means of an automated cuff. | Description | Comparison between acute (4h) and prolonged (1 and 2 weeks) clenbuterol hydrochloride or placebo supplementation on blood pressure (systolic and diastolic) as measured by means of an automated cuff. | Description | Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on hepatic glucose production as assessed during the two-step hyperinsulinemic-euglycemic clamp. | Description | Comparison between acute (4h) and prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on energy expenditure and substrate oxidation as assessed by means of indirect calorimetry. | Description | Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on sleeping energy expenditure and substrate oxidation as assessed by means of a metabolic chamber (indirect calorimetry). | Description | Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle glycogen as assessed in muscle biopsies. | Description | Comparison between prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle lipid content as assessed in muscle biopsies by wide-field microscopie. | Description | Comparison between acute (4h) and prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle gene expression of specific pathways as determined in muscle biopsies by means of RT-qPCR | Description | Comparison between acute (4h) and prolonged (2 weeks) clenbuterol hydrochloride or placebo supplementation on skeletal muscle protein expression of specific pathways as determined in muscle biopsies as determined by means of Western Blotting |
Sponsors
Sequence: | 48568452 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Maastricht University |
Overall Officials
Sequence: | 29425480 |
Role | Principal Investigator |
Name | Joris Hoeks, PhD |
Affiliation | principle investigator |
Design Group Interventions
Sequence: | 68517416 | Sequence: | 68517417 |
Design Group Id | 55891661 | Design Group Id | 55891662 |
Intervention Id | 52749963 | Intervention Id | 52749964 |
Eligibilities
Sequence: | 30919528 |
Gender | Male |
Minimum Age | 18 Years |
Maximum Age | 30 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Caucasian; Exclusion Criteria: Not meeting all inclusion criteria |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254187946 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 23 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 30 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 11 |
Designs
Sequence: | 30665204 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Intervention Model Description | Randomized, double-blinded, placebo-controlled, cross-over, single-center study |
Subject Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 29031896 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800277
2018-11-05
https://zephyrnet.com/?p=NCT03800277
NCT03800277https://www.clinicaltrials.gov/study/NCT03800277?tab=tableNANANAThe growing prevalence of obesity and type 2 diabetes (T2D) is a major public health problem. Recent studies have clearly established that the gut microbiota plays a key role in the investigator’s propensity to develop obesity and associated metabolic health disorders. The gut microbiota compositions plays a decisive role in glucose metabolism and the chronic inflammatory state associated with insulin resistance. Consuming prebiotic rich diet, including polyphenol and inulin rich food could help modulate favorably the gut microbiota which could lead to a reduction of endotoxemia and beneficial metabolic health effects.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-06 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2023-03-21 |
Start Month Year | November 5, 2018 |
Primary Completion Month Year | December 31, 2020 |
Verification Month Year | March 2023 |
Verification Date | 2023-03-31 |
Last Update Posted Date | 2023-03-21 |
Detailed Descriptions
Sequence: | 20600288 |
Description | It is now recognized that overweight individuals have altered microbiota which could lead to intestinal barrier defects and chronic inflammation disorders. Polyphenols such as Proanthocyanidins may modulate the gut microbiota thereby providing beneficial effects on metabolic health. Inulin is a well known prebiotic that could stimulate growth of favorable bacteria in the gut.
The overall goal is to determine the efficacy and synergy of a supplement of polyphenols from cranberry extract with or without a supplement of inulin from agaves to reduce chronic inflammation and endotoxemia and to improve glucose metabolism and insulin sensitivity by modulating microbiota of overweight human subjects with metabolic syndrome symptoms. |
Facilities
Sequence: | 198866359 |
Name | Institute of nutrition and functional foods, Laval University |
City | Québec |
State | Quebec |
Zip | G1V 0A6 |
Country | Canada |
Conditions
Sequence: | 51861283 | Sequence: | 51861284 | Sequence: | 51861285 | Sequence: | 51861286 |
Name | Endotoxemia | Name | Metabolic Syndrome | Name | Glucose Metabolism Disorders | Name | Insulin Resistance |
Downcase Name | endotoxemia | Downcase Name | metabolic syndrome | Downcase Name | glucose metabolism disorders | Downcase Name | insulin resistance |
Id Information
Sequence: | 39910003 |
Id Source | org_study_id |
Id Value | GASTRO-Phenulin (2016-317) |
Countries
Sequence: | 42308736 |
Name | Canada |
Removed | False |
Design Groups
Sequence: | 55288396 | Sequence: | 55288397 | Sequence: | 55288398 | Sequence: | 55288399 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Placebo Comparator |
Title | Cranberry and Agaves | Title | Cranberry and placebo | Title | Placebo and Agaves | Title | Placebo and placebo |
Description | Cranberry extract (2 capsules) + Agaves powder (1 single-dose packet) | Description | Cranberry extract (2 capsules) + Placebo powder (1 single-dose packet) | Description | Placebo (2 capsules) + Agaves powder (1 single-dose packet) | Description | Placebo (2 capsules) + Placebo powder (1 single-dose packet) |
Interventions
Sequence: | 52181049 | Sequence: | 52181050 | Sequence: | 52181051 |
Intervention Type | Dietary Supplement | Intervention Type | Dietary Supplement | Intervention Type | Dietary Supplement |
Name | Cranberry | Name | Agaves | Name | Placebo |
Description | Supplementation of polyphenols from cranberry extract | Description | Supplementation of inulin from Agaves powder | Description | Supplementation with placebo |
Design Outcomes
Sequence: | 176372665 | Sequence: | 176372666 | Sequence: | 176372667 | Sequence: | 176372668 | Sequence: | 176372669 | Sequence: | 176372670 | Sequence: | 176372671 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in metabolic endotoxemia: Measure concentration of Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) in plasma | Measure | Change in intestinal permeability: Measure concentration of zonulin in plasma | Measure | Change in inflammation state of the tissue: Measure concentration of calprotectin and lactoferrin in feces | Measure | Change in systemic inflammation: Measure concentration of inflammation biomarkers in the serum | Measure | Change in glucose serum concentration | Measure | Change in insulin and C-peptide serum concentration | Measure | Change in microbiota diversity: growth of Akkermancia muciniphila, Lactobacillus, Prevotella, Bifdobacterium and inhibition of Clostridium perfringens, C. difficile, Bacteroides spp.) |
Time Frame | At the beginning and the end of treatment (10 weeks) | Time Frame | At the beginning and the end of treatment (10 weeks) | Time Frame | At the beginning and the end of treatment (10 weeks) | Time Frame | At the beginning and the end of treatment (10 weeks) | Time Frame | At the beginning and the end of treatment (10 weeks) | Time Frame | At the beginning and the end of treatment (10 weeks) | Time Frame | At the beginning and the end of treatment (10 weeks) |
Description | effect of the supplements on variation in plasma concentration of LPS and LBP | Description | effect of the supplements on plasma concentration of zonulin | Description | effect of the supplements on fecal calprotectin and lactoferrin | Description | effect of the supplements on chronic inflammation (serum concentration of hsCRP, Il-6, TNF-alpha, IL-1 beta, IL-23) | Description | effect of the supplements on serum concentration of glucose | Description | effect of the supplements on serum concentration of insulin and C-peptide | Description | Global variation of the fecal microbiota and gut microbiota profiling |
Browse Conditions
Sequence: | 192230135 | Sequence: | 192230136 | Sequence: | 192230137 | Sequence: | 192230138 | Sequence: | 192230139 | Sequence: | 192230140 | Sequence: | 192230141 | Sequence: | 192230142 | Sequence: | 192230143 | Sequence: | 192230144 | Sequence: | 192230145 | Sequence: | 192230146 | Sequence: | 192230147 |
Mesh Term | Endotoxemia | Mesh Term | Metabolic Syndrome | Mesh Term | Insulin Resistance | Mesh Term | Metabolic Diseases | Mesh Term | Glucose Metabolism Disorders | Mesh Term | Hyperinsulinism | Mesh Term | Bacteremia | Mesh Term | Sepsis | Mesh Term | Infections | Mesh Term | Toxemia | Mesh Term | Systemic Inflammatory Response Syndrome | Mesh Term | Inflammation | Mesh Term | Pathologic Processes |
Downcase Mesh Term | endotoxemia | Downcase Mesh Term | metabolic syndrome | Downcase Mesh Term | insulin resistance | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | glucose metabolism disorders | Downcase Mesh Term | hyperinsulinism | Downcase Mesh Term | bacteremia | Downcase Mesh Term | sepsis | Downcase Mesh Term | infections | Downcase Mesh Term | toxemia | Downcase Mesh Term | systemic inflammatory response syndrome | Downcase Mesh Term | inflammation | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48031434 | Sequence: | 48031435 | Sequence: | 48031436 | Sequence: | 48031437 | Sequence: | 48031438 | Sequence: | 48031439 | Sequence: | 48031440 |
Agency Class | OTHER | Agency Class | OTHER_GOV | Agency Class | UNKNOWN | Agency Class | UNKNOWN | Agency Class | INDUSTRY | Agency Class | UNKNOWN | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Laval University | Name | Ministry of Agriculture, Fisheries and Food, Quebec | Name | Ministry of economic development, innovation and export trade, Quebec | Name | Diana Food, Symrise | Name | Atrium Innovations | Name | NutriAgaves, Mexico | Name | Société des Produits Nestlé (SPN) |
Overall Officials
Sequence: | 29104169 | Sequence: | 29104170 |
Role | Principal Investigator | Role | Study Director |
Name | Hélène Jacques, PhD | Name | Yves Desjardins, PhD |
Affiliation | Institute of nutrition and functional foods, Laval University | Affiliation | Institute of nutrition and functional foods, Laval University |
Design Group Interventions
Sequence: | 67778465 | Sequence: | 67778466 | Sequence: | 67778467 | Sequence: | 67778468 | Sequence: | 67778469 | Sequence: | 67778470 | Sequence: | 67778471 |
Design Group Id | 55288396 | Design Group Id | 55288397 | Design Group Id | 55288396 | Design Group Id | 55288398 | Design Group Id | 55288397 | Design Group Id | 55288398 | Design Group Id | 55288399 |
Intervention Id | 52181049 | Intervention Id | 52181049 | Intervention Id | 52181050 | Intervention Id | 52181050 | Intervention Id | 52181051 | Intervention Id | 52181051 | Intervention Id | 52181051 |
Eligibilities
Sequence: | 30583568 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
overweight (BMI 25-39.9 kg/m2) or waist circumference ≥ 80 cm (women) and ≥94 cm (men) Exclusion Criteria: chronic disease |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253859167 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 26 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30331732 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28710525 |
Responsible Party Type | Principal Investigator |
Name | Helene Jacques |
Title | Professor |
Affiliation | Laval University |
]]>
https://zephyrnet.com/NCT03800264
2018-05-02
https://zephyrnet.com/?p=NCT03800264
NCT03800264https://www.clinicaltrials.gov/study/NCT03800264?tab=tableNANANABackground: Atrial fibrillation (AF) is the most common cardiac arrhythmia that occurs after on pump coronary artery bypass graft (CABG) surgery. It is associated with postoperative complications, including increased risk of stroke, prolonged hospital stay and increased costs.
Objectives: The aim of this study was to find reliable, effective, safe and well tolerated tools for the prevention of AF after on pump coronary artery bypass surgery.
Patients and methods: The study included 176 patients (age range 40 to 79 years) and scheduled for elective on pump CABG operations without concomitant procedures. The patients were divided randomly into two equal groups. Group (A) in which bisoprolol was used for prophylaxis against atrial fibrillation after surgery. Group (B) in which bisoprolol and hydrocortisone were used for prophylaxis against atrial fibrillation after surgery. For each patient, the following data were collected: gender, preoperative diseases, intraoperative cross clamp time, cardiopulmonary bypass time, and Lt internal mammary Artery usage, incidence of postoperative atrial fibrillation, death, myocardial infarction chest infection and C – reactive protein levels.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-09 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2019-01-15 |
Start Month Year | May 2, 2018 |
Primary Completion Month Year | November 1, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-15 |
Detailed Descriptions
Sequence: | 20548777 |
Description | The study was conducted at The Cardiothoracic surgery intensive care unit of Ain Shams University hospitals during a period of 6 months. The study protocol was approved by "research and ethics committee" of anesthesia and intensive care department, Ain Shams University. Informative consent was obtained from the patients before enrolling in the study.
176 Patients were registered in the study. Patients were randomly allocated by computer-generated random number list into two study groups of 88 patients each, with a range of age between 40 and 79 years old and were undergoing elective on pump CABG operations without concomitant procedures. Group A: Patients received bisoprolol 5mg per oral (P.O.) in the evening of the operation and then one dose (5 mg) every twenty four hours during the next two days. Group B: Patients received bisoprolol as group (A) in addition hydrocortisone 100 mg intravenously is given in the evening of the operation and then 100 mg every eight hours during the next two days. Exclusion criteria for the study included: Patients with preoperative rhythm abnormalities (sick sinus syndrome, atrioventricular conduction abnormalities, history of chronic or intermittent AF), pretreatment with classes I and III antiarrhythmic agents, receiving anti-hypertensive drugs except angiotensin convertor enzyme (ACE) inhibitors, thyroid disease, renal or liver disease, peripheral arterial atherosclerotic disease, thrombophlebitis, uncontrolled diabetes mellitus, systemic bacterial or mycotic infection, active tuberculosis, Cushing's syndrome, peptic ulcer, psychotic mental disorder, Herpes Simplex keratitis and chronic obstructive pulmonary disease were not included in the study. Intraoperative technique: After sedation with diazepam (10 mg intramuscular), radial arterial catheterization, intravenous catheters, and a central venous catheter were introduced in the operating theater. Hemodynamic parameters; Heart rate monitoring, mean arterial pressure, rectal temperature, central venous pressure and arterial blood gas throughout the process was observed. Anesthesia was started by fentanyl (35 mg / kg) and muscle relaxation was achieved with pancronium (0.1 mg / kg), then endotracheal intubation using ventilation with 100% oxygen. The median incision of the sternum was used for cardiac exposure. The left internal mammary artery was harvested and the saphenous vein was prepared, if necessary. All operations were performed under cardiopulmonary bypass and moderate hypothermia (28-328C) with flow rates of 2.2-2.4 l / m2 and the mean perfusion pressure of 50-85 mm Hg. Heart failure was assisted by initial crystalloid cardioplegia (48C, 15 cc / kg) and heart preservation was assisted with 400 cc cold blood Cardioplegia every 20 minutes. The hot shut was performed shortly before removing the cross clamp. The venous cannula was inserted through the right atrial appendix. The arterial cannula was placed in the ascending aorta. 2.3. Postoperative Monitoring: All patients were continuously monitored at the ICU with electrocardiography (ECG), invasive blood pressure and with finger probe for oxygen saturation within 48 h. Patients developed atrial fibrillation received treatment according to their condition, if they are haemodynamically unstable electrical cardioversion (synchronized adjusted at 100 joules using biphasic electrical cardiovertor) was applied. If they are haemodynamically stable pharmacological cardioversion (amiodarone 5 mg/kg intravenous over 60 minutes, then 1.2 grams per day by continuous intravenous infusion) was used. (5) |
Facilities
Sequence: | 198402804 |
Name | Ramymahrose |
City | Cairo |
Zip | 02 |
Country | Egypt |
Browse Interventions
Sequence: | 95177231 | Sequence: | 95177232 | Sequence: | 95177233 | Sequence: | 95177234 | Sequence: | 95177235 | Sequence: | 95177236 | Sequence: | 95177237 | Sequence: | 95177238 | Sequence: | 95177239 | Sequence: | 95177240 | Sequence: | 95177241 | Sequence: | 95177242 | Sequence: | 95177243 | Sequence: | 95177244 |
Mesh Term | Hydrocortisone | Mesh Term | Bisoprolol | Mesh Term | Anti-Inflammatory Agents | Mesh Term | Antihypertensive Agents | Mesh Term | Sympatholytics | Mesh Term | Autonomic Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Adrenergic beta-1 Receptor Antagonists | Mesh Term | Adrenergic beta-Antagonists | Mesh Term | Adrenergic Antagonists | Mesh Term | Adrenergic Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | hydrocortisone | Downcase Mesh Term | bisoprolol | Downcase Mesh Term | anti-inflammatory agents | Downcase Mesh Term | antihypertensive agents | Downcase Mesh Term | sympatholytics | Downcase Mesh Term | autonomic agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | adrenergic beta-1 receptor antagonists | Downcase Mesh Term | adrenergic beta-antagonists | Downcase Mesh Term | adrenergic antagonists | Downcase Mesh Term | adrenergic agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51727237 | Sequence: | 51727238 | Sequence: | 51727239 |
Name | Prevention | Name | Atrial Fibrillation | Name | CABG |
Downcase Name | prevention | Downcase Name | atrial fibrillation | Downcase Name | cabg |
Id Information
Sequence: | 39805697 |
Id Source | org_study_id |
Id Value | Bisoprolol vs corticosteroi |
Countries
Sequence: | 42204449 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55147114 | Sequence: | 55147115 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | BISOPROLOL | Title | hydrocortisone |
Description | BISOPROLOL 5mg per oral (P.O.) in the evening of the operation and then one dose (5 mg) every twenty four hours during the next two days. | Description | hydrocortisone 100 mg intravenously is given in the evening of the operation and then 100 mg every eight hours during the next two days. |
Interventions
Sequence: | 52048849 |
Intervention Type | Drug |
Name | Bisoprolol |
Description | PREVENTIVE DOUBLE BLINDED |
Keywords
Sequence: | 79145061 | Sequence: | 79145062 | Sequence: | 79145063 | Sequence: | 79145064 |
Name | Bisoprolol, | Name | corticosteroid, | Name | atrial fibrillation | Name | cardiac surgery |
Downcase Name | bisoprolol, | Downcase Name | corticosteroid, | Downcase Name | atrial fibrillation | Downcase Name | cardiac surgery |
Design Outcomes
Sequence: | 175933170 |
Outcome Type | primary |
Measure | HEART RATE |
Time Frame | two days |
Description | atrial fibrillation |
Browse Conditions
Sequence: | 191700813 | Sequence: | 191700814 | Sequence: | 191700815 | Sequence: | 191700816 | Sequence: | 191700817 |
Mesh Term | Atrial Fibrillation | Mesh Term | Arrhythmias, Cardiac | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Pathologic Processes |
Downcase Mesh Term | atrial fibrillation | Downcase Mesh Term | arrhythmias, cardiac | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47907153 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Ain Shams University |
Design Group Interventions
Sequence: | 67607871 | Sequence: | 67607872 |
Design Group Id | 55147114 | Design Group Id | 55147115 |
Intervention Id | 52048849 | Intervention Id | 52048849 |
Eligibilities
Sequence: | 30506617 |
Gender | All |
Minimum Age | 40 Years |
Maximum Age | 79 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
– .176 Patients were registered in the study. .Range of age between 40 and 79 years old .Undergoing elective on pump CABG operations without concomitant procedures. Exclusion Criteria: : Patients with preoperative rhythm abnormalities (sick sinus syndrome, atrioventricular conduction abnormalities, |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254052887 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 6 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 40 |
Maximum Age Num | 79 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30255697 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Single |
Masking Description | BLINDED |
Intervention Model Description | DOUBLE BLINDED RANDOMIZED STUDY |
Subject Masked | True |
Intervention Other Names
Sequence: | 26456215 |
Intervention Id | 52048849 |
Name | HYDROCORTISONE |
Responsible Parties
Sequence: | 28636187 |
Responsible Party Type | Principal Investigator |
Name | RAMY AHMED |
Title | lecturer |
Affiliation | Ain Shams University |
]]>
https://zephyrnet.com/NCT03800251
2018-06-06
https://zephyrnet.com/?p=NCT03800251
NCT03800251https://www.clinicaltrials.gov/study/NCT03800251?tab=tableMichelle Walshmichowalsh@gmail.com+353 (01) 4085662The aim of the study is to use sequential ultrasound evaluation of the gastric volume to determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia preOp).
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2019-01-11 |
Start Month Year | June 6, 2018 |
Primary Completion Month Year | January 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-11 |
Detailed Descriptions
Sequence: | 20852117 |
Description | Recent research suggests that attention to nutrition before operation leads to a speedier recovery through moderating the metabolic responses to surgery, improving well-being, decreasing post-operative insulin resistance and attenuation loss of lean body mass. On other hand there are fasting guidelines in place to prevent from pulmonary aspiration. The current fasting guidelines of 2hrs for clear fluids come from some small studies performed in healthy non-pregnant adults and consensus agreement.
The aim of the study is to use sequential ultrasound evaluation of the gastric volume to determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia preOp – a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml). Patients who are fasting according to the current guidelines and agree to partake in the study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least 2hours before their scheduled theatre time. Patients will then have their gastric volume assessed at 15minutes intervals for 2 hours to determine how long it takes for the ingested fluid to leave the stomach. The results of the study will give us more information regarding gastric emptying in the investigator's patient population and may lead to reduced fasting times, increasing patient comfort and improving the patient experience. |
Facilities
Sequence: | 201287164 |
Status | Recruiting |
Name | Coombe Women and Infants University Hospital |
City | Dublin |
Zip | D08XW7X |
Country | Ireland |
Facility Contacts
Sequence: | 28281678 |
Facility Id | 201287164 |
Contact Type | primary |
Name | Petar Popivanov, Dr |
ppopivanov@coombe.ie | |
Phone | +353 (01) 408 5662 |
Facility Investigators
Sequence: | 18438571 |
Facility Id | 201287164 |
Role | Principal Investigator |
Name | Michelle Walsh, Dr |
Conditions
Sequence: | 52507027 | Sequence: | 52507028 |
Name | Gastric Emptying | Name | Pregnancy |
Downcase Name | gastric emptying | Downcase Name | pregnancy |
Id Information
Sequence: | 40398817 |
Id Source | org_study_id |
Id Value | 8-2018 |
Countries
Sequence: | 42835112 |
Name | Ireland |
Removed | False |
Design Groups
Sequence: | 55963380 |
Group Type | Other |
Title | Fasting parturients at term |
Description | Fasting parturients at term, admitted for elective cesarean section, who consent to partake in the study |
Interventions
Sequence: | 52814912 |
Intervention Type | Dietary Supplement |
Name | Nutricia PreOp – a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml |
Description | Fasting parturients at term, admitted for elective cesarean section and consent to partake in the study, will be given the intervention drink |
Keywords
Sequence: | 80324583 | Sequence: | 80324584 | Sequence: | 80324585 | Sequence: | 80324586 |
Name | Gastric Emptying | Name | Pregnancy | Name | Elective Cesarean section | Name | Fasting |
Downcase Name | gastric emptying | Downcase Name | pregnancy | Downcase Name | elective cesarean section | Downcase Name | fasting |
Design Outcomes
Sequence: | 178629619 | Sequence: | 178629620 | Sequence: | 178629621 | Sequence: | 178629622 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Time interval required to return to the fasting grade. | Measure | Number of participants with grade 0, 1 and 2 in fasting term parturients attending for elective cesarean section | Measure | Time taken for the antral cross sectional area (measured by ultrasound) to reach <9.6 cm2 (suggested cut off value for ingested volumes < 1.5ml.kg-1) after ingesting 400 ml carbohydrate drink | Measure | Antral cross sectional area at 2 hours |
Time Frame | 2 hours | Time Frame | 10 minutes | Time Frame | 2 hours | Time Frame | 2 hours |
Description | The stomach will be scanned and graded (Perlas grade 0-2) every 15 minutes based on the presence or absence of clear fluid in supine and right lateral decubitus position at 45 degrees elevation of the upper body, after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp). | Description | Initial "fasting" scan will be performed in all patients | Description | Sequential ultrasound scans will be performed at 15 min intervals for 2 hours. | Description | Ultrasound measurement of antral cross sectional area will be performed at 2 hours after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp). |
Sponsors
Sequence: | 48630073 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Coombe Women and Infants University Hospital |
Central Contacts
Sequence: | 12095043 | Sequence: | 12095044 |
Contact Type | primary | Contact Type | backup |
Name | Petar Popivanov | Name | Michelle Walsh |
Phone | +353 (01) 4085662 | Phone | +353 (01) 4085662 |
ppopivanov@coombe.ie | michowalsh@gmail.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68606449 |
Design Group Id | 55963380 |
Intervention Id | 52814912 |
Eligibilities
Sequence: | 30956738 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 50 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Elective LSCS Exclusion Criteria: Multiple pregnancy |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253953191 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 50 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30702314 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Patients who are fasting according to the guidelines and agree to partake in the study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least 2hrs before their scheduled theatre time and will then have their gastric volume assessed at 15min intervals for 2hrs to determine how long it takes for the ingested fluid to leave the stomach. |
Responsible Parties
Sequence: | 29069081 |
Responsible Party Type | Principal Investigator |
Name | Petar Popivanov |
Title | Consultant Anaesthetist |
Affiliation | Coombe Women and Infants University Hospital |
]]>
https://zephyrnet.com/NCT03800238
2019-02-01
https://zephyrnet.com/?p=NCT03800238
NCT03800238https://www.clinicaltrials.gov/study/NCT03800238?tab=tableNANANAThe purpose of this research is to examine the efficacy of telehealth as a delivery format for an education-based caregiver wellness program focusing on self-care. The study will examine two research questions. 1) Are outcomes equivalent for caregivers in an education based-wellness program delivered via telehealth and one delivered in person as measured by a general rating of health, the Center for Epidemiologic Studies Depression Scale – Revised (CESD-R), self-care behaviors (health self-care neglect, frequency of stress management and relaxation activities, and exercise frequency), self-efficacy, use of community resources, and the Bakas Caregiving Outcomes Scale (BCOS)? 2) Is class attendance equivalent for classes delivered via telehealth and in person? This research involves a specific education-based caregiver wellness program called Powerful Tools for Caregivers (PTC). PTC is an evidence-based six-week program that addresses caregiver health by promoting self-care. Collaborating community organizations offer the program at little to no cost.
This study will employ a quasi-experimental nonequivalent pretest-posttest design to compare outcomes from in-person to telehealth delivered PTC classes. PTC classes are conducted by a pair of class leaders who model concepts. Each pair of class leaders will conduct both a telehealth and in-person PTC class. Collaborating community organizations will recruit 105 caregivers to attend PTC classes delivered by 7 pairs of class leaders.
Telehealth classes will use VSee software to allow caregivers to participate in the PTC program synchronously via secure videoconferencing from their own home. VSee is a free software program designed to deliver secure telehealth services. Class leaders will guide participants in installation of the software on their home computer.
Participants will undergo assessment one week before and one week after the PTC program, and at six-month follow up. Outcome measures replicate previous PTC research and add additional outcomes meaningful to caregiver wellness. Statistical analysis will include descriptive statistics and a mixed design analysis of variance including repeated measures to examine differences in the variables of interest over time.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2020-10-29 |
Start Month Year | February 1, 2019 |
Primary Completion Month Year | October 8, 2020 |
Verification Month Year | October 2020 |
Verification Date | 2020-10-31 |
Last Update Posted Date | 2020-10-29 |
Detailed Descriptions
Sequence: | 20721590 |
Description | Purpose
An estimated 43.5 million Americans serve as an unpaid caregiver over the course of a year. Caregivers are a valuable part of healthcare systems, providing a framework for the medical system to work in the home. Caregivers assist in patient follow through with medical advice, transportation to medical appointments, activation of emergency medical services, and promotion of patient quality of life. Caregivers are an asset to the healthcare system, as they reduce overall healthcare costs; in 2013, unpaid care was estimated at 470 billion dollars a year in the United States. Unfortunately, caregivers are at risk for both physical and mental health problems. In-person programs do exist that are designed to help caregivers care for themselves and mitigate their increased health risks. However, many caregivers are unable to attend such programs. Caregivers face barriers to accessing wellness programming due to lack of time, distance from service delivery locations, availability of services, and health or caregiving demands limiting the ability to leave home. Telehealth offers a solution to many of the barriers caregivers report. Telehealth is the use of technology to deliver healthcare services at a distance. Telehealth allows people access to services regardless of physical location, availability of transportation, and availability of respite care. Telehealth also reduces travel related costs for both providers and clients. While telehealth may provide a solution to increase access to services for those who face barriers to in-person services, there is limited information on the efficacy of telehealth delivered services. No studies have been reported that directly compare outcomes from telehealth and in-person wellness programs for caregivers. This research will fill a needed gap to inform service delivery decision making related to telehealth delivered programming for caregivers. Consequently, the overall goal of this proposed research is to determine the efficacy of translating the PTC program to a telehealth delivery format. The specific objectives are: 1) To determine whether the outcomes are different for caregivers in a PTC program delivered via telehealth compared to one delivered in person. 2) To examine program attendance and reasons for missed sessions. These objectives will be addressed by examining the following outcomes: 1) a general rating of health, 2) the Center for Epidemiologic Studies Depression Scale – Revised (CESD-R), 3) self-care behaviors (health self-care neglect, frequency of stress management and relaxation activities, and exercise frequency), self-efficacy, use of community resources, 4) the overall caregiving experience as measured by the Bakas Caregiving Outcomes Scale (BCOS), and 5) class attendance including reasons for missed classes. The existing program that this study proposes to examine is Powerful Tools for Caregivers, which has demonstrated positive outcomes for caregivers when delivered in-person. These benefits include reduced health risk behaviors; increased frequency in participation in self-care activities such as relaxation, exercise, and use of stress management techniques; demonstrate increased self-efficacy; lower stress levels; and report decreased caregiver burden. If the telehealth delivery method is proven effective by this research, more caregivers will be able to receive these benefits, thereby promoting positive health behaviors that prevent physical and mental health problems in this at-risk population. PTC is an evidence-based six-week program that addresses caregiver health by promoting self-care. Collaborating community organizations offer the program at little to no cost. A preliminary feasibility study was done to prepare for the proposed research. The feasibility study involved four caregivers. Consistent class attendance and Telehealth Usability Questionnaire scores demonstrated the telehealth delivery format was feasible, and qualitative themes indicated caregivers had a positive experience. A pilot study was then conducted involving 18 caregivers in four PTC groups in four different states and examined both caregiver outcomes and the class leader experience of delivering PTC via telehealth. Results have informed the design of this proposed study. Methodology The proposed study is a collaboration between the National PTC Office, collaborating community agencies, and the principal investigator (PI) at Concordia University Wisconsin (CUW). The National PTC Office will provide supervision to assure fidelity to the PTC program. The National PTC Office will assist with recruiting existing PTC Class Leaders who are certified Master Trainers (those who are both certified PTC class leaders and certified to train other class leaders) to conduct PTC classes. PTC class leaders will be selected through an application process to meet criteria for experience in leading classes and to represent a diverse geographical region. These class leaders will undergo human subjects research training and work with the PI to assure compliance with the research protocol. The proposed study will employ a quasi-experimental nonequivalent pretest-posttest design to compare outcomes from in-person to telehealth delivered PTC classes. PTC classes are conducted by a pair of class leaders who model concepts. Each pair of class leaders will conduct both a telehealth and in-person PTC class. This will control for the influence of class leader personality on outcomes. Collaborating community organizations will recruit 105 caregivers to attend PTC classes delivered by seven pairs of class leaders. Class sizes will be unequal due to necessity. Traditional in-person PTC programs are delivered to groups of 10 caregivers. Telehealth classes are limited to five participants due to limitations in screen views and internet bandwidth. Class leaders require a video screen, as do each participant. It is distracting to view more than six video screens at once; furthermore, adding more than six participants degrades the video and audio quality due to limitations in home internet connection bandwidths. The in-person classes include partner discussions. Telehealth technology does not allow private partner discussions; however, the smaller group format is conducive to full group conversations for these aspects of the program. To control for the effect of class leaders' personality, class leaders will deliver one telehealth PTC program and one in-person PTC program. This creates unequal group sizes of 35 participants in the telehealth PTC group and 70 participants in the in-person PTC group. The sample of 105 caregivers was determined based on a power analysis calculated using G Power software and effect sizes and attrition rates from the pilot study data. In the pilot study the CESD-R had a large effect size, while the BCOS and the other health and self-care related variables on the survey had medium to small effect sizes. The PI selected the BCOS with a Cohen's d = 0.26 for the power analysis, an alpha error probability of 0.05, and power of 0.80 to calculate sample size using G Power software. The result was a recommended sample size of 82 participants. The pilot study had a 33% rate of attrition. Planning for this level of drop out at posttest and another 33% at 6-months required an additional 15 participants be added to the sample size for a total of 97 participants in each group. Participants will be recruited through the partnering community organizations of the PTC class leaders. Participants will be informal (unpaid) caregivers, speak English, have the cognitive ability to participate in PTC classes, and for the telehealth delivered classes have a home internet connection, computer with a camera and microphone, and demonstrate the cognitive ability to use a computer and participate in the program. PTC class leaders will screen participants to be sure they meet eligibility criteria. Telehealth classes will use VSee software to allow caregivers to participate in the PTC program synchronously via secure videoconferencing from their own home. VSee is a free software program designed to deliver secure telehealth services. Class leaders will guide participants in installation of the software on their home computer. The telehealth process was developed and tested in earlier phases of this research. Participants will undergo assessment one week before and one week after the PTC program, and at a six-month follow up. Outcome measures replicate previous PTC research and offer additional outcome measures meaningful to caregiver wellness. Assessments include: the Center for Epidemiologic Studies Depression Scale – Revised (CESD-R), the Bakas Caregiving Outcomes Scale (BCOS), and a PTC Taking Care of You Survey which includes items from the original PTC program outcomes research related to caregiver self-efficacy, health self-care neglect, exercise frequency, relaxation frequency, and service utilization. The survey will also include caregiver demographics and questions related to socialization. The CESD-R is an established tool to assess symptoms of depression and the BCOS captures both positive and negative aspects of the caregiver experience. Both tools have established reliability and validity. The three assessment tools will be delivered via one secure electronic survey link issued by the PI. PTC class leaders will record attendance and reasons for any missed classes. Data Analysis Microsoft Excel and SPSS version 25 software will be used for statistical analysis. Statistical analysis will include descriptive statistics, and a mixed design or split plot analysis of variance (ANOVA), which includes repeated measures, to examine differences in the variables of interest over time: CESD-R score, BCOS score, class attendance, caregiver self-efficacy, health self-care neglect, exercise frequency, relaxation frequency, frequency of service utilization, and frequency of socialization. Groups (telehealth delivered group n = 35 and in-person delivery model n = 70) will be analyzed for differences prior to running ANOVA. |
Facilities
Sequence: | 200107886 | Sequence: | 200107887 | Sequence: | 200107888 | Sequence: | 200107889 | Sequence: | 200107890 | Sequence: | 200107891 | Sequence: | 200107892 | Sequence: | 200107893 | Sequence: | 200107894 | Sequence: | 200107895 | Sequence: | 200107896 | Sequence: | 200107897 | Sequence: | 200107898 |
Name | OPICA Adult Day Program | Name | Health Projects Center | Name | Tampa General Hospital | Name | Southeast Idaho Council of Governments Inc | Name | Iowa State University (ISU) Extension and Outreach | Name | Michigan State University | Name | Lutheran Social Service | Name | Executive Services Corps – NE | Name | Concord Regional Visiting Nurse Association (VNA) | Name | Kettering Health Network | Name | Hope Grows and UPMC Health Plan | Name | Jane Joyce | Name | Central East Local Health Integration Network |
City | Los Angeles | City | Santa Cruz | City | Tampa | City | Pocatello | City | Webster City | City | Grand Rapids | City | Moorhead | City | Plattsmouth | City | Concord | City | Beavercreek | City | Allegheny | City | Morristown | City | Whitby |
State | California | State | California | State | Florida | State | Idaho | State | Iowa | State | Michigan | State | Minnesota | State | Nebraska | State | New Hampshire | State | Ohio | State | Pennsylvania | State | Tennessee | State | Ontario |
Zip | 90025 | Zip | 95060 | Zip | 33606 | Zip | 83201 | Zip | 50248 | Zip | 49503 | Zip | 56560 | Zip | 68048 | Zip | 03301 | Zip | 45431 | Zip | 15108 | Zip | 37814 | Zip | L1N 6K9 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | Canada |
Conditions
Sequence: | 52171115 |
Name | Caregivers |
Downcase Name | caregivers |
Id Information
Sequence: | 40158557 |
Id Source | org_study_id |
Id Value | ConcordiaUW |
Countries
Sequence: | 42568860 | Sequence: | 42568861 |
Name | United States | Name | Canada |
Removed | False | Removed | False |
Design Groups
Sequence: | 55593063 | Sequence: | 55593064 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Telehealth Delivery Format | Title | Standard Delivery Format |
Description | This group will participate in the Powerful Tools for Caregivers program using a telehealth delivery method. | Description | This group will participate in the Powerful Tools for Caregivers program in person. |
Interventions
Sequence: | 52485362 | Sequence: | 52485363 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Telehealth Delivery Format | Name | Standard Delivery Format |
Description | Participants will engage in a 6-week Powerful Tools for Caregivers program delivered via telehealth. | Description | Participants will engage in a 6-week Powerful Tools for Caregivers program delivered in the traditional in-person format. |
Keywords
Sequence: | 79868352 | Sequence: | 79868353 | Sequence: | 79868354 |
Name | caregiver | Name | wellness | Name | telehealth |
Downcase Name | caregiver | Downcase Name | wellness | Downcase Name | telehealth |
Design Outcomes
Sequence: | 177378456 | Sequence: | 177378457 | Sequence: | 177378458 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Center for Epidemiologic Studies Depression Scale – Revised (CESD-R) | Measure | Bakas Caregiving Outcomes Scale (BCOS) | Measure | Custom created questionnaire: PTC Taking Care of You Survey |
Time Frame | Assessing change in response to participation in the Powerful Tools for Caregivers (PTC program): Baseline/ 1 week prior to participation in PTC program, 1 week after completion of the PTC program, and 6-months after completion of PTC program. | Time Frame | Assessing change in response to participation in the Powerful Tools for Caregivers (PTC program): Baseline/ 1 week prior to participation in PTC program, 1 week after completion of the PTC program, and 6-months after completion of PTC program. | Time Frame | Assessing change in response to participation in the Powerful Tools for Caregivers (PTC program): Baseline/ 1 week prior to participation in PTC program, 1 week after completion of the PTC program, and 6-months after completion of PTC program. |
Description | Questionnaire assessing symptoms of depression; each question is rated on a 5-point Likert scale; total scores range from zero to 80 with a higher score indicating greater symptoms of depression. | Description | Questionnaire assessing the caregiving experience (includes both positive and negative changes related to caregiver role); each question is rated on a 7-point Likert scale; total scores can range from 15 10 105 with a higher score indicating a more positive caregiving experience. | Description | PTC Taking Care of You Survey which includes questions related to caregiver self-efficacy, health self-care neglect, exercise frequency, relaxation frequency, and service utilization. The survey will also include caregiver demographics and questions related to socialization. |
Sponsors
Sequence: | 48319189 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Concordia University Wisconsin |
Overall Officials
Sequence: | 29285297 |
Role | Principal Investigator |
Name | Katrina M Serwe, PhD |
Affiliation | Concordia University Wisconsin |
Design Group Interventions
Sequence: | 68148993 | Sequence: | 68148994 |
Design Group Id | 55593063 | Design Group Id | 55593064 |
Intervention Id | 52485362 | Intervention Id | 52485363 |
Eligibilities
Sequence: | 30765284 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
informal (unpaid) caregivers for an adult with a chronic condition Exclusion Criteria: • non-English speaking (the PTC program and materials will be delivered in English; participants will need to be proficient in English to engage with the other members of the class) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253877867 |
Number Of Facilities | 13 |
Registered In Calendar Year | 2019 |
Actual Duration | 20 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Designs
Sequence: | 30511451 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Masking Description | Data will be collected via survey and data analysis will be conducted blinded to study group assignment. |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28877745 |
Responsible Party Type | Principal Investigator |
Name | Katrina Serwe |
Title | Associate Professor |
Affiliation | Concordia University Wisconsin |
Study References
Sequence: | 52063162 | Sequence: | 52063163 | Sequence: | 52063161 | Sequence: | 52063160 | Sequence: | 52063164 | Sequence: | 52063165 | Sequence: | 52063166 | Sequence: | 52063167 | Sequence: | 52063168 | Sequence: | 52063169 | Sequence: | 52063170 | Sequence: | 52063171 | Sequence: | 52063172 | Sequence: | 52063173 |
Pmid | 12677080 | Pmid | 16980835 | Pmid | 25945189 | Pmid | 20652873 | Pmid | 28814991 | Pmid | 28661387 | Pmid | 17467080 | Pmid | 34233538 | ||||||||||||
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | derived |
Citation | Boise, L., Congleton, L., & Shannon, K. (2005). Empowering family caregivers: The powerful tools for caregiving program. Educational Gerontology, 31, 573-586. https://doi.org/10.1080/03601270590962523 | Citation | Burton LC, Zdaniuk B, Schulz R, Jackson S, Hirsch C. Transitions in spousal caregiving. Gerontologist. 2003 Apr;43(2):230-41. doi: 10.1093/geront/43.2.230. | Citation | Bakas T, Champion V, Perkins SM, Farran CJ, Williams LS. Psychometric testing of the revised 15-item Bakas Caregiving Outcomes Scale. Nurs Res. 2006 Sep-Oct;55(5):346-55. doi: 10.1097/00006199-200609000-00007. | Citation | American Occupational Therapy Association. (2013). Telehealth [Position paper]. American Journal of Occupational Therapy, 67(6, Suppl.), S69-S90. https://doi.org/10.5014/ajot.2013.67S69 | Citation | Cohn ER, Brannon JA, Cason J. Resolving barriers to licensure portability for telerehabilitation professionals. Int J Telerehabil. 2011 Dec 20;3(2):31-4. doi: 10.5195/ijt.2011.6078. eCollection 2011 Fall. No abstract available. | Citation | Eaton, W. W., Smith, C., Ybarra, M., Muntaner, C., & Tien, A. (2004). Center of Epidemiologic Studies Depression Scale: Review and revision (CESD and CESD-R). In M.E. Maruish (Ed.), The use of psychological testing for treatment planning and outcomes assessment (3rd ed.) (pp. 363-377). Mahwah, NJ: Lawrence Erlbaum. | Citation | National Alliance for Caregiving, & American Associate of Retired Persons Public Policy Institute. (2015, June). Executive summary: Caregiving in the U.S. Retrieved from http://www.caregiving.org/wp-content/uploads/2015/05/2015_CaregivingintheUS_Executive-Summary-June-4_WEB.pdf | Citation | Reinhard, S. C., Feinberg, L. F., Choula, R. & Houser, A. (2015). Valuing the invaluable: 2015 update, undeniable progress, but big gaps remain (AARP Public Policy Institute Report). Retrieved from http://www.aarp.org/content/dam/aarp/ppi/2015/valuing-the-invaluable-2015-update-new.pdf | Citation | Savundranayagam MY, Montgomery RJ, Kosloski K, Little TD. Impact of a psychoeducational program on three types of caregiver burden among spouses. Int J Geriatr Psychiatry. 2011 Apr;26(4):388-96. doi: 10.1002/gps.2538. | Citation | Serwe KM, Hersch GI, Pancheri K. Feasibility of Using Telehealth to Deliver the "Powerful Tools for Caregivers" Program. Int J Telerehabil. 2017 Jun 29;9(1):15-22. doi: 10.5195/ijt.2017.6214. eCollection 2017 Spring. | Citation | Serwe KM, Hersch GI, Pickens ND, Pancheri K. Caregiver Perceptions of a Telehealth Wellness Program. Am J Occup Ther. 2017 Jul/Aug;71(4):7104350010p1-7104350010p5. doi: 10.5014/ajot.2017.025619. | Citation | VSee. (2018). HIPAA and VSee video conferencing. Retrieved from https://vsee.com/hipaa/ | Citation | Won CW, Fitts SS, Favaro S, Olsen P, Phelan EA. Community-based "powerful tools" intervention enhances health of caregivers. Arch Gerontol Geriatr. 2008 Jan-Feb;46(1):89-100. doi: 10.1016/j.archger.2007.02.009. Epub 2007 Apr 27. | Citation | Serwe KM, Walmsley AL. The effectiveness of telehealth for a caregiver wellness program. J Telemed Telecare. 2021 Jul 7:1357633X21994009. doi: 10.1177/1357633X21994009. Online ahead of print. |
]]>
https://zephyrnet.com/NCT03800225
2019-01-03
https://zephyrnet.com/?p=NCT03800225
NCT03800225https://www.clinicaltrials.gov/study/NCT03800225?tab=tableNANANAThe purpose of this study is to determine whether anterior cruciate ligament injury in patients wishing to return to sports activities may be treated with repair supplemented with internal brace compared with a standard operation using a patella tendon autograft.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-09 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2019-10-02 |
Start Month Year | January 3, 2019 |
Primary Completion Month Year | September 4, 2019 |
Verification Month Year | September 2019 |
Verification Date | 2019-09-30 |
Last Update Posted Date | 2019-10-02 |
Facilities
Sequence: | 201290103 |
Name | Division of Sports Trauma, Palle Juul-Jensens Boulevard 99 |
City | Aarhus N |
Zip | 8200 |
Country | Denmark |
Conditions
Sequence: | 52507868 | Sequence: | 52507869 |
Name | Ligament; Laxity, Knee | Name | Anterior Cruciate Ligament Injury |
Downcase Name | ligament; laxity, knee | Downcase Name | anterior cruciate ligament injury |
Id Information
Sequence: | 40399426 |
Id Source | org_study_id |
Id Value | Danish EC – 1-10-72-223-18. |
Countries
Sequence: | 42835753 |
Name | Denmark |
Removed | False |
Design Groups
Sequence: | 55964353 | Sequence: | 55964354 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Repair | Title | Patella tendon graft |
Description | Anterior cruciate ligament repair with internal brace after anterior ligament rupture. | Description | The Patella tendon graft is harvested and used as a knew anterior cruciate ligament after rupture. |
Interventions
Sequence: | 52815813 |
Intervention Type | Procedure |
Name | Repair |
Description | Anterior ligament repair with internal brace. |
Design Outcomes
Sequence: | 178632266 | Sequence: | 178632267 | Sequence: | 178632268 | Sequence: | 178632269 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Knee Laxity | Measure | Patient reported outcome scores | Measure | Patient reported outcome scores | Measure | Pain measurement |
Time Frame | 12 Months | Time Frame | 12 Months | Time Frame | 12 Months | Time Frame | 12 Months |
Description | KT-1000 arthrometer | Description | Koos (Knee injury and Osteoarthritis Outcome Score) | Description | IKDC (International Knee Documentation Committee) | Description | NRS-pain score (Numeric rating scale) (10 worst pain – 0 No pain) |
Browse Conditions
Sequence: | 194770866 | Sequence: | 194770867 | Sequence: | 194770868 | Sequence: | 194770869 | Sequence: | 194770870 |
Mesh Term | Rupture | Mesh Term | Anterior Cruciate Ligament Injuries | Mesh Term | Wounds and Injuries | Mesh Term | Knee Injuries | Mesh Term | Leg Injuries |
Downcase Mesh Term | rupture | Downcase Mesh Term | anterior cruciate ligament injuries | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | knee injuries | Downcase Mesh Term | leg injuries |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48630819 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Aarhus University Hospital |
Design Group Interventions
Sequence: | 68607731 | Sequence: | 68607732 |
Design Group Id | 55964354 | Design Group Id | 55964353 |
Intervention Id | 52815813 | Intervention Id | 52815813 |
Eligibilities
Sequence: | 30957215 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Anterior cruciate ligament rupture Exclusion Criteria: Current malignant disease |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253940370 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 8 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30702791 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Health Services Research |
Time Perspective | |
Masking | Single |
Subject Masked | True |
Responsible Parties
Sequence: | 29069553 |
Responsible Party Type | Principal Investigator |
Name | Martin Lind |
Title | Professor |
Affiliation | Aarhus University Hospital |
]]>
https://zephyrnet.com/NCT03800212
2017-07-07
https://zephyrnet.com/?p=NCT03800212
NCT03800212https://www.clinicaltrials.gov/study/NCT03800212?tab=tableJulien TAIEB, Prjtaieb75@gmail.com01 56 09 35 56A Vater’s ampulloma is a rare digestive tumour which accounts for under 1% of all digestive tumours. The only curative treatment is complete excision (surgical or endoscopic) of the lesions which is possible in 80% of cases , with or without adjuvant treatment. The reference radical treatment is cephalic duodenopancreatectomy (CDP). The indication for adjuvant treatment is still debated: in view of the aggressive nature of the disease and the high recurrence rate, it would appear appropriate to offer adjuvant treatment, although several studies have failed to find any benefit on survival with post-operative radio-chemotherapy, the most widely studied treatment at present, compared to excision alone. At present there are no phase II studies specifically examining medical treatment of degenerated, inoperable Vater’s ampullomas. Some groups propose chemotherapies with 5-FU or gemcitabine, analogous to the treatments used for intestinal, pancreatic or biliary tumours, although neither one has been shown to date to be superior to the other, nor have decision-making criteria been clearly established.In conclusion, a national cohort study is proposed to undertake a prospective analysis of the outcome of all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy). The treatment methods will be left to the free choice of the investigator and all patients may be included, regardless of stage of their disease. In this study, freezing of tumour fragments is encouraged, as this cohort will be supplemented by a later biological study. In order to recruit sufficient patient numbers, the study will be based on participation of the cooperative groups involved in the management of digestive cancers.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-31 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2022-03-24 |
Start Month Year | July 7, 2017 |
Primary Completion Month Year | December 15, 2022 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-03-24 |
Detailed Descriptions
Sequence: | 20826200 |
Description | A Vater's ampulloma is a rare digestive tumour which accounts for under 1% of all digestive tumours. In terms of incidence, it is the 3rd most common biliary tract tumour after gallbladder cancer and common bile duct cancer. The incidence of ampullary adenocarcinoma is not well known although it is estimated to be around 0.49 per 100,000 people. The known risk factors are familial adenomatous polyposis (FAP) and Gardner's syndrome, HNPCC (Hereditary Non-Polyposis Colorectal Cancer) syndrome, Peutz-Jeghers syndrome, Crohn's disease and coeliac disease.
Except in its highly localised forms, ampulla of Vater carcinoma carries a poor prognosis. It is a highly lymphophilic disease which commonly metastasises, particularly to the lymph nodes and liver. The prognosis is however considerably better than that of pancreatic adenocarcinoma. In one study which compared 71 ampullomas with 144 adenocarcinomas of pancreatic head, the 5-year survival was 60% for the ampullary carcinomas compared to 20% for pancreatic adenocarcinomas. More generally, the 5-year survival rate in the literature is between 40-60% and, depending on the study, 10-year survival is approximately 38% . The only curative treatment is complete excision (surgical or endoscopic) of the lesions which is possible in 80% of cases , with or without adjuvant treatment. The reference radical treatment is cephalic duodenopancreatectomy (CDP). The 5-year survival rate in cases of adenocarcinoma excised by CPD is in the region of 50%, rising to 60-70% if no lymph node invasion is present, compared to 30% when lymph nodes are invaded and median survival is approximately 4.5 years . The indication for adjuvant treatment is still debated: in view of the aggressive nature of the disease and the high recurrence rate, it would appear appropriate to offer adjuvant treatment, although several studies have failed to find any benefit on survival with post-operative radio-chemotherapy, the most widely studied treatment at present, compared to excision alone . There is only one single randomised study comparing these two forms of management, which shows no benefit in terms of 2 and 5-year survival, although only a small number of patients had an ampullary tumour in this study . The conclusions of several retrospective studies are more subtle, showing results in favour of adjuvant treatment in patients with lymph node disease or a large tumour (T3/T4) . Some groups have tested the merits of peroperative irradiation. It would appear that this technique does not improve survival, although data on this subject are extremely patchy . Administration of exclusive adjuvant chemotherapy has been examined in a single randomised study. In this phase III study (ESPAC 3), median overall survival of patients who received adjuvant chemotherapy with FUFOL Mayo for 6 months (n=101) or gemcitabine (n=98) was not significantly improved compared to survival in patients undergoing surgery and not receiving complementary treatment (57.1 versus 43 months, HR= 0.85, p=0.32). A subgroup analysis suggested that the benefit of chemotherapy could be greater in the subgroup of patients with RO resection (p= 0.057, 91% of cases). Mean survival in patients suffering inoperable tumours is between 9 and 20.4 months depending on the study . It should be noted however that most of these studies have included tumours other than ampullomas (particularly small bowel adenocarcinomas), making it more difficult to interpret these results, and also that many are old results dating from before the era of modern chemotherapies. At present there are no phase II studies specifically examining medical treatment of degenerated, inoperable Vater's ampullomas. Some groups propose chemotherapies with 5-FU or gemcitabine, analogous to the treatments used for intestinal, pancreatic or biliary tumours, although neither one has been shown to date to be superior to the other, nor have decision-making criteria been clearly established. One phase II study published in 2009 proposed CAPOX as the reference treatment in light of the promising results obtained. Patients suffering from ampullary cancer in this study however were combined with patients who were suffering from small bowel adenocarcinoma. In conclusion, a national cohort study is proposed to undertake a prospective analysis of the outcome of all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy). The treatment methods will be left to the free choice of the investigator and all patients may be included, regardless of stage of their disease. In this study, freezing of tumour fragments is encouraged, as this cohort will be supplemented by a later biological study. In order to recruit sufficient patient numbers, the study will be based on participation of the cooperative groups involved in the management of digestive cancers. |
Facilities
Sequence: | 201073544 | Sequence: | 201073545 | Sequence: | 201073546 | Sequence: | 201073547 | Sequence: | 201073548 | Sequence: | 201073549 | Sequence: | 201073550 | Sequence: | 201073551 | Sequence: | 201073552 | Sequence: | 201073553 | Sequence: | 201073554 | Sequence: | 201073555 | Sequence: | 201073556 | Sequence: | 201073557 | Sequence: | 201073558 | Sequence: | 201073559 | Sequence: | 201073560 | Sequence: | 201073561 | Sequence: | 201073562 | Sequence: | 201073563 | Sequence: | 201073564 | Sequence: | 201073565 | Sequence: | 201073566 | Sequence: | 201073567 | Sequence: | 201073568 | Sequence: | 201073569 | Sequence: | 201073570 | Sequence: | 201073571 | Sequence: | 201073572 | Sequence: | 201073573 | Sequence: | 201073574 | Sequence: | 201073575 | Sequence: | 201073576 | Sequence: | 201073577 | Sequence: | 201073578 | Sequence: | 201073579 |
Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting |
Name | Ch D'Abbeville | Name | Chu Hotel Dieu | Name | Ch Annecy Genevois | Name | Ch Cote Basque | Name | Chu Saint Andre | Name | Polyclinique Bordeaux Nord Aquitaine | Name | Clinique Champeau | Name | Chu Estaing | Name | Hopitaux Civils de Colmar | Name | Ch – Sud Francilien | Name | Chu Francois Mitterrand | Name | Chd Vendee | Name | Le Kremlin Bicetre | Name | Chu Claude Huriez | Name | Hôpital Dupuytren | Name | Ch Nord Essonne | Name | Chu La Croix Rousse | Name | Hcl Edouard Herriot | Name | Hcl Pierre Benite | Name | Hopital de La Timone | Name | Hopital Saint Joseph | Name | Ch de Meaux | Name | CH MACON | Name | Chu Caremeau | Name | Chr Orleans | Name | Chu Avicenne | Name | Chu Cochin | Name | Chu La Pitie Salpetriere | Name | Hopital Europeen Georges Pompidou | Name | Ch Saint Jean | Name | CHU Hôpital de la Milétrie | Name | Ch Cornouaille | Name | CH | Name | Ch Saint Malo | Name | CLINIQUE | Name | Ch Bretagne Atlantique |
City | Abbeville | City | Angers | City | Annecy | City | Bayonne | City | Bordeaux | City | Bordeaux | City | Béziers | City | Clermont-Ferrand | City | Colmar | City | Corbeil-Essonnes | City | Dijon | City | La Roche-sur-Yon | City | Le Kremlin-Bicêtre | City | Lille | City | Limoges | City | Longjumeau | City | Lyon | City | Lyon | City | Lyon | City | Marseille | City | Marseille | City | Meaux | City | Mâcon | City | Nîmes | City | Orléans | City | Paris | City | Paris | City | Paris | City | Paris | City | Perpignan | City | Poitiers | City | Quimper | City | Reims | City | Saint-Malo | City | Strasbourg | City | Vannes |
Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France |
Facility Contacts
Sequence: | 28254257 | Sequence: | 28254258 | Sequence: | 28254259 | Sequence: | 28254260 | Sequence: | 28254261 | Sequence: | 28254262 | Sequence: | 28254263 | Sequence: | 28254264 | Sequence: | 28254265 | Sequence: | 28254266 | Sequence: | 28254267 | Sequence: | 28254268 | Sequence: | 28254269 | Sequence: | 28254270 | Sequence: | 28254271 | Sequence: | 28254272 | Sequence: | 28254273 | Sequence: | 28254274 | Sequence: | 28254275 | Sequence: | 28254276 | Sequence: | 28254277 | Sequence: | 28254278 | Sequence: | 28254279 | Sequence: | 28254280 | Sequence: | 28254281 | Sequence: | 28254282 | Sequence: | 28254283 | Sequence: | 28254284 | Sequence: | 28254285 | Sequence: | 28254286 | Sequence: | 28254287 | Sequence: | 28254288 | Sequence: | 28254289 | Sequence: | 28254290 | Sequence: | 28254291 | Sequence: | 28254292 |
Facility Id | 201073544 | Facility Id | 201073545 | Facility Id | 201073546 | Facility Id | 201073547 | Facility Id | 201073548 | Facility Id | 201073549 | Facility Id | 201073550 | Facility Id | 201073551 | Facility Id | 201073552 | Facility Id | 201073553 | Facility Id | 201073554 | Facility Id | 201073555 | Facility Id | 201073556 | Facility Id | 201073557 | Facility Id | 201073558 | Facility Id | 201073559 | Facility Id | 201073560 | Facility Id | 201073561 | Facility Id | 201073562 | Facility Id | 201073563 | Facility Id | 201073564 | Facility Id | 201073565 | Facility Id | 201073566 | Facility Id | 201073567 | Facility Id | 201073568 | Facility Id | 201073569 | Facility Id | 201073570 | Facility Id | 201073571 | Facility Id | 201073572 | Facility Id | 201073573 | Facility Id | 201073574 | Facility Id | 201073575 | Facility Id | 201073576 | Facility Id | 201073577 | Facility Id | 201073578 | Facility Id | 201073579 |
Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary |
Name | JOEL BUTEL | Name | NATHALIE BAIZE | Name | ROMAN COMBES | Name | FRANCK AUDEMAR | Name | CHABRUN | Name | BALHADERE | Name | MICHAEL HUMMELSBERGER | Name | DENIS PEZET | Name | LAURIANNE PLASTARAS | Name | SAMY LOUAFI | Name | SYLVAIN MANFREDI | Name | MORGAN AMIL | Name | Stéphane BENOIST | Name | christophe MARIETTE | Name | STEPHANE BOUVIER | Name | YOUNES ZEKRI | Name | MARIELLE GUILLET | Name | MUSTAPHA ADHAM | Name | OLIVIER GLEHEN | Name | MARINE BARRAUD BLANC | Name | HERVE PERRIER | Name | CHRISTOPHE LOCHER | Name | MARIE MARTIN BELLECOSTE | Name | CLAIRE PHILIPPE | Name | BRAHIM OUAHRANI | Name | THOMAS APARICIO | Name | ROMAIN CORIAT | Name | JEAN BAPTISTE BACHET | Name | ORIANNE COLUSSI | Name | FAIZA KHEMISSA AKOUZ | Name | David TOUGERON | Name | KARINE BIDEAU | Name | Olivier BOUCHE | Name | ROMAIN DESGRIPPES | Name | YOUSSEF TAZI | Name | DENIS GRASSET |
david.tougeron@chu-poitiers.fr | obouche@chu-reims.fr | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Facility Investigators
Sequence: | 18423508 | Sequence: | 18423509 | Sequence: | 18423510 | Sequence: | 18423511 | Sequence: | 18423512 | Sequence: | 18423513 | Sequence: | 18423514 | Sequence: | 18423515 | Sequence: | 18423516 | Sequence: | 18423517 | Sequence: | 18423518 | Sequence: | 18423519 |
Facility Id | 201073552 | Facility Id | 201073552 | Facility Id | 201073554 | Facility Id | 201073554 | Facility Id | 201073555 | Facility Id | 201073555 | Facility Id | 201073557 | Facility Id | 201073561 | Facility Id | 201073570 | Facility Id | 201073572 | Facility Id | 201073574 | Facility Id | 201073576 |
Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Principal Investigator |
Name | CAMARA | Name | BREYSACHER | Name | ANTOINE DROUILLARD | Name | JEAN LOUIS JOUVE | Name | RAME | Name | LALY | Name | GUILLAUME PIESSEN | Name | GRAILLOT | Name | CROMBE | Name | PERKINS | Name | David TOUGERON | Name | Olivier BOUCHE |
Conditions
Sequence: | 52439979 |
Name | Ampullary Adenocarcinoma |
Downcase Name | ampullary adenocarcinoma |
Id Information
Sequence: | 40350419 |
Id Source | org_study_id |
Id Value | AMPULLOMA COHORT |
Countries
Sequence: | 42783793 |
Name | France |
Removed | False |
Interventions
Sequence: | 52749667 |
Intervention Type | Drug |
Name | treatment for ampullary adenocarcinoma |
Description | all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy). |
Design Outcomes
Sequence: | 178389880 | Sequence: | 178389881 | Sequence: | 178389882 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Overall survival | Measure | RECURRENCE FREE SURVIVAL | Measure | PROGRESSION FREE SURVIVAL |
Time Frame | 5 years | Time Frame | 3 years | Time Frame | 5 years |
Description | The time interval between the date of diagnosis of the disease and date of death (all causes). Patients who are alive will be censured at the date of last news. | Description | The time interval between the date of diagnosis of the disease and the date of the recurrence or death (all causes). Patients who are alive without recurrence will be censured at the date of last news. | Description | Time interval between the date of starting treatment and the date of first progression (local or remote, clinical or radiological) or death (all causes). Patients who are alive without progression will be censured at the date of last news. Radiological progression will be defined according to RECIST version 1.1 criteria. |
Browse Conditions
Sequence: | 194511317 | Sequence: | 194511318 | Sequence: | 194511319 | Sequence: | 194511320 | Sequence: | 194511321 |
Mesh Term | Adenocarcinoma | Mesh Term | Carcinoma | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms |
Downcase Mesh Term | adenocarcinoma | Downcase Mesh Term | carcinoma | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48568192 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Federation Francophone de Cancerologie Digestive |
Overall Officials
Sequence: | 29425335 |
Role | Principal Investigator |
Name | Julien TAIEB |
Affiliation | Federation Francophone de Cancerologie Digestive |
Central Contacts
Sequence: | 12078922 |
Contact Type | primary |
Name | Julien TAIEB, Pr |
Phone | 01 56 09 35 56 |
jtaieb75@gmail.com | |
Phone Extension | +33 |
Role | Contact |
Eligibilities
Sequence: | 30919362 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy). |
Criteria | Inclusion Criteria:
Patients aged 18 years and older. Exclusion Criteria: Patients who cannot be followed up regularly for psychological, social, family or geographical reasons. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254187710 |
Number Of Facilities | 36 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30665038 |
Observational Model | Cohort |
Time Perspective | Prospective |
Intervention Other Names
Sequence: | 26807036 |
Intervention Id | 52749667 |
Name | no other intervention name to add |
Links
Sequence: | 4408587 |
Url | http://www.ffcd.fr/index.php/essais-therapeutiques/pancreas/283-ampullome |
Description | FFCD page |
Responsible Parties
Sequence: | 29031730 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800199
2019-04-13
https://zephyrnet.com/?p=NCT03800199
NCT03800199https://www.clinicaltrials.gov/study/NCT03800199?tab=tableEmine H. Tüzün, Prof. Dr.handan.tuzun@gmail.com+903926301370The aim of the investigator’s study is to determine the validity and reliability of the Turkish version of the Combined Index of Severity (ICAF) in Turkish patients with Fibromyalgia Syndrome (FMS).
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2022-08-16 |
Start Month Year | April 13, 2019 |
Primary Completion Month Year | June 2024 |
Verification Month Year | August 2022 |
Verification Date | 2022-08-31 |
Last Update Posted Date | 2022-08-16 |
Detailed Descriptions
Sequence: | 20827239 |
Description | The original form of the Combined Index of Severity of Fibromyalgia (ICAF) will be translated into Turkish by two Turkish mother tongue translators who also speak English in advanced level. Then these translations will be combined into one translation and translated back to English. These translations will send to 7 different health professions who had experience working with FMS patients. The pre-final version will be composed and tested on a group of patients with FMS. If necessary, readjustments will be made, and the final version will be investigated in FMS patients. Acceptability was assessed in terms of refusal rate, rates of missing responses, and administration time. Reliability was assessed using Cronbach's alpha and test-retest assessments. Re-test assessments will be conducted after one week from first assessment. Content validity was assessed by examining the floor and ceiling effects and skew of the distributions. Convergent and divergent validity was assessed by examining the Pearson's correlation coefficients. In addition, the confirmatory factor analysis will be done to evaluate the validity of ICAF. Responsiveness was determined by examining effect size (ES), standardized response means (SRM) and P values generated using Wilcoxon's test. |
Facilities
Sequence: | 201086948 |
Status | Recruiting |
Name | Eastern Mediterranean University |
City | Famagusta |
Country | Cyprus |
Facility Contacts
Sequence: | 28255017 |
Facility Id | 201086948 |
Contact Type | primary |
Name | Emine H Tuzun, Prof |
Phone | +903926301370 |
Phone Extension | 1370 |
Conditions
Sequence: | 52442549 |
Name | Fibromyalgia |
Downcase Name | fibromyalgia |
Id Information
Sequence: | 40352622 |
Id Source | org_study_id |
Id Value | ETK00-2018-0281 |
Countries
Sequence: | 42786433 |
Name | Cyprus |
Removed | False |
Design Groups
Sequence: | 55894551 |
Group Type | Experimental |
Title | Perceptive Rehabilitation (PR-group) |
Description | Perceptive rehabilitation group will receive a treatment that, as described by on Paolucci et al. (2015). This treatment will include small latex cones with different resistance. In each session there will be over 100 cones will be placed on a rigid wood with using elastic strips. The patient will be asked to lie down supine on the material. Patients weigh will create pressure and reaction force to his/her body. Treatments will be 2 times a week till 8 weeks. There will be in total 16 sessions. |
Interventions
Sequence: | 52752567 |
Intervention Type | Other |
Name | Perceptive rehabilitation |
Description | The first session will be an education session. Spinous processes will be reference line of the body and patient will lie down on cones. The therapist will ask the patient first to breathe normally and feel the pressure. This will lead the patient to relax and understand cones. Then, the patient will start with the diagrammatic breathing. After breath exercises patient will perform active exercises (include stretching, warming up and cooling down) on supervision. Exercises will include the whole body. Additional to this during the session therapist will ask about the pressure of cones and she will correct the patients' posture. At the end of all the session, the therapist will take a photo of the patients back with the aim of to document the pressure and hyperaemic areas. |
Keywords
Sequence: | 80236849 | Sequence: | 80236850 | Sequence: | 80236851 |
Name | health statues | Name | observational study | Name | questionnaire |
Downcase Name | health statues | Downcase Name | observational study | Downcase Name | questionnaire |
Design Outcomes
Sequence: | 178400131 | Sequence: | 178400132 | Sequence: | 178400133 | Sequence: | 178400134 | Sequence: | 178400135 | Sequence: | 178400136 | Sequence: | 178400137 | Sequence: | 178400138 |
Outcome Type | primary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Combined Index of Severity of Fibromyalgia | Measure | Revised-Fibromyalgia Impact Questionnaire (FIQR) | Measure | Socio-demographic and clinical characteristics | Measure | Body Mass Index (BMI) | Measure | Stanford Health Assessment Questionnaire (HAQ) | Measure | Fatigue Severity Scale (FSS) | Measure | Short-Form 36 (SF-36) | Measure | Pittsburgh Sleep Quality Index (PSQI) |
Time Frame | Changes from baseline severity at 12 weeks. | Time Frame | Changes from baseline at 12 weeks. | Time Frame | Changes from baseline at 12 weeks. | Time Frame | Changes from baseline at 12 weeks. | Time Frame | Changes from baseline at 12 weeks. | Time Frame | Changes from baseline at 12 weeks. | Time Frame | Changes from baseline at 12 weeks. | Time Frame | Changes from baseline at 12 weeks. |
Description | Composed of 59 items, measures the combined severity index of fibromyalgia divided into 4 factors: physical, emotional, social and active and passive coping.The ICAF score ranges from 0 to 84, with higher values indicating higher severity. | Description | The Turkish version of FIQR will be used in this study. This questionnaire has 21 individual questions. All these questions should be answered according to the past 7 days. FIQR has divided into three sections; 'function, overall impact and symptoms'. The total FIQR score will be calculated with the sum of the three domain scores. The total score will be out of 100. The higher score means a severe impact. | Description | Date of birth, sex, marital status, profession, education status and time of the diagnosis of FMS will be noted. | Description | Weight and height will be combined to report BMI in kg/m^2. | Description | This questionnaire will be use to asses general health of the participants.There are 20 questions in 8 sub categories of functioning (dressing, rising, eating, walking, hygiene, reach, grip, and usual activities), 1 question is about pain and 1 question is about general health. Disability index questions has four possible answers (without any difficulty: 0, with some difficulty: 1, with much difficulty: 2, unable to do: 3). Highest score represent the worsening. | Description | Turkish version of Fatigue Severity Scale (FSS) will be used in this study. This scale has 9 items. Each item should be scored (strongly disagrees) 0 to 7 (strongly agrees). The minimum score=9 and maximum score possible=63. Higher score=greater fatigue severity. The average score for all 9 items constitutes the FSS score. | Description | The quality of life questionnaire Short Form 36 (SF-36) is multidimensional, consisting of 36 items, divided into eight scales, each scale assesses a health concept, they are: limitations in physical activities because of health problems, limitations in social activities due to physical or emotional problems, limitations in daily activities due to health problems, body pain, mental health, limitations in daily activities due to emotional problems, vitality, perception of general health. All categories have their own score out of 100. Higher scores mean a better quality of life. | Description | Turkish version of Pittsburgh Sleep Quality Index (PSQI) will be used in this study. This is a self-reported index that has 19 items with Likert and open-ended response formats. This index should be answered according to the past month. Minimum Score "0" means "good sleep" and Maximum Score "30" means "disrupted sleep". |
Browse Conditions
Sequence: | 194522234 | Sequence: | 194522235 | Sequence: | 194522236 | Sequence: | 194522237 | Sequence: | 194522238 | Sequence: | 194522239 | Sequence: | 194522240 |
Mesh Term | Fibromyalgia | Mesh Term | Myofascial Pain Syndromes | Mesh Term | Muscular Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Rheumatic Diseases | Mesh Term | Neuromuscular Diseases | Mesh Term | Nervous System Diseases |
Downcase Mesh Term | fibromyalgia | Downcase Mesh Term | myofascial pain syndromes | Downcase Mesh Term | muscular diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | rheumatic diseases | Downcase Mesh Term | neuromuscular diseases | Downcase Mesh Term | nervous system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48570825 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | European University of Lefke |
Overall Officials
Sequence: | 29426932 | Sequence: | 29426933 | Sequence: | 29426934 | Sequence: | 29426935 |
Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator |
Name | Beraat Alptug, MSc | Name | Emine H. Tüzün, Prof. Dr. | Name | Levent Eker, M. D. | Name | Gülbin Ergin, PhD |
Affiliation | European University of Lefke | Affiliation | Eastern Mediterranean University | Affiliation | Eastern Mediterranean University | Affiliation | European University of Lefke |
Central Contacts
Sequence: | 12079362 | Sequence: | 12079363 |
Contact Type | primary | Contact Type | backup |
Name | Beraat Alptug, MSc | Name | Emine H. Tüzün, Prof. Dr. |
Phone | 05338498379 | Phone | +903926301370 |
balptug@eul.edu.tr | handan.tuzun@gmail.com | ||
Phone Extension | 1370 | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68521051 |
Design Group Id | 55894551 |
Intervention Id | 52752567 |
Eligibilities
Sequence: | 30920962 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Having a Fibromyalgia diagnosis according to Wolfe et al. (2016) criteria. Exclusion Criteria: Having physical and functional problems with FMS |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254190292 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 7 |
Designs
Sequence: | 30666634 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Questionnaire: Combined Index of Severity of Fibromyalgia (ICAF)
Intervention: Perceptive rehabilitation Procedure: Assessment of reliability, acceptability, validity and responsiveness. |
Responsible Parties
Sequence: | 29033331 |
Responsible Party Type | Principal Investigator |
Name | Beraat Alptug |
Title | Master Physiotherapist/ Principal Investigator |
Affiliation | European University of Lefke |
Study References
Sequence: | 52350530 |
Pmid | 26884794 |
Reference Type | background |
Citation | Paolucci T, Baldari C, Di Franco M, Didona D, Reis V, Vetrano M, Iosa M, Trifoglio D, Zangrando F, Spadini E, Saraceni VM, Guidetti L. A New Rehabilitation Tool in Fibromyalgia: The Effects of Perceptive Rehabilitation on Pain and Function in a Clinical Randomized Controlled Trial. Evid Based Complement Alternat Med. 2016;2016:7574589. doi: 10.1155/2016/7574589. Epub 2016 Jan 13. |
]]>
https://zephyrnet.com/NCT03800186
2018-06-01
https://zephyrnet.com/?p=NCT03800186
NCT03800186https://www.clinicaltrials.gov/study/NCT03800186?tab=tableNANANAThis study aimed to determine the influence of ageing on the incidence and site of femoral fractures in trauma patients, by taking the sex, body weight, and trauma mechanisms into account.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2019-01-11 |
Start Month Year | June 1, 2018 |
Primary Completion Month Year | December 30, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-11 |
Detailed Descriptions
Sequence: | 20548775 |
Description | This retrospective study reviewed data from adult trauma patients aged ≥ 20 years who were admitted into a Level I trauma center, between January 1, 2009 and December 31, 2016. According to the femoral fracture locations, 3859 adult patients with 4011 fracture sites were grouped into five subgroups: proximal type A (n = 1,359), proximal type B (n= 1,487), proximal type C (n = 59), femoral shaft (n = 640), and distal femur (n = 466) groups. A multivariate logistic regression analysis was applied to identify independent effects of the univariate predictive variables on the occurrence of fracture at a specific site. The propensity score accounts for the risk of a fracture at a specific femoral site was calculated and presented visually with age in a two-dimensional plot. |
Facilities
Sequence: | 198402803 |
Name | Kaohsiung Chang Gung Memorial Hospital |
City | Kaohsiung |
Zip | 83301 |
Country | Taiwan |
Conditions
Sequence: | 51727234 |
Name | FEMORAL FRACTURES |
Downcase Name | femoral fractures |
Id Information
Sequence: | 39805695 |
Id Source | org_study_id |
Id Value | CDRPG8H0011 |
Countries
Sequence: | 42204448 |
Name | Taiwan |
Removed | False |
Design Groups
Sequence: | 55147111 |
Title | Trauma femoral fracture |
Description | Patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury. Patients were grouping into five subgroups as patients with fracture of proximal type A, proximal type B, proximal type C, femoral shaft, and distal femur. |
Interventions
Sequence: | 52048842 | Sequence: | 52048843 | Sequence: | 52048844 | Sequence: | 52048845 | Sequence: | 52048846 |
Intervention Type | Other | Intervention Type | Other | Intervention Type | Other | Intervention Type | Other | Intervention Type | Other |
Name | Proximal type A | Name | Proximal type B | Name | Proximal type C | Name | femoral shaft | Name | distal femur |
Description | Patients with fracture of proximal type A | Description | Patients with fracture of proximal type B | Description | Patients with fracture of proximal type C | Description | Patients with fracture of femoral shaft | Description | Patients with fracture of distal femur |
Design Outcomes
Sequence: | 175933168 |
Outcome Type | primary |
Measure | Locations of femoral fracture |
Time Frame | up tp 2 months |
Description | To provide a summary of covariate information regarding the occurrence of femur Fractures at a specific site. |
Browse Conditions
Sequence: | 191700795 | Sequence: | 191700796 | Sequence: | 191700797 | Sequence: | 191700798 |
Mesh Term | Fractures, Bone | Mesh Term | Femoral Fractures | Mesh Term | Wounds and Injuries | Mesh Term | Leg Injuries |
Downcase Mesh Term | fractures, bone | Downcase Mesh Term | femoral fractures | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | leg injuries |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47907151 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Chang Gung Memorial Hospital |
Overall Officials
Sequence: | 29027132 |
Role | Study Chair |
Name | TSANG-TANG Hsieh, MD |
Affiliation | Chang Gung Memorial Hospital |
Design Group Interventions
Sequence: | 67607864 | Sequence: | 67607865 | Sequence: | 67607866 | Sequence: | 67607867 | Sequence: | 67607868 |
Design Group Id | 55147111 | Design Group Id | 55147111 | Design Group Id | 55147111 | Design Group Id | 55147111 | Design Group Id | 55147111 |
Intervention Id | 52048842 | Intervention Id | 52048843 | Intervention Id | 52048844 | Intervention Id | 52048845 | Intervention Id | 52048846 |
Eligibilities
Sequence: | 30506615 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 20 Years |
Maximum Age | 100 Years |
Healthy Volunteers | No |
Population | This retrospective study reviewed data from 27,462 trauma patients registered between January 1, 2009 and December 31, 2016. The inclusion criteria required patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury. Patients with incomplete data were excluded. |
Criteria | Inclusion Criteria:
Patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury Exclusion Criteria: Patients with incomplete data were excluded |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254052885 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 7 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 20 |
Maximum Age Num | 100 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30255695 |
Observational Model | Case-Control |
Time Perspective | Retrospective |
Responsible Parties
Sequence: | 28636185 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800173
2018-12-10
https://zephyrnet.com/?p=NCT03800173
NCT03800173https://www.clinicaltrials.gov/study/NCT03800173?tab=tableNANANAThis is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics of galidesivir following administration of single doses by IV infusion
<![CDATA[
Studies
Study First Submitted Date | 2018-12-12 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2021-07-23 |
Start Month Year | December 10, 2018 |
Primary Completion Month Year | April 30, 2019 |
Verification Month Year | July 2021 |
Verification Date | 2021-07-31 |
Last Update Posted Date | 2021-07-23 |
Results First Posted Date | 2021-07-23 |
Detailed Descriptions
Sequence: | 20730177 |
Description | This single ascending dose study will evaluate the safety, tolerability, and PK of single doses of galidesivir vs. placebo administered as IV infusions in healthy subjects enrolled in up to four dose cohorts of 8 subjects each. A single dose of study drug will be administered per cohort: 6 subjects will receive galidesivir IV, and 2 subjects will receive matching placebo. |
Facilities
Sequence: | 200188252 |
Name | PRA Health Sciences |
City | Lenexa |
State | Kansas |
Zip | 66219 |
Country | United States |
Browse Interventions
Sequence: | 96089218 | Sequence: | 96089219 | Sequence: | 96089220 |
Mesh Term | Galidesivir | Mesh Term | Antiviral Agents | Mesh Term | Anti-Infective Agents |
Downcase Mesh Term | galidesivir | Downcase Mesh Term | antiviral agents | Downcase Mesh Term | anti-infective agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52193274 |
Name | Marburg Virus Disease |
Downcase Name | marburg virus disease |
Id Information
Sequence: | 40175231 | Sequence: | 40175232 | Sequence: | 40175233 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | BCX4430-106 | Id Value | DMID18-0013 | Id Value | 272201300017C-18-0-1 |
Id Type | Other Identifier | Id Type | U.S. NIH Grant/Contract | ||
Id Type Description | NIAID | ||||
Id Link | https://reporter.nih.gov/quickSearch/272201300017C-18-0-1 |
Countries
Sequence: | 42587495 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55618629 | Sequence: | 55618630 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Galidesivir | Title | placebo |
Description | Galidesivir IV infusion | Description | Placebo IV infusion |
Interventions
Sequence: | 52507892 | Sequence: | 52507893 |
Intervention Type | Drug | Intervention Type | Drug |
Name | galidesivir | Name | placebo |
Description | galidesivir IV infusion | Description | placebo IV infusion |
Design Outcomes
Sequence: | 177461163 | Sequence: | 177461164 | Sequence: | 177461165 | Sequence: | 177461166 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Measure | Plasma PK – Galidesivir Cmax (Maximum Observed Concentration of Drug) | Measure | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Measure | Galidesivir Renal Clearance |
Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up period, up to 23 days from IMP dosing on Day 1. | Time Frame | Plasma PK parameters are based on sampling over a 21 day period | Time Frame | Plasma PK parameters are based on sampling over a 21 day period | Time Frame | Urine PK parameters are based on sampling over a 96 hour period. |
Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes. |
Browse Conditions
Sequence: | 193570784 | Sequence: | 193570785 | Sequence: | 193570786 | Sequence: | 193570787 | Sequence: | 193570788 | Sequence: | 193570789 | Sequence: | 193570790 |
Mesh Term | Virus Diseases | Mesh Term | Marburg Virus Disease | Mesh Term | Infections | Mesh Term | Hemorrhagic Fevers, Viral | Mesh Term | RNA Virus Infections | Mesh Term | Filoviridae Infections | Mesh Term | Mononegavirales Infections |
Downcase Mesh Term | virus diseases | Downcase Mesh Term | marburg virus disease | Downcase Mesh Term | infections | Downcase Mesh Term | hemorrhagic fevers, viral | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | filoviridae infections | Downcase Mesh Term | mononegavirales infections |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48339929 | Sequence: | 48339930 |
Agency Class | INDUSTRY | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | BioCryst Pharmaceuticals | Name | National Institute of Allergy and Infectious Diseases (NIAID) |
Overall Officials
Sequence: | 29297742 |
Role | Principal Investigator |
Name | Daniel Dickerson, MD, PhD |
Affiliation | PRA Health Sciences |
Design Group Interventions
Sequence: | 68179717 | Sequence: | 68179718 |
Design Group Id | 55618629 | Design Group Id | 55618630 |
Intervention Id | 52507892 | Intervention Id | 52507893 |
Eligibilities
Sequence: | 30778377 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 55 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Key Inclusion Criteria:
written informed consent Exclusion Criteria: clinically significant medical condition or medical history or psychiatric condition or history of psychiatric condition |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253970969 |
Number Of Facilities | 1 |
Number Of Nsae Subjects | 17 |
Number Of Sae Subjects | 2 |
Registered In Calendar Year | 2018 |
Actual Duration | 4 |
Were Results Reported | True |
Months To Report Results | 25 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 55 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30524481 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Investigator Masked | True |
Drop Withdrawals
Sequence: | 29004049 | Sequence: | 29004050 | Sequence: | 29004051 | Sequence: | 29004052 | Sequence: | 29004053 |
Result Group Id | 56112260 | Result Group Id | 56112261 | Result Group Id | 56112262 | Result Group Id | 56112263 | Result Group Id | 56112264 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up |
Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 |
Milestones
Sequence: | 41027449 | Sequence: | 41027450 | Sequence: | 41027451 | Sequence: | 41027452 | Sequence: | 41027453 | Sequence: | 41027454 | Sequence: | 41027455 | Sequence: | 41027456 | Sequence: | 41027457 | Sequence: | 41027458 | Sequence: | 41027459 | Sequence: | 41027460 | Sequence: | 41027461 | Sequence: | 41027462 | Sequence: | 41027463 | Sequence: | 41027464 | Sequence: | 41027465 | Sequence: | 41027466 | Sequence: | 41027467 | Sequence: | 41027468 | Sequence: | 41027469 | Sequence: | 41027470 | Sequence: | 41027471 | Sequence: | 41027472 | Sequence: | 41027473 |
Result Group Id | 56112260 | Result Group Id | 56112261 | Result Group Id | 56112262 | Result Group Id | 56112263 | Result Group Id | 56112264 | Result Group Id | 56112260 | Result Group Id | 56112261 | Result Group Id | 56112262 | Result Group Id | 56112263 | Result Group Id | 56112264 | Result Group Id | 56112260 | Result Group Id | 56112261 | Result Group Id | 56112262 | Result Group Id | 56112263 | Result Group Id | 56112264 | Result Group Id | 56112260 | Result Group Id | 56112261 | Result Group Id | 56112262 | Result Group Id | 56112263 | Result Group Id | 56112264 | Result Group Id | 56112260 | Result Group Id | 56112261 | Result Group Id | 56112262 | Result Group Id | 56112263 | Result Group Id | 56112264 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 |
Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | Safety Population | Title | Safety Population | Title | Safety Population | Title | Safety Population | Title | Safety Population | Title | PK Population | Title | PK Population | Title | PK Population | Title | PK Population | Title | PK Population | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 8 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 8 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 0 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 8 | Count | 6 | Count | 6 | Count | 6 | Count | 5 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 |
Milestone Description | Safety Population includes all subjects who received study drug. | Milestone Description | Safety Population includes all subjects who received study drug. | Milestone Description | Safety Population includes all subjects who received study drug. | Milestone Description | Safety Population includes all subjects who received study drug. | Milestone Description | Safety Population includes all subjects who received study drug. | Milestone Description | PK population included all subjects from whom at least 1 galidesivir PK parameter was estimated. | Milestone Description | PK population included all subjects from whom at least 1 galidesivir PK parameter was estimated. | Milestone Description | PK population included all subjects from whom at least 1 galidesivir PK parameter was estimated. | Milestone Description | PK population included all subjects from whom at least 1 galidesivir PK parameter was estimated. | Milestone Description | PK population included all subjects from whom at least 1 galidesivir PK parameter was estimated. | ||||||||||||||||||||||||||||||
Outcome Analyses
Sequence: | 16581196 | Sequence: | 16581197 | Sequence: | 16581198 |
Outcome Id | 30820261 | Outcome Id | 30820262 | Outcome Id | 30820262 |
Non Inferiority Type | Other | Non Inferiority Type | Other | Non Inferiority Type | Other |
Param Type | Slope | Param Type | Slope | Param Type | Slope |
Param Value | 0.982 | Param Value | 1.0 | Param Value | 1.086 |
P Value Modifier | P Value Modifier | P Value Modifier | |||
Ci N Sides | 2-Sided | Ci N Sides | 2-Sided | Ci N Sides | 2-Sided |
Ci Percent | 90.0 | Ci Percent | 90.0 | Ci Percent | 90.0 |
Ci Lower Limit | 0.868 | Ci Lower Limit | 0.872 | Ci Lower Limit | 0.952 |
Ci Upper Limit | 1.096 | Ci Upper Limit | 1.128 | Ci Upper Limit | 1.219 |
Groups Description | A model with In-transformed dose (dose continuous) as a fixed effect & subject as a random effect was applied to In-transformed Cmax. Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model & the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1. | Groups Description | A model with In-transformed dose (dose continuous) as a fixed effect & subject as a random effect was applied to In-transformed AUC0-inf Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model & the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1 | Groups Description | A model with In-transformed dose (dose continuous) as a fixed effect & subject as a random effect was applied to In-transformed AUC0-t. Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model & the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1. |
Outcome Analysis Groups
Sequence: | 32157965 | Sequence: | 32157966 | Sequence: | 32157967 | Sequence: | 32157968 | Sequence: | 32157969 | Sequence: | 32157970 | Sequence: | 32157971 | Sequence: | 32157972 | Sequence: | 32157973 | Sequence: | 32157974 | Sequence: | 32157975 | Sequence: | 32157976 |
Outcome Analysis Id | 16581196 | Outcome Analysis Id | 16581196 | Outcome Analysis Id | 16581196 | Outcome Analysis Id | 16581196 | Outcome Analysis Id | 16581197 | Outcome Analysis Id | 16581197 | Outcome Analysis Id | 16581197 | Outcome Analysis Id | 16581197 | Outcome Analysis Id | 16581198 | Outcome Analysis Id | 16581198 | Outcome Analysis Id | 16581198 | Outcome Analysis Id | 16581198 |
Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 |
Participant Flows
Sequence: | 3922836 |
Pre Assignment Details | A single dose of study drug was administered to subjects in each of cohorts 1 to 4. In each cohort, 6 subjects received galidesivir and 2 subjects received matching placebo. |
Outcome Counts
Sequence: | 74038503 | Sequence: | 74038504 | Sequence: | 74038505 | Sequence: | 74038506 | Sequence: | 74038507 | Sequence: | 74038508 | Sequence: | 74038509 | Sequence: | 74038510 | Sequence: | 74038511 | Sequence: | 74038512 | Sequence: | 74038513 | Sequence: | 74038514 | Sequence: | 74038515 | Sequence: | 74038516 | Sequence: | 74038517 | Sequence: | 74038518 | Sequence: | 74038519 |
Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820261 | Outcome Id | 30820261 | Outcome Id | 30820261 | Outcome Id | 30820261 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820263 | Outcome Id | 30820263 | Outcome Id | 30820263 | Outcome Id | 30820263 |
Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112268 | Result Group Id | 56112269 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 8 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 5 |
Provided Documents
Sequence: | 2581550 | Sequence: | 2581551 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2019-01-11 | Document Date | 2019-04-10 |
Url | https://ClinicalTrials.gov/ProvidedDocs/73/NCT03800173/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/73/NCT03800173/SAP_001.pdf |
Reported Event Totals
Sequence: | 27955633 | Sequence: | 27955634 | Sequence: | 27955635 | Sequence: | 27955636 | Sequence: | 27955637 | Sequence: | 27955638 | Sequence: | 27955639 | Sequence: | 27955640 | Sequence: | 27955641 | Sequence: | 27955642 | Sequence: | 27955643 | Sequence: | 27955644 | Sequence: | 27955645 | Sequence: | 27955646 | Sequence: | 27955647 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG003 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG004 | Ctgov Group Code | EG004 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 4 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 |
Subjects At Risk | 8 | Subjects At Risk | 8 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 |
Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 | Created At | 2023-08-09 03:53:25.778295 |
Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 | Updated At | 2023-08-09 03:53:25.778295 |
Reported Events
Sequence: | 528498131 | Sequence: | 528498063 | Sequence: | 528498064 | Sequence: | 528498065 | Sequence: | 528498066 | Sequence: | 528498067 | Sequence: | 528498068 | Sequence: | 528498069 | Sequence: | 528498070 | Sequence: | 528498071 | Sequence: | 528498072 | Sequence: | 528498073 | Sequence: | 528498074 | Sequence: | 528498075 | Sequence: | 528498076 | Sequence: | 528498077 | Sequence: | 528498078 | Sequence: | 528498079 | Sequence: | 528498080 | Sequence: | 528498081 | Sequence: | 528498082 | Sequence: | 528498083 | Sequence: | 528498084 | Sequence: | 528498085 | Sequence: | 528498086 | Sequence: | 528498087 | Sequence: | 528498088 | Sequence: | 528498089 | Sequence: | 528498090 | Sequence: | 528498091 | Sequence: | 528498092 | Sequence: | 528498093 | Sequence: | 528498094 | Sequence: | 528498095 | Sequence: | 528498096 | Sequence: | 528498097 | Sequence: | 528498098 | Sequence: | 528498099 | Sequence: | 528498100 | Sequence: | 528498101 | Sequence: | 528498102 | Sequence: | 528498103 | Sequence: | 528498104 | Sequence: | 528498105 | Sequence: | 528498106 | Sequence: | 528498107 | Sequence: | 528498108 | Sequence: | 528498109 | Sequence: | 528498110 | Sequence: | 528498111 | Sequence: | 528498112 | Sequence: | 528498113 | Sequence: | 528498114 | Sequence: | 528498115 | Sequence: | 528498116 | Sequence: | 528498117 | Sequence: | 528498118 | Sequence: | 528498119 | Sequence: | 528498120 | Sequence: | 528498121 | Sequence: | 528498122 | Sequence: | 528498123 | Sequence: | 528498124 | Sequence: | 528498125 | Sequence: | 528498126 | Sequence: | 528498127 | Sequence: | 528498128 | Sequence: | 528498129 | Sequence: | 528498130 | Sequence: | 528498132 | Sequence: | 528498133 | Sequence: | 528498134 | Sequence: | 528498135 | Sequence: | 528498136 | Sequence: | 528498137 | Sequence: | 528498138 | Sequence: | 528498139 | Sequence: | 528498140 | Sequence: | 528498141 | Sequence: | 528498142 | Sequence: | 528498143 | Sequence: | 528498144 | Sequence: | 528498145 | Sequence: | 528498146 | Sequence: | 528498147 |
Result Group Id | 56112277 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 | Result Group Id | 56112274 | Result Group Id | 56112275 | Result Group Id | 56112276 | Result Group Id | 56112277 | Result Group Id | 56112278 |
Ctgov Group Code | EG003 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 |
Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). | Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up visit, up to 23 days from IMP dosing on Day 1. All AEs were graded for severity using the modified 2014 DMID Adult Toxicity Grading Scale. Any AEs not covered by the DMID criteria were assessed and classified into 1 of 3 clearly defined categories (mild, moderate, or severe). |
Event Type | other | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other |
Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 8 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 | Subjects At Risk | 6 |
Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 2 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 |
Organ System | Blood and lymphatic system disorders | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Pregnancy, puerperium and perinatal conditions | Organ System | Pregnancy, puerperium and perinatal conditions | Organ System | Pregnancy, puerperium and perinatal conditions | Organ System | Pregnancy, puerperium and perinatal conditions | Organ System | Pregnancy, puerperium and perinatal conditions | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders |
Adverse Event Term | Iron deficiency anaemia | Adverse Event Term | gastrooesophageal cancer | Adverse Event Term | gastrooesophageal cancer | Adverse Event Term | gastrooesophageal cancer | Adverse Event Term | gastrooesophageal cancer | Adverse Event Term | gastrooesophageal cancer | Adverse Event Term | Abortion spontaneous | Adverse Event Term | Abortion spontaneous | Adverse Event Term | Abortion spontaneous | Adverse Event Term | Abortion spontaneous | Adverse Event Term | Abortion spontaneous | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Abdominal Distension | Adverse Event Term | Abdominal Distension | Adverse Event Term | Abdominal Distension | Adverse Event Term | Abdominal Distension | Adverse Event Term | Abdominal Distension | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Arthralgia | Adverse Event Term | Arthralgia | Adverse Event Term | Arthralgia | Adverse Event Term | Arthralgia | Adverse Event Term | Arthralgia | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Urticaria | Adverse Event Term | Urticaria | Adverse Event Term | Urticaria | Adverse Event Term | Urticaria | Adverse Event Term | Urticaria | Adverse Event Term | Hepatic lesion | Adverse Event Term | Hepatic lesion | Adverse Event Term | Hepatic lesion | Adverse Event Term | Hepatic lesion | Adverse Event Term | Hepatic lesion | Adverse Event Term | Iron deficiency anaemia | Adverse Event Term | Iron deficiency anaemia | Adverse Event Term | Iron deficiency anaemia | Adverse Event Term | Iron deficiency anaemia | Adverse Event Term | Leukocytosis | Adverse Event Term | Leukocytosis | Adverse Event Term | Leukocytosis | Adverse Event Term | Leukocytosis | Adverse Event Term | Leukocytosis | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Upper airway cough syndrome | Adverse Event Term | Upper airway cough syndrome | Adverse Event Term | Upper airway cough syndrome | Adverse Event Term | Upper airway cough syndrome | Adverse Event Term | Upper airway cough syndrome |
Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 |
Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) | Vocab | MedDRA (21.1) |
Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment |
Responsible Parties
Sequence: | 28890791 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3853580 |
Pi Employee | No |
Result Contacts
Sequence: | 3853545 |
Organization | BioCryst Pharmaceuticals Inc |
Name | Study Director |
Phone | +1 919-859-1302 |
clinicaltrials@biocryst.com | |
Outcomes
Sequence: | 30820260 | Sequence: | 30820261 | Sequence: | 30820262 | Sequence: | 30820263 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Plasma PK – Galidesivir Cmax (Maximum Observed Concentration of Drug) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Galidesivir Renal Clearance |
Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes. |
Time Frame | AEs were assessed and recorded from the time of signing the ICF through to the appropriate follow-up period, up to 23 days from IMP dosing on Day 1. | Time Frame | Plasma PK parameters are based on sampling over a 21 day period | Time Frame | Plasma PK parameters are based on sampling over a 21 day period | Time Frame | Urine PK parameters are based on sampling over a 96 hour period. |
Population | The safety population included all randomized subjects who received any amount of study drug (i.e. a partial infusion). | Population | The PK population included subjects for whom at least 1 PK parameter was estimated. The PK population was the primary population for the PK analysis. | Population | The PK population included subjects for whom at least 1 PK parameter was estimated. The PK population was the primary population for the PK analysis. Only 5 subjects were included in the 20 mg/kg cohort for AUC0-t analysis, as 1 subject was lost to follow-up after discharge from clinic on Day 5. | Population | The PK population included subjects for whom at least 1 PK parameter was estimated. The PK population was the primary population for the PK analysis. There were only 5 subjects in the 20 mg/kg cohort as 1 subject was lost to follow-up after discharge from clinic on Day 5. |
Units | participants | Units | ng/mL | Units | ng*h/mL | Units | L/hr |
Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | ||
Param Type | Number | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean |
Outcome Measurements
Sequence: | 235798870 | Sequence: | 235798869 | Sequence: | 235798866 | Sequence: | 235798867 | Sequence: | 235798868 | Sequence: | 235798871 | Sequence: | 235798872 | Sequence: | 235798873 | Sequence: | 235798874 | Sequence: | 235798875 | Sequence: | 235798876 | Sequence: | 235798877 | Sequence: | 235798878 | Sequence: | 235798879 | Sequence: | 235798880 | Sequence: | 235798881 | Sequence: | 235798882 | Sequence: | 235798883 | Sequence: | 235798884 | Sequence: | 235798885 | Sequence: | 235798886 | Sequence: | 235798887 | Sequence: | 235798888 | Sequence: | 235798889 | Sequence: | 235798890 | Sequence: | 235798891 | Sequence: | 235798892 | Sequence: | 235798893 | Sequence: | 235798894 | Sequence: | 235798895 | Sequence: | 235798896 | Sequence: | 235798897 | Sequence: | 235798898 | Sequence: | 235798899 | Sequence: | 235798900 | Sequence: | 235798901 | Sequence: | 235798902 | Sequence: | 235798903 | Sequence: | 235798904 | Sequence: | 235798905 | Sequence: | 235798906 | Sequence: | 235798907 | Sequence: | 235798908 | Sequence: | 235798909 | Sequence: | 235798910 | Sequence: | 235798911 | Sequence: | 235798912 | Sequence: | 235798913 | Sequence: | 235798914 | Sequence: | 235798915 | Sequence: | 235798916 | Sequence: | 235798917 | Sequence: | 235798918 | Sequence: | 235798919 | Sequence: | 235798920 | Sequence: | 235798921 |
Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820260 | Outcome Id | 30820261 | Outcome Id | 30820261 | Outcome Id | 30820261 | Outcome Id | 30820261 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820262 | Outcome Id | 30820263 | Outcome Id | 30820263 | Outcome Id | 30820263 | Outcome Id | 30820263 |
Result Group Id | 56112269 | Result Group Id | 56112268 | Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112268 | Result Group Id | 56112269 | Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112268 | Result Group Id | 56112269 | Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112268 | Result Group Id | 56112269 | Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112268 | Result Group Id | 56112269 | Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112268 | Result Group Id | 56112269 | Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112268 | Result Group Id | 56112269 | Result Group Id | 56112265 | Result Group Id | 56112266 | Result Group Id | 56112267 | Result Group Id | 56112268 | Result Group Id | 56112269 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 | Result Group Id | 56112270 | Result Group Id | 56112271 | Result Group Id | 56112272 | Result Group Id | 56112273 |
Ctgov Group Code | OG004 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 |
Classification | Subjects with at least 1 TEAE | Classification | Subjects with at least 1 TEAE | Classification | Subjects with at least 1 TEAE | Classification | Subjects with at least 1 TEAE | Classification | Subjects with at least 1 TEAE | Classification | Not related TEAEs | Classification | Not related TEAEs | Classification | Not related TEAEs | Classification | Not related TEAEs | Classification | Not related TEAEs | Classification | Related TEAEs | Classification | Related TEAEs | Classification | Related TEAEs | Classification | Related TEAEs | Classification | Related TEAEs | Classification | Mild TEAE | Classification | Mild TEAE | Classification | Mild TEAE | Classification | Mild TEAE | Classification | Mild TEAE | Classification | Moderate TEAE | Classification | Moderate TEAE | Classification | Moderate TEAE | Classification | Moderate TEAE | Classification | Moderate TEAE | Classification | Severe TEAE | Classification | Severe TEAE | Classification | Severe TEAE | Classification | Severe TEAE | Classification | Severe TEAE | Classification | Subjects with at least 1 SAE | Classification | Subjects with at least 1 SAE | Classification | Subjects with at least 1 SAE | Classification | Subjects with at least 1 SAE | Classification | Subjects with at least 1 SAE | Classification | Subject Discontinuation due to AE | Classification | Subject Discontinuation due to AE | Classification | Subject Discontinuation due to AE | Classification | Subject Discontinuation due to AE | Classification | Subject Discontinuation due to AE | Classification | AUC0-inf | Classification | AUC0-inf | Classification | AUC0-inf | Classification | AUC0-inf | Classification | AUC0-t | Classification | AUC0-t | Classification | AUC0-t | Classification | AUC0-t | ||||||||||||||||
Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Galidesivir Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. | Title | Plasma PK – Galidesivir Cmax (Maximum Observed Concentration of Drug) | Title | Plasma PK – Galidesivir Cmax (Maximum Observed Concentration of Drug) | Title | Plasma PK – Galidesivir Cmax (Maximum Observed Concentration of Drug) | Title | Plasma PK – Galidesivir Cmax (Maximum Observed Concentration of Drug) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Plasma PK – Galidesivir AUC (Area Under the Concentration vs. Time Curve) | Title | Galidesivir Renal Clearance | Title | Galidesivir Renal Clearance | Title | Galidesivir Renal Clearance | Title | Galidesivir Renal Clearance |
Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Any event reported on the subject's study record that occurred on or after the initiation of study drug was defined as treatment emergent (TEAE). | Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. Cmax for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Serial blood samples for PK assessment of plasma galidesivir were collected at the following time points:
Day 1 to Day 5: 0 hour (pre dose), halfway through the infusion (0.5 hour), 1 hour (end of the infusion), 1.25, 1.50, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose. AUC0-inf (AUC from time 0 extrapolated to infinite time) and AUC0-t (AUC from time 0 to time t, where "t" = the last quantifiable concentration) for galidesivir was estimated using non compartmental methods with Phoenix® WinNonlin® v8.1 or higher (Certara, Inc.). |
Description | Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes. | Description | Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes. | Description | Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes. | Description | Urine was collected from subjects over a 96 hour period per protocol, analyzed for galidesivir concentrations. Urine PK parameters including CLR (renal clearance of unchanged drug cumulatively over all collection intervals or in a specific interval) were estimated in SAS for Windows v9.4 or higher (SAS Institute, Inc.) based on the recorded urine concentrations and volumes. |
Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | ng/mL | Units | ng/mL | Units | ng/mL | Units | ng/mL | Units | ng*h/mL | Units | ng*h/mL | Units | ng*h/mL | Units | ng*h/mL | Units | ng*h/mL | Units | ng*h/mL | Units | ng*h/mL | Units | ng*h/mL | Units | L/hr | Units | L/hr | Units | L/hr | Units | L/hr |
Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean |
Param Value | 1 | Param Value | 4 | Param Value | 2 | Param Value | 0 | Param Value | 1 | Param Value | 2 | Param Value | 0 | Param Value | 1 | Param Value | 2 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 1 | Param Value | 2 | Param Value | 0 | Param Value | 1 | Param Value | 3 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 5540 | Param Value | 10300 | Param Value | 17730 | Param Value | 20490 | Param Value | 21160 | Param Value | 37080 | Param Value | 65860 | Param Value | 81230 | Param Value | 17150 | Param Value | 32360 | Param Value | 59590 | Param Value | 73350 | Param Value | 9.305 | Param Value | 11.66 | Param Value | 11.51 | Param Value | 7.131 |
Param Value Num | 1.0 | Param Value Num | 4.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 5540.0 | Param Value Num | 10300.0 | Param Value Num | 17730.0 | Param Value Num | 20490.0 | Param Value Num | 21160.0 | Param Value Num | 37080.0 | Param Value Num | 65860.0 | Param Value Num | 81230.0 | Param Value Num | 17150.0 | Param Value Num | 32360.0 | Param Value Num | 59590.0 | Param Value Num | 73350.0 | Param Value Num | 9.305 | Param Value Num | 11.66 | Param Value Num | 11.51 | Param Value Num | 7.131 |
Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 7.8 | Dispersion Value | 22.3 | Dispersion Value | 17.5 | Dispersion Value | 16.2 | Dispersion Value | 23.0 | Dispersion Value | 14.5 | Dispersion Value | 21.9 | Dispersion Value | 14.3 | Dispersion Value | 21.0 | Dispersion Value | 17.4 | Dispersion Value | 22.0 | Dispersion Value | 14.1 | Dispersion Value | 16.7 | Dispersion Value | 17.8 | Dispersion Value | 14.5 | Dispersion Value | 90.4 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 7.8 | Dispersion Value Num | 22.3 | Dispersion Value Num | 17.5 | Dispersion Value Num | 16.2 | Dispersion Value Num | 23.0 | Dispersion Value Num | 14.5 | Dispersion Value Num | 21.9 | Dispersion Value Num | 14.3 | Dispersion Value Num | 21.0 | Dispersion Value Num | 17.4 | Dispersion Value Num | 22.0 | Dispersion Value Num | 14.1 | Dispersion Value Num | 16.7 | Dispersion Value Num | 17.8 | Dispersion Value Num | 14.5 | Dispersion Value Num | 90.4 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Study References
Sequence: | 52087405 |
Pmid | 35182042 |
Reference Type | derived |
Citation | Mathis A, Collins D, Dobo S, Walling DM, Sheridan WP, Taylor R. Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2022 Apr;11(4):467-474. doi: 10.1002/cpdd.1037. Epub 2022 Feb 19. |
Baseline Counts
Sequence: | 11388279 | Sequence: | 11388280 | Sequence: | 11388281 | Sequence: | 11388282 | Sequence: | 11388283 | Sequence: | 11388284 |
Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall |
Count | 8 | Count | 6 | Count | 6 | Count | 6 | Count | 6 | Count | 32 |
Result Groups
Sequence: | 56112272 | Sequence: | 56112273 | Sequence: | 56112274 | Sequence: | 56112275 | Sequence: | 56112276 | Sequence: | 56112277 | Sequence: | 56112278 | Sequence: | 56112259 | Sequence: | 56112260 | Sequence: | 56112261 | Sequence: | 56112262 | Sequence: | 56112263 | Sequence: | 56112264 | Sequence: | 56112265 | Sequence: | 56112266 | Sequence: | 56112267 | Sequence: | 56112268 | Sequence: | 56112269 | Sequence: | 56112270 | Sequence: | 56112271 | Sequence: | 56112254 | Sequence: | 56112255 | Sequence: | 56112256 | Sequence: | 56112257 | Sequence: | 56112258 |
Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | BG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 |
Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline |
Title | 15 mg/kg Galidesivir | Title | 20 mg/kg Galidesivir | Title | Placebo | Title | 5 mg/kg Galidesivir | Title | 10 mg/kg Galidesivir | Title | 15 mg/kg Galidesivir | Title | 20 mg/kg Galidesivir | Title | Total | Title | Placebo | Title | 5 mg/kg Galidesivir | Title | 10 mg/kg Galidesivir | Title | 15 mg/kg Galidesivir | Title | 20 mg/kg Galidesivir | Title | Placebo | Title | 5 mg/kg Galidesivir | Title | 10 mg/kg Galidesivir | Title | 15 mg/kg Galidesivir | Title | 20 mg/kg Galidesivir | Title | 5 mg/kg Galidesivir | Title | 10 mg/kg Galidesivir | Title | Placebo | Title | 5 mg/kg Galidesivir | Title | 10 mg/kg Galidesivir | Title | 15 mg/kg Galidesivir | Title | 20 mg/kg Galidesivir |
Description | Single IV infusion 15 mg/kg galidesivir | Description | Single IV infusion 20 mg/kg galidesivir | Description | single placebo IV infusion | Description | Single IV infusion 5 mg/kg galidesivir | Description | Single IV infusion 10 mg/kg galidesivir | Description | Single IV infusion 15 mg/kg galidesivir | Description | Single IV infusion 20 mg/kg galidesivir | Description | Total of all reporting groups | Description | single placebo IV infusion | Description | Single IV infusion 5 mg/kg galidesivir | Description | Single IV infusion 10 mg/kg galidesivir | Description | Single IV infusion 15 mg/kg galidesivir | Description | Single IV infusion 20 mg/kg galidesivir | Description | single placebo IV infusion | Description | Single IV infusion 5 mg/kg galidesivir | Description | Single IV infusion 10 mg/kg galidesivir | Description | Single IV infusion 15 mg/kg galidesivir | Description | Single IV infusion 20 mg/kg galidesivir | Description | Single IV infusion 5 mg/kg galidesivir | Description | Single IV infusion 10 mg/kg galidesivir | Description | single placebo IV infusion | Description | Single IV infusion 5 mg/kg galidesivir | Description | Single IV infusion 10 mg/kg galidesivir | Description | Single IV infusion 15 mg/kg galidesivir | Description | Single IV infusion 20 mg/kg galidesivir |
Baseline Measurements
Sequence: | 125654190 | Sequence: | 125654191 | Sequence: | 125654192 | Sequence: | 125654193 | Sequence: | 125654194 | Sequence: | 125654195 | Sequence: | 125654196 | Sequence: | 125654197 | Sequence: | 125654198 | Sequence: | 125654199 | Sequence: | 125654200 | Sequence: | 125654201 | Sequence: | 125654202 | Sequence: | 125654203 | Sequence: | 125654204 | Sequence: | 125654205 | Sequence: | 125654206 | Sequence: | 125654207 | Sequence: | 125654208 | Sequence: | 125654209 | Sequence: | 125654210 | Sequence: | 125654211 | Sequence: | 125654212 | Sequence: | 125654213 | Sequence: | 125654214 | Sequence: | 125654215 | Sequence: | 125654216 | Sequence: | 125654217 | Sequence: | 125654218 | Sequence: | 125654219 | Sequence: | 125654220 | Sequence: | 125654221 | Sequence: | 125654222 | Sequence: | 125654223 | Sequence: | 125654224 | Sequence: | 125654225 | Sequence: | 125654226 | Sequence: | 125654227 | Sequence: | 125654228 | Sequence: | 125654229 | Sequence: | 125654230 | Sequence: | 125654231 | Sequence: | 125654232 | Sequence: | 125654233 | Sequence: | 125654234 | Sequence: | 125654235 | Sequence: | 125654236 | Sequence: | 125654237 | Sequence: | 125654238 | Sequence: | 125654239 | Sequence: | 125654240 | Sequence: | 125654241 | Sequence: | 125654242 | Sequence: | 125654243 | Sequence: | 125654244 | Sequence: | 125654245 | Sequence: | 125654246 | Sequence: | 125654247 | Sequence: | 125654248 | Sequence: | 125654249 |
Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 | Result Group Id | 56112254 | Result Group Id | 56112255 | Result Group Id | 56112256 | Result Group Id | 56112257 | Result Group Id | 56112258 | Result Group Id | 56112259 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 |
Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | White | Category | White | Category | White | Category | White | Category | White | Category | White | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | ||||||||||||
Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) |
Units | years | Units | years | Units | years | Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 31.1 | Param Value | 39.8 | Param Value | 33.5 | Param Value | 41.7 | Param Value | 31.8 | Param Value | 35.3 | Param Value | 5 | Param Value | 3 | Param Value | 1 | Param Value | 2 | Param Value | 2 | Param Value | 13 | Param Value | 3 | Param Value | 3 | Param Value | 5 | Param Value | 4 | Param Value | 4 | Param Value | 19 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 5 | Param Value | 1 | Param Value | 3 | Param Value | 0 | Param Value | 3 | Param Value | 12 | Param Value | 2 | Param Value | 5 | Param Value | 3 | Param Value | 6 | Param Value | 3 | Param Value | 19 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 |
Param Value Num | 31.1 | Param Value Num | 39.8 | Param Value Num | 33.5 | Param Value Num | 41.7 | Param Value Num | 31.8 | Param Value Num | 35.3 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 13.0 | Param Value Num | 3.0 | Param Value Num | 3.0 | Param Value Num | 5.0 | Param Value Num | 4.0 | Param Value Num | 4.0 | Param Value Num | 19.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 5.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 3.0 | Param Value Num | 12.0 | Param Value Num | 2.0 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 6.0 | Param Value Num | 3.0 | Param Value Num | 19.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 6.88 | Dispersion Value | 10.76 | Dispersion Value | 8.76 | Dispersion Value | 12.04 | Dispersion Value | 8.98 | Dispersion Value | 9.87 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 6.88 | Dispersion Value Num | 10.76 | Dispersion Value Num | 8.76 | Dispersion Value Num | 12.04 | Dispersion Value Num | 8.98 | Dispersion Value Num | 9.87 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 | Number Analyzed | 8 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 6 | Number Analyzed | 32 |
]]>
https://zephyrnet.com/NCT03800160
2018-04-01
https://zephyrnet.com/?p=NCT03800160
NCT03800160https://www.clinicaltrials.gov/study/NCT03800160?tab=tableNANANAMetabolic surgery, as a recognition treatment option for patients with clinical morbid obesity, is gaining increasing appreciation. In addition to substantial weight loss, emerging studies have highlighted that metabolic surgery can substantially ameliorate obesity-related metabolic diseases, including but not limited to type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, obstructive sleep apnea-hypopnea syndrome (OSAHS) and polycystic ovary syndrome (PCOS)in severely obese patients. However, further investigations with larger sample size and longer observation time still needed to clarity the efficacy and safety of metabolic surgery in Chinese patients with obesity and encouraging future research in this field.
<![CDATA[
Studies
Study First Submitted Date | 2018-05-14 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2020-05-05 |
Start Month Year | April 1, 2018 |
Primary Completion Month Year | April 1, 2028 |
Verification Month Year | May 2020 |
Verification Date | 2020-05-31 |
Last Update Posted Date | 2020-05-05 |
Facilities
Sequence: | 200389533 |
Name | Beijing Friendship Hospital |
City | Beijing |
State | Beijing |
Zip | 100050 |
Country | China |
Conditions
Sequence: | 52256601 |
Name | Metabolic Surgery |
Downcase Name | metabolic surgery |
Id Information
Sequence: | 40220832 |
Id Source | org_study_id |
Id Value | GC-MBD |
Countries
Sequence: | 42636416 |
Name | China |
Removed | False |
Keywords
Sequence: | 79989912 | Sequence: | 79989913 | Sequence: | 79989914 |
Name | metabolic surgery | Name | metabolic disease | Name | multicenter |
Downcase Name | metabolic surgery | Downcase Name | metabolic disease | Downcase Name | multicenter |
Design Outcomes
Sequence: | 177692279 | Sequence: | 177692278 | Sequence: | 177692280 | Sequence: | 177692281 | Sequence: | 177692282 | Sequence: | 177692283 | Sequence: | 177692284 | Sequence: | 177692285 | Sequence: | 177692286 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | the adverse events rate of different metabolic surgeries | Measure | the excess weight loss effect of different metabolic surgeries after 1year | Measure | the excess weight loss effect of metabolic surgery with long-time follow-ups | Measure | the excess weight loss effect of metabolic surgery with long-time follow-ups | Measure | the excess weight loss effect of metabolic surgery with long-time follow-ups | Measure | the glycemic control level of metabolic surgery with long-time follow-ups | Measure | the glycemic control level of metabolic surgery with long-time follow-ups | Measure | the glycemic control level of metabolic surgery with long-time follow-ups | Measure | the glycemic control level of metabolic surgery with long-time follow-ups |
Time Frame | 30 days after surgery | Time Frame | 1 year after surgery | Time Frame | 3 years | Time Frame | 5 years | Time Frame | 10 years | Time Frame | 1 year after surgery | Time Frame | 3 year after surgery | Time Frame | 5 year after surgery | Time Frame | 10 year after surgery |
Description | show the surgical safety by 30 days follow-up according to guideline(such as: bleeding, leak, obstruction, re-operation for complication) | Description | Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2) | Description | Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2) | Description | Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2) | Description | Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2) | Description | the change of HbA1c, glucose level, C-peptide and insulin levels | Description | the change of HbA1c, glucose level, C-peptide and insulin levels | Description | the change of HbA1c, glucose level, C-peptide and insulin levels | Description | the change of HbA1c, glucose level, C-peptide and insulin levels |
Sponsors
Sequence: | 48399141 | Sequence: | 48399142 | Sequence: | 48399143 | Sequence: | 48399144 | Sequence: | 48399145 | Sequence: | 48399146 | Sequence: | 48399147 | Sequence: | 48399148 | Sequence: | 48399149 | Sequence: | 48399150 | Sequence: | 48399151 | Sequence: | 48399152 | Sequence: | 48399153 | Sequence: | 48399154 | Sequence: | 48399155 | Sequence: | 48399156 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER_GOV | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Beijing Friendship Hospital | Name | Beijing Tiantan Hospital | Name | Beijing Shijitan Hospital, Capital Medical University | Name | Beijing Hospital | Name | Peking Union Medical College Hospital | Name | Shanxi Dayi Hospital | Name | The Second Hospital of Hebei Medical University | Name | Tianjin Medical University General Hospital | Name | Inner Mongolia People's Hospital | Name | Henan Provincial People's Hospital | Name | Qilu Hospital of Shandong University | Name | The First Hospital of Hebei Medical University | Name | The Second People's Hospital of Xinxiang Henan | Name | Tangshan Gongren Hospital | Name | Tianjin Nankai Hospital | Name | Tianjin First Central Hospital |
Eligibilities
Sequence: | 30815016 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | patients with morbid obesity who are suitable and willing to accept metabolic surgical procedure and also agree with the registry |
Criteria | Inclusion Criteria:
be able to receive metabolic surgery, including but not limit to LSG and LRYGB Exclusion Criteria: can not be able to understand and willing to participate in this registry with signature |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254076071 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30560979 |
Observational Model | Case-Only |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28927383 |
Responsible Party Type | Principal Investigator |
Name | Zhongtao Zhang |
Title | Director of general surgery, principal investigator |
Affiliation | Beijing Friendship Hospital |
]]>
https://zephyrnet.com/NCT03800147
2019-01-24
https://zephyrnet.com/?p=NCT03800147
NCT03800147https://www.clinicaltrials.gov/study/NCT03800147?tab=tableWolf-Dietrich Hardt, Prof. Dr.hardt@micro.biol.ethz.ch+41 44 632 51 43Recent experiments in the lab of Prof. WD Hardt revealed, that in mice, 24 h exposure to a high-fat diet results in a breakdown of colonization resistance against Salmonella typhimurium. Mechanistic experiments identified bile acids as the mediator for reduced colonization resistance. Exposure to a high fat diet leads to increased bile acid secretion which in turn modify the intestinal microbiota.
It is now the aim to verify the results of this study in human healthy volunteers. The nutritional habits of all participants will carefully be evaluated. In the intervention phase, participants will be exposed to either high-fat or low-fat diet and a controlled dose of the non-pathogenic bacteria E. coli Nissle. E. coli Nissle is the active compound for “Mutaflor®” and other probiotics.
It is planned to enumerate E. coli Nissle counts in the stool after Mutaflor ingestion and to quantify other changes of the human microbiota. The hypothesis is that a high-fat diet leads to increased bile acid secretion results in favorable growth conditions for E. coli Nissle, resulting in high bacterial counts in the stool.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-13 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2019-01-11 |
Start Month Year | January 24, 2019 |
Primary Completion Month Year | September 24, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-11 |
Detailed Descriptions
Sequence: | 20852442 |
Description | Infectious diarrhea causes substantial morbidity in Western countries and the developing world and leads to the use of considerable health resources. Antibiotic resistance continues to increase, potentially leading to a decrease in therapeutic options in the future. Important pathogens include Salmonella typhimurium (S. typhimurium) and pathogenic Escherichia coli (E. coli) which are genetically closely related.
The human intestine has considerable colonization resistance against bacterial pathogens. This resistance is largely mediated by the gut microbiota. Therefore, previous exposure to antibiotics or immunosuppression leading to a breakdown of the intestinal defense systems increase the risk for subsequent infection with S. typhimurium. The composition of the human microbiome undergoes dramatic changes upon exposure to various factors including nutrition, physical activity, drugs and much more. Most studies focused on long-term exposure to various factors; however, since bacterial growth is rapid (doubling time of S. typhimurium under optimal conditions = 20min), even short-term variations in the environment could dramatically influence the human microbiota. In the lab of Prof. WD Hardt, a mouse model of S. typhimurium enterocolitis has been established. Since most mouse strains are resistant against colonization with S. typhimurium, pretreatment with antibiotics is a requirement for induction of S. typhimurium enterolitis. However, recent experiments in the Hardt lab revealed, that in mice, 24 h exposure to a high-fat diet also results in a breakdown of colonization resistance, leading to Salmonella enterocolitis upon S. typhimurium infection. The same is true for E. coli strains. Subsequent experiments demonstrated that exposure to fatty acids is sufficient to overcome colonization resistance. Mechanistic experiments identified fat-elicited bile-release as the underlying mechanism: Exposure to a high fat diet leads to increased bile acid secretion; S. typhimurium can tolerate 10-fold higher bile acid concentrations than commensal bacterial, leading to a growth advantage of S. typhimurium compared to competing bacteria (WD Hardt et al., unpublished data). The aim of this study is to verify the results of this study in human healthy volunteers. The nutritional habits of all participants will be carefully evaluated. In the intervention phase, participants will be exposed to either high-fat or low-fat diet and a controlled dose of the non-pathogenic bacteria E. coli Nissle. E. coli Nissle is the active compound for "Mutaflor®" and other probiotics. E. coli Nissle has therapeutic effects for the treatment of chronic inflammatory intestinal diseases. In contrast to other non-pathogenic E. coli strains, it exhibits a specific pattern of fitness factors but lacks prominent virulence factors. In vivo and in vitro experiments demonstrated both, protective effects against infection with intestinal pathogens as well as potent immunomodulatory properties. Growth of E. coli Nissle in the human gut resembles growth of S. typhimurium. Both bacteriae also share metabolic requirements for intestinal growth. Therefore, growth E. coli Nissle in the human intestine can be used as a marker for growth of E. coli strains, Salmonella typhimurium and related pathogens. It is planned to enumerate E. coli Nissle counts in the stool after Mutaflor ingestion and to quantify other changes of the human microbiota. The hypothesize is that a high-fat diet, leading to increased bile acid secretion results in favorable growth conditions for E. coli Nissle, resulting in high bacterial counts in the stool. The results of the study will help improving the understanding of the consequences of nutritional composition on the vulnerability of the human organism to bacterial infections. Such an improved understanding might enable designing preventive measures for the growth of unwanted E. coli strains (e.g. ESBL, pathogenic) or S. typhimurium infection and/ or a severe disease course and might ultimately help limiting antibiotic use and the evolution of antibiotic resistant pathogens. |
Facilities
Sequence: | 201290098 |
Name | Institute of Microbiology (D-BIOL), ETH Zurich |
City | Zürich |
Zip | 8093 |
Country | Switzerland |
Facility Contacts
Sequence: | 28281942 |
Facility Id | 201290098 |
Contact Type | primary |
Name | Wolf-Dietrich Hardt, Prof. Dr. |
hardt@micro.biol.ethz.ch | |
Phone | +41446325143 |
Phone Extension | +41446325143 |
Conditions
Sequence: | 52507863 |
Name | Escherichia Coli Infections |
Downcase Name | escherichia coli infections |
Id Information
Sequence: | 40399423 |
Id Source | org_study_id |
Id Value | FAT Study |
Countries
Sequence: | 42835750 |
Name | Switzerland |
Removed | False |
Design Groups
Sequence: | 55964347 | Sequence: | 55964348 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | High-fat diet | Title | Low-fat diet |
Description | Participants will follow a high-fat diet. During the intervention phase, they will inoculate "Mutaflor Suspension" (E. coli Nissle 1917) (Single dose, 5 ml = 5×10^8 CFU).
Blood samples, stool samples and clinical information will be collected during the study. |
Description | Participants will follow a low-fat diet. During the intervention phase, they will inoculate "Mutaflor Suspension" (E. coli Nissle 1917) (Single dose, 5 ml = 5×10^8 CFU).
Blood samples, stool samples and clinical information will be collected during the study. |
Interventions
Sequence: | 52815808 | Sequence: | 52815809 | Sequence: | 52815810 | Sequence: | 52815811 |
Intervention Type | Drug | Intervention Type | Other | Intervention Type | Other | Intervention Type | Other |
Name | "Mutaflor Suspension" (E. coli Nissle 1917) | Name | Blood samples | Name | Stool samples | Name | Clinical information |
Description | Inoculation of "Mutaflor Suspension" (E. coli Nissle 1917) | Description | Blood samples will be collected and analyzed at different study time points | Description | Stool samples will be collected and analyzed at different study time points | Description | Clinical information will be collected at different study time points using questionnaires |
Design Outcomes
Sequence: | 178632250 | Sequence: | 178632251 | Sequence: | 178632252 | Sequence: | 178632253 | Sequence: | 178632254 | Sequence: | 178632255 | Sequence: | 178632256 | Sequence: | 178632257 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Maximum concentration of E. coli Nissle bacteriae in all stool samples of each participant | Measure | Comparison of E. coli Nissle concentration in feces between high-fat diet and low-fat diet | Measure | Chemical composition of blood | Measure | Chemical composition of stool | Measure | Microbiota composition: taxonomic composition | Measure | Microbiota composition: metagenomic properties | Measure | Microbiota composition: E. coli content | Measure | Antibody response against E. coli Nissle |
Time Frame | 1, 2 and 5 days after E. coli Nissle inoculation | Time Frame | 1, 2 and 5 days after E. coli Nissle inoculation | Time Frame | Week 1 – 8 | Time Frame | Week 1 – 8 | Time Frame | Week 1 – 8 | Time Frame | Week 1 – 8 | Time Frame | Week 1 – 8 | Time Frame | 3 weeks after inoculation of E. coli Nissle |
Description | Each participant's fecal samples will be analyzed for E. coli Nissle bacteriae. Only the stool samples acquired in intervention phase 1 will be considered. For each participant, the maximum concentration of E. coli Nissle in all stool samples (assessed by qPCR) will be used for the calculation of the primary outcome. | Description | The concentration of E. coli Nissle bacteriae (CFU per g feces) in participants exposed to high-fat diet will be compared to the concentration of E. coli Nissle bacteriae in individuals exposed to low-fat diet (Mann-Whitney U test, a p-value <0.05 will be considered significant). | Description | For each participant's blood samples the chemical composition including bile acids, lipids, cholesterol and other compounds related to fat, cholesterol and bile acid metabolism will be determined (concentration, per μl blood). Samples at baseline, during intervention phase and the washout phase will be analyzed. For each compound the group exposed to low-fat diet and high-fat diet will be compared, respectively (intervention phase) or the group with the lowest and highest fat ingestion according to the nutritional protocol. | Description | For each participant's stool samples the chemical composition including bile acids, lipids, cholesterol and other compounds related to fat, cholesterol and bile acid metabolism will be determined (concentration, per g stool). Samples at baseline, during intervention phase and the washout phase will be analyzed. For each compound the group exposed to low-fat diet and high-fat diet will be compared, respectively (intervention phase) or the group with the lowest and highest fat ingestion according to the nutritional protocol. | Description | Same as 4, only the microbiota taxonomic composition in stool samples will be analyzed by ribosomal RNA gene sequencing. Analysis will also include tests for microbiota diversity (i.e. number of bacteria species identified). Findings will be compared to changes occurring in the microbiota of participants in the other study group. | Description | Same as 4, only the metagenomic properties of the microbiota in stool samples will be analyzed by whole genome shotgun sequencing. Analyses will also test for metabolic pathways used by the microbiota. Microbiological and molecular biology methods will also be used to characterize bacteria strains associated with high-fat diet, low-fat diet and/ or changes in bile acid concentration. | Description | Same as 4, only the E. coli content of stool samples will be analyzed by sequencing and conventional plating techniques. This will quantify E. coli Nissle and also all endogenous E. coli strains present in the sample. | Description | Antibody titers against E. coli Nissle will be determined by bacterial FACS or other appropriate techniques. Antibody titers at baseline, at 2 weeks and at 3 weeks will be determined. Individuals exposed to low-fat diet and high-fat diet will be compared. Measured variable: Antibody titers against E. coli Nissle and various E. coli strains. |
Browse Conditions
Sequence: | 194770852 | Sequence: | 194770853 | Sequence: | 194770854 | Sequence: | 194770855 | Sequence: | 194770856 | Sequence: | 194770857 |
Mesh Term | Escherichia coli Infections | Mesh Term | Enterobacteriaceae Infections | Mesh Term | Gram-Negative Bacterial Infections | Mesh Term | Bacterial Infections | Mesh Term | Bacterial Infections and Mycoses | Mesh Term | Infections |
Downcase Mesh Term | escherichia coli infections | Downcase Mesh Term | enterobacteriaceae infections | Downcase Mesh Term | gram-negative bacterial infections | Downcase Mesh Term | bacterial infections | Downcase Mesh Term | bacterial infections and mycoses | Downcase Mesh Term | infections |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48630816 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Zurich |
Overall Officials
Sequence: | 29461030 |
Role | Principal Investigator |
Name | Wolf-Dietrich Hardt, Prof. Dr. |
Affiliation | ETH Zurich, Institute of Microbiology |
Central Contacts
Sequence: | 12095168 | Sequence: | 12095169 |
Contact Type | primary | Contact Type | backup |
Name | Benjamin Misselwitz, MD | Name | Wolf-Dietrich Hardt, Prof. Dr. |
Phone | +41 44 255 1111 | Phone | +41 44 632 51 43 |
benjamin.misselwitz@usz.ch | hardt@micro.biol.ethz.ch | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68607722 | Sequence: | 68607723 | Sequence: | 68607724 | Sequence: | 68607725 | Sequence: | 68607726 | Sequence: | 68607727 | Sequence: | 68607728 | Sequence: | 68607729 |
Design Group Id | 55964347 | Design Group Id | 55964348 | Design Group Id | 55964347 | Design Group Id | 55964348 | Design Group Id | 55964347 | Design Group Id | 55964348 | Design Group Id | 55964347 | Design Group Id | 55964348 |
Intervention Id | 52815808 | Intervention Id | 52815808 | Intervention Id | 52815809 | Intervention Id | 52815809 | Intervention Id | 52815810 | Intervention Id | 52815810 | Intervention Id | 52815811 | Intervention Id | 52815811 |
Eligibilities
Sequence: | 30957212 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 85 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Individuals free of abdominal complaints or symptoms Exclusion Criteria: Previous history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and surgery for anorectal disorders) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253937720 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 85 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30702788 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | Single |
Masking Description | Participants will not be blinded regarding the composition of their nutrition. Investigators performing stool and blood analyses will be blinded to the group assignment of the participants. |
Intervention Model Description | randomized controlled crossover clinical study |
Investigator Masked | True |
Intervention Other Names
Sequence: | 26841617 |
Intervention Id | 52815808 |
Name | Mutaflor Suspension |
Responsible Parties
Sequence: | 29069550 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800134
2018-12-06
https://zephyrnet.com/?p=NCT03800134
NCT03800134https://www.clinicaltrials.gov/study/NCT03800134?tab=tableNANANAThis is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-07 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2023-07-19 |
Start Month Year | December 6, 2018 |
Primary Completion Month Year | April 30, 2024 |
Verification Month Year | July 2023 |
Verification Date | 2023-07-31 |
Last Update Posted Date | 2023-07-19 |
Facilities
Sequence: | 199022230 | Sequence: | 199022231 | Sequence: | 199022232 | Sequence: | 199022233 | Sequence: | 199022234 | Sequence: | 199022235 | Sequence: | 199022236 | Sequence: | 199022237 | Sequence: | 199022238 | Sequence: | 199022239 | Sequence: | 199022240 | Sequence: | 199022241 | Sequence: | 199022242 | Sequence: | 199022243 | Sequence: | 199022244 | Sequence: | 199022245 | Sequence: | 199022246 | Sequence: | 199022247 | Sequence: | 199022248 | Sequence: | 199022249 | Sequence: | 199022250 | Sequence: | 199022251 | Sequence: | 199022252 | Sequence: | 199022253 | Sequence: | 199022254 | Sequence: | 199022255 | Sequence: | 199022256 | Sequence: | 199022257 | Sequence: | 199022258 | Sequence: | 199022259 | Sequence: | 199022260 | Sequence: | 199022261 | Sequence: | 199022262 | Sequence: | 199022263 | Sequence: | 199022264 | Sequence: | 199022265 | Sequence: | 199022266 | Sequence: | 199022267 | Sequence: | 199022268 | Sequence: | 199022269 | Sequence: | 199022270 | Sequence: | 199022271 | Sequence: | 199022272 | Sequence: | 199022273 | Sequence: | 199022274 | Sequence: | 199022275 | Sequence: | 199022276 | Sequence: | 199022277 | Sequence: | 199022278 | Sequence: | 199022279 | Sequence: | 199022280 | Sequence: | 199022281 | Sequence: | 199022282 | Sequence: | 199022283 | Sequence: | 199022284 | Sequence: | 199022285 | Sequence: | 199022286 | Sequence: | 199022287 | Sequence: | 199022288 | Sequence: | 199022289 | Sequence: | 199022290 | Sequence: | 199022291 | Sequence: | 199022292 | Sequence: | 199022293 | Sequence: | 199022294 | Sequence: | 199022295 | Sequence: | 199022296 | Sequence: | 199022297 | Sequence: | 199022298 | Sequence: | 199022299 | Sequence: | 199022300 | Sequence: | 199022301 | Sequence: | 199022302 | Sequence: | 199022303 | Sequence: | 199022304 | Sequence: | 199022305 | Sequence: | 199022306 | Sequence: | 199022307 | Sequence: | 199022308 | Sequence: | 199022309 | Sequence: | 199022310 | Sequence: | 199022311 | Sequence: | 199022312 | Sequence: | 199022313 | Sequence: | 199022314 | Sequence: | 199022315 | Sequence: | 199022316 | Sequence: | 199022317 | Sequence: | 199022318 | Sequence: | 199022319 | Sequence: | 199022320 | Sequence: | 199022321 | Sequence: | 199022322 | Sequence: | 199022323 | Sequence: | 199022324 | Sequence: | 199022325 | Sequence: | 199022326 | Sequence: | 199022327 | Sequence: | 199022328 | Sequence: | 199022329 | Sequence: | 199022330 | Sequence: | 199022331 | Sequence: | 199022332 | Sequence: | 199022333 | Sequence: | 199022334 | Sequence: | 199022335 | Sequence: | 199022336 | Sequence: | 199022337 | Sequence: | 199022338 | Sequence: | 199022339 | Sequence: | 199022340 | Sequence: | 199022341 | Sequence: | 199022342 | Sequence: | 199022343 | Sequence: | 199022344 | Sequence: | 199022345 | Sequence: | 199022346 | Sequence: | 199022347 | Sequence: | 199022348 | Sequence: | 199022349 | Sequence: | 199022350 | Sequence: | 199022351 | Sequence: | 199022352 | Sequence: | 199022353 | Sequence: | 199022354 | Sequence: | 199022355 | Sequence: | 199022356 | Sequence: | 199022357 | Sequence: | 199022358 | Sequence: | 199022359 | Sequence: | 199022360 | Sequence: | 199022361 | Sequence: | 199022362 | Sequence: | 199022363 | Sequence: | 199022364 | Sequence: | 199022365 | Sequence: | 199022366 | Sequence: | 199022367 | Sequence: | 199022368 | Sequence: | 199022414 | Sequence: | 199022369 | Sequence: | 199022370 | Sequence: | 199022371 | Sequence: | 199022372 | Sequence: | 199022373 | Sequence: | 199022374 | Sequence: | 199022375 | Sequence: | 199022376 | Sequence: | 199022377 | Sequence: | 199022378 | Sequence: | 199022379 | Sequence: | 199022380 | Sequence: | 199022381 | Sequence: | 199022382 | Sequence: | 199022383 | Sequence: | 199022384 | Sequence: | 199022385 | Sequence: | 199022386 | Sequence: | 199022387 | Sequence: | 199022388 | Sequence: | 199022389 | Sequence: | 199022390 | Sequence: | 199022391 | Sequence: | 199022392 | Sequence: | 199022393 | Sequence: | 199022394 | Sequence: | 199022395 | Sequence: | 199022396 | Sequence: | 199022397 | Sequence: | 199022398 | Sequence: | 199022399 | Sequence: | 199022400 | Sequence: | 199022401 | Sequence: | 199022402 | Sequence: | 199022403 | Sequence: | 199022404 | Sequence: | 199022405 | Sequence: | 199022406 | Sequence: | 199022407 | Sequence: | 199022408 | Sequence: | 199022409 | Sequence: | 199022410 | Sequence: | 199022411 | Sequence: | 199022412 | Sequence: | 199022413 | Sequence: | 199022415 | Sequence: | 199022416 | Sequence: | 199022417 | Sequence: | 199022418 | Sequence: | 199022419 | Sequence: | 199022420 | Sequence: | 199022421 | Sequence: | 199022422 | Sequence: | 199022423 | Sequence: | 199022424 | Sequence: | 199022425 | Sequence: | 199022426 | Sequence: | 199022427 | Sequence: | 199022428 | Sequence: | 199022429 | Sequence: | 199022430 | Sequence: | 199022431 | Sequence: | 199022432 | Sequence: | 199022433 | Sequence: | 199022434 | Sequence: | 199022435 | Sequence: | 199022436 | Sequence: | 199022437 | Sequence: | 199022438 | Sequence: | 199022439 | Sequence: | 199022440 | Sequence: | 199022441 | Sequence: | 199022442 | Sequence: | 199022443 | Sequence: | 199022444 | Sequence: | 199022445 | Sequence: | 199022446 | Sequence: | 199022447 | Sequence: | 199022448 | Sequence: | 199022449 | Sequence: | 199022450 | Sequence: | 199022451 | Sequence: | 199022452 | Sequence: | 199022453 | Sequence: | 199022454 | Sequence: | 199022455 | Sequence: | 199022456 | Sequence: | 199022457 | Sequence: | 199022458 | Sequence: | 199022459 | Sequence: | 199022460 |
Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | 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City | Phoenix | City | Duarte | City | Orange | City | Aurora | City | Boca Raton | City | Jacksonville | City | Chicago | City | Wichita | City | Ashland | City | Lexington | City | Silver Spring | City | Towson | City | Duluth | City | Minneapolis | City | Morristown | City | New York | City | New York | City | Port Jefferson Station | City | Durham | City | Bend | City | Medford | City | Pittsburgh | City | Charleston | City | Charleston | City | Austin | City | Fort Worth | City | Houston | City | Houston | City | Fairfax | City | Kirkland | City | Seattle | City | Buenos Aires | City | Caba | City | Caba | City | La Plata | City | Pergamino | City | Rosario | City | San Salvador de Jujuy | City | Viedma | City | Graz | City | Innsbruck | City | Rankweil | City | Wien | City | Wien | City | Gent | City | Liège | City | Mons | City | Barretos | City | Belo Horizonte | City | Campinas | City | Curitiba | City | Florianópolis | City | Natal | City | Porto Alegre | City | Santa Maria | City | Sao Paulo | City | Sao Paulo | City | São José do Rio Preto | City | Teresina | City | Vitoria | City | Plovdiv | City | Sofia | City | Sofia | City | Sofia | City | Edmonton | City | Kitchener | City | Levis | City | Montreal | City | Montreal | City | Saskatoon | City | Quebec | City | Santiago | City | Santiago | City | Temuco | City | Viña del Mar | City | Beijing | City | Beijing | City | Beijing | City | Beijing | City | Changsha | City | Changsha | City | Changzhou | City | Chengdu | City | Guangzhou | City | Guangzhou | City | Guiyang | City | Hangzhou | City | Hangzhou | City | Hangzhou | City | Hangzhou | City | Hefei | City | Kunming | City | Linhai | City | Nanchang | City | Ningbo | City | Shanghai | City | Shanghai | City | Shenyang | City | Shenyang | City | Shenzhen | City | Shenzhen | City | Tianjin | City | Urumqi | City | Wuhan | City | Wuhan | City | Xiamen | City | Xintai | City | Yangzhou | City | Zhengzhou | City | San José | City | San José | City | Avignon Cedex | City | Lyon Cedex 08 | City | Nice | City | Toulon Cedex 9 | City | Vantoux | City | Bielefeld | City | Frankfurt am Main | City | Immenstadt | City | Köln | City | Budapest | City | Gyöngyös – Mátraháza | City | Győr | City | Székesfehérvár | City | Törökbálint | City | Ahmedabad | City | Gurgaon | City | Gurgaon | City | Kolkata | City | Manipal | City | Mumbai | City | Mumbai | City | Mysuru | City | Namakkal | City | Nashik | City | New Delhi | City | New Delhi | City | Thane | City | Vishakhapatnam | City | Davao City | City | Ancona | City | Bari | City | Bergamo | City | Firenze | City | Milano | City | Monza | City | Padova | City | Roma | City | Verona | City | Habikino-shi | City | Himeji-shi | City | Hiroshima-shi | City | Hiroshima-shi | City | Iwakuni-shi | City | Kitaadachi-gun | City | Kitakyushu-shi | City | Kurashiki shi | City | Nagoya-shi | City | Niigata-shi | City | Okayama-shi | City | Osakasayama-shi | City | Toyoake-shi | City | Wakayama-shi | City | Busan | City | Cheongju-si | City | Seongnam-si | City | Seoul | City | Seoul | City | Suwon-si | City | Suwon | City | Aguascalientes | City | Chihuahua | City | Guadalajara | City | Monterrey | City | Monterrey | City | México | City | México | City | Pachuca de Soto | City | Arnhem | City | Nijmegen | City | Bellavista | City | Lima | City | Lima | City | Lima | City | Lima | City | Iloilo City | City | Makati | City | Quezon City | City | Białystok | City | Olsztyn | City | Warszawa | City | Warszawa | City | Suceava | City | Kazan | City | Krasnoyarsk | City | Moscow | City | Moscow | City | Moscow | City | Moscow | City | Nizhniy Novgorod | City | Obninsk | City | Rostov-on-Don | City | St. Petersburg | City | Tomsk | City | Yaroslavl | City | Alicante | City | Barcelona | City | Madrid | City | Málaga | City | Oviedo | City | Pamplona | City | San Sebastian | City | Santiago De Compostela (A Coruña) | City | Changhua | City | Taichung City | City | Taichung | City | Tainan City | City | Tainan City | City | Taipei City | City | Taipei | City | Taipei | City | Bangkok | City | Bangkok | City | Chiang Mai | City | Chiang Rai | City | Khon Kaen | City | Lampang | City | Hanoi | City | Ho Chi Minh | City | Ho Chi Minh | City | Ho Chi Minh |
State | Arizona | State | California | State | California | State | Colorado | State | Florida | State | Florida | State | Illinois | State | Kansas | State | Kentucky | State | Kentucky | State | Maryland | State | Maryland | State | Minnesota | State | Minnesota | State | New Jersey | State | New York | State | New York | State | New York | State | North Carolina | State | Oregon | State | Oregon | State | Pennsylvania | State | South Carolina | State | South Carolina | State | Texas | State | Texas | State | Texas | State | Texas | State | Virginia | State | Washington | State | Washington | State | Alberta | State | Ontario | State | Quebec | State | Quebec | State | Quebec | State | Saskatchewan | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | Argentina | Country | Argentina | Country | Argentina | Country | Argentina | Country | Argentina | Country | Argentina | Country | Argentina | Country | Argentina | Country | Austria | Country | Austria | Country | Austria | Country | Austria | Country | Austria | Country | Belgium | Country | Belgium | Country | Belgium | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Brazil | Country | Bulgaria | Country | Bulgaria | Country | Bulgaria | Country | Bulgaria | Country | Canada | Country | Canada | Country | Canada | Country | Canada | Country | Canada | Country | Canada | Country | Canada | Country | Chile | Country | Chile | Country | Chile | Country | Chile | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | Costa Rica | Country | Costa Rica | Country | France | Country | France | Country | France | Country | France | Country | France | Country | Germany | Country | Germany | Country | Germany | Country | Germany | Country | Hungary | Country | Hungary | Country | Hungary | Country | Hungary | Country | Hungary | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | India | Country | Philippines | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Mexico | Country | Mexico | Country | Mexico | Country | Mexico | Country | Mexico | Country | Mexico | Country | Mexico | Country | Mexico | Country | Netherlands | Country | Netherlands | Country | Peru | Country | Peru | Country | Peru | Country | Peru | Country | Peru | Country | Philippines | Country | Philippines | Country | Philippines | Country | Poland | Country | Poland | Country | Poland | Country | Poland | Country | Romania | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Russian Federation | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Taiwan | Country | Taiwan | Country | Taiwan | Country | Taiwan | Country | Taiwan | Country | Taiwan | Country | Taiwan | Country | Taiwan | Country | Thailand | Country | Thailand | Country | Thailand | Country | Thailand | Country | Thailand | Country | Thailand | Country | Vietnam | Country | Vietnam | Country | Vietnam | Country | Vietnam |
Browse Interventions
Sequence: | 95520962 | Sequence: | 95520961 | Sequence: | 95520963 | Sequence: | 95520964 | Sequence: | 95520965 | Sequence: | 95520966 | Sequence: | 95520967 | Sequence: | 95520968 | Sequence: | 95520969 | Sequence: | 95520970 | Sequence: | 95520971 | Sequence: | 95520972 | Sequence: | 95520973 | Sequence: | 95520974 | Sequence: | 95520975 | Sequence: | 95520976 | Sequence: | 95520977 | Sequence: | 95520978 |
Mesh Term | Cisplatin | Mesh Term | Paclitaxel | Mesh Term | Carboplatin | Mesh Term | Gemcitabine | Mesh Term | Pemetrexed | Mesh Term | Durvalumab | Mesh Term | Antineoplastic Agents, Phytogenic | Mesh Term | Antineoplastic Agents | Mesh Term | Tubulin Modulators | Mesh Term | Antimitotic Agents | Mesh Term | Mitosis Modulators | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antimetabolites, Antineoplastic | Mesh Term | Antimetabolites | Mesh Term | Enzyme Inhibitors | Mesh Term | Folic Acid Antagonists | Mesh Term | Nucleic Acid Synthesis Inhibitors | Mesh Term | Antineoplastic Agents, Immunological |
Downcase Mesh Term | cisplatin | Downcase Mesh Term | paclitaxel | Downcase Mesh Term | carboplatin | Downcase Mesh Term | gemcitabine | Downcase Mesh Term | pemetrexed | Downcase Mesh Term | durvalumab | Downcase Mesh Term | antineoplastic agents, phytogenic | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | tubulin modulators | Downcase Mesh Term | antimitotic agents | Downcase Mesh Term | mitosis modulators | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antimetabolites, antineoplastic | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | folic acid antagonists | Downcase Mesh Term | nucleic acid synthesis inhibitors | Downcase Mesh Term | antineoplastic agents, immunological |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51900090 |
Name | Non-Small Cell Lung Cancer |
Downcase Name | non-small cell lung cancer |
Id Information
Sequence: | 39945662 | Sequence: | 39945663 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | D9106C00001 | Id Value | 2018-002997-29 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42338381 | Sequence: | 42338382 | Sequence: | 42338383 | Sequence: | 42338384 | Sequence: | 42338385 | Sequence: | 42338386 | Sequence: | 42338387 | Sequence: | 42338388 | Sequence: | 42338389 | Sequence: | 42338390 | Sequence: | 42338391 | Sequence: | 42338392 | Sequence: | 42338393 | Sequence: | 42338394 | Sequence: | 42338395 | Sequence: | 42338396 | Sequence: | 42338397 | Sequence: | 42338398 | Sequence: | 42338399 | Sequence: | 42338400 | Sequence: | 42338401 | Sequence: | 42338402 | Sequence: | 42338403 | Sequence: | 42338404 | Sequence: | 42338405 | Sequence: | 42338406 | Sequence: | 42338407 | Sequence: | 42338408 | Sequence: | 42338409 | Sequence: | 42338410 |
Name | United States | Name | Argentina | Name | Austria | Name | Belgium | Name | Brazil | Name | Bulgaria | Name | Canada | Name | Chile | Name | China | Name | Costa Rica | Name | France | Name | Germany | Name | Hungary | Name | India | Name | Italy | Name | Japan | Name | Korea, Republic of | Name | Mexico | Name | Netherlands | Name | Peru | Name | Philippines | Name | Poland | Name | Romania | Name | Russian Federation | Name | Spain | Name | Taiwan | Name | Thailand | Name | Vietnam | Name | Puerto Rico | Name | Ukraine |
Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | True | Removed | True |
Design Groups
Sequence: | 55310918 | Sequence: | 55310919 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Arm 1: Durvalumab + platinum-based chemotherapy | Title | Arm 2: Placebo + platinum-based chemotherapy |
Description | Durvalumab (MEDI4736) in concurrence with platinum-based chemotherapy.
All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion: carboplatin/paclitaxel |
Description | Placebo in concurrence with platinum-based chemotherapy.
All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion: carboplatin/paclitaxel |
Interventions
Sequence: | 52215666 | Sequence: | 52215667 | Sequence: | 52215668 | Sequence: | 52215669 | Sequence: | 52215670 | Sequence: | 52215671 |
Intervention Type | Drug | Intervention Type | Other | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Durvalumab | Name | Placebo | Name | Carboplatin/Paclitaxel | Name | Cisplatin/Gemcitabine | Name | Pemetrexed/Cisplatin | Name | Pemetrexed/Carboplatin |
Description | Durvalumab IV (intravenous infusion) | Description | Placebo IV (intravenous infusion) | Description | Carboplatin/Paclitaxel, as per standard of care | Description | Cisplatin/Gemcitabine, as per standard of care | Description | Pemetrexed/Cisplatin, as per standard of care | Description | Pemetrexed/Carboplatin, as per standard of care |
Keywords
Sequence: | 79435392 |
Name | Resectable Non-small Cell Lung Cancer, NSCLC, Carcinoma, Non-small Cell Lung Cancer |
Downcase Name | resectable non-small cell lung cancer, nsclc, carcinoma, non-small cell lung cancer |
Design Outcomes
Sequence: | 176456741 | Sequence: | 176456742 | Sequence: | 176456743 | Sequence: | 176456744 | Sequence: | 176456745 | Sequence: | 176456746 | Sequence: | 176456747 | Sequence: | 176456748 | Sequence: | 176456749 | Sequence: | 176456750 | Sequence: | 176456751 | Sequence: | 176456752 | Sequence: | 176456753 | Sequence: | 176456754 | Sequence: | 176456755 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other |
Measure | Pathological Complete Response (pCR) in modified intent-to-treat (mITT) | Measure | Event-Free Survival (EFS) | Measure | Disease-free survival (DFS) in modified resected population | Measure | Major Pathological Response (mPR) | Measure | Overall Survival (OS) | Measure | Event-free survival (EFS) in PD-L1-TC ≥1% positive patients | Measure | pCR in PD-L1-TC ≥1% positive patients | Measure | Disease-Free Survival (DFS) in PD-L1-TC ≥1% positive patients | Measure | Major Pathological Response (mPR) in PD-L1-TC ≥1% positive patients | Measure | Overall Survival (OS) in PD-L1-TC ≥1% positive patients | Measure | To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery | Measure | To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery | Measure | To assess the PK of durvalumab in blood (through concentration) | Measure | Presence of ADA for durvalumab | Measure | Number of participants with all adverse events as assessed by CTCAE v5.0 |
Time Frame | From screening pathology to an average of 15 weeks after first dose. | Time Frame | Up to 5.5 years after first patient randomized. | Time Frame | From date of randomization to 5.5 years after date of resection | Time Frame | From screening pathology to an average of 15 weeks after first dose. | Time Frame | From date of randomization to 5.5 years after randomization | Time Frame | From date of randomization to 5.5 years after randomization | Time Frame | From screening pathology to an average of 15 weeks after first dose | Time Frame | From date of randomization to 5.5 years after date of resection | Time Frame | From screening pathology to an average of 15 weeks after first dose. | Time Frame | From date of randomization to 5.5 years after randomization. | Time Frame | From date of screening to 6 months after last dose of IP | Time Frame | From date of screening to 6 months after last dose of IP | Time Frame | From date of randomization to 2 months after resection | Time Frame | From date of randomization to 3 months after last dose of IP | Time Frame | 64 months |
Description | Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes. | Description | An event defined as documented RECIST 1.1 local or distant recurrence of lung cancer; death due to any cause; disease progression that precludes surgery or discovered upon attempting surgery that prevents completion of surgery. | Description | To assess disease-related symptoms, functioning, and global health status/quality of life in patients. | Description | To assess disease-related symptoms, functioning, and global health status/quality of life in patients. | Description | To assess concentration of durvalumab in bloodstream. | Description | To evaluate the presence of antibodies following treatment with study medications. |
Browse Conditions
Sequence: | 192394941 | Sequence: | 192394942 | Sequence: | 192394947 | Sequence: | 192394943 | Sequence: | 192394944 | Sequence: | 192394945 | Sequence: | 192394946 | Sequence: | 192394948 | Sequence: | 192394949 | Sequence: | 192394950 |
Mesh Term | Lung Neoplasms | Mesh Term | Carcinoma, Non-Small-Cell Lung | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Neoplasms | Mesh Term | Thoracic Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Respiratory Tract Diseases | Mesh Term | Carcinoma, Bronchogenic | Mesh Term | Bronchial Neoplasms |
Downcase Mesh Term | lung neoplasms | Downcase Mesh Term | carcinoma, non-small-cell lung | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract neoplasms | Downcase Mesh Term | thoracic neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | carcinoma, bronchogenic | Downcase Mesh Term | bronchial neoplasms |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48064101 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | AstraZeneca |
Overall Officials
Sequence: | 29125433 |
Role | Principal Investigator |
Name | John Heymach, MD |
Affiliation | UT MD Anderson Cancer Institute |
Design Group Interventions
Sequence: | 67808131 | Sequence: | 67808132 | Sequence: | 67808133 | Sequence: | 67808134 | Sequence: | 67808135 | Sequence: | 67808136 | Sequence: | 67808137 | Sequence: | 67808138 | Sequence: | 67808139 | Sequence: | 67808140 |
Design Group Id | 55310918 | Design Group Id | 55310919 | Design Group Id | 55310918 | Design Group Id | 55310919 | Design Group Id | 55310918 | Design Group Id | 55310919 | Design Group Id | 55310918 | Design Group Id | 55310919 | Design Group Id | 55310918 | Design Group Id | 55310919 |
Intervention Id | 52215666 | Intervention Id | 52215667 | Intervention Id | 52215668 | Intervention Id | 52215668 | Intervention Id | 52215669 | Intervention Id | 52215669 | Intervention Id | 52215670 | Intervention Id | 52215670 | Intervention Id | 52215671 | Intervention Id | 52215671 |
Eligibilities
Sequence: | 30604343 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 120 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age ≥18 years Exclusion Criteria: History of allogeneic organ transplantation |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253923711 |
Number Of Facilities | 231 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 120 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 12 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30351704 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Caregiver Masked | True |
Intervention Other Names
Sequence: | 26543156 |
Intervention Id | 52215666 |
Name | MEDI4736 |
Responsible Parties
Sequence: | 28725073 |
Responsible Party Type | Sponsor |
Ipd Information Types
Sequence: | 3318216 | Sequence: | 3318217 |
Name | Study Protocol | Name | Statistical Analysis Plan (SAP) |
]]>
https://zephyrnet.com/NCT03800121
2018-11-19
https://zephyrnet.com/?p=NCT03800121
NCT03800121https://www.clinicaltrials.gov/study/NCT03800121?tab=tableEmilie REDERSTORFFerederstorff@cgfl.fr03 80 73 75 00Sarcomas are rare cancers with a high risk of metastatic progression and a major pejorative factor with respect to patient survival. The estimation of the metastatic risk of sarcomas is very complex given the histological heterogeneity of this entity. It is therefore essential that, at diagnosis, a reliable evaluation of this metastatic potential be made, in order to adapt the therapeutic strategy as well as possible.
It has recently been discovered that sarcomas secrete many exosomes that appear to play an important role in tumorogenesis, growth, tumor progression and the onset of metastases. They contain many proteins and nucleic acids (DNA, RNA, microRNA), reflecting the characteristics of the tumor. It has been shown that the amount of exosomes can be correlated with the grade of malignancy of the tumor. Present in the blood, exosomes offer the possibility of non-invasively analyzing the molecular information of the cancer cell. As a result, the study of serum exosomes derived from sarcomas has a high potential as a liquid biopsy to evaluate cancer pathogenesis, progression, and treatment efficacy.
The purpose of this study is to demonstrate in patients with sarcomas that exosomes can be used to monitor their disease and be used as a predictor of the risk of recurrence.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2022-04-05 |
Start Month Year | November 19, 2018 |
Primary Completion Month Year | November 19, 2022 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-04-05 |
Detailed Descriptions
Sequence: | 20838609 |
Description | The main objective of this pilot study is to quantify exosomes and analyze their protein and RNA content in patients with sarcoma with disease:
localized before and after treatment with surgery, The secondary objectives are: Determine whether the initial exosome concentration and the protein and RNA profile they contain vary with the localized or metastatic stage of the disease. |
Facilities
Sequence: | 201181501 | Sequence: | 201181502 | Sequence: | 201181503 |
Status | Recruiting | Status | Recruiting | Status | Recruiting |
Name | CHU de Besançon | Name | Centre Georges François Leclerc | Name | CHU de Poitiers |
City | Besançon | City | Dijon | City | Poitiers |
Zip | 25000 | Zip | 21000 | Zip | 86000 |
Country | France | Country | France | Country | France |
Facility Contacts
Sequence: | 28264829 | Sequence: | 28264830 | Sequence: | 28264831 | Sequence: | 28264832 |
Facility Id | 201181501 | Facility Id | 201181501 | Facility Id | 201181502 | Facility Id | 201181503 |
Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | primary |
Name | Loic CHAIGNEAU | Name | Alice HERVIEU | Name | Nicolas ISAMBERT, PU-PH | ||
echaigneau@chu-besancon.fr | ahervieu@cgfl.fr | nicolas.isambert@chu-poitiers.fr | |||||
Phone | 03 80 73 75 00 | Phone | 05 49 44 45 38 | ||||
Facility Investigators
Sequence: | 18429402 | Sequence: | 18429403 | Sequence: | 18429404 | Sequence: | 18429405 | Sequence: | 18429406 | Sequence: | 18429407 |
Facility Id | 201181501 | Facility Id | 201181501 | Facility Id | 201181502 | Facility Id | 201181502 | Facility Id | 201181503 | Facility Id | 201181503 |
Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator | Role | Sub-Investigator |
Name | Elsa KALBACHER | Name | Guillaume MEYNARD | Name | Sylvain CAUSERET | Name | Isabelle DESMOULINS | Name | Sheik EMAMBUX | Name | Camille EVRARD |
Conditions
Sequence: | 52470947 |
Name | Sarcoma |
Downcase Name | sarcoma |
Id Information
Sequence: | 40373524 |
Id Source | org_study_id |
Id Value | 2018-A01393-52 |
Countries
Sequence: | 42809047 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55926253 | Sequence: | 55926254 |
Title | Localized sarcoma with neoadjuvant chemotherapy | Title | Metastatic or locally advanced sarcoma |
Description | In total, several blood tests specific to the EXOSARC study will be necessary:
A first blood test of 7 mL during the initial assessment (inclusion) |
Description | In total, several blood tests specific to the EXOSARC study will be necessary :
A first blood of 7 mL during the initial assessment (inclusion) |
Interventions
Sequence: | 52781179 |
Intervention Type | Biological |
Name | Blood samples |
Description | Localized sarcoma group : 1 blood sample during inclusion (7 ml) + 1 blood sample before surgery (32 ml) + 1 blood sample 1 month after surgery (32 ml) + 1 blood sample 3 month after surgery (32 ml) + 1 blood sample 6 month after surgery (32 ml)
Metastatic sarcoma group : 1 blood sample during inclusion (7 ml) + 1 blood sample during chemotherapy cure 1 (32 ml) + 1 blood sample during chemotherapy cure 3 (32 ml) + 1 blood sample during chemotherapy cure 6 (32 ml) |
Keywords
Sequence: | 80275626 |
Name | exosomes |
Downcase Name | exosomes |
Design Outcomes
Sequence: | 178503443 |
Outcome Type | primary |
Measure | concentration of exosomes in blood |
Time Frame | up to 6 months after inclusion |
Description | blood samples |
Browse Conditions
Sequence: | 194632159 | Sequence: | 194632160 | Sequence: | 194632161 | Sequence: | 194632162 |
Mesh Term | Sarcoma | Mesh Term | Neoplasms, Connective and Soft Tissue | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms |
Downcase Mesh Term | sarcoma | Downcase Mesh Term | neoplasms, connective and soft tissue | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48597856 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Centre Georges Francois Leclerc |
Central Contacts
Sequence: | 12085491 | Sequence: | 12085492 |
Contact Type | primary | Contact Type | backup |
Name | Alice HERVIEU | Name | Emilie REDERSTORFF |
Phone | 03 80 73 75 00 | Phone | 03 80 73 75 00 |
ahervieu@cgfl.fr | erederstorff@cgfl.fr | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68560360 | Sequence: | 68560361 |
Design Group Id | 55926253 | Design Group Id | 55926254 |
Intervention Id | 52781179 | Intervention Id | 52781179 |
Eligibilities
Sequence: | 30937356 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Patients with soft tissue sarcoma |
Criteria | Inclusion Criteria:
Men and women newly diagnosed with localized, metastatic or locally advanced soft tissue sarcoma Exclusion Criteria: Patients who meet at least one of the following criteria will not be eligible: Patient with another synchronous tumor, |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254246486 |
Number Of Facilities | 3 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30682977 |
Observational Model | Cohort |
Time Perspective | Prospective |
Intervention Other Names
Sequence: | 26822672 | Sequence: | 26822673 |
Intervention Id | 52781179 | Intervention Id | 52781179 |
Name | Localized sarcoma | Name | Metastatic sarcoma |
Responsible Parties
Sequence: | 29049706 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800108
2018-05-30
https://zephyrnet.com/?p=NCT03800108
NCT03800108https://www.clinicaltrials.gov/study/NCT03800108?tab=tableNANANAThis study evaluates the role of subthalamic nucleus (STN) stimulation location and frequency on a range of cognitive processes in Parkinson’s patients who have undergone Deep Brain Stimulation (DBS).
<![CDATA[
Studies
Study First Submitted Date | 2018-05-23 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2022-08-31 |
Start Month Year | May 30, 2018 |
Primary Completion Month Year | September 30, 2023 |
Verification Month Year | August 2022 |
Verification Date | 2022-08-31 |
Last Update Posted Date | 2022-08-31 |
Detailed Descriptions
Sequence: | 20850603 |
Description | Pre- and post- DBS implantation brain scans will be reviewed by the study team to see if patients' DBS settings can be personalized. If so, study subjects will undergo adjustments to their DBS settings and be asked to perform cognitive tests. Some patients will be asked to come back for a second visit for brain scans. |
Facilities
Sequence: | 201277247 |
Name | Cleveland Clinic |
City | Cleveland |
State | Ohio |
Zip | 44195 |
Country | United States |
Conditions
Sequence: | 52503084 |
Name | Parkinson Disease |
Downcase Name | parkinson disease |
Id Information
Sequence: | 40395924 |
Id Source | org_study_id |
Id Value | 17-1350 |
Countries
Sequence: | 42832463 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55959191 |
Group Type | Other |
Title | Personalized DBS adjustments |
Description | Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs |
Interventions
Sequence: | 52811073 |
Intervention Type | Procedure |
Name | Personalized DBS adjustments |
Description | Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs |
Design Outcomes
Sequence: | 178616979 | Sequence: | 178616980 | Sequence: | 178616981 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Reaction time | Measure | Verbal Fluency | Measure | Finger tapping speed |
Time Frame | 30-60 minutes after stimulation adjustment | Time Frame | 30-60 minutes after stimulation adjustment | Time Frame | 30-60 minutes after stimulation adjustment |
Description | Subjects will complete one or more measures of cognitive processing requiring speeded responses to stimuli. Changes in reaction time will be compared to 'off stimulation' | Description | Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation' | Description | Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation' |
Browse Conditions
Sequence: | 194752853 | Sequence: | 194752854 | Sequence: | 194752855 | Sequence: | 194752856 | Sequence: | 194752857 | Sequence: | 194752858 | Sequence: | 194752859 | Sequence: | 194752860 | Sequence: | 194752861 |
Mesh Term | Parkinson Disease | Mesh Term | Parkinsonian Disorders | Mesh Term | Basal Ganglia Diseases | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Movement Disorders | Mesh Term | Synucleinopathies | Mesh Term | Neurodegenerative Diseases |
Downcase Mesh Term | parkinson disease | Downcase Mesh Term | parkinsonian disorders | Downcase Mesh Term | basal ganglia diseases | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | movement disorders | Downcase Mesh Term | synucleinopathies | Downcase Mesh Term | neurodegenerative diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48626626 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Darlene Floden |
Overall Officials
Sequence: | 29458469 |
Role | Principal Investigator |
Name | Darlene Floden, PhD |
Affiliation | The Cleveland Clinic |
Design Group Interventions
Sequence: | 68601126 |
Design Group Id | 55959191 |
Intervention Id | 52811073 |
Eligibilities
Sequence: | 30954615 |
Gender | All |
Minimum Age | 40 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Between 40 and 70 years of age, Exclusion Criteria: History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy) Hearing or visual impairment precluding cognitive testing. Exclusion criteria for Day 2 procedures: Inability to safely undergo MRI procedure (i.e., metal objects like prostheses, pacemakers) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253909874 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 40 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Designs
Sequence: | 30700195 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29066961 |
Responsible Party Type | Sponsor-Investigator |
Name | Darlene Floden |
Title | Staff Neuropsychologist |
Affiliation | The Cleveland Clinic |
]]>
https://zephyrnet.com/NCT03800095
2019-03-14
https://zephyrnet.com/?p=NCT03800095
NCT03800095https://www.clinicaltrials.gov/study/NCT03800095?tab=tableLise LACLAUTREdrci@chu-clermontferrand.fr0473754963Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.
Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients’ quality of life .
<![CDATA[
Studies
Study First Submitted Date | 2018-09-13 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2021-03-24 |
Start Month Year | March 14, 2019 |
Primary Completion Month Year | August 14, 2023 |
Verification Month Year | March 2021 |
Verification Date | 2021-03-31 |
Last Update Posted Date | 2021-03-24 |
Detailed Descriptions
Sequence: | 20852120 |
Description | Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.
Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life . |
Facilities
Sequence: | 201287202 | Sequence: | 201287203 | Sequence: | 201287204 | Sequence: | 201287205 | Sequence: | 201287206 | Sequence: | 201287207 |
Status | Not yet recruiting | Status | Recruiting | Status | Recruiting | Status | Not yet recruiting | Status | Recruiting | Status | Not yet recruiting |
Name | Centre Hospitalier Métropole Savoie | Name | Chu Clermont-Ferrand | Name | Chu Limoges | Name | Centre Léon Bérard | Name | Institut de Cancérologie de la Loire | Name | CH Jacques Lacarin |
City | Chambéry | City | Clermont-Ferrand | City | Limoges | City | Lyon | City | Saint-Priest-en-Jarez | City | Vichy |
Zip | 73000 | Zip | 63003 | Zip | 87042 | Zip | 69008 | Zip | 42271 | Zip | 03200 |
Country | France | Country | France | Country | France | Country | France | Country | France | Country | France |
Facility Contacts
Sequence: | 28281681 | Sequence: | 28281682 | Sequence: | 28281683 | Sequence: | 28281684 | Sequence: | 28281685 | Sequence: | 28281686 |
Facility Id | 201287202 | Facility Id | 201287203 | Facility Id | 201287204 | Facility Id | 201287205 | Facility Id | 201287206 | Facility Id | 201287207 |
Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary |
Name | Laurent SUTTON | Name | Lise LACLAUTRE | Name | Stéphane MOREAU | Name | Anne-Sophie MICHALLET | Name | Denis GUYOTAT | Name | Karine SOULIER-GUERIN |
drci@chu-clermontferrand.fr | |||||||||||
Phone | 0473754963 | ||||||||||
Facility Investigators
Sequence: | 18438572 | Sequence: | 18438573 | Sequence: | 18438574 | Sequence: | 18438575 | Sequence: | 18438576 | Sequence: | 18438577 | Sequence: | 18438578 | Sequence: | 18438579 | Sequence: | 18438580 | Sequence: | 18438581 | Sequence: | 18438582 | Sequence: | 18438583 |
Facility Id | 201287202 | Facility Id | 201287202 | Facility Id | 201287203 | Facility Id | 201287203 | Facility Id | 201287204 | Facility Id | 201287204 | Facility Id | 201287205 | Facility Id | 201287205 | Facility Id | 201287206 | Facility Id | 201287206 | Facility Id | 201287207 | Facility Id | 201287207 |
Role | Principal Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Sub-Investigator | Role | Principal Investigator | Role | Sub-Investigator |
Name | Laurent SUTTON | Name | Matthieu CRETINON | Name | Virginie GUASTELLA | Name | Jacques-Olivier BAY | Name | Stéphane MOREAU | Name | Bertrand SARDIN | Name | Anne-Sophie MICHALLET | Name | Gisèle CHVETZOF | Name | Denis GUYOTAT | Name | Stéphanie MORISSON | Name | Karine SOULIER-GUERIN | Name | Franck DELPRETTI |
Conditions
Sequence: | 52507033 | Sequence: | 52507034 | Sequence: | 52507035 | Sequence: | 52507036 |
Name | Acute Myeloid Leukemia | Name | Myelodysplastic Syndrome | Name | Diffuse Large B Cell Lymphoma | Name | Palliative Care |
Downcase Name | acute myeloid leukemia | Downcase Name | myelodysplastic syndrome | Downcase Name | diffuse large b cell lymphoma | Downcase Name | palliative care |
Id Information
Sequence: | 40398822 | Sequence: | 40398823 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | CHU-406 | Id Value | 2017-A02515-48 |
Id Type | Other Identifier | ||
Id Type Description | 2017-A02515-48 | ||
Countries
Sequence: | 42835119 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55963389 | Sequence: | 55963390 |
Group Type | Experimental | Group Type | Experimental |
Title | Conventional haematological care | Title | Conventional care associated with a monthly consultation |
Description | Patients with haematological malignancy Conventional haematological care | Description | Patients with haematological malignancy Conventional care associated with a monthly consultation realized by a palliative and supportive care team |
Interventions
Sequence: | 52814921 |
Intervention Type | Drug |
Name | Early palliative care integration |
Description | The follow-up time for each patient is 12 months with evaluation of the main objective by a standardized questionnaire: The Functional Assessment of Cancer Therapy-Anaemia (FACT-An) Scale at 6 months. Throughout the study, patients included will receive conventional haematological care and the interventional arm will benefit in addition to a monthly consultation by a palliative care team. |
Keywords
Sequence: | 80324598 | Sequence: | 80324599 | Sequence: | 80324600 | Sequence: | 80324601 | Sequence: | 80324602 |
Name | Supportive care | Name | Early palliative care | Name | Quality of life | Name | Symptoms management | Name | Haematological malignancy |
Downcase Name | supportive care | Downcase Name | early palliative care | Downcase Name | quality of life | Downcase Name | symptoms management | Downcase Name | haematological malignancy |
Design Outcomes
Sequence: | 178629639 | Sequence: | 178629637 | Sequence: | 178629638 | Sequence: | 178629640 | Sequence: | 178629641 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | overall survival | Measure | Quality of life evaluation: standardized questionnaire | Measure | Presence of discomfort symptoms | Measure | Satisfaction of the care pathwaydesired by the patient | Measure | cost-effectiveness analysis |
Time Frame | at day 1 : from the randomization until the date of death or until 1 year [study end]. | Time Frame | at 6 months | Time Frame | at Day 0, 3 months, 6 months, 9 months, 12 months | Time Frame | at 12 months or death | Time Frame | at 12 months or death |
Description | Evaluation of quality of life by a standardized questionnaire : Functional Assessment of Cancer Therapy-Anemia (FACT-An). The higher is the score the better is the quality of life. FACT-An is composed by five subscales: Physical Well-Being [score range 0-28], Social/Family Well-Being [score range 0-28], Emotional Well-Being [score range 0-24], and Functional Well-Being [score range 0-28] and specific questions concerning anemia [score range 0-80]. The score at each items is summed. The sum is multiplied par the number of items in the subscale and then divided by the number of items answered. This produces the subscale score. The subscale scores are added to derive total score [score range 0-188]. | Description | evaluated by Edmonton scale (depressive syndrome measured by the geriatric depression scale GDS) | Description | matching between patients desires writing in the medical file and the providing care | Description | The cost criteria selected will be all the direct medical costs inherent in care in both arms (costs of hospitalizations, consultations, treatments, medical devices). |
Browse Conditions
Sequence: | 194767661 | Sequence: | 194767662 | Sequence: | 194767663 | Sequence: | 194767664 | Sequence: | 194767665 | Sequence: | 194767666 | Sequence: | 194767667 | Sequence: | 194767668 | Sequence: | 194767669 | Sequence: | 194767670 | Sequence: | 194767671 | Sequence: | 194767672 | Sequence: | 194767673 | Sequence: | 194767674 | Sequence: | 194767675 |
Mesh Term | Neoplasms | Mesh Term | Lymphoma, Large B-Cell, Diffuse | Mesh Term | Hematologic Neoplasms | Mesh Term | Myelodysplastic Syndromes | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Bone Marrow Diseases | Mesh Term | Hematologic Diseases | Mesh Term | Lymphoma, B-Cell | Mesh Term | Lymphoma, Non-Hodgkin | Mesh Term | Lymphoma | Mesh Term | Lymphoproliferative Disorders | Mesh Term | Lymphatic Diseases | Mesh Term | Immunoproliferative Disorders | Mesh Term | Immune System Diseases | Mesh Term | Neoplasms by Site |
Downcase Mesh Term | neoplasms | Downcase Mesh Term | lymphoma, large b-cell, diffuse | Downcase Mesh Term | hematologic neoplasms | Downcase Mesh Term | myelodysplastic syndromes | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | bone marrow diseases | Downcase Mesh Term | hematologic diseases | Downcase Mesh Term | lymphoma, b-cell | Downcase Mesh Term | lymphoma, non-hodgkin | Downcase Mesh Term | lymphoma | Downcase Mesh Term | lymphoproliferative disorders | Downcase Mesh Term | lymphatic diseases | Downcase Mesh Term | immunoproliferative disorders | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | neoplasms by site |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48630078 | Sequence: | 48630079 | Sequence: | 48630080 | Sequence: | 48630081 | Sequence: | 48630082 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | UNKNOWN | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | University Hospital, Clermont-Ferrand | Name | Fondation Apicil | Name | Association des foulées de la Haute Lozère | Name | Association CEMSBM | Name | Connaître et Combattre les Myélodysplasies |
Central Contacts
Sequence: | 12095048 |
Contact Type | primary |
Name | Lise LACLAUTRE |
Phone | 0473754963 |
drci@chu-clermontferrand.fr | |
Role | Contact |
Design Group Interventions
Sequence: | 68606459 | Sequence: | 68606460 |
Design Group Id | 55963390 | Design Group Id | 55963389 |
Intervention Id | 52814921 | Intervention Id | 52814921 |
Eligibilities
Sequence: | 30956743 |
Gender | All |
Minimum Age | 70 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients are over 70 years old Exclusion Criteria: All patients with a curative project (induction chemotherapy ou allogenic transplantation) |
Adult | False |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253953286 |
Number Of Facilities | 6 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 70 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30702319 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Masking Description | no masking |
Responsible Parties
Sequence: | 29069086 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800082
2021-08-01
https://zephyrnet.com/?p=NCT03800082
NCT03800082https://www.clinicaltrials.gov/study/NCT03800082?tab=tableMyra Leyden, MAmyra.leyden@utoronto.ca416.978.1327The overall goal of this program of research is to develop and systematically evaluate an integrated smartphone and web-based intervention (at heart [formerly called HEARTPA♀N]) to provide evidence-informed symptom triage and self-management support to reduce pain and increase health-related quality of life (HRQoL) in women with heart disease. The investigators will use the individual and family self-management theory, mobile device functionality and the pervasive information architecture of mHealth interventions, and follow the sequential phased approach recommended by the Medical Research Council (MRC) to develop at heart (progressive WebApp). Funding was received from the Canadian Institutes of Health Research to develop the architecture and conduct usability testing (Phase 2, complete) to ensure it is easy to use, efficient and satisfying to operate. In Phase 3 (current proposal), feasibility in terms of implementation (accrual rates, acceptability and level of engagement) and initial estimation of effectiveness outcomes (estimates of magnitude of effect) will be evaluated in a pilot randomized controlled trial (RCT). The Phase 3 pilot study will enable the investigators to refine the prototype, inform the methodology, and calculate the sample size for a larger multi-site RCT (Phase 4, future work).
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-11 |
Last Update Posted Date | 2021-07-28 |
Start Month Year | August 1, 2021 |
Primary Completion Month Year | August 31, 2022 |
Verification Month Year | July 2021 |
Verification Date | 2021-07-31 |
Last Update Posted Date | 2021-07-28 |
Detailed Descriptions
Sequence: | 20721654 |
Description | Phase 3 (Study 3): Pilot Randomized Controlled Trial of the at heart (formerly called HEARTPA♀N) Intervention.
The at heart intervention is the first of its kind; there are no previous trials of the efficacy of such an intervention to decrease pain and improve HRQoL in women with heart disease. The investigators will undertake a process and preliminary effect evaluation of the intervention for women with heart disease, as guided by the MRC framework. The primary objective is to determine the feasibility of implementing an RCT of the intervention. A process evaluation will be conducted to examine: 1) the feasibility of randomization, recruitment and retention, 2) acceptability and barriers to implementing the intervention (including the symptom triage algorithms), and 3) the extent of engagement with the intervention. The investigators will also undertake a preliminary efficacy evaluation of the primary outcomes. Based on the investigator's theorized mechanism of change, they hypothesize that the intervention will reduce pain and improve HRQoL (primary outcomes). The investigators will assess the variability and sensitivity to change for both outcomes. Prior to conducting a full scale RCT of a complex intervention, such as at heart, the MRC recommends that a pilot trial be performed. Results from this pilot trial will inform the success of a future RCT in three ways: 1) help determine sample size calculation for the full-scale trial, 2) test procedures (recruitment, randomization, follow-up), which will make up the design of the full-scale trial, and 3) test feasibility of implementing the intervention, particularly by estimating rates of recruitment and retention. Triage algorithms and self-management interventions will be developed using a strong theoretical framework, informed by needs assessments and a comprehensive integrated mixed methods systematic review, with preliminary acceptability and usability testing by end-users. The investigators anticipate minimal risk to safety but will track adverse events using the Adverse Event Form. Moreover, latest WebApp technologies have been integrated through the use of a Chatbot named 'Holly'. |
Facilities
Sequence: | 200108476 |
Status | Recruiting |
Name | Monica Parry |
City | Toronto |
State | Ontario |
Zip | M5T 1P8 |
Country | Canada |
Facility Contacts
Sequence: | 28106426 | Sequence: | 28106427 |
Facility Id | 200108476 | Facility Id | 200108476 |
Contact Type | primary | Contact Type | backup |
Name | Monica Parry, PhD | Name | Arland O'Hara, BA |
monica.parry@utoronto.ca | arland.ohara@utoronto.ca | ||
Phone | 416.946.3561 | ||
Conditions
Sequence: | 52171271 | Sequence: | 52171272 | Sequence: | 52171273 | Sequence: | 52171274 |
Name | Pain | Name | Cardiac Ischemia | Name | Women | Name | Pain, Chronic |
Downcase Name | pain | Downcase Name | cardiac ischemia | Downcase Name | women | Downcase Name | pain, chronic |
Id Information
Sequence: | 40158662 |
Id Source | org_study_id |
Id Value | 389044 |
Countries
Sequence: | 42568966 |
Name | Canada |
Removed | False |
Design Groups
Sequence: | 55593212 | Sequence: | 55593213 |
Group Type | No Intervention | Group Type | Experimental |
Title | Control | Title | Treatment |
Description | Participants allocated to the control group will receive the usual care and supports provided to women with cardiac pain, including usual clinic appointments and follow-up. | Description | Participants allocated to the treatment group will also learn how to use the progressive WebApp intervention. The intervention will be delivered on restricted password-protected applications that will permit tracking of adherence (number of logins to app and website using Google Analytics). Participants will be encouraged to log-in regularly to the progressive WebApp (via automated alerts) over the 3-month period to complete a Heart and/or Wellness Check. A Chatbot named 'Holly' will assist women with log-in and maintaining health and wellness. Participants will be directed to the PC for technical problems. |
Interventions
Sequence: | 52485518 |
Intervention Type | Behavioral |
Name | at heart (changed from HEARTPA♀N during usability testing) |
Description | An integrated smartphone and web-based intervention (at heart) to provide evidence-informed symptom triage and self-management support to reduce pain and increase health-related quality of life (HRQoL) in women with heart disease. The intervention for participants randomized to the treatment group will consist of regular use of a progressive WebApp that is managed by a Chatbot named 'Holly', in addition to usual care, for a period of 3 months. |
Keywords
Sequence: | 79868598 |
Name | Women, Self-Management, Cardiac Pain |
Downcase Name | women, self-management, cardiac pain |
Design Outcomes
Sequence: | 177378994 | Sequence: | 177378995 | Sequence: | 177378996 | Sequence: | 177378997 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Feasibility (recruitment, retention, engagement) | Measure | Feasibility (acceptability, satisfaction) | Measure | Pain (Brief Pain Inventory) | Measure | Health-related quality of life (HRQOL) |
Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months |
Description | A process evaluation will be used to assess the feasibility of the implementation of the intervention. The PC will track any issues or difficulties encountered during trial implementation, such as problems using the app. Engagement will be assessed using Google Analytics, which will track patterns of app and website usage. Engagement with the app diary will be defined as 100% with daily entries for 3 months. Engagement with goal setting will be defined as 100% when 12 goals are identified over the 3-month period. Criteria for implementation success: recruitment rates > 70%, retention > 85%, minimal technical difficulties reported by < 10%, engagement > 80%, and minimal missed responses. Prevalence of refusal, retention, engagement and technical difficulties reported will be calculated with their 95% confidence intervals. | Description | The investigators will also assess acceptability and satisfaction in all participants in the intervention group using a modified Acceptability e-Scale (AES). The modified AES includes 9 items, each with a 5-point Likert response. Higher scores represent better acceptability/satisfaction. Responses are summed and averaged. Criteria for implementation success: AES mean summary score > 4. | Description | A preliminary efficacy evaluation will also be undertaken focusing on the outcomes of pain. Pain will be measured using the Brief Pain Inventory-Short Form (BPI-SF), which rates pain severity and the degree to which pain interferes with mood, sleep, and other physical activities such as work, social activity and relations with others. We will investigate the variability and sensitivity to change for pain (T2-T1). We will calculate the number of participants who report clinically meaningful decreases in pain, which has been defined for the BPI-SF as a two-point difference in worst pain. Variability will be estimated using the mean/median scores and standard deviation, in each group separately, at pre and post-test. | Description | A preliminary efficacy evaluation will also be undertaken focusing on the outcomes of HRQOL. HRQOL will be measured using the SF-36v2TM, which contains 36 items and yields a score for each of the 8 domains of health: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role emotional), and mental health. We will investigate the variability and sensitivity to change for HRQOL (T2-T1). Sensitivity to change will be assessed by determining the number of participants who had a clinically meaningful increase in HRQOL: ≥ 15 points in physical functioning, general health and mental health; ≥ 16.7 in role emotional functioning; ≥ 18.5 points in role physical functioning and vitality; ≥ 20 points in bodily pain; and ≥ 25 points in social functioning. |
Browse Conditions
Sequence: | 193486879 | Sequence: | 193486880 | Sequence: | 193486881 | Sequence: | 193486882 | Sequence: | 193486883 | Sequence: | 193486884 | Sequence: | 193486885 | Sequence: | 193486886 | Sequence: | 193486887 | Sequence: | 193486888 | Sequence: | 193486889 | Sequence: | 193486890 | Sequence: | 193486891 |
Mesh Term | Heart Diseases | Mesh Term | Coronary Artery Disease | Mesh Term | Myocardial Ischemia | Mesh Term | Ischemia | Mesh Term | Chronic Pain | Mesh Term | Cardiovascular Diseases | Mesh Term | Pathologic Processes | Mesh Term | Pain | Mesh Term | Neurologic Manifestations | Mesh Term | Coronary Disease | Mesh Term | Arteriosclerosis | Mesh Term | Arterial Occlusive Diseases | Mesh Term | Vascular Diseases |
Downcase Mesh Term | heart diseases | Downcase Mesh Term | coronary artery disease | Downcase Mesh Term | myocardial ischemia | Downcase Mesh Term | ischemia | Downcase Mesh Term | chronic pain | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | pain | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | coronary disease | Downcase Mesh Term | arteriosclerosis | Downcase Mesh Term | arterial occlusive diseases | Downcase Mesh Term | vascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319324 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Toronto |
Overall Officials
Sequence: | 29285370 |
Role | Principal Investigator |
Name | Monica Parry, PhD |
Affiliation | University of Toronto |
Central Contacts
Sequence: | 12008886 | Sequence: | 12008887 |
Contact Type | primary | Contact Type | backup |
Name | Monica Parry, PhD | Name | Myra Leyden, MA |
Phone | 416.946-3561 | Phone | 416.978.1327 |
monica.parry@utoronto.ca | myra.leyden@utoronto.ca | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68149175 |
Design Group Id | 55593213 |
Intervention Id | 52485518 |
Eligibilities
Sequence: | 30765374 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
women greater than 18 years of age with obstructive and non-obstructive CAD pain, post PCI/cardiac surgery pain lasting greater than 3 months Exclusion Criteria: severe cognitive impairment assessed using the Six-Item Screener |
Gender Description | We will use the PRAXY Gender Questionnaire – Short Form |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253884876 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30511540 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | Single |
Masking Description | It is not possible to blind the participants to group allocation due to the specific nature of the intervention; however, a data analyst at the University of Toronto's Faculty of Nursing who is blinded to treatment allocation will conduct the analysis ensuring neutrality of the outcome assessment. |
Intervention Model Description | A two group parallel single blind pilot RCT. |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28877835 |
Responsible Party Type | Principal Investigator |
Name | Monica Parry |
Title | Associate Professor and Coordinator, Nurse Practitioner Programs |
Affiliation | University of Toronto |
Study References
Sequence: | 52063423 |
Pmid | 32156763 |
Reference Type | derived |
Citation | Parry M, Dhukai A, Clarke H, Bjornnes AK, Cafazzo JA, Cooper L, Harvey P, Katz J, Lalloo C, Leegaard M, Legare F, Lovas M, McFetridge-Durdle J, McGillion M, Norris C, Parente L, Patterson R, Pilote L, Pink L, Price J, Stinson J, Uddin A, Victor JC, Watt-Watson J, Auld C, Faubert C, Park D, Park M, Rickard B, DeBonis VS. Development and usability testing of HEARTPAfemale symbolN: protocol for a mixed methods strategy to develop an integrated smartphone and web-based intervention for women with cardiac pain. BMJ Open. 2020 Mar 9;10(3):e033092. doi: 10.1136/bmjopen-2019-033092. |
]]>
https://zephyrnet.com/NCT03800069
2018-12-03
https://zephyrnet.com/?p=NCT03800069
NCT03800069https://www.clinicaltrials.gov/study/NCT03800069?tab=tableNANANAThis study is testing the accuracy of a point of care device that tests liver function within 20 minutes. The target population will be any adult who had liver function tests ordered and to be drawn on the same day as enrollment.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-12-04 |
Start Month Year | December 3, 2018 |
Primary Completion Month Year | May 30, 2019 |
Verification Month Year | December 2020 |
Verification Date | 2020-12-31 |
Last Update Posted Date | 2020-12-04 |
Detailed Descriptions
Sequence: | 20852135 |
Description | Outpatient diagnostics are slow and expensive due to turnaround times, complex workflows and high cost. Sometimes patients do not make it to laboratory testing if a lab is not available on site. Delays in testing can affect medical outcomes or patients can be lost to follow up.
Group K developed a paper microfluidic platform with an accompanying mobile application(app). The paper microfluidic device is a simple, inexpensive wax backed device with three testing areas. These areas have a mix of dried proprietary reagents that when combined with a patients drop of blood, or in the future, saliva or urine, will produce results in a color change. An app is then used to interpret the color change and output results to a doctor. The target population is adults who have an indication to collect a liver function panel that will be drawn on the same day as their clinic visit or during their inpatient hospital |
Facilities
Sequence: | 201287245 |
Name | The Hospital of the University of Pennslyvania |
City | Philadelphia |
State | Pennsylvania |
Zip | 19104 |
Country | United States |
Conditions
Sequence: | 52507071 | Sequence: | 52507072 | Sequence: | 52507073 | Sequence: | 52507074 |
Name | Liver Diseases | Name | Healthy | Name | Cirrhosis, Liver | Name | Fibrosis |
Downcase Name | liver diseases | Downcase Name | healthy | Downcase Name | cirrhosis, liver | Downcase Name | fibrosis |
Id Information
Sequence: | 40398844 |
Id Source | org_study_id |
Id Value | 829476 |
Countries
Sequence: | 42835140 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55963432 |
Title | Arm 1 |
Description | A finger stick sample is collected and tested on the study device. |
Interventions
Sequence: | 52814958 |
Intervention Type | Device |
Name | Group K Diagnostic point of care device |
Description | Arm 1 will have a finger prick sample collected to test the ability of Group K Diagnostic point of care device and app to identify liver function values. |
Design Outcomes
Sequence: | 178629740 | Sequence: | 178629741 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Regression curve and correlation coefficient | Measure | The consistent accuracy of the diagnostic device |
Time Frame | 1 year | Time Frame | 1 year |
Description | Each data point will represent one observation or one test run. The investigators will use regression methods to determine the linear relationship between standard lab results and Group K diagnostic's device. | Description | Lowest level frequency of detection must be detected 90% of the time. This will become the functional lower limit. The same with the highest level of frequency. |
Browse Conditions
Sequence: | 194767797 | Sequence: | 194767798 | Sequence: | 194767799 | Sequence: | 194767800 | Sequence: | 194767801 |
Mesh Term | Liver Diseases | Mesh Term | Liver Cirrhosis | Mesh Term | Fibrosis | Mesh Term | Pathologic Processes | Mesh Term | Digestive System Diseases |
Downcase Mesh Term | liver diseases | Downcase Mesh Term | liver cirrhosis | Downcase Mesh Term | fibrosis | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | digestive system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48630106 | Sequence: | 48630107 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Pennsylvania | Name | Group K Diagnostics Inc. |
Overall Officials
Sequence: | 29460580 |
Role | Principal Investigator |
Name | Vandana Khungar, MD, MSc |
Affiliation | Director of Inpatient Hepatology |
Design Group Interventions
Sequence: | 68606505 |
Design Group Id | 55963432 |
Intervention Id | 52814958 |
Eligibilities
Sequence: | 30956762 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | Study population will be selected from inpatient and clinic setting at The Hospital of the University of Pennsylvania. |
Criteria | Inclusion Criteria:
Have a liver function testing for the required 6 tests completed (Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), albumin, bilirubin, and total protein) Exclusion Criteria: Inadequate blood sample obtained from finger stick |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253953380 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 5 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30702338 |
Observational Model | Cohort |
Time Perspective | Cross-Sectional |
Provided Documents
Sequence: | 2602663 | Sequence: | 2602664 |
Document Type | Study Protocol | Document Type | Informed Consent Form |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | True |
Has Sap | False | Has Sap | False |
Document Date | 2018-11-28 | Document Date | 2018-11-28 |
Url | https://ClinicalTrials.gov/ProvidedDocs/69/NCT03800069/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/69/NCT03800069/ICF_001.pdf |
Responsible Parties
Sequence: | 29069105 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800056
2021-04-23
https://zephyrnet.com/?p=NCT03800056
NCT03800056https://www.clinicaltrials.gov/study/NCT03800056?tab=tableMarie-Christine VANTYGHEM, MD,PhDmc-vantyghem@chru-lille.fr320 44 45 17Autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (APECED) is an autosomal recessive disease caused by mutations in the autoimmune regulator (AIRE) gene, characterized by the clinical triad of chronic mucocutaneous candidiasis (CMC), hypoparathyroidism, and adrenal insufficiency. CMC can be complicated by systemic candidiasis or oral squamous cell carcinomas (SCCs) and may lead to death. The role of chronic Candida infection in the etiopathogenesis of oral SCC is unclear. Long term use of fluconazole lead to emergence of C. albicans strains with azoles decreased susceptibility. CMC is associated with an impaired Th17 cell response, however, it remains unclear whether decreased serum IL-17 and IL-22 levels are related to a defect in cytokine production or to neutralizing autoantibodies resulting from mutations in the AIRE gene
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-02-16 |
Start Month Year | April 23, 2021 |
Primary Completion Month Year | April 2026 |
Verification Month Year | February 2022 |
Verification Date | 2022-02-28 |
Last Update Posted Date | 2022-02-16 |
Facilities
Sequence: | 199355800 |
Status | Recruiting |
Name | Hop Claude Huriez Chu Lille |
City | Lille |
Zip | 59037 |
Country | France |
Facility Contacts
Sequence: | 28021724 |
Facility Id | 199355800 |
Contact Type | primary |
Phone | 0320445962 |
Facility Investigators
Sequence: | 18278777 |
Facility Id | 199355800 |
Role | Principal Investigator |
Name | Marie-Christine VANTIGHEM, MD,PhD |
Conditions
Sequence: | 51993306 |
Name | Polyendocrinopathies, Autoimmune |
Downcase Name | polyendocrinopathies, autoimmune |
Id Information
Sequence: | 40019989 | Sequence: | 40019990 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 2017_36 | Id Value | 2017-A03135-48 |
Id Type | Other Identifier | ||
Id Type Description | ID-RCB number, ANSM | ||
Countries
Sequence: | 42415115 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55396646 | Sequence: | 55396647 |
Title | Group 1 APS 1 | Title | Group 2 APS2 |
Description | Patients with a APS type 1 whose molecular diagnosis (mutation of the AIRE gene) has been established in the diagnosis of the disease, regardless of their mycological status (history of mycosis) or the presence of antifungal treatment. | Description | Patients with APS type 2: – with adrenal insufficiency for 50% of them. – a delay of two weeks after stopping antifungal or antibiotic treatment in patients is to be respected. |
Keywords
Sequence: | 79586390 | Sequence: | 79586391 | Sequence: | 79586392 |
Name | APECED syndrome | Name | autoimmune polyendocrinopathy | Name | chronic mucocutaneous candidiasis |
Downcase Name | apeced syndrome | Downcase Name | autoimmune polyendocrinopathy | Downcase Name | chronic mucocutaneous candidiasis |
Design Outcomes
Sequence: | 176753772 |
Outcome Type | primary |
Measure | the frequency of appearance of Candida yeast strains |
Time Frame | Baseline: one session |
Description | the frequency of appearance of Candida yeast strains found in mycological samples from both urinary and oral patients. |
Browse Conditions
Sequence: | 192782881 | Sequence: | 192782882 | Sequence: | 192782883 | Sequence: | 192782884 |
Mesh Term | Polyendocrinopathies, Autoimmune | Mesh Term | Endocrine System Diseases | Mesh Term | Autoimmune Diseases | Mesh Term | Immune System Diseases |
Downcase Mesh Term | polyendocrinopathies, autoimmune | Downcase Mesh Term | endocrine system diseases | Downcase Mesh Term | autoimmune diseases | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48152566 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University Hospital, Lille |
Overall Officials
Sequence: | 29183115 |
Role | Principal Investigator |
Name | Marie-Christine VANTYGHEM, MD,PhD |
Affiliation | University Hospital, Lille |
Central Contacts
Sequence: | 11969112 |
Contact Type | primary |
Name | Marie-Christine VANTYGHEM, MD,PhD |
Phone | 320 44 45 17 |
mc-vantyghem@chru-lille.fr | |
Phone Extension | +33 |
Role | Contact |
Eligibilities
Sequence: | 30660803 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | 85 Years |
Healthy Volunteers | No |
Population | Patients will be included during their routine follow-up for adrenal insufficiency or hypoparathyroidism in the endocrinology department of the University Hospital of Lille, in adult or pediatric endocrinology. |
Criteria | Inclusion Criteria:
For both of groups, inclusion criteria are : children aged 0 to 17 years old with the consent of both parents, and men and women between the ages of 18 and 85. Exclusion Criteria: impossibility to receive informed information for adults, or impossibility to receive enlightened information for the holders of parental authority if minor subject |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254273703 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Maximum Age Num | 85 |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30407622 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28774142 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03800043
2019-01-15
https://zephyrnet.com/?p=NCT03800043
NCT03800043https://www.clinicaltrials.gov/study/NCT03800043?tab=tableNANANAThis study evaluates the social impact of children’s dental perception from children with or without caries experience. For this, children and their parents are shown pictures of child faces with healthy teeth, decayed teeth and teeth after dental treatment.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-06-23 |
Start Month Year | January 15, 2019 |
Primary Completion Month Year | July 31, 2019 |
Verification Month Year | June 2021 |
Verification Date | 2021-06-30 |
Last Update Posted Date | 2021-06-23 |
Detailed Descriptions
Sequence: | 20762922 |
Description | Appearance and abnormalities in the face influences the life of children: attractive children get estimated as more competent and find friends easier than those with a less attractive appearance. Therefore this study aimes to evaluate the social impact of children's dental perception from children with or without own caries experience (and their parents). Both groups (with/without caries experience) are shown pictures of children with different dental status (healthy teeth, decayed teeth and teeth after dental treatment) and asked to complete established questionnaires.The division into the groups is based on photos of the children with visible teeth.
The results should be evaluated descriptively and graphically. Also the comparison between the answers of both groups for the three different dental status is planned. |
Facilities
Sequence: | 200458043 |
Name | Department of Preventive Dentistry, Periodontology and Cariology, University Medical Center Goettingen, Germany |
City | Göttingen |
State | Lower Saxony |
Zip | 37075 |
Country | Germany |
Conditions
Sequence: | 52277450 |
Name | Dental Caries in Children |
Downcase Name | dental caries in children |
Id Information
Sequence: | 40235456 |
Id Source | org_study_id |
Id Value | 25/2/18 |
Countries
Sequence: | 42653033 |
Name | Germany |
Removed | False |
Design Groups
Sequence: | 55711570 | Sequence: | 55711571 |
Title | Children with own caries experience | Title | Children without own caries experience |
Description | Children with own caries experience (visible on a photo; teeth clearly visible), sufficient compliance | Description | Children without own caries experience (visible on a photo; teeth clearly visible), sufficient compliance |
Keywords
Sequence: | 80018954 | Sequence: | 80018955 | Sequence: | 80018956 | Sequence: | 80018957 | Sequence: | 80018958 |
Name | Early Childhood Caries | Name | children | Name | dentistry | Name | face perception | Name | dental appearance |
Downcase Name | early childhood caries | Downcase Name | children | Downcase Name | dentistry | Downcase Name | face perception | Downcase Name | dental appearance |
Design Outcomes
Sequence: | 177770630 | Sequence: | 177770631 | Sequence: | 177770632 | Sequence: | 177770633 | Sequence: | 177770634 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary |
Measure | Children: Evaluation of the whole photos | Measure | Children: Evaluation of the mouth on the photo | Measure | Children: Evaluation of their own teeth | Measure | Why do you feel like this? | Measure | Related parents: Evaluation of the whole photos |
Time Frame | 2-3 minutes | Time Frame | 2-3 minutes | Time Frame | 1-2 minutes | Time Frame | 1-2 minutes | Time Frame | 1-2 minutes |
Description | Questionnaire: "How would you feel having a friend looking like this?" (showing the photos of the three different dental status) (4 point face scale of Soares et al. 2015) | Description | Questionnaire: "How would you feel having a friend with a mouth looking like this" (showing the photos of the three different dental status) (4 point face scale of Soares et al. 2015) | Description | Questionnaire: "How do you feel when thinking about your own teeth?" (4 point face scale of Soares et al. 2015) | Description | Questionnaire: Evaluate the pictures with the adjectives: clever, rude, kind, honest, confident, careful, helpful, stupid, naughty (4 point scale. 'strongly agree' = 4; 'agree' = 3; 'disagree' = 2; 'strongly disagree' = 1) |
Browse Conditions
Sequence: | 193892724 | Sequence: | 193892725 | Sequence: | 193892726 | Sequence: | 193892727 |
Mesh Term | Dental Caries | Mesh Term | Tooth Demineralization | Mesh Term | Tooth Diseases | Mesh Term | Stomatognathic Diseases |
Downcase Mesh Term | dental caries | Downcase Mesh Term | tooth demineralization | Downcase Mesh Term | tooth diseases | Downcase Mesh Term | stomatognathic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48418635 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Göttingen |
Overall Officials
Sequence: | 29342606 |
Role | Study Director |
Name | Annette Wiegand, Prof. Dr. |
Affiliation | Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany |
Eligibilities
Sequence: | 30827025 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 4 Years |
Maximum Age | 9 Years |
Population | children with or without caries experience and their parents |
Criteria | Inclusion Criteria:
(parent of an child of) age 4-9 years Exclusion Criteria: missing agreement to participate in the study |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254123706 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 6 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 4 |
Maximum Age Num | 9 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30572955 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28939377 |
Responsible Party Type | Principal Investigator |
Name | Claudia Tschammler |
Title | Dr. Claudia Tschammler, Principal Investigator |
Affiliation | University of Göttingen |
]]>
https://zephyrnet.com/NCT03800030
2018-10-07
https://zephyrnet.com/?p=NCT03800030
NCT03800030https://www.clinicaltrials.gov/study/NCT03800030?tab=tableNANANAInvestigation of frequency specific transcranial alternating current stimulation on cognitive control signals in frontal cortex
<![CDATA[
Studies
Study First Submitted Date | 2018-12-18 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-05-18 |
Start Month Year | October 7, 2018 |
Primary Completion Month Year | July 25, 2019 |
Verification Month Year | September 2019 |
Verification Date | 2019-09-30 |
Last Update Posted Date | 2020-05-18 |
Results First Posted Date | 2020-05-18 |
Detailed Descriptions
Sequence: | 20562938 |
Description | Previous evidence suggests that there are specific frequency bands associated with different aspects of cognitive control. In specific delta (2-4Hz) and beta (15-30Hz) are associated with increased levels of abstraction for learned rules; and theta (5-8Hz) and gamma (30-50Hz) has been associated with increased set-size or number of learned rules. Here we aim to find causal evidence in support of these previous correlational findings by applying cross-frequency transcranial alternating current stimulation (tACS) in the specific frequency bands previously shown to be task-relevant. In a crossover design, we stimulate subjects with either delta-beta or theta-gamma tACS during performance of a hierarchical cognitive control task that manipulates the level of abstraction and set-size of rules that must be learned in order to make the correct button press. |
Facilities
Sequence: | 198527940 |
Name | University of North Carolina, Chapel Hill |
City | Chapel Hill |
State | North Carolina |
Zip | 27599 |
Country | United States |
Conditions
Sequence: | 51763009 | Sequence: | 51763010 |
Name | Cognitive Control | Name | Executive Function |
Downcase Name | cognitive control | Downcase Name | executive function |
Id Information
Sequence: | 39832110 | Sequence: | 39832111 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 18-0003 | Id Value | R01MH101547 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/R01MH101547 |
Countries
Sequence: | 42231925 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55184003 | Sequence: | 55184004 | Sequence: | 55184005 | Sequence: | 55184006 | Sequence: | 55184007 | Sequence: | 55184008 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | Theta-gamma, Delta-beta, Sham | Title | Theta-gamma, Sham, Delta-beta | Title | Delta-beta, Theta-gamma, Sham tACS | Title | Delta-beta, Sham, Theta-gamma tACS | Title | Sham, Delta-beta, Theta-gamma tACS | Title | Sham, Theta-gamma, Delta-beta tACS |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Theta-gamma tACS, then Delta-beta tACS, then Sham tACS |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Theta-gamma tACS, then Sham tACS, then Delta-beta tACS |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Delta-beta tACS, then Theta-gamma tACS, then Sham tACS |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Delta-beta tACS, then Sham tACS, then Theta-gamma tACS |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Sham tACS, then Delta-beta tACS, then Theta-gamma tACS |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Sham tACS, then Theta-gamma tACS, then Delta-beta tACS |
Interventions
Sequence: | 52084248 | Sequence: | 52084249 | Sequence: | 52084250 |
Intervention Type | Device | Intervention Type | Device | Intervention Type | Device |
Name | Theta-gamma tACS | Name | Delta-beta tACS | Name | Sham tACS |
Description | NeuroConn technologies, direct current-stimulator plus | Description | NeuroConn technologies, direct current-stimulator plus | Description | NeuroConn technologies, direct current-stimulator plus |
Keywords
Sequence: | 79195444 | Sequence: | 79195445 | Sequence: | 79195446 |
Name | tACS | Name | Cognitive Control | Name | Executive Function |
Downcase Name | tacs | Downcase Name | cognitive control | Downcase Name | executive function |
Design Outcomes
Sequence: | 176064988 | Sequence: | 176064989 | Sequence: | 176064990 | Sequence: | 176064991 | Sequence: | 176064992 | Sequence: | 176064993 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Reaction Time for Trials With High Abstraction Relative to Low Abstraction | Measure | Reaction Time for Trials With High Set-size Relative to Low Set-size | Measure | Delta Phase to Beta Amplitude Coupling Strength | Measure | Theta Phase to Gamma Amplitude Coupling Strength | Measure | Percent Correct for Trials With High Abstraction Relative to Low Abstraction | Measure | Percent Correct for Trials With High Set-size Relative to Low Set-size |
Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks |
Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The reaction time difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The reaction time difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. | Description | Delta-beta tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between delta phase and beta amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the beta amplitude time series relative to the delta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | Theta-gamma tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between theta phase and gamma amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the gamma amplitude time series relative to the theta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The accuracy difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The accuracy difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. |
Sponsors
Sequence: | 47939520 | Sequence: | 47939521 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of North Carolina, Chapel Hill | Name | National Institute of Mental Health (NIMH) |
Overall Officials
Sequence: | 29045812 |
Role | Principal Investigator |
Name | Flavio Frohlich, PhD |
Affiliation | University of North Carolina, Chapel Hill |
Design Group Interventions
Sequence: | 67654547 | Sequence: | 67654548 | Sequence: | 67654549 | Sequence: | 67654550 | Sequence: | 67654551 | Sequence: | 67654552 | Sequence: | 67654553 | Sequence: | 67654554 | Sequence: | 67654555 | Sequence: | 67654556 | Sequence: | 67654557 | Sequence: | 67654558 | Sequence: | 67654559 | Sequence: | 67654560 | Sequence: | 67654561 | Sequence: | 67654562 | Sequence: | 67654563 | Sequence: | 67654564 |
Design Group Id | 55184006 | Design Group Id | 55184005 | Design Group Id | 55184007 | Design Group Id | 55184008 | Design Group Id | 55184003 | Design Group Id | 55184004 | Design Group Id | 55184006 | Design Group Id | 55184005 | Design Group Id | 55184007 | Design Group Id | 55184008 | Design Group Id | 55184003 | Design Group Id | 55184004 | Design Group Id | 55184006 | Design Group Id | 55184005 | Design Group Id | 55184007 | Design Group Id | 55184008 | Design Group Id | 55184003 | Design Group Id | 55184004 |
Intervention Id | 52084248 | Intervention Id | 52084248 | Intervention Id | 52084248 | Intervention Id | 52084248 | Intervention Id | 52084248 | Intervention Id | 52084248 | Intervention Id | 52084249 | Intervention Id | 52084249 | Intervention Id | 52084249 | Intervention Id | 52084249 | Intervention Id | 52084249 | Intervention Id | 52084249 | Intervention Id | 52084250 | Intervention Id | 52084250 | Intervention Id | 52084250 | Intervention Id | 52084250 | Intervention Id | 52084250 | Intervention Id | 52084250 |
Eligibilities
Sequence: | 30526476 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 35 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Between the ages of 18 and 35 years Exclusion Criteria: Attention Deficit Hyperactivity Disorder (currently under treatment) |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254093109 |
Number Of Facilities | 1 |
Number Of Nsae Subjects | 81 |
Registered In Calendar Year | 2018 |
Actual Duration | 9 |
Were Results Reported | True |
Months To Report Results | 9 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 35 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 6 |
Designs
Sequence: | 30275383 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | Double |
Masking Description | Double-blinded. Neither the investigator nor the participants knows which form of stimulation is received. |
Intervention Model Description | Healthy participants will receive three waveforms of transcranial alternating current stimulation (tACS). Delta-beta, Theta-gamma, and Sham. |
Subject Masked | True |
Investigator Masked | True |
Milestones
Sequence: | 40753428 | Sequence: | 40753429 | Sequence: | 40753430 | Sequence: | 40753431 | Sequence: | 40753432 | Sequence: | 40753433 | Sequence: | 40753434 | Sequence: | 40753435 | Sequence: | 40753436 | Sequence: | 40753437 | Sequence: | 40753438 | Sequence: | 40753439 | Sequence: | 40753440 | Sequence: | 40753441 | Sequence: | 40753442 | Sequence: | 40753443 | Sequence: | 40753444 | Sequence: | 40753445 | Sequence: | 40753446 | Sequence: | 40753447 | Sequence: | 40753448 | Sequence: | 40753449 | Sequence: | 40753450 | Sequence: | 40753451 | Sequence: | 40753452 | Sequence: | 40753453 | Sequence: | 40753454 | Sequence: | 40753455 | Sequence: | 40753456 | Sequence: | 40753457 | Sequence: | 40753458 | Sequence: | 40753459 | Sequence: | 40753460 | Sequence: | 40753461 | Sequence: | 40753462 | Sequence: | 40753463 | Sequence: | 40753464 | Sequence: | 40753465 | Sequence: | 40753466 | Sequence: | 40753467 | Sequence: | 40753468 | Sequence: | 40753469 | Sequence: | 40753470 | Sequence: | 40753471 | Sequence: | 40753472 | Sequence: | 40753473 | Sequence: | 40753474 | Sequence: | 40753475 | Sequence: | 40753476 | Sequence: | 40753477 | Sequence: | 40753478 | Sequence: | 40753479 | Sequence: | 40753480 | Sequence: | 40753481 | Sequence: | 40753482 | Sequence: | 40753483 | Sequence: | 40753484 | Sequence: | 40753485 | Sequence: | 40753486 | Sequence: | 40753487 | Sequence: | 40753488 | Sequence: | 40753489 | Sequence: | 40753490 | Sequence: | 40753491 | Sequence: | 40753492 | Sequence: | 40753493 | Sequence: | 40753494 | Sequence: | 40753495 | Sequence: | 40753496 | Sequence: | 40753497 | Sequence: | 40753498 | Sequence: | 40753499 | Sequence: | 40753500 | Sequence: | 40753501 | Sequence: | 40753502 | Sequence: | 40753503 | Sequence: | 40753504 | Sequence: | 40753505 | Sequence: | 40753506 | Sequence: | 40753507 | Sequence: | 40753508 | Sequence: | 40753509 | Sequence: | 40753510 | Sequence: | 40753511 | Sequence: | 40753512 | Sequence: | 40753513 | Sequence: | 40753514 | Sequence: | 40753515 | Sequence: | 40753516 | Sequence: | 40753517 | Sequence: | 40753518 | Sequence: | 40753519 | Sequence: | 40753520 | Sequence: | 40753521 | Sequence: | 40753522 | Sequence: | 40753523 | Sequence: | 40753524 | Sequence: | 40753525 | Sequence: | 40753526 | Sequence: | 40753527 | Sequence: | 40753528 | Sequence: | 40753529 | Sequence: | 40753530 | Sequence: | 40753531 | Sequence: | 40753532 | Sequence: | 40753533 | Sequence: | 40753534 | Sequence: | 40753535 | Sequence: | 40753536 | Sequence: | 40753537 | Sequence: | 40753538 | Sequence: | 40753539 | Sequence: | 40753540 | Sequence: | 40753541 | Sequence: | 40753542 | Sequence: | 40753543 | Sequence: | 40753544 | Sequence: | 40753545 | Sequence: | 40753546 | Sequence: | 40753547 | Sequence: | 40753548 | Sequence: | 40753549 | Sequence: | 40753550 | Sequence: | 40753551 | Sequence: | 40753552 | Sequence: | 40753553 |
Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 | Result Group Id | 55825933 | Result Group Id | 55825934 | Result Group Id | 55825935 | Result Group Id | 55825936 | Result Group Id | 55825937 | Result Group Id | 55825938 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 |
Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Baseline | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | Pre-Randomization Period (1 Week) | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Intervention | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | First Washout (1 Week) | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Intervention | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Second Washout (1 Week) | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention | Period | Third Intervention |
Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 4 | Count | 4 | Count | 4 | Count | 6 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 5 | Count | 4 | Count | 4 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 4 | Count | 4 | Count | 4 | Count | 5 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 4 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 |
Outcome Analyses
Sequence: | 16453000 | Sequence: | 16453001 | Sequence: | 16453002 | Sequence: | 16453003 | Sequence: | 16453004 | Sequence: | 16453005 |
Outcome Id | 30603521 | Outcome Id | 30603522 | Outcome Id | 30603523 | Outcome Id | 30603524 | Outcome Id | 30603525 | Outcome Id | 30603526 |
Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority |
P Value Modifier | P Value Modifier | P Value Modifier | P Value Modifier | P Value Modifier | P Value Modifier | ||||||
P Value | 0.031 | P Value | 0.935 | P Value | 0.04 | P Value | 0.02 | P Value | 0.54 | P Value | 0.007 |
Method | t-test, 2 sided | Method | t-test, 2 sided | Method | t-test, 1 sided | Method | t-test, 1 sided | Method | t-test, 2 sided | Method | t-test, 2 sided |
Method Description | degrees of freedom = 22 t-statistic = 2.305 | Method Description | degrees of freedom = 22 t-statistic = 0.083 | Method Description | degrees of freedom = 22 t-statistic = 1.833 | Method Description | degrees of freedom = 22 t-statistic = 2.174 | Method Description | degrees of freedom = 22 t-statistic = -0.623 | Method Description | degrees of freedom = 22 t-statistic = 2.989 |
Outcome Analysis Groups
Sequence: | 31908775 | Sequence: | 31908776 | Sequence: | 31908777 | Sequence: | 31908778 | Sequence: | 31908779 | Sequence: | 31908780 | Sequence: | 31908781 | Sequence: | 31908782 | Sequence: | 31908783 | Sequence: | 31908784 | Sequence: | 31908785 | Sequence: | 31908786 | Sequence: | 31908787 |
Outcome Analysis Id | 16453000 | Outcome Analysis Id | 16453000 | Outcome Analysis Id | 16453001 | Outcome Analysis Id | 16453001 | Outcome Analysis Id | 16453002 | Outcome Analysis Id | 16453002 | Outcome Analysis Id | 16453002 | Outcome Analysis Id | 16453003 | Outcome Analysis Id | 16453003 | Outcome Analysis Id | 16453004 | Outcome Analysis Id | 16453004 | Outcome Analysis Id | 16453005 | Outcome Analysis Id | 16453005 |
Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825941 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825941 |
Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG002 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG002 |
Participant Flows
Sequence: | 3897728 |
Outcome Counts
Sequence: | 73515587 | Sequence: | 73515588 | Sequence: | 73515589 | Sequence: | 73515590 | Sequence: | 73515591 | Sequence: | 73515592 | Sequence: | 73515593 | Sequence: | 73515594 | Sequence: | 73515595 | Sequence: | 73515596 | Sequence: | 73515597 | Sequence: | 73515598 | Sequence: | 73515599 | Sequence: | 73515600 | Sequence: | 73515601 | Sequence: | 73515602 | Sequence: | 73515603 | Sequence: | 73515604 |
Outcome Id | 30603521 | Outcome Id | 30603521 | Outcome Id | 30603521 | Outcome Id | 30603522 | Outcome Id | 30603522 | Outcome Id | 30603522 | Outcome Id | 30603523 | Outcome Id | 30603523 | Outcome Id | 30603523 | Outcome Id | 30603524 | Outcome Id | 30603524 | Outcome Id | 30603524 | Outcome Id | 30603525 | Outcome Id | 30603525 | Outcome Id | 30603525 | Outcome Id | 30603526 | Outcome Id | 30603526 | Outcome Id | 30603526 |
Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 | Count | 23 |
Provided Documents
Sequence: | 2565769 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2020-01-09 |
Url | https://ClinicalTrials.gov/ProvidedDocs/30/NCT03800030/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27770413 | Sequence: | 27770414 | Sequence: | 27770415 | Sequence: | 27770416 | Sequence: | 27770417 | Sequence: | 27770418 | Sequence: | 27770419 | Sequence: | 27770420 | Sequence: | 27770421 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 11 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 15 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 10 | Subjects Affected | 0 |
Subjects At Risk | 24 | Subjects At Risk | 24 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 26 |
Created At | 2023-08-06 14:23:55.652996 | Created At | 2023-08-06 14:23:55.652996 | Created At | 2023-08-06 14:23:55.652996 | Created At | 2023-08-06 14:23:55.652996 | Created At | 2023-08-06 14:23:55.652996 | Created At | 2023-08-06 14:23:55.652996 | Created At | 2023-08-06 14:23:55.652996 | Created At | 2023-08-06 14:23:55.652996 | Created At | 2023-08-06 14:23:55.652996 |
Updated At | 2023-08-06 14:23:55.652996 | Updated At | 2023-08-06 14:23:55.652996 | Updated At | 2023-08-06 14:23:55.652996 | Updated At | 2023-08-06 14:23:55.652996 | Updated At | 2023-08-06 14:23:55.652996 | Updated At | 2023-08-06 14:23:55.652996 | Updated At | 2023-08-06 14:23:55.652996 | Updated At | 2023-08-06 14:23:55.652996 | Updated At | 2023-08-06 14:23:55.652996 |
Reported Events
Sequence: | 524306661 | Sequence: | 524306662 | Sequence: | 524306663 | Sequence: | 524306664 | Sequence: | 524306665 | Sequence: | 524306666 | Sequence: | 524306667 | Sequence: | 524306668 | Sequence: | 524306669 | Sequence: | 524306670 | Sequence: | 524306671 | Sequence: | 524306672 | Sequence: | 524306673 | Sequence: | 524306674 | Sequence: | 524306675 | Sequence: | 524306676 | Sequence: | 524306677 | Sequence: | 524306678 | Sequence: | 524306679 | Sequence: | 524306680 | Sequence: | 524306681 | Sequence: | 524306682 | Sequence: | 524306683 | Sequence: | 524306684 | Sequence: | 524306685 | Sequence: | 524306686 | Sequence: | 524306687 | Sequence: | 524306688 | Sequence: | 524306689 | Sequence: | 524306690 | Sequence: | 524306691 | Sequence: | 524306692 | Sequence: | 524306693 | Sequence: | 524306694 | Sequence: | 524306695 | Sequence: | 524306696 |
Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 | Result Group Id | 55825942 | Result Group Id | 55825943 | Result Group Id | 55825944 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 |
Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. | Time Frame | Adverse events were assessed over an approximate 3-week period using a stimulation side effects questionnaire provided to participants after every presentation of each intervention. Data were not collected beyond the third intervention. |
Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other |
Subjects Affected | 9 | Subjects Affected | 10 | Subjects Affected | 7 | Subjects Affected | 2 | Subjects Affected | 4 | Subjects Affected | 2 | Subjects Affected | 2 | Subjects Affected | 5 | Subjects Affected | 4 | Subjects Affected | 3 | Subjects Affected | 3 | Subjects Affected | 5 | Subjects Affected | 3 | Subjects Affected | 3 | Subjects Affected | 2 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 3 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 3 | Subjects Affected | 1 | Subjects Affected | 3 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 |
Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 | Subjects At Risk | 24 | Subjects At Risk | 26 | Subjects At Risk | 26 |
Event Count | 9 | Event Count | 10 | Event Count | 7 | Event Count | 2 | Event Count | 4 | Event Count | 2 | Event Count | 2 | Event Count | 5 | Event Count | 4 | Event Count | 3 | Event Count | 3 | Event Count | 5 | Event Count | 3 | Event Count | 3 | Event Count | 2 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 3 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 3 | Event Count | 1 | Event Count | 3 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 |
Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations |
Adverse Event Term | Tingling | Adverse Event Term | Tingling | Adverse Event Term | Tingling | Adverse Event Term | Flickering lights | Adverse Event Term | Flickering lights | Adverse Event Term | Flickering lights | Adverse Event Term | Itching | Adverse Event Term | Itching | Adverse Event Term | Itching | Adverse Event Term | Burning sensation | Adverse Event Term | Burning sensation | Adverse Event Term | Burning sensation | Adverse Event Term | Scalp pain | Adverse Event Term | Scalp pain | Adverse Event Term | Scalp pain | Adverse Event Term | Neck pain | Adverse Event Term | Neck pain | Adverse Event Term | Neck pain | Adverse Event Term | Dizziness | Adverse Event Term | Dizziness | Adverse Event Term | Dizziness | Adverse Event Term | Local redness | Adverse Event Term | Local redness | Adverse Event Term | Local redness | Adverse Event Term | Sleepiness | Adverse Event Term | Sleepiness | Adverse Event Term | Sleepiness | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Ringing noise | Adverse Event Term | Ringing noise | Adverse Event Term | Ringing noise | Adverse Event Term | Blurred vision | Adverse Event Term | Blurred vision | Adverse Event Term | Blurred vision |
Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 |
Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment |
Responsible Parties
Sequence: | 28655290 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3828472 |
Pi Employee | Yes |
Result Contacts
Sequence: | 3828437 |
Organization | University of North Carolina at Chapel Hill |
Name | Justin Riddle, PhD |
Phone | 6617131602 |
justin_riddle@med.unc.edu | |
Outcomes
Sequence: | 30603521 | Sequence: | 30603522 | Sequence: | 30603523 | Sequence: | 30603524 | Sequence: | 30603525 | Sequence: | 30603526 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary |
Title | Reaction Time for Trials With High Abstraction Relative to Low Abstraction | Title | Reaction Time for Trials With High Set-size Relative to Low Set-size | Title | Delta Phase to Beta Amplitude Coupling Strength | Title | Theta Phase to Gamma Amplitude Coupling Strength | Title | Percent Correct for Trials With High Abstraction Relative to Low Abstraction | Title | Percent Correct for Trials With High Set-size Relative to Low Set-size |
Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The reaction time difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The reaction time difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. | Description | Delta-beta tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between delta phase and beta amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the beta amplitude time series relative to the delta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | Theta-gamma tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between theta phase and gamma amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the gamma amplitude time series relative to the theta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The accuracy difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The accuracy difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. |
Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks | Time Frame | through study completion, an average of 3 weeks |
Population | One participant excluded from behavioral analysis because they did not follow task instructions. | Population | One participant excluded from behavioral analysis because they did not follow task instructions. | Population | One participant excluded from coupling analysis because they did not follow task instructions. | Population | One participant was excluded from coupling analysis because they did not follow task instructions. | Population | One participant excluded from behavioral analysis because they did not follow task instructions. | Population | One participant excluded from behavioral analysis because they did not follow task instructions. |
Units | seconds | Units | seconds | Units | Z-score | Units | Z-score | Units | percent correct | Units | percent correct |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 234047562 | Sequence: | 234047563 | Sequence: | 234047564 | Sequence: | 234047565 | Sequence: | 234047566 | Sequence: | 234047567 | Sequence: | 234047568 | Sequence: | 234047569 | Sequence: | 234047570 | Sequence: | 234047571 | Sequence: | 234047572 | Sequence: | 234047573 | Sequence: | 234047574 | Sequence: | 234047575 | Sequence: | 234047576 | Sequence: | 234047577 | Sequence: | 234047578 | Sequence: | 234047579 |
Outcome Id | 30603521 | Outcome Id | 30603521 | Outcome Id | 30603521 | Outcome Id | 30603522 | Outcome Id | 30603522 | Outcome Id | 30603522 | Outcome Id | 30603523 | Outcome Id | 30603523 | Outcome Id | 30603523 | Outcome Id | 30603524 | Outcome Id | 30603524 | Outcome Id | 30603524 | Outcome Id | 30603525 | Outcome Id | 30603525 | Outcome Id | 30603525 | Outcome Id | 30603526 | Outcome Id | 30603526 | Outcome Id | 30603526 |
Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 | Result Group Id | 55825939 | Result Group Id | 55825940 | Result Group Id | 55825941 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 |
Title | Reaction Time for Trials With High Abstraction Relative to Low Abstraction | Title | Reaction Time for Trials With High Abstraction Relative to Low Abstraction | Title | Reaction Time for Trials With High Abstraction Relative to Low Abstraction | Title | Reaction Time for Trials With High Set-size Relative to Low Set-size | Title | Reaction Time for Trials With High Set-size Relative to Low Set-size | Title | Reaction Time for Trials With High Set-size Relative to Low Set-size | Title | Delta Phase to Beta Amplitude Coupling Strength | Title | Delta Phase to Beta Amplitude Coupling Strength | Title | Delta Phase to Beta Amplitude Coupling Strength | Title | Theta Phase to Gamma Amplitude Coupling Strength | Title | Theta Phase to Gamma Amplitude Coupling Strength | Title | Theta Phase to Gamma Amplitude Coupling Strength | Title | Percent Correct for Trials With High Abstraction Relative to Low Abstraction | Title | Percent Correct for Trials With High Abstraction Relative to Low Abstraction | Title | Percent Correct for Trials With High Abstraction Relative to Low Abstraction | Title | Percent Correct for Trials With High Set-size Relative to Low Set-size | Title | Percent Correct for Trials With High Set-size Relative to Low Set-size | Title | Percent Correct for Trials With High Set-size Relative to Low Set-size |
Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The reaction time difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The reaction time difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The reaction time difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The reaction time difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The reaction time difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The reaction time difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. | Description | Delta-beta tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between delta phase and beta amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the beta amplitude time series relative to the delta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | Delta-beta tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between delta phase and beta amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the beta amplitude time series relative to the delta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | Delta-beta tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between delta phase and beta amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the beta amplitude time series relative to the delta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | Theta-gamma tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between theta phase and gamma amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the gamma amplitude time series relative to the theta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | Theta-gamma tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between theta phase and gamma amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the gamma amplitude time series relative to the theta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | Theta-gamma tACS was hypothesized to increase cross frequency coupling strength (higher value) between the targeted frequency bands. Phase amplitude coupling between theta phase and gamma amplitude was calculated for the two minute electrical brain recordings after stimulation. A null distribution was calculated by shuffling the gamma amplitude time series relative to the theta phase time series and then calculating coupling strength. The outcome measure is the z-transformed value of the genuine phase amplitude coupling relative to the null distribution. | Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The accuracy difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The accuracy difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | For low abstraction conditions, subjects must memorize a color to button mapping. For high abstraction conditions, subject must make a perceptual judgement on the similarity of two objects based on either texture or shape as cued by a color. The accuracy difference between high and low abstraction conditions was hypothesized to decrease when delta-beta tACS was delivered. As a control for the placebo effect of stimulation, the difference between delta-beta tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The accuracy difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The accuracy difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. | Description | The accuracy difference between high and low set-size conditions was hypothesized to decrease when theta-gamma tACS is delivered. As a control for the placebo effect of stimulation, the difference between theta-gamma tACS and sham tACS, or placebo, was used for statistical analysis. |
Units | seconds | Units | seconds | Units | seconds | Units | seconds | Units | seconds | Units | seconds | Units | Z-score | Units | Z-score | Units | Z-score | Units | Z-score | Units | Z-score | Units | Z-score | Units | percent correct | Units | percent correct | Units | percent correct | Units | percent correct | Units | percent correct | Units | percent correct |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 0.1247 | Param Value | 0.1444 | Param Value | 0.1022 | Param Value | 0.1905 | Param Value | 0.1853 | Param Value | 0.1888 | Param Value | -0.0873 | Param Value | 0.1123 | Param Value | -0.1250 | Param Value | 0.1615 | Param Value | 0.0706 | Param Value | 0.0577 | Param Value | 0.5661 | Param Value | -0.2944 | Param Value | 0.7246 | Param Value | -2.2871 | Param Value | -4.3252 | Param Value | -4.1667 |
Param Value Num | 0.1247 | Param Value Num | 0.1444 | Param Value Num | 0.1022 | Param Value Num | 0.1905 | Param Value Num | 0.1853 | Param Value Num | 0.1888 | Param Value Num | -0.0873 | Param Value Num | 0.1123 | Param Value Num | -0.125 | Param Value Num | 0.1615 | Param Value Num | 0.0706 | Param Value Num | 0.0577 | Param Value Num | 0.5661 | Param Value Num | -0.2944 | Param Value Num | 0.7246 | Param Value Num | -2.2871 | Param Value Num | -4.3252 | Param Value Num | -4.1667 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Dispersion Value | 0.0800 | Dispersion Value | 0.0832 | Dispersion Value | 0.0947 | Dispersion Value | 0.0676 | Dispersion Value | 0.1057 | Dispersion Value | 0.0760 | Dispersion Value | 0.3035 | Dispersion Value | 0.2939 | Dispersion Value | 0.2651 | Dispersion Value | 0.3563 | Dispersion Value | 0.3496 | Dispersion Value | 0.4043 | Dispersion Value | 3.1678 | Dispersion Value | 7.4718 | Dispersion Value | 6.6416 | Dispersion Value | 2.9242 | Dispersion Value | 6.8997 | Dispersion Value | 4.3264 |
Dispersion Value Num | 0.08 | Dispersion Value Num | 0.0832 | Dispersion Value Num | 0.0947 | Dispersion Value Num | 0.0676 | Dispersion Value Num | 0.1057 | Dispersion Value Num | 0.076 | Dispersion Value Num | 0.3035 | Dispersion Value Num | 0.2939 | Dispersion Value Num | 0.2651 | Dispersion Value Num | 0.3563 | Dispersion Value Num | 0.3496 | Dispersion Value Num | 0.4043 | Dispersion Value Num | 3.1678 | Dispersion Value Num | 7.4718 | Dispersion Value Num | 6.6416 | Dispersion Value Num | 2.9242 | Dispersion Value Num | 6.8997 | Dispersion Value Num | 4.3264 |
Study References
Sequence: | 51655900 |
Pmid | 33741402 |
Reference Type | derived |
Citation | Riddle J, McFerren A, Frohlich F. Causal role of cross-frequency coupling in distinct components of cognitive control. Prog Neurobiol. 2021 Jul;202:102033. doi: 10.1016/j.pneurobio.2021.102033. Epub 2021 Mar 16. |
Baseline Counts
Sequence: | 11314640 |
Result Group Id | 55825932 |
Ctgov Group Code | BG000 |
Units | Participants |
Scope | overall |
Count | 26 |
Result Groups
Sequence: | 55825934 | Sequence: | 55825935 | Sequence: | 55825932 | Sequence: | 55825933 | Sequence: | 55825936 | Sequence: | 55825937 | Sequence: | 55825938 | Sequence: | 55825939 | Sequence: | 55825940 | Sequence: | 55825941 | Sequence: | 55825942 | Sequence: | 55825943 | Sequence: | 55825944 |
Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | BG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 |
Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event |
Title | Theta-gamma, Sham, Delta-beta | Title | Delta-beta, Theta-gamma, Sham tACS | Title | All Participants | Title | Theta-gamma, Delta-beta, Sham | Title | Delta-beta, Sham, Theta-gamma tACS | Title | Sham, Delta-beta, Theta-gamma tACS | Title | Sham, Theta-gamma, Delta-beta tACS | Title | Theta-gamma tACS | Title | Delta-beta tACS | Title | Sham tACS | Title | Theta-gamma tACS | Title | Delta-beta tACS | Title | Sham tACS |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Theta-gamma tACS, then Sham tACS, then Delta-beta tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Delta-beta tACS, then Theta-gamma tACS, then Sham tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task. | Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Theta-gamma tACS, then Delta-beta tACS, then Sham tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Delta-beta tACS, then Sham tACS, then Theta-gamma tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Sham tACS, then Delta-beta tACS, then Theta-gamma tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus |
Description | Every participant will receive Theta-gamma tACS, Delta-beta tACS, and Sham tACS on separate sessions during performance of a computerized task.
Sequence: Sham tACS, then Theta-gamma tACS, then Delta-beta tACS Theta-gamma tACS: NeuroConn technologies, direct current-stimulator plus Delta-beta tACS: NeuroConn technologies, direct current-stimulator plus Sham tACS: NeuroConn technologies, direct current-stimulator plus |
Description | Every participant will receive Theta-gamma tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus | Description | Every participant will receive Delta-beta tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus | Description | Every participant will receive Sham tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus | Description | Every participant will receive Theta-gamma tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus | Description | Every participant will receive Delta-beta tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus | Description | Every participant will receive Sham tACS during performance of a computerized task using NeuroConn technologies, direct current-stimulator plus |
Baseline Measurements
Sequence: | 124852607 | Sequence: | 124852608 | Sequence: | 124852609 | Sequence: | 124852610 | Sequence: | 124852611 | Sequence: | 124852612 | Sequence: | 124852613 | Sequence: | 124852614 | Sequence: | 124852615 | Sequence: | 124852616 | Sequence: | 124852617 | Sequence: | 124852618 | Sequence: | 124852619 | Sequence: | 124852620 | Sequence: | 124852621 | Sequence: | 124852622 | Sequence: | 124852623 | Sequence: | 124852624 | Sequence: | 124852625 | Sequence: | 124852626 |
Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 | Result Group Id | 55825932 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 |
Classification | United States | ||||||||||||||||||||||||||||||||||||||
Category | Female | Category | Male | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Unknown or Not Reported | Category | American Indian or Alaska Native | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | White | Category | More than one race | Category | Unknown or Not Reported | ||||||||||||||||
Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Region of Enrollment | Title | Baseline Reaction Time Difference for Abstraction | Title | Baseline Reaction Time Difference for Set-Size | Title | Baseline Percent Correct Difference for Abstraction | Title | Baseline Percent Correct Difference for Set-Size | Title | Baseline Delta Phase to Beta Amplitude Coupling | Title | Theta Phase to Gamma Amplitude Coupling Strength |
Description | There are four task conditions in a two-by-two design for high and low set-size and high and low abstraction. The reaction time for both high abstraction conditions are averaged and the average reaction time for both low abstraction conditions is subtracted. Thus, a single reaction metric is derived that is the relative change in reaction time as a function of the abstraction of the task. | Description | There are four task conditions in a two-by-two design for high and low set-size and high and low abstraction. The reaction time for both high set-size conditions are averaged and the average reaction time for both low set-size conditions is subtracted. Thus, a single reaction metric is derived that is the relative change in reaction time as a function of the set-size of the task. | Description | There are four task conditions in a two-by-two design for high and low set-size and high and low abstraction. The percent correct for both high abstraction conditions are averaged and the average percent correct for both low abstraction conditions is subtracted. Thus, a single metric is derived that is the relative change in percent correct as a function of the abstraction of the task. | Description | There are four task conditions in a two-by-two design for high and low set-size and high and low abstraction. The percent correct for both high st-size conditions are averaged and the average percent correct for both low set-size conditions is subtracted. Thus, a single metric is derived that is the relative change in percent correct as a function of the set-size of the task. | Description | During resting-state EEG, the Hilbert transform is applied at delta (2-3 Hz) and beta (18-22 Hz) frequency band. The phase of delta and the amplitude of beta frequency oscillations are combined into a single hybrid signal. Then, this signal is averaged and the magnitude of the resulting vector is taken as the coupling strength. To account for spurious findings, a null distribution is calculated by randomly shifting the time series of amplitude values. The final coupling measure is z-transformed by subtracting the mean and dividing by the standard deviation of the null distribution. | Description | During resting-state EEG, the Hilbert transform is applied at theta (4-8 Hz) and gamma (30-50 Hz) frequency band. The phase of theta and the amplitude of gamma frequency oscillations are combined into a single hybrid signal. Then, this signal is averaged and the magnitude of the resulting vector is taken as the coupling strength. To account for spurious findings, a null distribution is calculated by randomly shifting the time series of amplitude values. The final coupling measure is z-transformed by subtracting the mean and dividing by the standard deviation of the null distribution. | ||||||||||||||||||||||||||||
Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | seconds | Units | seconds | Units | percent correct | Units | percent correct | Units | Z-score | Units | Z-score |
Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 19.654 | Param Value | 21 | Param Value | 5 | Param Value | 5 | Param Value | 17 | Param Value | 4 | Param Value | 0 | Param Value | 5 | Param Value | 1 | Param Value | 1 | Param Value | 15 | Param Value | 0 | Param Value | 4 | Param Value | 26 | Param Value | 0.1637 | Param Value | 0.2272 | Param Value | 0.0679 | Param Value | -1.0190 | Param Value | 0.0406 | Param Value | 0.0739 |
Param Value Num | 19.654 | Param Value Num | 21.0 | Param Value Num | 5.0 | Param Value Num | 5.0 | Param Value Num | 17.0 | Param Value Num | 4.0 | Param Value Num | 0.0 | Param Value Num | 5.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 15.0 | Param Value Num | 0.0 | Param Value Num | 4.0 | Param Value Num | 26.0 | Param Value Num | 0.1637 | Param Value Num | 0.2272 | Param Value Num | 0.0679 | Param Value Num | -1.019 | Param Value Num | 0.0406 | Param Value Num | 0.0739 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||
Dispersion Value | 1.4951 | Dispersion Value | 0.1012 | Dispersion Value | 0.0844 | Dispersion Value | 4.9692 | Dispersion Value | 4.4569 | Dispersion Value | 0.3232 | Dispersion Value | 0.4214 | ||||||||||||||||||||||||||
Dispersion Value Num | 1.4951 | Dispersion Value Num | 0.1012 | Dispersion Value Num | 0.0844 | Dispersion Value Num | 4.9692 | Dispersion Value Num | 4.4569 | Dispersion Value Num | 0.3232 | Dispersion Value Num | 0.4214 | ||||||||||||||||||||||||||
Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 | Number Analyzed | 26 |
Population Description | One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis. | Population Description | One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis. | Population Description | One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis. | Population Description | One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis. | Population Description | One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis. | Population Description | One participant excluded from behavioral analysis because they did not follow task instructions. Two participants did not complete the full study and thus were excluded from analysis. | ||||||||||||||||||||||||||||
]]>
https://zephyrnet.com/NCT03800017
2023-01-01
https://zephyrnet.com/?p=NCT03800017
NCT03800017https://www.clinicaltrials.gov/study/NCT03800017?tab=tableSatvir S Dhillon, MScSatvir.Dhillon@hli.ubc.ca1-604-806-8835Dyspnea (i.e. breathlessness) and exercise intolerance are common symptoms for patients with interstitial lung disease (ILD), yet it is not known why. It has been suggested that muscle dysfunction may contribute to dyspnea and exercise intolerance in ILD. Our study aims to: i) examine differences in the structure and function of the leg muscles in ILD patients, ii) determine if leg muscle fatigue contributes to dyspnea and exercise limitation in patients with ILD, and iii) determine the effects of breathing extra oxygen on leg muscle fatigue, as well as ability to exercise in ILD patients.
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Studies
Study First Submitted Date | 2018-11-21 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-11-03 |
Start Month Year | January 1, 2023 |
Primary Completion Month Year | December 31, 2024 |
Verification Month Year | November 2022 |
Verification Date | 2022-11-30 |
Last Update Posted Date | 2022-11-03 |
Detailed Descriptions
Sequence: | 20852142 |
Description | PURPOSE:
The primary purpose of the proposed work is to characterize skeletal muscle function in patients with interstitial lung disease (ILD), and to determine the physiological and sensory consequences of impaired skeletal muscle function in ILD during exercise. HYPOTHESES: The hypotheses are threefold; i) patients with ILD will have impaired skeletal muscle function when compared to healthy controls, ii) impairments in skeletal muscle function predispose ILD patients to exercise-induced quadriceps muscle fatigue, increase the perception of exertional dyspnea, as well as reduce exercise tolerance, and iii) delivery of supplemental oxygen during exercise mitigates exercise-induced quadriceps muscle fatigue, attenuates the perceived intensity of dyspnea, and improves exercise tolerance. OBJECTIVE: The objective of the proposed study is to comprehensively investigate skeletal muscle dysfunction in patients with ILD and characterize its impact on dyspnea and exercise tolerance. In doing so, the proposed work will be the first to comprehensively assess skeletal muscle function in patients with ILD as well as determine its functional consequences. The results will provide important insight into the putative role of skeletal muscle dysfunction on exercise limitation in patient with ILD. JUSTIFICATION: ILD refers to a diverse group of diseases that share common physiological characteristics resulting from inflammation and/or fibrosis of the lung parenchyma. ILD has an estimated prevalence of approximately 67-81 cases per 100 000 individuals. Given the heterogeneity of disease sub-types, it is difficult to determine a precise median survival for patients with ILD, however; in patients with idiopathic pulmonary fibrosis, the most common ILD sub-type, have a median survival of only 2-3 years from the time of diagnosis. For patients with ILD, dyspnea (i.e. breathlessness) is the most common symptom. Dyspnea can be extremely debilitating, particularly during physical exertion. The clinical significance of dyspnea in ILD is underscored by its strong correlation with quality of life and mortality. Patients attempt to minimize dyspnea by avoiding physical activity, resulting in deconditioning and an associated reduction in functional capacity. The importance of maintaining functional capacity is highlighted by the fact that ILD patients with the lowest physical activity levels have the lowest quality of life and the highest mortality. The effective management of dyspnea and exercise intolerance is therefore of critical importance when considering the management of patients with ILD. The pathophysiological mechanisms of dyspnea and exercise intolerance in ILD are complex, multifactorial, and poorly understood. Indeed, relatively few studies that have adequately investigated the mechanistic basis of dyspnea and exercise intolerance in patients with ILD. It is generally agreed upon that exercise limitation in ILD is related to the combination of altered respiratory mechanics, gas exchange impairment, and circulatory limitation. However, it is assumed that dyspnea and exercise intolerance are exclusively related to the respiratory and circulatory impairment associated with the pathogenesis of ILD. While this assumption is reasonable, it ignores the potentially crucial role of skeletal muscle dysfunction as a source of dyspnea and exercise intolerance. Recent experimental evidence indicates that skeletal muscle dysfunction contributes to both dyspnea and exercise intolerance in COPD. A growing body of literature supports the notion that skeletal muscle dysfunction is common in ILD. While the precise mechanisms remain unclear, several well-established skeletal muscle dysfunction-promoting factors are present in many ILD patients, including: chronic hypoxaemia, oxidative stress, pulmonary and systemic inflammation, physical deconditioning, malnutrition, and corticosteroid use. These factors may act individually or synergistically to impair skeletal muscle function by causing muscle atrophy, mitochondrial dysfunction, a reduction in type I muscle fibre proportion, and increases in intramuscular fat. To our knowledge, there is limited imaging data of skeletal muscle morphology in ILD, and assessments of skeletal muscle oxidative capacity, and contractile function have not been concurrently obtained. If present, skeletal muscle dysfunction likely reduces locomotor muscle oxidative capacity, leading to premature fatigue, increased dyspnea, and diminished exercise tolerance. Most importantly, there is no data on the physiological effects of skeletal muscle fatigue and dysfunction on dyspnea and exercise capacity nor whether targeted treatment options such as supplemental oxygen (O2) delivery can attenuate muscle fatigue. Accordingly, the aims of the proposed research are threefold: i) to characterize skeletal muscle function in patients with ILD compared to healthy controls, ii) to determine the influence of skeletal muscle dysfunction on dyspnea, fatigue, and exercise intolerance in patients with ILD compared to healthy controls, and iii) to determine if improving exercise tolerance using supplemental oxygen relieves exercise-induce skeletal muscle fatigue in ILD patients. RESEARCH DESIGN: Experimental hypotheses tested using combination of research designs. To test the hypotheses i) and ii), the investigators will use a cross sectional design. To test hypothesis iii), the investigators will use a single-blind placebo-controlled study design. METHODS Participants will report to the laboratory on four separate occasions separated by a minimum of 48 hours, and each visit will last ~2-3 hours. Visit 1: Participants will complete medical history screening, complete a series of questionnaires concerning chronic activity-related dyspnea, quality of life, and physical activity. Participants will then have their height and weight measured and perform pulmonary function testing. Finally, participants will perform a symptom limited incremental cycle exercise test. Detailed physiological and sensory measurements will be obtained immediately before and throughout the incremental cycle exercise test. Visit 1 will be intended to characterize participant's pulmonary function and exercise capacity. Visit 2: Participants will undergo a magnetic resonance imaging scan to assess the volume and the fat percentage of their quadriceps muscles They will then perform a series of tests aimed at evaluating their quadriceps muscle function, including: i) assessment of maximum voluntary quadriceps muscles strength, and ii) the non-invasive assessment of the oxidative capacity of their quadriceps muscle using near-infrared spectroscopy. Data from visit 2 will be used to address hypothesis 1 by characterizing participant's quadriceps muscle function. Visits 3: Participants will perform a constant-load exercise test to exhaustion while breathing ambient air (i.e., 20.93% oxygen). The work load will be set at 75% of the highest work rate achieved during the incremental exercise test performed during visit 1. Data from visits 3 and 4 will be used to address hypothesis 2 by characterizing the effect of exercise on skeletal muscle fatigue in patients with ILD and healthy controls. Visit 4: Participants will perform a constant-load exercise test while breathing supplemental oxygen (i.e., 60% oxygen). The work load will be set at 75% of the highest work rate achieved during the incremental exercise test performed during visit 1 and the test will be terminated once participants reach the same time that they achieved during the constant-load exercise test on Day 3. Data from visit 4 will be used to address hypothesis 3 by determining if supplemental oxygen can be used to alleviate exercise-induced skeletal muscle fatigue in patients with ILD and healthy controls. |
Conditions
Sequence: | 52507098 | Sequence: | 52507099 | Sequence: | 52507100 | Sequence: | 52507101 | Sequence: | 52507102 |
Name | Interstitial Lung Disease | Name | Idiopathic Pulmonary Fibrosis | Name | Hypersensitivity Pneumonitis | Name | Scleroderma | Name | Nonspecific Interstitial Pneumonia |
Downcase Name | interstitial lung disease | Downcase Name | idiopathic pulmonary fibrosis | Downcase Name | hypersensitivity pneumonitis | Downcase Name | scleroderma | Downcase Name | nonspecific interstitial pneumonia |
Id Information
Sequence: | 40398855 |
Id Source | org_study_id |
Id Value | H18-02059 |
Design Groups
Sequence: | 55963465 | Sequence: | 55963466 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Hyperoxia | Title | Healthy Controls |
Description | During exercise on visit 4, participants in both groups (i.e., ILD patients and controls) will breathe supplemental oxygen (i.e., 60% oxygen) during constant-load exercise. | Description | During exercise on visit 3, participants in both groups (i.e., ILD patients and controls) will breathe ambient air (i.e., 20.93% oxygen) during constant-load exercise. |
Interventions
Sequence: | 52814977 |
Intervention Type | Biological |
Name | Hyperoxia |
Description | Participants breathe 60% oxygen during exercise |
Design Outcomes
Sequence: | 178629817 | Sequence: | 178629818 | Sequence: | 178629819 | Sequence: | 178629820 | Sequence: | 178629821 | Sequence: | 178629822 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in standardized dyspnea score during the constant load exercise test (visit 3) | Measure | Change in standardized dyspnea score during the constant load exercise test (visit 4) | Measure | Change in leg muscle strength measured following the constant load exercise test (visit 3) | Measure | Change in leg muscle strength measured following the constant load exercise test (visit 4) | Measure | Quadriceps muscle oxidative capacity measured using near-infrared spectroscopy | Measure | Quadriceps muscle volume measured using magnetic resonance imaging |
Time Frame | Dyspnea will be measured once every minute during exercise on visit 3 (up to 7 weeks after baseline) until participants reach volitional exhaustion (assessed for up to 30 minutes) | Time Frame | Dyspnea will be measured once every minute during exercise on visit 4 (up to 8 weeks after baseline) until participants reach volitional exhaustion (assessed for up to 30 minutes) | Time Frame | Leg muscle strength will be measured before and after exercise (assessed for up to 40 minutes) on visit 3 (up to 8 weeks after baseline) | Time Frame | Leg muscle strength will be measured before and after exercise (assessed for up to 40 minutes) on visit 4 (up to 8 weeks after baseline) | Time Frame | On visit 2, approximately 3 weeks post-baseline (visit 1) | Time Frame | On visit 2, approximately 3 weeks post-baseline (visit 1) |
Description | Dyspnea rating, measured using the Borg 0-10 category ratio scale, will be assessed every 1 minute during the constant-load exercise test on visit 3. | Description | Dyspnea rating, measured using the Borg 0-10 category ratio scale, will be assessed every 1 minute during the constant-load exercise test on visit 4. | Description | Leg muscle strength will be measured before (at rest) and 3 min after the constant-load exercise test on visit 3 using the femoral magnetic stimulation technique. | Description | Leg muscle strength will be measured before (at rest) and 3 min after the constant-load exercise test on visit 4 using the femoral magnetic stimulation technique. | Description | Quadriceps muscle oxidative capacity will measured using near-infrared spectroscopy. Parameters will be measured over 5 minutes once on visit 2 | Description | Quadriceps muscle volume will be measured using magnetic resonance imaging. Parameters will be measured over 15 minutes once on visit 2 |
Browse Conditions
Sequence: | 194767876 | Sequence: | 194767877 | Sequence: | 194767878 | Sequence: | 194767879 | Sequence: | 194767880 | Sequence: | 194767881 | Sequence: | 194767882 | Sequence: | 194767883 | Sequence: | 194767884 | Sequence: | 194767885 | Sequence: | 194767886 | Sequence: | 194767887 | Sequence: | 194767888 | Sequence: | 194767889 | Sequence: | 194767890 |
Mesh Term | Pneumonia | Mesh Term | Lung Diseases | Mesh Term | Pulmonary Fibrosis | Mesh Term | Idiopathic Pulmonary Fibrosis | Mesh Term | Lung Diseases, Interstitial | Mesh Term | Alveolitis, Extrinsic Allergic | Mesh Term | Hypersensitivity | Mesh Term | Fibrosis | Mesh Term | Pathologic Processes | Mesh Term | Respiratory Tract Infections | Mesh Term | Infections | Mesh Term | Respiratory Tract Diseases | Mesh Term | Immune System Diseases | Mesh Term | Respiratory Hypersensitivity | Mesh Term | Hypersensitivity, Immediate |
Downcase Mesh Term | pneumonia | Downcase Mesh Term | lung diseases | Downcase Mesh Term | pulmonary fibrosis | Downcase Mesh Term | idiopathic pulmonary fibrosis | Downcase Mesh Term | lung diseases, interstitial | Downcase Mesh Term | alveolitis, extrinsic allergic | Downcase Mesh Term | hypersensitivity | Downcase Mesh Term | fibrosis | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | respiratory tract infections | Downcase Mesh Term | infections | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | respiratory hypersensitivity | Downcase Mesh Term | hypersensitivity, immediate |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48630120 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of British Columbia |
Overall Officials
Sequence: | 29460589 |
Role | Principal Investigator |
Name | Jordan A Guenette, PhD |
Affiliation | University of British Columbia |
Central Contacts
Sequence: | 12095056 | Sequence: | 12095057 |
Contact Type | primary | Contact Type | backup |
Name | Yannick Molgat-seon, PhD | Name | Satvir S Dhillon, MSc |
Phone | 1-604-682-2344 | Phone | 1-604-806-8835 |
yannick.molgat-seon@hli.ubc.ca | Satvir.Dhillon@hli.ubc.ca | ||
Phone Extension | 63258 | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68606541 | Sequence: | 68606542 |
Design Group Id | 55963466 | Design Group Id | 55963465 |
Intervention Id | 52814977 | Intervention Id | 52814977 |
Eligibilities
Sequence: | 30956773 |
Gender | All |
Minimum Age | 40 Years |
Maximum Age | 80 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria for ILD Patients:
Age 40-80 years (inclusive) Inclusion Criteria for Healthy Controls: Age 40-80 (inclusive) Exclusion Criteria for the ILD patients: Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease) Exclusion Criteria for Healthy Controls: Currently smoking or previously smoked more than 10 pack-years |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253953517 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 40 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30702349 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | Single |
Subject Masked | True |
Responsible Parties
Sequence: | 29069116 |
Responsible Party Type | Principal Investigator |
Name | Jordan Guenette |
Title | Associate Professor |
Affiliation | University of British Columbia |
]]>
https://zephyrnet.com/NCT03800004
2018-07-30
https://zephyrnet.com/?p=NCT03800004
NCT03800004https://www.clinicaltrials.gov/study/NCT03800004?tab=tableKatrina PiercePierce.Katrina@mayo.edu507-266-1078This study examines the bone health in children with atopic dermatitis
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-03-01 |
Start Month Year | July 30, 2018 |
Primary Completion Month Year | December 2024 |
Verification Month Year | February 2023 |
Verification Date | 2023-02-28 |
Last Update Posted Date | 2023-03-01 |
Detailed Descriptions
Sequence: | 20574452 |
Description | The goal of this study is to objectively evaluate bone health and contributing factors in children with AD. This will be compared with existing normative data. Such an objective prospective study, directly looking at bone health in children has not yet been done. This will be done using bone densitometry (DXA) and high-resolution peripheral quantitative computed tomography (HR-pQCT) for the accurate and precise measurement of bone health status. HR-pQCT is a cutting-edge technology available at only at a few academic centers in the United States that is used to measure bone strength with minimal doses of radiation. In addition, blood and urine metabolic parameters related to bone health will be analyzed, and data will be correlated with eczema severity. The results from this study will allow us to design large-scale, multi-institutional studies on bone health in this population and ultimately to guide decision making in children who may be at risk specifically regarding treatment recommendations and supportive care.
The specific aims of this project are: To determine bone mineral density (BMD) and cortical and trabecular bone strength in children with atopic dermatitis, using DXA and to compare this with normative data. |
Facilities
Sequence: | 198634213 |
Status | Recruiting |
Name | Mayo Clinic |
City | Rochester |
State | Minnesota |
Zip | 55906 |
Country | United States |
Facility Contacts
Sequence: | 27942023 | Sequence: | 27942024 |
Facility Id | 198634213 | Facility Id | 198634213 |
Contact Type | primary | Contact Type | backup |
Name | Henry Nguyen, MD | Name | Katrina Pierce |
Nguyen.Henry@mayo.edu | pierce.katrina@mayo.edu | ||
Phone | 507-284-4673 | Phone | 507-266-1078 |
Facility Investigators
Sequence: | 18227991 |
Facility Id | 198634213 |
Role | Principal Investigator |
Name | Megha M Tollefson, MD |
Conditions
Sequence: | 51791193 | Sequence: | 51791192 |
Name | Eczema | Name | Atopic Dermatitis |
Downcase Name | eczema | Downcase Name | atopic dermatitis |
Id Information
Sequence: | 39856314 |
Id Source | org_study_id |
Id Value | 17-007112 |
Countries
Sequence: | 42254742 |
Name | United States |
Removed | False |
Keywords
Sequence: | 79244741 |
Name | Bone Health |
Downcase Name | bone health |
Design Outcomes
Sequence: | 176155987 | Sequence: | 176155988 | Sequence: | 176155989 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Correlate bone mineral density to normative data | Measure | Correlate bone age with the Eczema area and severity index and the Scoring atopic dermatitis score | Measure | Correlate bone age with serum markers |
Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years |
Description | To determine bone mineral density (BMD) and cortical and trabecular bone strength in children with atopic dermatitis, using dual energy x-ray absorptiometry (DXA) and High-resolution peripheral quantitative computed tomography (HR-pQCT) and to compare this with normative data. | Description | To correlate bone mineral density with eczema severity using Eczema area and severity index (EASI) and Scoring atopic dermatitis (SCORAD) scores | Description | To determine if bone mineral density in children with atopic dermatitis correlates with bone age and bone-health specific serum markers |
Browse Conditions
Sequence: | 191956395 | Sequence: | 191956401 | Sequence: | 191956394 | Sequence: | 191956396 | Sequence: | 191956397 | Sequence: | 191956398 | Sequence: | 191956399 | Sequence: | 191956400 | Sequence: | 191956402 | Sequence: | 191956403 |
Mesh Term | Dermatitis | Mesh Term | Hypersensitivity, Immediate | Mesh Term | Dermatitis, Atopic | Mesh Term | Eczema | Mesh Term | Skin Diseases | Mesh Term | Skin Diseases, Genetic | Mesh Term | Genetic Diseases, Inborn | Mesh Term | Skin Diseases, Eczematous | Mesh Term | Hypersensitivity | Mesh Term | Immune System Diseases |
Downcase Mesh Term | dermatitis | Downcase Mesh Term | hypersensitivity, immediate | Downcase Mesh Term | dermatitis, atopic | Downcase Mesh Term | eczema | Downcase Mesh Term | skin diseases | Downcase Mesh Term | skin diseases, genetic | Downcase Mesh Term | genetic diseases, inborn | Downcase Mesh Term | skin diseases, eczematous | Downcase Mesh Term | hypersensitivity | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47964981 | Sequence: | 47964982 |
Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Mayo Clinic | Name | Pediatric Dermatology Research Alliance |
Overall Officials
Sequence: | 29061061 | Sequence: | 29061062 |
Role | Principal Investigator | Role | Study Director |
Name | Megha M Tollefson, MD | Name | Henry Nguyen, MD |
Affiliation | Mayo Clinic | Affiliation | Mayo Clinic |
Central Contacts
Sequence: | 11932090 | Sequence: | 11932091 |
Contact Type | primary | Contact Type | backup |
Name | Henry Nguyen, MD | Name | Katrina Pierce |
Phone | 507-284-4673 | Phone | 507-266-1078 |
Nguyen.Henry@mayo.edu | Pierce.Katrina@mayo.edu | ||
Role | Contact | Role | Contact |
Eligibilities
Sequence: | 30542319 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 5 Years |
Maximum Age | 17 Years |
Healthy Volunteers | No |
Population | Children with a diagnosis of moderate to severe atopic dermatitis as made by a dermatologist |
Criteria | Inclusion Criteria:
Children 5 to 17 years of age with a diagnosis of moderate to severe atopic dermatitis as made by a dermatologist Exclusion Criteria: Those without a confirmed diagnosis of moderate to severe atopic dermatitis |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254209554 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 5 |
Maximum Age Num | 17 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Designs
Sequence: | 30290829 |
Observational Model | Cohort |
Time Perspective | Prospective |
Links
Sequence: | 4355635 |
Url | https://www.mayo.edu/research/clinical-trials |
Description | Mayo Clinic Clinical Trials |
Responsible Parties
Sequence: | 28669626 |
Responsible Party Type | Principal Investigator |
Name | Megha M. Tollefson, M.D. |
Title | Principal Investigator |
Affiliation | Mayo Clinic |
Study References
Sequence: | 51686565 | Sequence: | 51686566 | Sequence: | 51686567 | Sequence: | 51686568 |
Pmid | 25353616 | Pmid | 19673879 | Pmid | 20850893 | Pmid | 28207767 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Garg N, Silverberg JI. Association between eczema and increased fracture and bone or joint injury in adults: a US population-based study. JAMA Dermatol. 2015 Jan;151(1):33-41. doi: 10.1001/jamadermatol.2014.2098. | Citation | Haeck IM, Hamdy NA, Timmer-de Mik L, Lentjes EG, Verhaar HJ, Knol MJ, de Bruin-Weller MS, Bruijnzeel-Koomen CA. Low bone mineral density in adult patients with moderate to severe atopic dermatitis. Br J Dermatol. 2009 Dec;161(6):1248-54. doi: 10.1111/j.1365-2133.2009.09327.x. Epub 2009 Jun 4. | Citation | van Velsen SG, Knol MJ, van Eijk RL, de Vroede MA, de Wit TC, Lam MG, Haeck IM, de Bruin-Weller MS, Bruijnzeel-Koomen CA, Pasmans SG. Bone mineral density in children with moderate to severe atopic dermatitis. J Am Acad Dermatol. 2010 Nov;63(5):824-31. doi: 10.1016/j.jaad.2009.12.015. Epub 2010 Sep 17. | Citation | Wu CY, Lu YY, Lu CC, Su YF, Tsai TH, Wu CH. Osteoporosis in adult patients with atopic dermatitis: A nationwide population-based study. PLoS One. 2017 Feb 16;12(2):e0171667. doi: 10.1371/journal.pone.0171667. eCollection 2017. |
]]>
https://zephyrnet.com/NCT03799991
2021-03-01
https://zephyrnet.com/?p=NCT03799991
NCT03799991https://www.clinicaltrials.gov/study/NCT03799991?tab=tableYuri Agrawal, MDyagrawa1@jhmi.edu4105023107Nearly 2 out of 3 patients with Alzheimer’s disease (AD) experience problems with balance and mobility, which places such patients at increased risk of falling. The vestibular (inner ear balance) system plays an important role in balance stability, and vestibular therapy (VT) is well-known to improve balance function in healthy older adults. In this study, the investigators will conduct a first-in-kind randomized clinical trial to evaluate whether vestibular therapy improves reduces falls in patients with AD, in whom this treatment has never been studied.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-12-14 |
Start Month Year | March 1, 2021 |
Primary Completion Month Year | June 30, 2024 |
Verification Month Year | December 2022 |
Verification Date | 2022-12-31 |
Last Update Posted Date | 2022-12-14 |
Facilities
Sequence: | 200962641 |
Status | Recruiting |
Name | Johns Hopkins University School of Medicine |
City | Baltimore |
State | Maryland |
Zip | 21287 |
Country | United States |
Facility Contacts
Sequence: | 28246642 |
Facility Id | 200962641 |
Contact Type | primary |
Name | Yuri Agrawal |
Facility Investigators
Sequence: | 18419491 |
Facility Id | 200962641 |
Role | Principal Investigator |
Name | John Carey, MD |
Conditions
Sequence: | 52421116 | Sequence: | 52421117 | Sequence: | 52421118 |
Name | Vestibular Diseases | Name | Vestibular Disorder | Name | Alzheimer Disease |
Downcase Name | vestibular diseases | Downcase Name | vestibular disorder | Downcase Name | alzheimer disease |
Id Information
Sequence: | 40335745 |
Id Source | org_study_id |
Id Value | IRB00273752 |
Countries
Sequence: | 42763393 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55870259 | Sequence: | 55870260 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Vestibular therapy | Title | Active control |
Description | Vestibular therapy (Vestibular physical therapy) entails an 8-week course of exercises delivered by a physical therapist designed to improve vestibular function. | Description | The active control regimen consists of eye movement exercises (e.g. smooth pursuit eye movements) and also general conditioning exercises (e.g. range of motion exercises, lifting light weights with the arms and legs). This regimen is "vestibular neutral" in that head movements which specifically challenge the vestibular system are avoided. |
Interventions
Sequence: | 52729826 | Sequence: | 52729827 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Vestibular physical therapy | Name | Active control |
Description | Vestibular therapy is a set of exercises delivered by a physical therapist involving head movements. The therapy is delivered over a course of 8 weeks. | Description | Strength and flexibility exercises that do not involve head movements. |
Design Outcomes
Sequence: | 178312633 |
Outcome Type | primary |
Measure | Number of participant falls |
Time Frame | 1 year |
Description | Incidence of falls over a 1-year follow-up period |
Browse Conditions
Sequence: | 194435913 | Sequence: | 194435914 | Sequence: | 194435915 | Sequence: | 194435916 | Sequence: | 194435917 | Sequence: | 194435918 | Sequence: | 194435919 | Sequence: | 194435920 | Sequence: | 194435921 | Sequence: | 194435922 | Sequence: | 194435923 | Sequence: | 194435924 | Sequence: | 194435925 |
Mesh Term | Vestibular Diseases | Mesh Term | Alzheimer Disease | Mesh Term | Dementia | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Tauopathies | Mesh Term | Neurodegenerative Diseases | Mesh Term | Neurocognitive Disorders | Mesh Term | Mental Disorders | Mesh Term | Labyrinth Diseases | Mesh Term | Ear Diseases | Mesh Term | Otorhinolaryngologic Diseases |
Downcase Mesh Term | vestibular diseases | Downcase Mesh Term | alzheimer disease | Downcase Mesh Term | dementia | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | tauopathies | Downcase Mesh Term | neurodegenerative diseases | Downcase Mesh Term | neurocognitive disorders | Downcase Mesh Term | mental disorders | Downcase Mesh Term | labyrinth diseases | Downcase Mesh Term | ear diseases | Downcase Mesh Term | otorhinolaryngologic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48551044 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Johns Hopkins University |
Overall Officials
Sequence: | 29414995 |
Role | Principal Investigator |
Name | Yuri Agrawal, MD |
Affiliation | Johns Hopkins University |
Central Contacts
Sequence: | 12074544 |
Contact Type | primary |
Name | Yuri Agrawal, MD |
Phone | 4105023107 |
yagrawa1@jhmi.edu | |
Role | Contact |
Design Group Interventions
Sequence: | 68489214 | Sequence: | 68489215 |
Design Group Id | 55870259 | Design Group Id | 55870260 |
Intervention Id | 52729826 | Intervention Id | 52729827 |
Eligibilities
Sequence: | 30908871 |
Gender | All |
Minimum Age | 60 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Diagnosis of AD based on the National Institute on Aging-Alzheimer Association 2011 criteria that is mild-moderate (CDR=0.5-2). Exclusion Criteria: Diagnosis of severe AD (CDR≥3). |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254168668 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 60 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30654582 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Subject Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 29021238 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52331765 |
Pmid | 35918757 |
Reference Type | derived |
Citation | Yesantharao LV, Rosenberg P, Oh E, Leoutsakos J, Munro CA, Agrawal Y. Vestibular therapy to reduce falls in people with Alzheimer's disease: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2022 Aug 2;8(1):167. doi: 10.1186/s40814-022-01133-w. |
]]>
https://zephyrnet.com/NCT03799978
2019-03-09
https://zephyrnet.com/?p=NCT03799978
NCT03799978https://www.clinicaltrials.gov/study/NCT03799978?tab=tableNANANAThis is a single-center, open-label, randomized, two way crossover study to investigate the food effect on the pharmacokinetics of ACT-541468 in healthy male subjects.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-04-12 |
Start Month Year | March 9, 2019 |
Primary Completion Month Year | March 18, 2019 |
Verification Month Year | April 2019 |
Verification Date | 2019-04-30 |
Last Update Posted Date | 2019-04-12 |
Facilities
Sequence: | 199964474 |
Name | CEPHA s.r.o. |
City | Pilsen |
Zip | 323 00 |
Country | Czechia |
Conditions
Sequence: | 52138949 |
Name | Healthy |
Downcase Name | healthy |
Id Information
Sequence: | 40135017 |
Id Source | org_study_id |
Id Value | ID-078-113 |
Countries
Sequence: | 42542638 |
Name | Czechia |
Removed | False |
Design Groups
Sequence: | 55559285 | Sequence: | 55559286 |
Group Type | Experimental | Group Type | Experimental |
Title | Treatment A: ACT-541468 50 mg under fasted conditions | Title | Treatment B: ACT-541468 50 mg under fed conditions |
Description | Single oral dose administered on Day 1 under fasted conditions. | Description | Single oral dose administered on Day 1 administered after food intake. |
Interventions
Sequence: | 52454849 |
Intervention Type | Drug |
Name | ACT-541468 |
Description | ACT-541468 50 mg film-coated tablets |
Design Outcomes
Sequence: | 177263386 | Sequence: | 177263385 | Sequence: | 177263387 | Sequence: | 177263388 | Sequence: | 177263389 | Sequence: | 177263390 | Sequence: | 177263391 |
Outcome Type | other | Outcome Type | primary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Pharmacokinetic endpoint: AUC0-inf | Measure | Pharmacokinetic endpoint: AUC0-24 | Measure | Pharmacokinetic endpoint: Cmax | Measure | Pharmacokinetic endpoint: tmax | Measure | Pharmacokinetic endpoint: t½ | Measure | Treatment-emergent adverse events | Measure | Serious treatment-emergent adverse events |
Time Frame | Multiple timepoints; duration: up to 48 hours in each treatment period | Time Frame | Multiple timepoints; duration: up to 48 hours in each treatment period | Time Frame | Multiple timepoints; duration: up to 48 hours in each treatment period | Time Frame | Multiple timepoints; duration: up to 48 hours in each treatment period | Time Frame | Multiple timepoints; duration: up to 48 hours in each treatment period | Time Frame | From study treatment administration up to EOT; duration: up to 48 hours in each treatment period | Time Frame | From study treatment administration up to EOT; duration: up to 48 hours in each treatment period |
Description | AUC from time zero to infinity | Description | Area under the plasma concentration-time curve (AUC) from time zero to 24 h | Description | Maximum plasma concentration | Description | Time to reach maximum plasma concentration | Description | Terminal elimination half-life |
Sponsors
Sequence: | 48290664 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Idorsia Pharmaceuticals Ltd. |
Overall Officials
Sequence: | 29268505 |
Role | Study Director |
Name | Clinical Trials |
Affiliation | Idorsia Pharmaceuticals Ltd. |
Design Group Interventions
Sequence: | 68107376 | Sequence: | 68107377 |
Design Group Id | 55559285 | Design Group Id | 55559286 |
Intervention Id | 52454849 | Intervention Id | 52454849 |
Eligibilities
Sequence: | 30747691 |
Gender | Male |
Minimum Age | 18 Years |
Maximum Age | 45 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Signed informed consent prior to any study-mandated procedure Exclusion Criteria: History of major medical or surgical disorders, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed) |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254121761 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 0 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 45 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 6 |
Designs
Sequence: | 30493974 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Two way crossover |
Responsible Parties
Sequence: | 28860254 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799965
2017-12-01
https://zephyrnet.com/?p=NCT03799965
NCT03799965https://www.clinicaltrials.gov/study/NCT03799965?tab=tableemine yurt, doctordremine@gmail.com+905054782609Investigation of the effect of Enhanced Recovery After Surgery (ERAS) program on postoperative results of patients operated for open heart surgery.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-30 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-31 |
Start Month Year | December 1, 2017 |
Primary Completion Month Year | January 1, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-31 |
Detailed Descriptions
Sequence: | 20727159 |
Description | The ERAS protocol, also known as evidence based "fast-track surgery" (FTS), is an evidence based combination of findings regarding suggestions for patient care on various levels of the perioperative period, which work in synergy for accelerating the postoperative recovery period. It has been used sucessfully for many surgical disciplines, primarily colorectal surgery, since it was first reported in 1997. However, there is a significant insufficiency of this patient oriented rehabilitation program regarding cardiovascular surgeries. This study is to compare the postoperative follow up periods of patients with ERAS protocol and patients with standard protocol who were both operated for cardiac surgery.
Following approval of the local ethics committee, 210 patients who are operated for elective cardiac surgery are enrolled in this prospective randomized clinical trial. The patients who are not applied the ERAS protocol are evaluated in the control group (n=51). The findings regarding the patients under ERAS protocol are evaluated based on evidence. Our primary is to compare the durations of stay in the intensive care unit and in hospital; our secondary is to compare the incidences of complications of the groups. The demographic data, operative measurements, complication rates, the amounts of perioperative bleeding and drainage and the duration of stay in the intensive care unit and hospital are recorded. |
Facilities
Sequence: | 200159267 |
Status | Recruiting |
Name | Emine yurt |
City | Kocaeli |
State | Derince |
Zip | 41400 |
Country | Turkey |
Facility Contacts
Sequence: | 28113717 | Sequence: | 28113718 |
Facility Id | 200159267 | Facility Id | 200159267 |
Contact Type | primary | Contact Type | backup |
Name | ipek y duzyol, doctor | Name | emine yurt, doctor |
ipekyd@hotmail.com | dremine@gmail.com | ||
Phone | +905067922217 | Phone | +905054782609 |
Conditions
Sequence: | 52185435 | Sequence: | 52185436 |
Name | Enhanced Recovery After Surgery | Name | Open Heart Surgery |
Downcase Name | enhanced recovery after surgery | Downcase Name | open heart surgery |
Id Information
Sequence: | 40169040 |
Id Source | org_study_id |
Id Value | KUGOKAEK 2017/369 |
Countries
Sequence: | 42580633 |
Name | Turkey |
Removed | False |
Design Groups
Sequence: | 55609067 | Sequence: | 55609068 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | ERAS protocol are evaluated | Title | ERAS protocol are not evaluated |
Description | It is to compare the durations of stay in the intensive care unit and in hospital It is to compare the incidences of complications of the groups |
Description | It is to compare the durations of stay in the intensive care unit and in hospital It is to compare the incidences of complications of the groups |
Interventions
Sequence: | 52499380 | Sequence: | 52499381 |
Intervention Type | Other | Intervention Type | Other |
Name | ERAS (Enhanced Recovery After Surgery ) are evaluated | Name | ERAS are not evaluated |
Description | In this arm ERAS( Enhanced Recovery After Surgery) protocol will be inserted.The findings regarding the patients under ERAS protocol are evaluated based on evidence. | Description | In this arm ERAS( Enhanced Recovery After Surgery) protocol will not be inserted.The findings regarding the patients under ERAS protocol are evaluated based on evidence. |
Design Outcomes
Sequence: | 177431890 | Sequence: | 177431891 |
Outcome Type | primary | Outcome Type | primary |
Measure | durations of stay | Measure | complications |
Time Frame | 24 hours | Time Frame | 24 hours |
Description | compare the durations of stay in the intensive care unit and in hospital | Description | compare the incidences of complications |
Sponsors
Sequence: | 48332280 | Sequence: | 48332281 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Kocaeli Derince Education and Research Hospital | Name | Kocaeli University |
Central Contacts
Sequence: | 12012290 | Sequence: | 12012291 |
Contact Type | primary | Contact Type | backup |
Name | Ipek Y duzyol, doctor | Name | emine yurt, doctor |
Phone | +905067922217 | Phone | +905054782609 |
ipekyd@hotmail.com | dremine@gmail.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68168115 | Sequence: | 68168116 |
Design Group Id | 55609067 | Design Group Id | 55609068 |
Intervention Id | 52499380 | Intervention Id | 52499381 |
Eligibilities
Sequence: | 30773549 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
over 18 years old; Exclusion Criteria: Patients who refuse to participate in the study; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952598 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 13 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Designs
Sequence: | 30519680 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28885981 |
Responsible Party Type | Principal Investigator |
Name | Ipek Yakin Duzyol |
Title | specialist doctor |
Affiliation | Kocaeli Derince Education and Research Hospital |
]]>
https://zephyrnet.com/NCT03799952
2019-02-07
https://zephyrnet.com/?p=NCT03799952
NCT03799952https://www.clinicaltrials.gov/study/NCT03799952?tab=tableNANANAThe objective of this study is to recruit a group of older adults and study a broad set of physical health, mental health, and social outcomes when participants exercise with an older adult, peer-led exercise program.
The program to be evaluated is called Zoomers on the Go. It is a 12-week program which involves two 60-minute sessions per week and educates participants about falls, along with aerobic and resistance exercise, flexibility, and balance activities. The program is offered to older adults (age 50+) and it is delivered in their community by an older adult who is trained as a certified Zoomers group exercise leader.
Participants will be recruited, then randomized so that half of them can participate in a Zoomers class in the spring (intervention group) while half will have to wait until the fall of 2019 (control group). Pre-testing for both groups will begin around March 2019. The intervention group will participate in the program for 12 weeks, then there will be post-testing following this 12-weeks for both groups. Outcomes will be compared for the intervention and control groups, to determine if there are changes in the data pre- to post-measurements that are evident solely for the intervention group.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-20 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-07-14 |
Start Month Year | February 7, 2019 |
Primary Completion Month Year | November 28, 2019 |
Verification Month Year | July 2021 |
Verification Date | 2021-07-31 |
Last Update Posted Date | 2021-07-14 |
Results First Posted Date | 2021-07-14 |
Detailed Descriptions
Sequence: | 20713083 |
Description | This study is a randomized control trial where subjects will be randomly assigned to a control or an intervention group. Participants will be recruited through general advertisements (e.g. radio, newspaper, posters), in Fredericton and surrounding areas. These participants will be volunteers, and no compensation will be provided besides having access to a free exercise program in their community. Eligibility will be determined by the research staff prior to the baseline assessment day.Eligible participants will be evaluated at an initial day of testing at either a Horizon CommunityHealth Centre or at the University of New Brunswick in the Cardiometabolic Exercise and Lifestyle Laboratory (CELLab). This first visit will involve the confirmation of eligibility, reading and signing a consent form, and the administration of the measurements discussed previously. All research staff will have received the appropriate training to deliver these fitness assessments, finger pricks, and interviews.
At the end of the baseline visit, research staff will randomly assign participants to the intervention or control group. The participant will wear a pedometer for seven consecutive days following this initial visit. The paper form for any information collected (e.g. consent form) will be stored in the CELLab at UNB in a locked cabinet. The CELLab has limited access; only staff has access through a password to the lab. All information will be linked to a participant number for which the only linkable personal information (e.g., name, age, sex) will be kept in a password protected computer and only the Principal Investigator, Co-Investigators, and Research Coordinator will have access to this information. Information will be stored for a maximum of 7 years. Following this baseline assessment, participants in the intervention group will be assigned to an exercise program most convenient to them. This is a 12-week exercise program, offered twice a week. Full attendance is not mandatory for being a participant. This is a peer-led exercise program, meaning it is instructed by a leader of similar age. This leader has received extensive Fitness New Brunswick training to deliver a program aimed to reduce the risk of falls and help older adults safely increase their physical activity levels. This 60-minute exercise program involves aerobic and resistance exercise, as well as flexibility and balance activities. The program is currently designed to help individuals meet the physical activity guidelines. Participants' numbers will be used to register attendance from the leaders. Following this 12-week intervention or control period, participants will repeat all the baseline assessments (including questionnaires and interviews), with an exception that they will not have to wear the pedometer in the follow up visit. The primary objective will be to determine whether participants' experiences with the program were positive or negative, and specifically identifying participants' attributions of why/how the exercise intervention positively impacted their physical and/or mental health. |
Facilities
Sequence: | 200013871 |
Name | Kinesiology Building |
City | Fredericton |
State | New Brunswick |
Zip | E3B 5A3 |
Country | Canada |
Conditions
Sequence: | 52147766 | Sequence: | 52147767 |
Name | Aging | Name | Fall |
Downcase Name | aging | Downcase Name | fall |
Id Information
Sequence: | 40141580 |
Id Source | org_study_id |
Id Value | 2019-01Zoom |
Countries
Sequence: | 42550768 |
Name | Canada |
Removed | False |
Design Groups
Sequence: | 55568470 | Sequence: | 55568471 |
Group Type | Experimental | Group Type | No Intervention |
Title | Intervention | Title | Control |
Description | Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length. | Description | Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks. |
Interventions
Sequence: | 52463575 |
Intervention Type | Behavioral |
Name | Zoomers on the Go Exercise Program |
Description | 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour. |
Keywords
Sequence: | 79834602 | Sequence: | 79834603 | Sequence: | 79834604 |
Name | Older adult | Name | Peer-led exercise program | Name | Risk of falling |
Downcase Name | older adult | Downcase Name | peer-led exercise program | Downcase Name | risk of falling |
Design Outcomes
Sequence: | 177297610 | Sequence: | 177297611 | Sequence: | 177297612 | Sequence: | 177297613 | Sequence: | 177297614 | Sequence: | 177297615 | Sequence: | 177297616 | Sequence: | 177297617 | Sequence: | 177297618 | Sequence: | 177297619 | Sequence: | 177297620 | Sequence: | 177297621 | Sequence: | 177297622 | Sequence: | 177297623 | Sequence: | 177297624 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Balance | Measure | Walking Speed | Measure | Flexibility | Measure | Strength, Arm Curl Test | Measure | Strength, Chair Stand Test | Measure | Depression, Anxiety, Stress | Measure | Perceived Quality of Life | Measure | Researcher-generated Measure of Exercise Self-efficacy Based on Bandura's Concept of Self-efficacy | Measure | Connectedness, Sense of Belonging, and Friendships | Measure | The Amount of Bodily Sway When Performing Tasks and Balancing. | Measure | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Measure | Measured on a Portable Biomechanical Board. | Measure | Systolic Blood Pressure | Measure | Resting Heart Rate | Measure | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine for Cholesterol Levels |
Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Following the 12 week program | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Pre and post (after the 12 weeks) | Time Frame | Pre and post (after the 12 weeks) | Time Frame | Pre and post (after the 12 weeks) | Time Frame | Pre and post (before and after the 12 week exercise program) |
Description | One leg stand test (seconds) | Description | 6-minute test (meters walked) | Description | Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. | Description | Number of bicep curls with light weight | Description | Chair stand test, number of chair stand in 30 seconds | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The outcome measure on exercise self-efficacy (based on Bandura's concept of self-efficacy) is measured on a 1-4 scale. A higher score is more desirable than a lower score | Description | All collected information via interviews with participants | Description | Measured by a portable biomechanical board. Can detect sway through sensors. | Description | Blood draw via finger prick and analyzed with a Cardiochek machine
An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
Description | An individual's centre of mass as determined by sensors on a biomechanical board. | Description | Blood pressure cuff (mmHg) | Description | Radial pulse palpation (bpm) | Description | An individual's cholesterol levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
Sponsors
Sequence: | 48298227 | Sequence: | 48298228 | Sequence: | 48298229 | Sequence: | 48298230 | Sequence: | 48298231 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | University of New Brunswick | Name | New Brunswick Health Research Foundation | Name | Horizon Health Network | Name | Universite de Moncton | Name | Fitness New Brunswick |
Design Group Interventions
Sequence: | 68119628 |
Design Group Id | 55568470 |
Intervention Id | 52463575 |
Eligibilities
Sequence: | 30752360 |
Gender | All |
Minimum Age | 50 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
50 years of age or older Exclusion Criteria: Under 50 years of age |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254174930 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 9 |
Were Results Reported | True |
Months To Report Results | 12 |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 50 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 5 |
Number Of Secondary Outcomes To Measure | 2 |
Number Of Other Outcomes To Measure | 8 |
Designs
Sequence: | 30498628 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Single |
Intervention Model Description | Randomized to a control or intervention group. The intervention group will have pre- and post-testing following 12-weeks of exercise, while the control group will have pre- and post-testing following 12-weeks of "normal" activity. |
Subject Masked | True |
Drop Withdrawals
Sequence: | 28975585 | Sequence: | 28975586 | Sequence: | 28975587 | Sequence: | 28975588 |
Result Group Id | 56079277 | Result Group Id | 56079278 | Result Group Id | 56079277 | Result Group Id | 56079278 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Program was too easy, discontinued | Reason | Program was too easy, discontinued | Reason | Lost to Follow-up | Reason | Lost to Follow-up |
Count | 1 | Count | 0 | Count | 0 | Count | 2 |
Milestones
Sequence: | 40992015 | Sequence: | 40992016 | Sequence: | 40992017 | Sequence: | 40992018 | Sequence: | 40992019 | Sequence: | 40992020 |
Result Group Id | 56079277 | Result Group Id | 56079278 | Result Group Id | 56079277 | Result Group Id | 56079278 | Result Group Id | 56079277 | Result Group Id | 56079278 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 31 | Count | 31 | Count | 30 | Count | 29 | Count | 1 | Count | 2 |
Participant Flows
Sequence: | 3920076 |
Recruitment Details | Recruitment occurred between January and March 2019. Participants were recruited through radio advertisements, newspapers, posters, and social media. Per the participants availability they were allocated to the randomization or preferred arm. |
Pre Assignment Details | Participants were excluded if they were not cleared by the Get Active Questionnaire and did not receive clearance from their primary physician to participate |
Outcome Counts
Sequence: | 73972381 | Sequence: | 73972382 | Sequence: | 73972383 | Sequence: | 73972384 | Sequence: | 73972385 | Sequence: | 73972386 | Sequence: | 73972387 | Sequence: | 73972388 | Sequence: | 73972389 | Sequence: | 73972390 | Sequence: | 73972391 | Sequence: | 73972392 | Sequence: | 73972393 | Sequence: | 73972394 | Sequence: | 73972395 | Sequence: | 73972396 | Sequence: | 73972397 | Sequence: | 73972398 | Sequence: | 73972399 | Sequence: | 73972400 |
Outcome Id | 30793035 | Outcome Id | 30793035 | Outcome Id | 30793036 | Outcome Id | 30793036 | Outcome Id | 30793037 | Outcome Id | 30793037 | Outcome Id | 30793038 | Outcome Id | 30793038 | Outcome Id | 30793039 | Outcome Id | 30793039 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793045 | Outcome Id | 30793045 | Outcome Id | 30793047 | Outcome Id | 30793047 | Outcome Id | 30793048 | Outcome Id | 30793048 |
Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 30 | Count | 29 | Count | 30 | Count | 29 | Count | 30 | Count | 29 | Count | 30 | Count | 29 | Count | 30 | Count | 29 | Count | 30 | Count | 29 | Count | 30 | Count | 29 | Count | 30 | Count | 29 | Count | 30 | Count | 29 | Count | 30 | Count | 29 |
Provided Documents
Sequence: | 2577769 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2018-11-23 |
Url | https://ClinicalTrials.gov/ProvidedDocs/52/NCT03799952/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27934075 | Sequence: | 27934076 | Sequence: | 27934077 | Sequence: | 27934078 | Sequence: | 27934079 | Sequence: | 27934080 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 30 | Subjects At Risk | 30 | Subjects At Risk | 30 | Subjects At Risk | 29 | Subjects At Risk | 29 | Subjects At Risk | 29 |
Created At | 2023-08-08 21:34:49.899586 | Created At | 2023-08-08 21:34:49.899586 | Created At | 2023-08-08 21:34:49.899586 | Created At | 2023-08-08 21:34:49.899586 | Created At | 2023-08-08 21:34:49.899586 | Created At | 2023-08-08 21:34:49.899586 |
Updated At | 2023-08-08 21:34:49.899586 | Updated At | 2023-08-08 21:34:49.899586 | Updated At | 2023-08-08 21:34:49.899586 | Updated At | 2023-08-08 21:34:49.899586 | Updated At | 2023-08-08 21:34:49.899586 | Updated At | 2023-08-08 21:34:49.899586 |
Responsible Parties
Sequence: | 28864902 |
Responsible Party Type | Principal Investigator |
Name | Danielle Bouchard |
Title | Associate Professor |
Affiliation | University of New Brunswick |
Result Agreements
Sequence: | 3850820 |
Pi Employee | No |
Result Contacts
Sequence: | 3850785 |
Organization | University of New Brunswick |
Name | Dr. Danielle Bouchard |
Phone | 1 (506) 443-3908 |
danielle.bouchard@unb.ca | |
Outcomes
Sequence: | 30793035 | Sequence: | 30793036 | Sequence: | 30793037 | Sequence: | 30793038 | Sequence: | 30793039 | Sequence: | 30793040 | Sequence: | 30793041 | Sequence: | 30793042 | Sequence: | 30793043 | Sequence: | 30793044 | Sequence: | 30793045 | Sequence: | 30793046 | Sequence: | 30793047 | Sequence: | 30793048 | Sequence: | 30793049 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Other Pre-specified | Outcome Type | Other Pre-specified | Outcome Type | Other Pre-specified | Outcome Type | Other Pre-specified | Outcome Type | Other Pre-specified | Outcome Type | Other Pre-specified | Outcome Type | Other Pre-specified | Outcome Type | Other Pre-specified |
Title | Balance | Title | Walking Speed | Title | Flexibility | Title | Strength, Arm Curl Test | Title | Strength, Chair Stand Test | Title | Depression, Anxiety, Stress | Title | Perceived Quality of Life | Title | Researcher-generated Measure of Exercise Self-efficacy Based on Bandura's Concept of Self-efficacy | Title | Connectedness, Sense of Belonging, and Friendships | Title | The Amount of Bodily Sway When Performing Tasks and Balancing. | Title | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Title | Measured on a Portable Biomechanical Board. | Title | Systolic Blood Pressure | Title | Resting Heart Rate | Title | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine for Cholesterol Levels |
Description | One leg stand test (seconds) | Description | 6-minute test (meters walked) | Description | Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. | Description | Number of bicep curls with light weight | Description | Chair stand test, number of chair stand in 30 seconds | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The outcome measure on exercise self-efficacy (based on Bandura's concept of self-efficacy) is measured on a 1-4 scale. A higher score is more desirable than a lower score | Description | All collected information via interviews with participants | Description | Measured by a portable biomechanical board. Can detect sway through sensors. | Description | Blood draw via finger prick and analyzed with a Cardiochek machine
An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
Description | An individual's centre of mass as determined by sensors on a biomechanical board. | Description | Blood pressure cuff (mmHg) | Description | Radial pulse palpation (bpm) | Description | An individual's cholesterol levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Change pre and post (after the 12 weeks) | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Following the 12 week program | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Pre and post (before and after the 12 week exercise program) | Time Frame | Pre and post (after the 12 weeks) | Time Frame | Pre and post (after the 12 weeks) | Time Frame | Pre and post (after the 12 weeks) | Time Frame | Pre and post (before and after the 12 week exercise program) |
Units | score on a scale | Units | meters | Units | centimeters | Units | reps/30 seconds | Units | reps/30 seconds | Units | score on a scale | Units | score on a scale | Units | mmol/L | Units | mmHg | Units | beats per minute | ||||||||||
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 235564785 | Sequence: | 235564786 | Sequence: | 235564787 | Sequence: | 235564766 | Sequence: | 235564767 | Sequence: | 235564768 | Sequence: | 235564769 | Sequence: | 235564770 | Sequence: | 235564771 | Sequence: | 235564772 | Sequence: | 235564773 | Sequence: | 235564774 | Sequence: | 235564775 | Sequence: | 235564776 | Sequence: | 235564777 | Sequence: | 235564778 | Sequence: | 235564779 | Sequence: | 235564780 | Sequence: | 235564781 | Sequence: | 235564782 | Sequence: | 235564783 | Sequence: | 235564784 | Sequence: | 235564788 | Sequence: | 235564789 | Sequence: | 235564790 | Sequence: | 235564791 | Sequence: | 235564792 | Sequence: | 235564793 | Sequence: | 235564794 | Sequence: | 235564795 | Sequence: | 235564796 | Sequence: | 235564797 | Sequence: | 235564798 | Sequence: | 235564799 | Sequence: | 235564800 | Sequence: | 235564801 | Sequence: | 235564802 | Sequence: | 235564803 | Sequence: | 235564804 | Sequence: | 235564805 | Sequence: | 235564806 | Sequence: | 235564807 | Sequence: | 235564808 | Sequence: | 235564809 | Sequence: | 235564810 | Sequence: | 235564811 | Sequence: | 235564812 | Sequence: | 235564813 | Sequence: | 235564814 | Sequence: | 235564815 | Sequence: | 235564816 | Sequence: | 235564817 | Sequence: | 235564818 | Sequence: | 235564819 | Sequence: | 235564820 | Sequence: | 235564821 | Sequence: | 235564822 | Sequence: | 235564823 | Sequence: | 235564824 | Sequence: | 235564825 | Sequence: | 235564826 | Sequence: | 235564827 | Sequence: | 235564828 | Sequence: | 235564829 | Sequence: | 235564830 | Sequence: | 235564831 | Sequence: | 235564832 | Sequence: | 235564833 | Sequence: | 235564834 | Sequence: | 235564835 | Sequence: | 235564836 | Sequence: | 235564837 | Sequence: | 235564838 | Sequence: | 235564839 | Sequence: | 235564840 | Sequence: | 235564841 | Sequence: | 235564842 | Sequence: | 235564843 | Sequence: | 235564844 | Sequence: | 235564845 |
Outcome Id | 30793038 | Outcome Id | 30793039 | Outcome Id | 30793039 | Outcome Id | 30793035 | Outcome Id | 30793035 | Outcome Id | 30793035 | Outcome Id | 30793035 | Outcome Id | 30793035 | Outcome Id | 30793035 | Outcome Id | 30793035 | Outcome Id | 30793035 | Outcome Id | 30793036 | Outcome Id | 30793036 | Outcome Id | 30793036 | Outcome Id | 30793036 | Outcome Id | 30793037 | Outcome Id | 30793037 | Outcome Id | 30793037 | Outcome Id | 30793037 | Outcome Id | 30793038 | Outcome Id | 30793038 | Outcome Id | 30793038 | Outcome Id | 30793039 | Outcome Id | 30793039 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793040 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793041 | Outcome Id | 30793045 | Outcome Id | 30793045 | Outcome Id | 30793045 | Outcome Id | 30793045 | Outcome Id | 30793047 | Outcome Id | 30793047 | Outcome Id | 30793047 | Outcome Id | 30793047 | Outcome Id | 30793048 | Outcome Id | 30793048 | Outcome Id | 30793048 | Outcome Id | 30793048 |
Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 | Result Group Id | 56079279 | Result Group Id | 56079280 |
Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Classification | Post | Classification | Pre | Classification | Pre | Classification | Pre (eyes open) | Classification | Pre (eyes open) | Classification | Post (eyes open) | Classification | Post (eyes open) | Classification | Pre (eyes closed) | Classification | Pre (eyes closed) | Classification | Post (eyes closed) | Classification | Post (eyes closed) | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Post | Classification | Pre Stress (0-28) | Classification | Pre Stress (0-28) | Classification | Post Stress (0-28) | Classification | Post Stress (0-28) | Classification | Pre Anxiety (0-20) | Classification | Pre Anxiety (0-20) | Classification | Post Anxiety (0-20) | Classification | Post Anxiety (0-20) | Classification | Pre Depression (0-34) | Classification | Pre Depression (0-34) | Classification | Post Depression (0-34) | Classification | Post Depression (0-34) | Classification | Pre Physical Functioning | Classification | Pre Physical Functioning | Classification | Post Physical Functioning | Classification | Post Physical Functioning | Classification | Pre Limitations due to Physical Health | Classification | Pre Limitations due to Physical Health | Classification | Post Limitations due to Physical Health | Classification | Post Limitations due to Physical Health | Classification | Pre Pain | Classification | Pre Pain | Classification | Post Pain | Classification | Post Pain | Classification | Pre General Health | Classification | Pre General Health | Classification | Post General Health | Classification | Post General Health | Classification | Pre Energy/Fatigue | Classification | Pre Energy/Fatigue | Classification | Post Energy/Fatigue | Classification | Post Energy/Fatigue | Classification | Pre Social Functioning | Classification | Pre Social Functioning | Classification | Post Social Functioning | Classification | Post Social Functioning | Classification | Pre Limitations Emotional Problems | Classification | Pre Limitations Emotional Problems | Classification | Post Limitations Emotional Problems | Classification | Post Limitations Emotional Problems | Classification | Pre Emotional Well-Being | Classification | Pre Emotional Well-Being | Classification | Post Emotional Well-Being | Classification | Post Emotional Well-Being | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post | Classification | Pre | Classification | Pre | Classification | Post | Classification | Post |
Title | Strength, Arm Curl Test | Title | Strength, Chair Stand Test | Title | Strength, Chair Stand Test | Title | Balance | Title | Balance | Title | Balance | Title | Balance | Title | Balance | Title | Balance | Title | Balance | Title | Balance | Title | Walking Speed | Title | Walking Speed | Title | Walking Speed | Title | Walking Speed | Title | Flexibility | Title | Flexibility | Title | Flexibility | Title | Flexibility | Title | Strength, Arm Curl Test | Title | Strength, Arm Curl Test | Title | Strength, Arm Curl Test | Title | Strength, Chair Stand Test | Title | Strength, Chair Stand Test | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Depression, Anxiety, Stress | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Perceived Quality of Life | Title | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Title | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Title | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Title | Blood Draw Via Finger Prick and Analyzed With a Cardiochek Machine | Title | Systolic Blood Pressure | Title | Systolic Blood Pressure | Title | Systolic Blood Pressure | Title | Systolic Blood Pressure | Title | Resting Heart Rate | Title | Resting Heart Rate | Title | Resting Heart Rate | Title | Resting Heart Rate |
Description | Number of bicep curls with light weight | Description | Chair stand test, number of chair stand in 30 seconds | Description | Chair stand test, number of chair stand in 30 seconds | Description | One leg stand test (seconds) | Description | One leg stand test (seconds) | Description | One leg stand test (seconds) | Description | One leg stand test (seconds) | Description | One leg stand test (seconds) | Description | One leg stand test (seconds) | Description | One leg stand test (seconds) | Description | One leg stand test (seconds) | Description | 6-minute test (meters walked) | Description | 6-minute test (meters walked) | Description | 6-minute test (meters walked) | Description | 6-minute test (meters walked) | Description | Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. | Description | Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. | Description | Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. | Description | Back scratch test (cm). The Back Scratch Test is a measure of flexibility of your upper body. Place your right hand behind your back with your palm out and your fingers extended up. Reach up as far as possible and attempt to touch the fingers of your two hands together. Some people are not able to touch at all, while others' fingers may overlap. Position fingers so that they are pointing toward each other. The distance between the fingertips of one hand and the other is measured to the nearest half-inch. If fingers overlap, the amount of the overlap will be measured. Fingertips just touching receive a score of "0". If fingers do not touch, it is a negative score of the distance between the fingers, measured to the nearest .5 or half inch. It is a positive score if fingers overlap, measuring the overlap to the nearest .5 or half inch. | Description | Number of bicep curls with light weight | Description | Number of bicep curls with light weight | Description | Number of bicep curls with light weight | Description | Chair stand test, number of chair stand in 30 seconds | Description | Chair stand test, number of chair stand in 30 seconds | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | Depression Anxiety Stress Scales – 21 item (DASS-21) was used to measure past week depression, anxiety, and stress. Low is better. (Lovibond & Lovibond, 1995). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | The Short Form Health Survey – 36 items (SF-36) was used to measure day-to-day functioning and quality of life (Ware & Sherbourne, 1992). The scale is composed of eight domain subscales (i.e., Physical Functioning, Role Limitations due to Physical Health, Pain, General Health, Energy/Fatigue, Social Functioning, Role Limitations due to Emotional Problems, Emotional Well-Being) scored from 0 (worst) to 100 (excellent). | Description | Blood draw via finger prick and analyzed with a Cardiochek machine
An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
Description | Blood draw via finger prick and analyzed with a Cardiochek machine
An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
Description | Blood draw via finger prick and analyzed with a Cardiochek machine
An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
Description | Blood draw via finger prick and analyzed with a Cardiochek machine
An individual's glucose levels in capillary blood, taken by a finger prick and assessed with a Cardiochek machine |
Description | Blood pressure cuff (mmHg) | Description | Blood pressure cuff (mmHg) | Description | Blood pressure cuff (mmHg) | Description | Blood pressure cuff (mmHg) | Description | Radial pulse palpation (bpm) | Description | Radial pulse palpation (bpm) | Description | Radial pulse palpation (bpm) | Description | Radial pulse palpation (bpm) |
Units | reps/30 seconds | Units | reps/30 seconds | Units | reps/30 seconds | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | meters | Units | meters | Units | meters | Units | meters | Units | centimeters | Units | centimeters | Units | centimeters | Units | centimeters | Units | reps/30 seconds | Units | reps/30 seconds | Units | reps/30 seconds | Units | reps/30 seconds | Units | reps/30 seconds | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | mmol/L | Units | mmol/L | Units | mmol/L | Units | mmol/L | Units | mmHg | Units | mmHg | Units | mmHg | Units | mmHg | Units | beats per minute | Units | beats per minute | Units | beats per minute | Units | beats per minute |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 17.4 | Param Value | 14.1 | Param Value | 13.6 | Param Value | 26.7 | Param Value | 27.9 | Param Value | 34.7 | Param Value | 29.7 | Param Value | 5.0 | Param Value | 4.9 | Param Value | 5.3 | Param Value | 4.4 | Param Value | 476 | Param Value | 507 | Param Value | 539 | Param Value | 504 | Param Value | -7.5 | Param Value | -5.2 | Param Value | -5.7 | Param Value | -4.7 | Param Value | 20.1 | Param Value | 17.3 | Param Value | 23.9 | Param Value | 17.9 | Param Value | 14.1 | Param Value | 6.0 | Param Value | 5.7 | Param Value | 4.1 | Param Value | 8.2 | Param Value | 3.5 | Param Value | 2.6 | Param Value | 3.2 | Param Value | 5.0 | Param Value | 4.8 | Param Value | 3.2 | Param Value | 3.2 | Param Value | 5.5 | Param Value | 78.0 | Param Value | 80.9 | Param Value | 81.2 | Param Value | 80.4 | Param Value | 78.3 | Param Value | 81.7 | Param Value | 90.8 | Param Value | 79.0 | Param Value | 73.5 | Param Value | 79.1 | Param Value | 71.9 | Param Value | 71.0 | Param Value | 71.2 | Param Value | 72.4 | Param Value | 75.5 | Param Value | 69.8 | Param Value | 63.5 | Param Value | 67.4 | Param Value | 68.7 | Param Value | 65.4 | Param Value | 90.2 | Param Value | 88.9 | Param Value | 92.1 | Param Value | 86.4 | Param Value | 84.6 | Param Value | 78.8 | Param Value | 88.9 | Param Value | 84.0 | Param Value | 80.4 | Param Value | 82.5 | Param Value | 84.7 | Param Value | 78.7 | Param Value | 5.34 | Param Value | 5.61 | Param Value | 4.70 | Param Value | 5.11 | Param Value | 123.8 | Param Value | 127.5 | Param Value | 125.7 | Param Value | 124.5 | Param Value | 68.1 | Param Value | 70.5 | Param Value | 63.0 | Param Value | 67.2 |
Param Value Num | 17.4 | Param Value Num | 14.1 | Param Value Num | 13.6 | Param Value Num | 26.7 | Param Value Num | 27.9 | Param Value Num | 34.7 | Param Value Num | 29.7 | Param Value Num | 5.0 | Param Value Num | 4.9 | Param Value Num | 5.3 | Param Value Num | 4.4 | Param Value Num | 476.0 | Param Value Num | 507.0 | Param Value Num | 539.0 | Param Value Num | 504.0 | Param Value Num | -7.5 | Param Value Num | -5.2 | Param Value Num | -5.7 | Param Value Num | -4.7 | Param Value Num | 20.1 | Param Value Num | 17.3 | Param Value Num | 23.9 | Param Value Num | 17.9 | Param Value Num | 14.1 | Param Value Num | 6.0 | Param Value Num | 5.7 | Param Value Num | 4.1 | Param Value Num | 8.2 | Param Value Num | 3.5 | Param Value Num | 2.6 | Param Value Num | 3.2 | Param Value Num | 5.0 | Param Value Num | 4.8 | Param Value Num | 3.2 | Param Value Num | 3.2 | Param Value Num | 5.5 | Param Value Num | 78.0 | Param Value Num | 80.9 | Param Value Num | 81.2 | Param Value Num | 80.4 | Param Value Num | 78.3 | Param Value Num | 81.7 | Param Value Num | 90.8 | Param Value Num | 79.0 | Param Value Num | 73.5 | Param Value Num | 79.1 | Param Value Num | 71.9 | Param Value Num | 71.0 | Param Value Num | 71.2 | Param Value Num | 72.4 | Param Value Num | 75.5 | Param Value Num | 69.8 | Param Value Num | 63.5 | Param Value Num | 67.4 | Param Value Num | 68.7 | Param Value Num | 65.4 | Param Value Num | 90.2 | Param Value Num | 88.9 | Param Value Num | 92.1 | Param Value Num | 86.4 | Param Value Num | 84.6 | Param Value Num | 78.8 | Param Value Num | 88.9 | Param Value Num | 84.0 | Param Value Num | 80.4 | Param Value Num | 82.5 | Param Value Num | 84.7 | Param Value Num | 78.7 | Param Value Num | 5.34 | Param Value Num | 5.61 | Param Value Num | 4.7 | Param Value Num | 5.11 | Param Value Num | 123.8 | Param Value Num | 127.5 | Param Value Num | 125.7 | Param Value Num | 124.5 | Param Value Num | 68.1 | Param Value Num | 70.5 | Param Value Num | 63.0 | Param Value Num | 67.2 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Dispersion Value | 3.5 | Dispersion Value | 2.6 | Dispersion Value | 2.7 | Dispersion Value | 14.4 | Dispersion Value | 16.4 | Dispersion Value | 13.4 | Dispersion Value | 15.6 | Dispersion Value | 3.4 | Dispersion Value | 3.2 | Dispersion Value | 3.5 | Dispersion Value | 2.9 | Dispersion Value | 94.3 | Dispersion Value | 90.3 | Dispersion Value | 82.5 | Dispersion Value | 79.7 | Dispersion Value | 9.9 | Dispersion Value | 9.7 | Dispersion Value | 9.9 | Dispersion Value | 9.9 | Dispersion Value | 5.1 | Dispersion Value | 4.1 | Dispersion Value | 4.9 | Dispersion Value | 4.4 | Dispersion Value | 3.5 | Dispersion Value | 5.6 | Dispersion Value | 6.2 | Dispersion Value | 3.9 | Dispersion Value | 7.7 | Dispersion Value | 3.8 | Dispersion Value | 4.7 | Dispersion Value | 3.3 | Dispersion Value | 7.5 | Dispersion Value | 6.3 | Dispersion Value | 3.8 | Dispersion Value | 5.6 | Dispersion Value | 9.1 | Dispersion Value | 21.2 | Dispersion Value | 20.1 | Dispersion Value | 20.2 | Dispersion Value | 18.8 | Dispersion Value | 33.9 | Dispersion Value | 28.8 | Dispersion Value | 24.1 | Dispersion Value | 32.8 | Dispersion Value | 22.3 | Dispersion Value | 17.6 | Dispersion Value | 20.8 | Dispersion Value | 23.0 | Dispersion Value | 19.1 | Dispersion Value | 11.8 | Dispersion Value | 15.6 | Dispersion Value | 16.4 | Dispersion Value | 19.1 | Dispersion Value | 18.0 | Dispersion Value | 16.3 | Dispersion Value | 17.6 | Dispersion Value | 14.9 | Dispersion Value | 16.3 | Dispersion Value | 13.7 | Dispersion Value | 19.1 | Dispersion Value | 28.3 | Dispersion Value | 33.8 | Dispersion Value | 25.3 | Dispersion Value | 32.1 | Dispersion Value | 13.5 | Dispersion Value | 12.4 | Dispersion Value | 10.2 | Dispersion Value | 13.2 | Dispersion Value | 0.69 | Dispersion Value | 1.05 | Dispersion Value | 0.52 | Dispersion Value | 0.65 | Dispersion Value | 12.6 | Dispersion Value | 11.1 | Dispersion Value | 14.9 | Dispersion Value | 9.5 | Dispersion Value | 9.4 | Dispersion Value | 6.7 | Dispersion Value | 7.0 | Dispersion Value | 7.6 |
Dispersion Value Num | 3.5 | Dispersion Value Num | 2.6 | Dispersion Value Num | 2.7 | Dispersion Value Num | 14.4 | Dispersion Value Num | 16.4 | Dispersion Value Num | 13.4 | Dispersion Value Num | 15.6 | Dispersion Value Num | 3.4 | Dispersion Value Num | 3.2 | Dispersion Value Num | 3.5 | Dispersion Value Num | 2.9 | Dispersion Value Num | 94.3 | Dispersion Value Num | 90.3 | Dispersion Value Num | 82.5 | Dispersion Value Num | 79.7 | Dispersion Value Num | 9.9 | Dispersion Value Num | 9.7 | Dispersion Value Num | 9.9 | Dispersion Value Num | 9.9 | Dispersion Value Num | 5.1 | Dispersion Value Num | 4.1 | Dispersion Value Num | 4.9 | Dispersion Value Num | 4.4 | Dispersion Value Num | 3.5 | Dispersion Value Num | 5.6 | Dispersion Value Num | 6.2 | Dispersion Value Num | 3.9 | Dispersion Value Num | 7.7 | Dispersion Value Num | 3.8 | Dispersion Value Num | 4.7 | Dispersion Value Num | 3.3 | Dispersion Value Num | 7.5 | Dispersion Value Num | 6.3 | Dispersion Value Num | 3.8 | Dispersion Value Num | 5.6 | Dispersion Value Num | 9.1 | Dispersion Value Num | 21.2 | Dispersion Value Num | 20.1 | Dispersion Value Num | 20.2 | Dispersion Value Num | 18.8 | Dispersion Value Num | 33.9 | Dispersion Value Num | 28.8 | Dispersion Value Num | 24.1 | Dispersion Value Num | 32.8 | Dispersion Value Num | 22.3 | Dispersion Value Num | 17.6 | Dispersion Value Num | 20.8 | Dispersion Value Num | 23.0 | Dispersion Value Num | 19.1 | Dispersion Value Num | 11.8 | Dispersion Value Num | 15.6 | Dispersion Value Num | 16.4 | Dispersion Value Num | 19.1 | Dispersion Value Num | 18.0 | Dispersion Value Num | 16.3 | Dispersion Value Num | 17.6 | Dispersion Value Num | 14.9 | Dispersion Value Num | 16.3 | Dispersion Value Num | 13.7 | Dispersion Value Num | 19.1 | Dispersion Value Num | 28.3 | Dispersion Value Num | 33.8 | Dispersion Value Num | 25.3 | Dispersion Value Num | 32.1 | Dispersion Value Num | 13.5 | Dispersion Value Num | 12.4 | Dispersion Value Num | 10.2 | Dispersion Value Num | 13.2 | Dispersion Value Num | 0.69 | Dispersion Value Num | 1.05 | Dispersion Value Num | 0.52 | Dispersion Value Num | 0.65 | Dispersion Value Num | 12.6 | Dispersion Value Num | 11.1 | Dispersion Value Num | 14.9 | Dispersion Value Num | 9.5 | Dispersion Value Num | 9.4 | Dispersion Value Num | 6.7 | Dispersion Value Num | 7.0 | Dispersion Value Num | 7.6 |
Study References
Sequence: | 52040799 |
Pmid | 33573594 |
Reference Type | derived |
Citation | Bouchard DR, Olthuis JV, Bouffard-Levasseur V, Shannon C, McDonald T, Senechal M. Peer-led exercise program for ageing adults to improve physical functions – a randomized trial. Eur Rev Aging Phys Act. 2021 Feb 11;18(1):2. doi: 10.1186/s11556-021-00257-x. |
Baseline Counts
Sequence: | 11379728 | Sequence: | 11379729 | Sequence: | 11379730 |
Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 30 | Count | 29 | Count | 59 |
Result Groups
Sequence: | 56079274 | Sequence: | 56079275 | Sequence: | 56079276 | Sequence: | 56079277 | Sequence: | 56079278 | Sequence: | 56079279 | Sequence: | 56079280 | Sequence: | 56079281 | Sequence: | 56079282 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Intervention | Title | Control | Title | Total | Title | Intervention | Title | Control | Title | Intervention | Title | Control | Title | Intervention | Title | Control |
Description | Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour. |
Description | Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks. | Description | Total of all reporting groups | Description | Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour. |
Description | Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks. | Description | Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour. |
Description | Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks. | Description | Participants are offered to attend a 12-week exercise program, classes offered twice a week, each class 60 minutes in length.
Zoomers on the Go Exercise Program: 60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour. |
Description | Participants are instructed to continue with their daily activities and their "normal" physical activity levels for 12-weeks. |
Baseline Measurements
Sequence: | 125539998 | Sequence: | 125539999 | Sequence: | 125539989 | Sequence: | 125539990 | Sequence: | 125539991 | Sequence: | 125539992 | Sequence: | 125539993 | Sequence: | 125539994 | Sequence: | 125539995 | Sequence: | 125539996 | Sequence: | 125539997 | Sequence: | 125540000 | Sequence: | 125540001 | Sequence: | 125540002 | Sequence: | 125540003 | Sequence: | 125540004 | Sequence: | 125540005 | Sequence: | 125540006 | Sequence: | 125540007 | Sequence: | 125540008 | Sequence: | 125540009 | Sequence: | 125540010 | Sequence: | 125540011 | Sequence: | 125540012 | Sequence: | 125540013 | Sequence: | 125540014 | Sequence: | 125540015 | Sequence: | 125540016 | Sequence: | 125540017 | Sequence: | 125540018 | Sequence: | 125540019 | Sequence: | 125540020 | Sequence: | 125540021 |
Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 | Result Group Id | 56079274 | Result Group Id | 56079275 | Result Group Id | 56079276 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Classification | Canada | Classification | Canada | Classification | Canada | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race/Ethnicity, Customized | Title | Region of Enrollment | Title | Region of Enrollment | Title | Region of Enrollment | Title | Body Mass Index (BMI) | Title | Body Mass Index (BMI) | Title | Body Mass Index (BMI) | Title | Occupation (Retired) | Title | Occupation (Retired) | Title | Occupation (Retired) | Title | Marital Status (Married) | Title | Marital Status (Married) | Title | Marital Status (Married) | Title | Household Income (>$100,000/year) | Title | Household Income (>$100,000/year) | Title | Household Income (>$100,000/year) | Title | Physical Activity Level (Steps/day) | Title | Physical Activity Level (Steps/day) | Title | Physical Activity Level (Steps/day) | Title | Physical Activity Level (MVPA/week) | Title | Physical Activity Level (MVPA/week) | Title | Physical Activity Level (MVPA/week) |
Description | Race/Ethnicity not collected | Description | Race/Ethnicity not collected | Description | Race/Ethnicity not collected | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Units | Participants | Units | Participants | Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | participants | Units | participants | Units | kg/m^2 | Units | kg/m^2 | Units | kg/m^2 | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Steps/day | Units | Steps/day | Units | Steps/day | Units | Minutes of MVPA per week | Units | Minutes of MVPA per week | Units | Minutes of MVPA per week |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 0 | Param Value | 0 | Param Value | 66.6 | Param Value | 66.1 | Param Value | 66.4 | Param Value | 28 | Param Value | 23 | Param Value | 51 | Param Value | 2 | Param Value | 6 | Param Value | 8 | Param Value | 0 | Param Value | 30 | Param Value | 29 | Param Value | 59 | Param Value | 28.9 | Param Value | 25.8 | Param Value | 27.4 | Param Value | 19 | Param Value | 14 | Param Value | 33 | Param Value | 14 | Param Value | 20 | Param Value | 34 | Param Value | 6.0 | Param Value | 6.0 | Param Value | 12 | Param Value | 6349 | Param Value | 7221 | Param Value | 6762 | Param Value | 68 | Param Value | 48 | Param Value | 58 |
Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 66.6 | Param Value Num | 66.1 | Param Value Num | 66.4 | Param Value Num | 28.0 | Param Value Num | 23.0 | Param Value Num | 51.0 | Param Value Num | 2.0 | Param Value Num | 6.0 | Param Value Num | 8.0 | Param Value Num | 0.0 | Param Value Num | 30.0 | Param Value Num | 29.0 | Param Value Num | 59.0 | Param Value Num | 28.9 | Param Value Num | 25.8 | Param Value Num | 27.4 | Param Value Num | 19.0 | Param Value Num | 14.0 | Param Value Num | 33.0 | Param Value Num | 14.0 | Param Value Num | 20.0 | Param Value Num | 34.0 | Param Value Num | 6.0 | Param Value Num | 6.0 | Param Value Num | 12.0 | Param Value Num | 6349.0 | Param Value Num | 7221.0 | Param Value Num | 6762.0 | Param Value Num | 68.0 | Param Value Num | 48.0 | Param Value Num | 58.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 7.2 | Dispersion Value | 7.0 | Dispersion Value | 7.2 | Dispersion Value | 4.5 | Dispersion Value | 4.8 | Dispersion Value | 4.9 | Dispersion Value | 2903 | Dispersion Value | 2964 | Dispersion Value | 2939 | Dispersion Value | 68 | Dispersion Value | 81 | Dispersion Value | 74 | ||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 7.2 | Dispersion Value Num | 7.0 | Dispersion Value Num | 7.2 | Dispersion Value Num | 4.5 | Dispersion Value Num | 4.8 | Dispersion Value Num | 4.9 | Dispersion Value Num | 2903.0 | Dispersion Value Num | 2964.0 | Dispersion Value Num | 2939.0 | Dispersion Value Num | 68.0 | Dispersion Value Num | 81.0 | Dispersion Value Num | 74.0 | ||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 | Number Analyzed | 30 | Number Analyzed | 29 | Number Analyzed | 59 |
Population Description | Not collected | Population Description | Not collected | Population Description | Not collected | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Calculate Percentage | No | Calculate Percentage | No | Calculate Percentage | No |
]]>
https://zephyrnet.com/NCT03799939
2019-02-05
https://zephyrnet.com/?p=NCT03799939
NCT03799939https://www.clinicaltrials.gov/study/NCT03799939?tab=tableNANANAChimney trial is designed to compare the effectiveness and safety of specifically designated polyvinylidene fluoride mesh (PVDF, Dynamesh IPST) to controls in a multi center, randomized setting.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-08-17 |
Start Month Year | February 5, 2019 |
Primary Completion Month Year | July 2022 |
Verification Month Year | August 2021 |
Verification Date | 2021-08-31 |
Last Update Posted Date | 2021-08-17 |
Detailed Descriptions
Sequence: | 20735867 |
Description | The European Hernia Society recommends the use of prophylactic mesh when permanent colostomy is made. The results of previous trials using keyhole technique are partially unsatisfactory. Specifically designed PVDF mesh used in this trial showed promising results in previous small trial.
Chimney trial is designed to compare the effectiveness and safety of mesh group to controls operated with no preventive mesh in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection or low Haartman's procedure for rectal adenocarcinoma. |
Facilities
Sequence: | 200244762 | Sequence: | 200244763 | Sequence: | 200244764 | Sequence: | 200244765 | Sequence: | 200244766 | Sequence: | 200244767 | Sequence: | 200244768 |
Name | Helsinki University Hospital | Name | Keski-Suomi Central Hospital | Name | Oulu University Hospital | Name | Seinäjoki Central Hospital | Name | Tampere University Hospital | Name | Turku University Hospital | Name | Maziar Nikberg |
City | Helsinki | City | Jyväskylä | City | Oulu | City | Seinäjoki | City | Tampere | City | Turku | City | Västerås |
Country | Finland | Country | Finland | Country | Finland | Country | Finland | Country | Finland | Country | Finland | Country | Sweden |
Conditions
Sequence: | 52208319 | Sequence: | 52208320 | Sequence: | 52208321 |
Name | Parastomal Hernia | Name | Rectal Adenocarcinoma | Name | Abdominoperineal Resection |
Downcase Name | parastomal hernia | Downcase Name | rectal adenocarcinoma | Downcase Name | abdominoperineal resection |
Id Information
Sequence: | 40186303 |
Id Source | org_study_id |
Id Value | 305/2018 |
Countries
Sequence: | 42599797 | Sequence: | 42599798 |
Name | Finland | Name | Sweden |
Removed | False | Removed | False |
Design Groups
Sequence: | 55634925 | Sequence: | 55634926 |
Group Type | Active Comparator | Group Type | No Intervention |
Title | Intervention group | Title | Control group |
Description | Polyvinylidene fluoride mesh used in this trial (Dynamesh IPST) is synthetic mesh with central tube to accommodate bowel tightly and designed to prevent and treat parastomal hernia. | Description | Participants in control group are operated with no preventive mesh. |
Interventions
Sequence: | 52522285 |
Intervention Type | Device |
Name | Intervention group |
Description | Polyvinylidene fluoride mesh (Dynamesh IPST) is used on intraperitoneal onlay position to prevent parastomal hernia. |
Design Outcomes
Sequence: | 177512082 | Sequence: | 177512083 | Sequence: | 177512084 | Sequence: | 177512085 | Sequence: | 177512086 | Sequence: | 177512087 | Sequence: | 177512088 | Sequence: | 177512089 | Sequence: | 177512090 | Sequence: | 177512091 | Sequence: | 177512092 | Sequence: | 177512093 | Sequence: | 177512094 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Incidence of parastomal hernia | Measure | Incidence of parastomal hernia at long term follow up | Measure | Surgical site infection rate | Measure | Complications | Measure | Stoma related complications | Measure | Reoperation rate | Measure | Operative time | Measure | Length of stay | Measure | Rand 36 quality of life | Measure | Quality of life measured by Colostomy impact score | Measure | Medico-economic substudy | Measure | Radiological substudy of stoma distance | Measure | Radiological substudy of adipose tissue thickness |
Time Frame | 12 months | Time Frame | 5 years | Time Frame | 30 days | Time Frame | 30 days | Time Frame | 5 years | Time Frame | 5 years | Time Frame | 1 day | Time Frame | 30 days | Time Frame | 5 years | Time Frame | 5 years | Time Frame | 5 years | Time Frame | 3 years | Time Frame | 3 years |
Description | Incidence of parastomal hernia at 12 months follow up | Description | Incidence of parastomal hernia during 5 years of follow up | Description | Surgical site infections measured by Clavien-Dindo Classification | Description | Complications measured by Clavien-Dindo Classification | Description | Stoma related complications measured by Clavien-Dindo Classification | Description | Need for reoperations | Description | Operative time | Description | Length of stay at the hospital | Description | Quality of life measured by Rand-36 quality of life questionnaire | Description | Quality of life measured by Colostomy impact score | Description | Medico-economic substudy including both short and long term costs included in both groups | Description | Distance of stoma from midline defined by umbilicus | Description | Thickness of adipose tissue on computer tomography scan on contralateral site of stoma |
Browse Conditions
Sequence: | 193627771 | Sequence: | 193627770 |
Mesh Term | Pathological Conditions, Anatomical | Mesh Term | Hernia |
Downcase Mesh Term | pathological conditions, anatomical | Downcase Mesh Term | hernia |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list |
Sponsors
Sequence: | 48353890 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Oulu |
Overall Officials
Sequence: | 29306099 |
Role | Principal Investigator |
Name | Elisa Mäkäräinen-Uhlbäck, M.D. |
Affiliation | Oulu University Hospital |
Design Group Interventions
Sequence: | 68199471 |
Design Group Id | 55634925 |
Intervention Id | 52522285 |
Eligibilities
Sequence: | 30787000 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
18 years or older Exclusion Criteria: Abdominoperineal resection or Hartmann's operation by laparotomy or conversion to laparotomy |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989876 |
Number Of Facilities | 7 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 12 |
Designs
Sequence: | 30533070 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Single |
Masking Description | Participants are unaware of the randomization group. |
Intervention Model Description | Chimney trial is a prospective randomized controlled multicenter trial. |
Subject Masked | True |
Responsible Parties
Sequence: | 28899364 |
Responsible Party Type | Principal Investigator |
Name | Elisa Makarainen-Uhlback |
Title | Principal Investigator |
Affiliation | University of Oulu |
Study References
Sequence: | 52103276 |
Pmid | 31779699 |
Reference Type | derived |
Citation | Makarainen-Uhlback E, Wiik H, Kossi J, Nikberg M, Ohtonen P, Rautio T. Chimney Trial: study protocol for a randomized controlled trial. Trials. 2019 Nov 28;20(1):652. doi: 10.1186/s13063-019-3764-y. |
]]>
https://zephyrnet.com/NCT03799926
2019-02-18
https://zephyrnet.com/?p=NCT03799926
NCT03799926https://www.clinicaltrials.gov/study/NCT03799926?tab=tableNANANATo investigate the efficacy of each ZG-801 starting dose and the titration algorithm of ZG-801 for the treatment of hyperkalemia in Japanese patients.
To evaluate the safety of ZG-801 for the chronic use (total over 52 weeks). In addition, to confirm the safety after the discontinuation of ZG-801 treatment on 1 week follow-up.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-03-25 |
Start Month Year | February 18, 2019 |
Primary Completion Month Year | November 6, 2019 |
Verification Month Year | March 2021 |
Verification Date | 2021-03-31 |
Last Update Posted Date | 2021-03-25 |
Facilities
Sequence: | 200108504 |
Name | Zeria Investigative Sites |
City | Kanagawa |
Country | Japan |
Conditions
Sequence: | 52171317 |
Name | Hyperkalemia |
Downcase Name | hyperkalemia |
Id Information
Sequence: | 40158677 |
Id Source | org_study_id |
Id Value | ZG-801-01 |
Countries
Sequence: | 42568976 |
Name | Japan |
Removed | False |
Design Groups
Sequence: | 55593234 | Sequence: | 55593235 | Sequence: | 55593236 | Sequence: | 55593237 | Sequence: | 55593238 | Sequence: | 55593239 | Sequence: | 55593240 | Sequence: | 55593241 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | Stratum 1: 8.4 g patiromer | Title | Stratum 1: 16.8 g patiromer | Title | Stratum 1: placebo of 8.4 g patiromer | Title | Stratum 1: placebo of 16.8 g patiromer | Title | Stratum 2: 8.4 g patiromer | Title | Stratum 2: 16.8 g patiromer | Title | Stratum 3: 8.4 g patiromer | Title | Stratum 3: 16.8 g patiromer |
Description | Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline | Description | Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline | Description | Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline | Description | Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline | Description | Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline | Description | Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline | Description | Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline | Description | Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline |
Interventions
Sequence: | 52485544 | Sequence: | 52485545 | Sequence: | 52485546 | Sequence: | 52485547 | Sequence: | 52485548 | Sequence: | 52485549 | Sequence: | 52485550 | Sequence: | 52485551 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | patiromer | Name | patiromer | Name | placebo | Name | placebo | Name | patiromer | Name | patiromer | Name | patiromer | Name | patiromer |
Description | Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1) | Description | Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1) | Description | Placebo starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1) | Description | Placebo starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1) | Description | Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2) | Description | Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2) | Description | Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3) | Description | Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3) |
Design Outcomes
Sequence: | 177379077 | Sequence: | 177379078 | Sequence: | 177379079 | Sequence: | 177379080 | Sequence: | 177379081 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose | Measure | Change in serum potassium 4 weeks after the start of administration in each group of starting dose | Measure | Proportion of subjects with a normalized serum potassium level at 4 weeks after the start of administration in each group of starting dose | Measure | Incidence of adverse events | Measure | Incidence of adverse drug reactions |
Time Frame | Baseline to week 1 | Time Frame | Baseline to week 4 | Time Frame | Week 4 | Time Frame | Over 52-week study period | Time Frame | Over 52-week study period |
Browse Conditions
Sequence: | 193486993 | Sequence: | 193486994 | Sequence: | 193486995 |
Mesh Term | Hyperkalemia | Mesh Term | Water-Electrolyte Imbalance | Mesh Term | Metabolic Diseases |
Downcase Mesh Term | hyperkalemia | Downcase Mesh Term | water-electrolyte imbalance | Downcase Mesh Term | metabolic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319342 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Zeria Pharmaceutical |
Design Group Interventions
Sequence: | 68149209 | Sequence: | 68149210 | Sequence: | 68149211 | Sequence: | 68149212 | Sequence: | 68149213 | Sequence: | 68149214 | Sequence: | 68149215 | Sequence: | 68149216 |
Design Group Id | 55593234 | Design Group Id | 55593235 | Design Group Id | 55593236 | Design Group Id | 55593237 | Design Group Id | 55593238 | Design Group Id | 55593239 | Design Group Id | 55593240 | Design Group Id | 55593241 |
Intervention Id | 52485544 | Intervention Id | 52485545 | Intervention Id | 52485546 | Intervention Id | 52485547 | Intervention Id | 52485548 | Intervention Id | 52485549 | Intervention Id | 52485550 | Intervention Id | 52485551 |
Eligibilities
Sequence: | 30765388 |
Gender | All |
Minimum Age | 20 Years |
Maximum Age | 80 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Males and females ages 18 – 80 Exclusion Criteria: Subjects with hospitalization for hyper- or hypoglycemia with Type 2 diabetes or for acute exacerbations of heart failure within the previous 3 months |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253885881 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 8 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 20 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30511554 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28877849 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799913
2019-04-10
https://zephyrnet.com/?p=NCT03799913
NCT03799913https://www.clinicaltrials.gov/study/NCT03799913?tab=tableZhigang Zhang, M.D.zzg2011@zju.edu.cn86+057189713631The goal of this clinical trial is to study the feasibility and efficacy of anti-MESO antigen receptors (CARs) T cell therapy for relapsed and refractory ovarian cancer.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-04-10 |
Start Month Year | April 10, 2019 |
Primary Completion Month Year | October 2021 |
Verification Month Year | April 2019 |
Verification Date | 2019-04-30 |
Last Update Posted Date | 2019-04-10 |
Detailed Descriptions
Sequence: | 20741242 |
Description | Primary Objectives
1.To determine the feasibility ad safety of anti-MESO CAR-T cells in treating patients with MESO-positive ovarian cancer. Secondary Objectives To access the efficacy of anti-MESO CAR-T cells in patients with ovarian cancer. |
Facilities
Sequence: | 200280791 |
Status | Recruiting |
Name | The Second Affiliated hospital of Zhejiang University School of Medicine |
City | Hangzhou |
State | Zhejiang |
Zip | 310009 |
Country | China |
Facility Contacts
Sequence: | 28132913 |
Facility Id | 200280791 |
Contact Type | primary |
Name | Jianwei Zhou, M.D. |
jianwei-zhou@163.com | |
Phone | 0571-89713634 |
Browse Interventions
Sequence: | 96133392 | Sequence: | 96133393 | Sequence: | 96133394 | Sequence: | 96133395 | Sequence: | 96133396 | Sequence: | 96133397 | Sequence: | 96133398 | Sequence: | 96133399 | Sequence: | 96133400 | Sequence: | 96133401 | Sequence: | 96133402 |
Mesh Term | Cyclophosphamide | Mesh Term | Fludarabine | Mesh Term | Immunosuppressive Agents | Mesh Term | Immunologic Factors | Mesh Term | Physiological Effects of Drugs | Mesh Term | Antirheumatic Agents | Mesh Term | Antineoplastic Agents, Alkylating | Mesh Term | Alkylating Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antineoplastic Agents | Mesh Term | Myeloablative Agonists |
Downcase Mesh Term | cyclophosphamide | Downcase Mesh Term | fludarabine | Downcase Mesh Term | immunosuppressive agents | Downcase Mesh Term | immunologic factors | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | antirheumatic agents | Downcase Mesh Term | antineoplastic agents, alkylating | Downcase Mesh Term | alkylating agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | myeloablative agonists |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52221705 |
Name | Ovarian Cancer |
Downcase Name | ovarian cancer |
Id Information
Sequence: | 40195753 |
Id Source | org_study_id |
Id Value | MESO |
Countries
Sequence: | 42609743 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55650003 |
Group Type | Experimental |
Title | anti-MESO CAR-T cells |
Description | Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients |
Interventions
Sequence: | 52535510 | Sequence: | 52535511 | Sequence: | 52535512 |
Intervention Type | Biological | Intervention Type | Drug | Intervention Type | Drug |
Name | anti-MESO CAR-T cells | Name | Fludarabine | Name | Cyclophosphamide |
Description | Retroviral vector-transduced autologous T cells to express anti-MESO CARs | Description | 30mg/m2/d | Description | 300mg/m2/d |
Keywords
Sequence: | 79942018 | Sequence: | 79942019 | Sequence: | 79942020 | Sequence: | 79942021 |
Name | CAR-T | Name | MESO | Name | Ovarian Cancer | Name | Relapsed and Refractory |
Downcase Name | car-t | Downcase Name | meso | Downcase Name | ovarian cancer | Downcase Name | relapsed and refractory |
Design Outcomes
Sequence: | 177562099 | Sequence: | 177562100 | Sequence: | 177562101 | Sequence: | 177562102 | Sequence: | 177562103 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 | Measure | Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm | Measure | Progress Free Survival (PFS) after administration | Measure | Duration of CAR-positive T cells in circulation | Measure | Detection of PD1 antibody in serum |
Time Frame | 1 years post infusion | Time Frame | 12 months post infusion | Time Frame | 12 months post infusion | Time Frame | 12 months post infusion | Time Frame | 12 months post infusion |
Browse Conditions
Sequence: | 193679156 | Sequence: | 193679157 | Sequence: | 193679158 | Sequence: | 193679159 | Sequence: | 193679160 | Sequence: | 193679161 | Sequence: | 193679162 | Sequence: | 193679163 | Sequence: | 193679164 | Sequence: | 193679165 | Sequence: | 193679166 | Sequence: | 193679167 | Sequence: | 193679168 | Sequence: | 193679169 | Sequence: | 193679170 | Sequence: | 193679171 | Sequence: | 193679172 | Sequence: | 193679173 | Sequence: | 193679174 |
Mesh Term | Ovarian Neoplasms | Mesh Term | Carcinoma, Ovarian Epithelial | Mesh Term | Endocrine Gland Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Ovarian Diseases | Mesh Term | Adnexal Diseases | Mesh Term | Genital Diseases, Female | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Genital Neoplasms, Female | Mesh Term | Urogenital Neoplasms | Mesh Term | Genital Diseases | Mesh Term | Endocrine System Diseases | Mesh Term | Gonadal Disorders | Mesh Term | Carcinoma | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type |
Downcase Mesh Term | ovarian neoplasms | Downcase Mesh Term | carcinoma, ovarian epithelial | Downcase Mesh Term | endocrine gland neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | ovarian diseases | Downcase Mesh Term | adnexal diseases | Downcase Mesh Term | genital diseases, female | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | genital neoplasms, female | Downcase Mesh Term | urogenital neoplasms | Downcase Mesh Term | genital diseases | Downcase Mesh Term | endocrine system diseases | Downcase Mesh Term | gonadal disorders | Downcase Mesh Term | carcinoma | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366590 | Sequence: | 48366591 | Sequence: | 48366592 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Zhejiang University | Name | Second Affiliated Hospital, School of Medicine, Zhejiang University | Name | Hrain Biotechnology Co., Ltd. |
Overall Officials
Sequence: | 29312998 |
Role | Study Chair |
Name | Jianwei Zhou, M.D. |
Affiliation | Zhejiang University |
Central Contacts
Sequence: | 12020629 |
Contact Type | primary |
Name | Zhigang Zhang, M.D. |
Phone | 86+057189713631 |
zzg2011@zju.edu.cn | |
Role | Contact |
Design Group Interventions
Sequence: | 68217624 | Sequence: | 68217625 | Sequence: | 68217626 |
Design Group Id | 55650003 | Design Group Id | 55650003 | Design Group Id | 55650003 |
Intervention Id | 52535510 | Intervention Id | 52535511 | Intervention Id | 52535512 |
Eligibilities
Sequence: | 30794811 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
18 to 70 Years Old, female; Exclusion Criteria: Accompanied by other uncontrolled malignant tumors; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004483 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30540851 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28907171 |
Responsible Party Type | Principal Investigator |
Name | Zhigang Zhang |
Title | Dr |
Affiliation | Zhejiang University |
]]>
https://zephyrnet.com/NCT03799900
2018-11-01
https://zephyrnet.com/?p=NCT03799900
NCT03799900https://www.clinicaltrials.gov/study/NCT03799900?tab=tableNANANABased on the pharmacological class of rapastinel, this study will be conducted to evaluate the abuse potential of single doses of rapastinel as compared with ketamine, a NMDAR antagonist that is a Schedule III dissociative anesthetic, and placebo in recreational polydrug users.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-15 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-05-16 |
Start Month Year | November 1, 2018 |
Primary Completion Month Year | March 24, 2019 |
Verification Month Year | May 2019 |
Verification Date | 2019-05-31 |
Last Update Posted Date | 2019-05-16 |
Facilities
Sequence: | 199965077 |
Name | Vince and Associates Clinical Research Inc |
City | Overland Park |
State | Kansas |
Zip | 66212 |
Country | United States |
Browse Interventions
Sequence: | 95996913 | Sequence: | 95996914 | Sequence: | 95996915 | Sequence: | 95996916 | Sequence: | 95996917 | Sequence: | 95996918 | Sequence: | 95996919 | Sequence: | 95996920 | Sequence: | 95996921 | Sequence: | 95996922 | Sequence: | 95996923 | Sequence: | 95996924 | Sequence: | 95996925 | Sequence: | 95996926 |
Mesh Term | Ketamine | Mesh Term | Analgesics | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Anesthetics, Dissociative | Mesh Term | Anesthetics, Intravenous | Mesh Term | Anesthetics, General | Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Excitatory Amino Acid Antagonists | Mesh Term | Excitatory Amino Acid Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | ketamine | Downcase Mesh Term | analgesics | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | anesthetics, dissociative | Downcase Mesh Term | anesthetics, intravenous | Downcase Mesh Term | anesthetics, general | Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | excitatory amino acid antagonists | Downcase Mesh Term | excitatory amino acid agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52139008 |
Name | Human Abuse Potential |
Downcase Name | human abuse potential |
Id Information
Sequence: | 40135065 |
Id Source | org_study_id |
Id Value | RAP-PK-12 |
Countries
Sequence: | 42542690 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55559347 | Sequence: | 55559348 | Sequence: | 55559349 | Sequence: | 55559350 | Sequence: | 55559351 | Sequence: | 55559352 | Sequence: | 55559353 | Sequence: | 55559354 | Sequence: | 55559355 | Sequence: | 55559356 | Sequence: | 55559357 | Sequence: | 55559358 | Sequence: | 55559359 |
Group Type | Experimental | Group Type | Placebo Comparator | Group Type | Experimental | Group Type | Placebo Comparator | Group Type | Experimental | Group Type | Placebo Comparator | Group Type | Experimental | Group Type | Placebo Comparator | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Active Comparator | Group Type | Placebo Comparator |
Title | Part 1, Cohort 1: Ketamine Low Dose | Title | Part 1, Cohort 1: Placebo | Title | Part 1, Cohort 2: Ketamine Medium Dose | Title | Part 1, Cohort 2: Placebo | Title | Part 1, Cohort 3 (Optional): Ketamine High Dose | Title | Part 1, Cohort 3 (Optional): Placebo | Title | Part 2, Qualification Phase: Ketamine | Title | Part 2, Qualification Phase: Placebo | Title | Part 2, Treatment Phase: Rapastinel Low Dose | Title | Part 2, Treatment Phase: Rapastinel Medium Dose | Title | Part 2, Treatment Phase: Rapastinel High Dose | Title | Part 2, Treatment Phase: Ketamine | Title | Part 2, Treatment Phase: Placebo |
Description | Some participants will be administered a single IV dose of ketamine on Day 1. | Description | Some participants will be administered a single IV dose of placebo on Day 1. | Description | Some participants will be administered a single IV dose of ketamine on Day 1. | Description | Some participants will be administered a single IV dose of placebo on Day 1. | Description | Optional: some participants will be administered a single IV dose of ketamine on Day 1. | Description | Optional: some participants will be administered a single IV dose of placebo on Day 1. | Description | Participants will receive IV ketamine on Day 1 and placebo on Day 2 in a randomized crossover manner. | Description | Participants will receive IV ketamine on Day 2 and placebo on Day 1 in a randomized crossover manner. | Description | Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. | Description | Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. | Description | Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. | Description | Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. | Description | Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. |
Interventions
Sequence: | 52454912 | Sequence: | 52454913 | Sequence: | 52454914 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Rapastinel | Name | Ketamine | Name | Placebo |
Description | During the Treatment Phase in Part 2, participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. | Description | Part 1
Part 2, Qualification Phase: Participants will be administered single IV doses of ketamine and placebo in a randomized crossover manner Part 2, Treatment Phase: Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. |
Description | Part 1
Part 2, Qualification Phase: Participants will be administered single IV doses of ketamine and placebo in a randomized crossover manner Part 2, Treatment Phase: Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner. |
Design Outcomes
Sequence: | 177263647 | Sequence: | 177263648 | Sequence: | 177263649 | Sequence: | 177263650 | Sequence: | 177263651 | Sequence: | 177263652 | Sequence: | 177263653 | Sequence: | 177263654 | Sequence: | 177263655 | Sequence: | 177263656 | Sequence: | 177263657 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Maximum effect (Emax) for "At this Moment" Drug Liking visual analog scale (VAS). | Measure | Maximum effect (Emax) | Measure | Minimum effect (Emin) | Measure | Time to Emax (TEmax) | Measure | Time to Emin (TEmin) | Measure | Time averaged area under the effect curve (TA_AUE) | Measure | Maximum plasma drug concentration (Cmax) | Measure | Area under the plasma concentration versus time curve from time 0 to the last quantifiable concentration (AUClast) | Measure | Adverse events | Measure | Proportion of abnormal electrocardiograms | Measure | Columbia-Suicide Severity Rating Scale |
Time Frame | Treatment Phase: Pre-dose and up to 24 hours post-dose | Time Frame | Treatment Phase: Pre-dose and up to 24 hours post-dose | Time Frame | Treatment Phase: Pre-dose and up to 24 hours post-dose | Time Frame | Treatment Phase: Pre-dose and up to 24 hours post-dose | Time Frame | Treatment Phase: Pre-dose and up to 24 hours post-dose | Time Frame | Treatment Phase: Hour 0 and up to 24 Hours post-dose | Time Frame | Treatment Phase: Pre-dose and up to 24 hours post-dose | Time Frame | Treatment Phase: Pre-dose and up to 24 hours post-dose | Time Frame | Part 1: 6 weeks, Part 2: 9 weeks | Time Frame | Part 1: 6 weeks, Part 2: 9 weeks | Time Frame | Part 1: 6 weeks, Part 2: 9 weeks |
Description | The drug liking VAS measures the participant's liking for the drug and is scored from 0 to 100, with 0 reflecting "Strong disliking" and 100 reflecting "Strong liking". | Description | The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (least severe) to 5 (most severe). |
Sponsors
Sequence: | 48290711 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Naurex, Inc, an affiliate of Allergan plc |
Overall Officials
Sequence: | 29268533 |
Role | Study Director |
Name | Sheng Fang Su |
Affiliation | Allergan |
Design Group Interventions
Sequence: | 68107457 | Sequence: | 68107458 | Sequence: | 68107459 | Sequence: | 68107460 | Sequence: | 68107461 | Sequence: | 68107462 | Sequence: | 68107463 | Sequence: | 68107464 | Sequence: | 68107465 | Sequence: | 68107466 | Sequence: | 68107467 | Sequence: | 68107468 | Sequence: | 68107469 |
Design Group Id | 55559357 | Design Group Id | 55559355 | Design Group Id | 55559356 | Design Group Id | 55559347 | Design Group Id | 55559349 | Design Group Id | 55559351 | Design Group Id | 55559353 | Design Group Id | 55559358 | Design Group Id | 55559348 | Design Group Id | 55559350 | Design Group Id | 55559352 | Design Group Id | 55559354 | Design Group Id | 55559359 |
Intervention Id | 52454912 | Intervention Id | 52454912 | Intervention Id | 52454912 | Intervention Id | 52454913 | Intervention Id | 52454913 | Intervention Id | 52454913 | Intervention Id | 52454913 | Intervention Id | 52454913 | Intervention Id | 52454914 | Intervention Id | 52454914 | Intervention Id | 52454914 | Intervention Id | 52454914 | Intervention Id | 52454914 |
Eligibilities
Sequence: | 30747725 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 55 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Participant must be a current recreational polydrug user Exclusion Criteria: Evidence of drug or alcohol dependence (excluding nicotine and caffeine) within the past 2 years |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254121861 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 4 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 55 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 10 |
Designs
Sequence: | 30494008 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28860288 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799887
2010-10-20
https://zephyrnet.com/?p=NCT03799887
NCT03799887https://www.clinicaltrials.gov/study/NCT03799887?tab=tableNANANABody weight supported treadmill training (BWSTT) is an important rehabilitative choice for neurologically impaired subjects such as Parkinson’s disease (PD). The aim of the study is to evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life and fatigue in moderate to advanced PD.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | October 20, 2010 |
Primary Completion Month Year | October 20, 2010 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20727169 |
Description | Body weight supported treadmill training (BWSTT) is an important rehabilitative choice for neurologically impaired subjects such as Parkinson's disease (PD). The aim of the study is to evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life and fatigue in moderate to advanced PD. Thirty five patients were randomly assigned to one of the three groups according to the percentage unweighed: 0% BWSTT, 10% BWSTT and 20% BWSTT. All patients participated 30 minutes BWSTT sessions 5 days a week, for 6 weeks. Primary outcomes were 6 minute walk test (6MWT), Berg balance scale (BBS), Unified Parkinson's Disease Rating Scale (UPDRS); and secondary outcomes were Nottingham health profile (NHP), Fatigue Impact Scale (FIS) and Fatigue Severity Scale (FSS) which were performed at the beginning and end of the rehabilitation. |
Facilities
Sequence: | 200159378 |
Name | Tuğba Atan |
City | Çorum |
Zip | 19100 |
Country | Turkey |
Conditions
Sequence: | 52185460 |
Name | Parkinson Disease |
Downcase Name | parkinson disease |
Id Information
Sequence: | 40169059 |
Id Source | org_study_id |
Id Value | 2010-171 |
Countries
Sequence: | 42580650 |
Name | Turkey |
Removed | False |
Design Groups
Sequence: | 55609094 | Sequence: | 55609095 | Sequence: | 55609096 |
Group Type | Active Comparator | Group Type | Experimental | Group Type | Experimental |
Title | 0% unweighed BWSTT | Title | 10% unweighed BWSTT | Title | 20% unweighed BWSTT |
Description | 0% unweighed Body Weight Supported Treadmill Training | Description | 0% unweighed Body Weight Supported Treadmill Training | Description | 20% unweighed Body Weight Supported Treadmill Training |
Interventions
Sequence: | 52499406 | Sequence: | 52499407 | Sequence: | 52499408 |
Intervention Type | Behavioral | Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | 0% unweighed BWSTT | Name | 10% unweighed BWSTT | Name | 20% unweighed BWSTT |
Description | 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.
After CRP, participants were provided 30 minutes 0% unweighed BWSTT sessions including a 5 minutes warm – up and cool – down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions). |
Description | 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.
After CRP, participants were provided 30 minutes 10% unweighed BWSTT sessions including a 5 minutes warm – up and cool – down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions). |
Description | 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.
After CRP, participants were provided 30 minutes 20% unweighed BWSTT sessions including a 5 minutes warm – up and cool – down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions). |
Keywords
Sequence: | 79888706 | Sequence: | 79888707 | Sequence: | 79888708 | Sequence: | 79888709 | Sequence: | 79888710 |
Name | Parkinson's disease | Name | gait | Name | balance | Name | treadmill training | Name | fatigue |
Downcase Name | parkinson's disease | Downcase Name | gait | Downcase Name | balance | Downcase Name | treadmill training | Downcase Name | fatigue |
Design Outcomes
Sequence: | 177431970 | Sequence: | 177431971 | Sequence: | 177431972 | Sequence: | 177431973 | Sequence: | 177431974 | Sequence: | 177431975 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | 6 Minute Walk Test (6MWT) | Measure | Berg Balance Scale (BBS): | Measure | Unified Parkinson's Disease Rating Scale (UPDRS): | Measure | Nottingham Health Profile (NHP): | Measure | Fatigue Impact Scale (FIS): | Measure | Fatigue Severity Scale (FSS): |
Time Frame | 6 weeks | Time Frame | 6 weeks | Time Frame | 6 weeks | Time Frame | 6 weeks | Time Frame | 6 weeks | Time Frame | 6 weeks |
Description | Functional exercise capacity was assessed by distance walked in 6 minutes (6MWT). The patient was asked to walk as long as possible for 6 minutes on a 30 meters of marked and flat ground, at a self selected speed. 6MWT is a submaximal exercise test and can be used to assess treatment response . | Description | It contains 14 instructions and 0 – 4 points is given for each instruction according to the performance of the patients. 0 points are given when the patient totally could not do the activity while 4 points are given when the patient completes the activity independently. | Description | It is used to follow the clinical status of PD. It consists of four main parts (totally 183 points): mentation, behavior and mood (UPDRS I: 16 points), activities of daily living (UPDRS II: 52 points), motor examination (UPDRS III: 92 points), treatment complications (UPDRS IV: 23 points). | Description | It contains 38 items that address pain, physical mobility, emotional reactions, energy, social isolation, and sleep dimensions. Higher scores indicate worse quality of life. | Description | This scale assesses the cognitive, physical and social effects of fatigue during the last one week in a total of 40 – item questionnaire (0 = no problem, 4 = maximum problem). | Description | This scale assesses the severity of fatigue during the last one week in a total of 9 – item questionnaire (1 = strongly disagree, 7 = strongly agree). The total score ranges from 9 – 63, in which higher score means higher severity of fatigue . |
Browse Conditions
Sequence: | 193540034 | Sequence: | 193540035 | Sequence: | 193540036 | Sequence: | 193540037 | Sequence: | 193540038 | Sequence: | 193540039 | Sequence: | 193540040 | Sequence: | 193540041 | Sequence: | 193540042 | Sequence: | 193540043 | Sequence: | 193540044 |
Mesh Term | Parkinson Disease | Mesh Term | Fatigue | Mesh Term | Body Weight | Mesh Term | Parkinsonian Disorders | Mesh Term | Basal Ganglia Diseases | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Movement Disorders | Mesh Term | Synucleinopathies | Mesh Term | Neurodegenerative Diseases |
Downcase Mesh Term | parkinson disease | Downcase Mesh Term | fatigue | Downcase Mesh Term | body weight | Downcase Mesh Term | parkinsonian disorders | Downcase Mesh Term | basal ganglia diseases | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | movement disorders | Downcase Mesh Term | synucleinopathies | Downcase Mesh Term | neurodegenerative diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332315 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Hitit University |
Design Group Interventions
Sequence: | 68168151 | Sequence: | 68168152 | Sequence: | 68168153 |
Design Group Id | 55609094 | Design Group Id | 55609095 | Design Group Id | 55609096 |
Intervention Id | 52499406 | Intervention Id | 52499407 | Intervention Id | 52499408 |
Eligibilities
Sequence: | 30773563 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 85 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Clinical diagnosis of Parkinson's disease according to the UK Brain Bank criteria. Exclusion Criteria: Subjects had cardiovascular, inflammatory or musculoskeletal problems that could prevent them to participate in an exercise program. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952660 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 0 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 85 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30519694 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28885995 |
Responsible Party Type | Principal Investigator |
Name | Tuğba Atan |
Title | Assoc. Prof. |
Affiliation | Hitit University |
]]>
https://zephyrnet.com/NCT03799874
2019-07-01
https://zephyrnet.com/?p=NCT03799874
NCT03799874https://www.clinicaltrials.gov/study/NCT03799874?tab=tableNANANAThis study will be a multi-center, prospective, randomized, partially double-blind, placebo-controlled Phase II clinical trial of inhaled CO (iCO) for the treatment of ARDS. The trial will be conducted at 7 tertiary care medical centers including Weill Cornell Medicine/NewYork-Presbyterian Hospital, Brigham and Women’s Hospital (BWH), Massachusetts General Hospital (MGH), Duke University Hospital, Durham Veterans Administration Medical Center, New York-Presbyterian Brooklyn Methodist Hospital, and Duke Regional Hospital. The purpose of this study is to evaluate the safety, tolerability, and efficacy of inhaled carbon monoxide (iCO) for the treatment of ARDS and to examine the biologic readouts of low dose iCO therapy in patients with ARDS
<![CDATA[
Studies
Study First Submitted Date | 2018-12-06 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-08-23 |
Start Month Year | July 1, 2019 |
Primary Completion Month Year | December 2023 |
Verification Month Year | August 2022 |
Verification Date | 2022-08-31 |
Last Update Posted Date | 2022-08-23 |
Detailed Descriptions
Sequence: | 20850604 |
Description | Acute respiratory distress syndrome (ARDS) is a devastating disease affecting military, veteran, and civilian populations. ARDS is a syndrome of severe acute lung inflammation and hypoxemic respiratory failure with an incidence of 180,000 cases annually in the United States. Despite recent advances in critical care management and lung protective ventilation strategies, ARDS morbidity and mortality remain unacceptably high. The lack of specific effective therapies for ARDS indicates a need for new treatments that target novel pathways. Carbon monoxide (CO) represents a novel therapeutic modality in ARDS based on data obtained in experimental models of ARDS over the past decade.
CO has been shown to be protective in experimental models of acute lung injury (ALI) and sepsis. Furthermore, multiple human studies have demonstrated that experimental administration of several different concentrations of CO is well tolerated and that low dose inhaled CO can be safely administered to subjects in a controlled research environment. The investigators have previously conducted a Phase I trial of low dose iCO in ARDS which demonstrated that precise administration of low dose iCO (100 and 200 ppm) is feasible, well-tolerated, and safe in patients with sepsis-induced ARDS. The purpose of this study is to assess the safety and efficacy of low dose inhaled carbon monoxide (iCO) therapy in mechanically ventilated patients with ARDS. |
Facilities
Sequence: | 201277248 | Sequence: | 201277249 | Sequence: | 201277250 | Sequence: | 201277251 | Sequence: | 201277252 | Sequence: | 201277253 | Sequence: | 201277254 |
Name | Massachusetts General Hospital | Name | Brigham and Women's Hospital | Name | Washington University | Name | New York-Presbyterian Brooklyn Methodist Hospital | Name | Weill Cornell Medical College | Name | Duke Regional Hospital | Name | Duke University Hospital |
City | Boston | City | Boston | City | Saint Louis | City | Brooklyn | City | New York | City | Durham | City | Durham |
State | Massachusetts | State | Massachusetts | State | Missouri | State | New York | State | New York | State | North Carolina | State | North Carolina |
Zip | 02114 | Zip | 02115 | Zip | 63130 | Zip | 11215 | Zip | 10065 | Zip | 27704 | Zip | 27710 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States |
Browse Interventions
Sequence: | 96590314 | Sequence: | 96590315 | Sequence: | 96590316 | Sequence: | 96590317 | Sequence: | 96590318 | Sequence: | 96590319 |
Mesh Term | Carbon Monoxide | Mesh Term | Antimetabolites | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Gasotransmitters | Mesh Term | Neurotransmitter Agents | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | carbon monoxide | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | gasotransmitters | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52503085 |
Name | Acute Respiratory Distress Syndrome |
Downcase Name | acute respiratory distress syndrome |
Id Information
Sequence: | 40395925 | Sequence: | 40395926 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 2018P002051 | Id Value | CDMRP-PR171025, W81XWH1810667 |
Id Type | Other Grant/Funding Number | ||
Id Type Description | United States Army Medical Research Acquisition Activity | ||
Countries
Sequence: | 42832464 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55959192 | Sequence: | 55959193 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Inhaled Carbon Monoxide | Title | Medical air |
Description | Inhaled Carbon Monoxide at 200 ppm for up to 90 minutes daily for 3 days. | Description | Inhaled Medical Air for up to 90 minutes daily for 3 days. |
Interventions
Sequence: | 52811074 | Sequence: | 52811075 |
Intervention Type | Drug | Intervention Type | Other |
Name | Inhaled Carbon Monoxide at 200 ppm | Name | Inhaled Medical air |
Description | Inhaled Carbon Monoxide at 200 ppm for 90 minutes daily for 3 days. | Description | Inhaled Medical Air for up to 90 minutes daily for 3 days. |
Design Outcomes
Sequence: | 178616982 | Sequence: | 178616983 | Sequence: | 178616984 | Sequence: | 178616985 | Sequence: | 178616986 | Sequence: | 178616987 | Sequence: | 178616988 | Sequence: | 178616989 | Sequence: | 178616990 | Sequence: | 178616991 | Sequence: | 178616992 | Sequence: | 178616993 | Sequence: | 178616994 | Sequence: | 178616995 | Sequence: | 178616996 | Sequence: | 178616997 | Sequence: | 178616998 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Primary Safety Outcome: Number of pre-specified administration-related adverse events. | Measure | Primary Efficacy Outcome: Change in Mitochondrial DNA (mtDNA) level from day 1 to day 5 | Measure | Lung injury score (LIS) on days 1-5, and on day 7 | Measure | PaO2/FiO2 ratio on days 1-5, and on day 7 | Measure | Oxygenation Index (OI) on days 1-5, and day 7 | Measure | Dead Space Fraction (Vd/Vt) on days 1-3, and day 7 | Measure | Sequential Organ Failure Assessment (SOFA) score on days 1-5, 7, 14, 28 | Measure | Change in biomarkers of autophagy | Measure | Change in biomarkers of inflammation and inflammasome activation | Measure | Change in lipid mediators | Measure | Change in biomarkers of mitochondrial quality control | Measure | Ventilator-free days at day 28 | Measure | ICU-free days at day 28 | Measure | Hospital-free days at day 60 | Measure | Hospital mortality to day 28 and 60 | Measure | Montreal Cognitive Assessment- MoCA-Blind | Measure | Hayling Sentence Completion Test |
Time Frame | 7 days | Time Frame | 5 days | Time Frame | 7 days | Time Frame | 7 days | Time Frame | 7 days | Time Frame | 7 days | Time Frame | 28 days | Time Frame | 5 days | Time Frame | 5 days | Time Frame | 5 days | Time Frame | 5 days | Time Frame | 28 days | Time Frame | 28 days | Time Frame | 60 days | Time Frame | 60 days | Time Frame | 6 months | Time Frame | 6 months |
Description | Safety of inhaled CO, defined by the incidence of pre-specified administration-related AEs (as defined below) and spontaneously reported AEs through study day 7.
Acute MI within 48 hours of study drug administration |
Description | Mitochondrial DNA (mtDNA) plasma levels will be measured by quantitative PCR of human NADH dehydrogenase 1. | Description | The Lung Injury Score (LIS) is a composite 4-point scoring system including the PaO2/FiO2, PEEP, quasi-static respiratory compliance, and the extent of infiltrates on the chest X-ray. Each of the four components is categorized from 0 to 4, where a higher number is worse. The total Lung Injury Score is obtained by dividing the aggregate sum by the number of components used. Previous randomized clinical trials in ARDS have shown that a decreased LIS correlates with improvement in lung physiology as well as important clinical outcomes including mortality and ventilator-free days (VFDs). | Description | PaO2/FiO2 will be measured daily on days 1-5 and on day 7 in ventilated subjects. | Description | The oxygenation index will be measured daily on days 1-5 and on day 7 in ventilated subjects. Oxygenation index is calculated as (FiO2 X mean airway pressure)/PaO2. | Description | The dead space fraction will be measured daily on days 1-3 and on day 7 in ventilated subjects. | Description | Organ failure will be assessed using the SOFA score. SOFA scores will be assessed daily on days 1-5, and thereafter on days 7, 14, and 28, as the SOFA score has been shown to be a reliable prognostic indicator of outcomes in critically ill patients. To calculate the Sequential Organ Failure Assessment (SOFA) score, each of the six components (Respiratory, Coagulation, Liver, Cardiovascular, Central Nervous System, Renal) is categorized from 0-4, where a higher number is worse. The SOFA score (0-24) will be calculated by summing all six components. | Description | Autophagy markers (eg. LC3B) will be measured in plasma daily on days 1-3 and on day 5. | Description | Cytokine plasma levels (eg. IL-18) will be measured by ELISA daily on days 1-3 and on day 5. | Description | Lipid mediators (LM) and specialized pro-resolving mediators (SPMs) will be measured in plasma using liquid chromatography-tandem mass spectrometry (LC-MS-MS) based methods daily on days 1-3 and on day 5. | Description | Mitochondrial quality control biomarkers (eg. Pink1, Wipi1) will be measured in peripheral blood mononuclear cells (PBMCs) daily on days 1-3 and on day 5. | Description | Ventilator-free days to day 28 are defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a subject returns to assisted breathing and subsequently achieves unassisted breathing to day 28, VFDs will be counted from the end of the last period of assisted breathing to day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days. | Description | ICU-free days will be assessed on day 28. ICU-free days is defined as the number of days between randomization and day 28 in which the patient is in the ICU (for any part of a day). | Description | Hospital-free days will be assessed on day 60. Hospital-free days are days alive post hospital discharge through day 60. Patients who die on or prior to day 60 are assigned zero hospital-free days. | Description | Mortality will be assessed on day 28 and day 60 | Description | The MoCA-Blind will be administered at 6 months via telephone interview to assess 4 items examining attention, verbal learning and memory, executive functions/language, and orientation. The test is scored out of 22 with 18 and above considered normal. | Description | The Hayling Sentence Completion Test will be administered at 6 months via telephone interview. The Hayling Sentence Completion Test is a neuropsychological test consisting of two types of sentence completion. The first section is scored based on time taken to complete the sentence. The second section is scored based on time taken to complete a sentence as well as the quality of answer. These scores are combined and scaled according to age. |
Browse Conditions
Sequence: | 194752862 | Sequence: | 194752863 | Sequence: | 194752864 | Sequence: | 194752865 | Sequence: | 194752866 | Sequence: | 194752867 | Sequence: | 194752868 | Sequence: | 194752869 | Sequence: | 194752870 | Sequence: | 194752871 | Sequence: | 194752872 | Sequence: | 194752873 |
Mesh Term | Respiratory Distress Syndrome | Mesh Term | Respiratory Distress Syndrome, Newborn | Mesh Term | Acute Lung Injury | Mesh Term | Syndrome | Mesh Term | Disease | Mesh Term | Pathologic Processes | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Respiration Disorders | Mesh Term | Infant, Premature, Diseases | Mesh Term | Infant, Newborn, Diseases | Mesh Term | Lung Injury |
Downcase Mesh Term | respiratory distress syndrome | Downcase Mesh Term | respiratory distress syndrome, newborn | Downcase Mesh Term | acute lung injury | Downcase Mesh Term | syndrome | Downcase Mesh Term | disease | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | respiration disorders | Downcase Mesh Term | infant, premature, diseases | Downcase Mesh Term | infant, newborn, diseases | Downcase Mesh Term | lung injury |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48626627 | Sequence: | 48626628 | Sequence: | 48626629 | Sequence: | 48626630 | Sequence: | 48626631 | Sequence: | 48626632 | Sequence: | 48626633 | Sequence: | 48626634 | Sequence: | 48626635 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | FED | Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | FED | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Brigham and Women's Hospital | Name | Massachusetts General Hospital | Name | Weill Medical College of Cornell University | Name | Duke University | Name | Durham VA Medical Center | Name | New York Presbyterian Brooklyn Methodist Hospital | Name | Duke Regional Hospital | Name | U.S. Army Medical Research Acquisition Activity | Name | Washington University School of Medicine |
Overall Officials
Sequence: | 29458470 |
Role | Principal Investigator |
Name | Rebecca Baron, MD |
Affiliation | Brigham and Women's Hospital |
Design Group Interventions
Sequence: | 68601127 | Sequence: | 68601128 |
Design Group Id | 55959192 | Design Group Id | 55959193 |
Intervention Id | 52811074 | Intervention Id | 52811075 |
Eligibilities
Sequence: | 30954616 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
All intubated patients ≥ 18 years old with ARDS ARDS is defined when all four of the following criteria are met: A PaO2/FiO2 ratio ≤ 300 with at least 5 cm H2O positive end-expiratory airway pressure (PEEP) Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: Age less than 18 years |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253909900 |
Number Of Facilities | 7 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 9 |
Number Of Other Outcomes To Measure | 6 |
Designs
Sequence: | 30700196 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Masking Description | The study drug will be blinded to the study staff using identical tanks containing either CO or placebo air. The administering respiratory therapist (RT) and a physician study staff member will be unblinded to the treatment assignments. |
Subject Masked | True |
Caregiver Masked | True |
Intervention Other Names
Sequence: | 26839054 |
Intervention Id | 52811074 |
Name | iCO |
Responsible Parties
Sequence: | 29066962 |
Responsible Party Type | Principal Investigator |
Name | Rebecca Baron |
Title | Associate Professor of Medicine |
Affiliation | Brigham and Women's Hospital |
Study References
Sequence: | 52410158 | Sequence: | 52410159 | Sequence: | 52410160 | Sequence: | 52410161 | Sequence: | 52410162 | Sequence: | 52410163 | Sequence: | 52410164 | Sequence: | 52410165 | Sequence: | 52410166 | Sequence: | 52410167 | Sequence: | 52410168 | Sequence: | 52410169 | Sequence: | 52410170 | Sequence: | 52410171 |
Pmid | 24391478 | Pmid | 12133657 | Pmid | 25770182 | Pmid | 19465554 | Pmid | 26320156 | Pmid | 9149675 | Pmid | 15557136 | Pmid | 1194155 | Pmid | 5430001 | Pmid | 11704374 | Pmid | 11247913 | Pmid | 26186946 | Pmid | 30518685 | Pmid | 29100885 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Nakahira K, Kyung SY, Rogers AJ, Gazourian L, Youn S, Massaro AF, Quintana C, Osorio JC, Wang Z, Zhao Y, Lawler LA, Christie JD, Meyer NJ, Mc Causland FR, Waikar SS, Waxman AB, Chung RT, Bueno R, Rosas IO, Fredenburgh LE, Baron RM, Christiani DC, Hunninghake GM, Choi AM. Circulating mitochondrial DNA in patients in the ICU as a marker of mortality: derivation and validation. PLoS Med. 2013 Dec;10(12):e1001577; discussion e1001577. doi: 10.1371/journal.pmed.1001577. Epub 2013 Dec 31. | Citation | Brealey D, Brand M, Hargreaves I, Heales S, Land J, Smolenski R, Davies NA, Cooper CE, Singer M. Association between mitochondrial dysfunction and severity and outcome of septic shock. Lancet. 2002 Jul 20;360(9328):219-23. doi: 10.1016/S0140-6736(02)09459-X. | Citation | Jung SS, Moon JS, Xu JF, Ifedigbo E, Ryter SW, Choi AM, Nakahira K. Carbon monoxide negatively regulates NLRP3 inflammasome activation in macrophages. Am J Physiol Lung Cell Mol Physiol. 2015 May 15;308(10):L1058-67. doi: 10.1152/ajplung.00400.2014. Epub 2015 Mar 13. | Citation | Rhodes MA, Carraway MS, Piantadosi CA, Reynolds CM, Cherry AD, Wester TE, Natoli MJ, Massey EW, Moon RE, Suliman HB. Carbon monoxide, skeletal muscle oxidative stress, and mitochondrial biogenesis in humans. Am J Physiol Heart Circ Physiol. 2009 Jul;297(1):H392-9. doi: 10.1152/ajpheart.00164.2009. Epub 2009 May 22. | Citation | Fredenburgh LE, Kraft BD, Hess DR, Harris RS, Wolf MA, Suliman HB, Roggli VL, Davies JD, Winkler T, Stenzler A, Baron RM, Thompson BT, Choi AM, Welty-Wolf KE, Piantadosi CA. Effects of inhaled CO administration on acute lung injury in baboons with pneumococcal pneumonia. Am J Physiol Lung Cell Mol Physiol. 2015 Oct 15;309(8):L834-46. doi: 10.1152/ajplung.00240.2015. Epub 2015 Aug 28. | Citation | Hausberg M, Somers VK. Neural circulatory responses to carbon monoxide in healthy humans. Hypertension. 1997 May;29(5):1114-8. doi: 10.1161/01.hyp.29.5.1114. | Citation | Mayr FB, Spiel A, Leitner J, Marsik C, Germann P, Ullrich R, Wagner O, Jilma B. Effects of carbon monoxide inhalation during experimental endotoxemia in humans. Am J Respir Crit Care Med. 2005 Feb 15;171(4):354-60. doi: 10.1164/rccm.200404-446OC. Epub 2004 Nov 19. | Citation | Peterson JE, Stewart RD. Predicting the carboxyhemoglobin levels resulting from carbon monoxide exposures. J Appl Physiol. 1975 Oct;39(4):633-8. doi: 10.1152/jappl.1975.39.4.633. | Citation | Stewart RD, Peterson JE, Baretta ED, Bachand RT, Hosko MJ, Herrmann AA. Experimental human exposure to carbon monoxide. Arch Environ Health. 1970 Aug;21(2):154-64. doi: 10.1080/00039896.1970.10667214. No abstract available. | Citation | Zevin S, Saunders S, Gourlay SG, Jacob P, Benowitz NL. Cardiovascular effects of carbon monoxide and cigarette smoking. J Am Coll Cardiol. 2001 Nov 15;38(6):1633-8. doi: 10.1016/s0735-1097(01)01616-3. | Citation | Ren X, Dorrington KL, Robbins PA. Respiratory control in humans after 8 h of lowered arterial PO2, hemodilution, or carboxyhemoglobinemia. J Appl Physiol (1985). 2001 Apr;90(4):1189-95. doi: 10.1152/jappl.2001.90.4.1189. | Citation | Pecorella SR, Potter JV, Cherry AD, Peacher DF, Welty-Wolf KE, Moon RE, Piantadosi CA, Suliman HB. The HO-1/CO system regulates mitochondrial-capillary density relationships in human skeletal muscle. Am J Physiol Lung Cell Mol Physiol. 2015 Oct 15;309(8):L857-71. doi: 10.1152/ajplung.00104.2015. Epub 2015 Jul 17. | Citation | Fredenburgh LE, Perrella MA, Barragan-Bradford D, Hess DR, Peters E, Welty-Wolf KE, Kraft BD, Harris RS, Maurer R, Nakahira K, Oromendia C, Davies JD, Higuera A, Schiffer KT, Englert JA, Dieffenbach PB, Berlin DA, Lagambina S, Bouthot M, Sullivan AI, Nuccio PF, Kone MT, Malik MJ, Porras MAP, Finkelsztein E, Winkler T, Hurwitz S, Serhan CN, Piantadosi CA, Baron RM, Thompson BT, Choi AM. A phase I trial of low-dose inhaled carbon monoxide in sepsis-induced ARDS. JCI Insight. 2018 Dec 6;3(23):e124039. doi: 10.1172/jci.insight.124039. | Citation | Rosas IO, Goldberg HJ, Collard HR, El-Chemaly S, Flaherty K, Hunninghake GM, Lasky JA, Lederer DJ, Machado R, Martinez FJ, Maurer R, Teller D, Noth I, Peters E, Raghu G, Garcia JGN, Choi AMK. A Phase II Clinical Trial of Low-Dose Inhaled Carbon Monoxide in Idiopathic Pulmonary Fibrosis. Chest. 2018 Jan;153(1):94-104. doi: 10.1016/j.chest.2017.09.052. Epub 2017 Oct 31. |
]]>
https://zephyrnet.com/NCT03799861
2018-07-05
https://zephyrnet.com/?p=NCT03799861
NCT03799861https://www.clinicaltrials.gov/study/NCT03799861?tab=tableNANANAHeart rate (HR) is not routinely assessed during newborn resuscitations in low- and lower-middle income countries (LMICs). Many non-breathing newborns classified as fresh stillbirths have a heartbeat and are live born. The effect of a low-cost monitor for measuring HR on the problem of misclassification of stillbirths in LMICs is unknown.
Knowledge of HR during newborn resuscitation might also result in timely administration of appropriate interventions, and improvement in outcomes. Helping Babies Breathe (HBB), a resuscitation algorithm developed by the American Academy of Pediatrics (AAP), is widely accepted as the standard of care for newborn resuscitation in low-resource settings. In keeping with the International Liaison Committee on Resuscitation (ILCOR) recommendations that HR be measured during newborn resuscitation, HBB calls for HR assessment after 1 minute of positive-pressure ventilation with good chest movement (or sooner if there is a helper who can palpate/auscultate heart rate). However, given the frequent reality of a single provider attending deliveries in LMICs, as well as the currently available methods for assessing HR (i.e. palpitation or auscultation), assessment of HR is challenging to perform without delaying or stopping the provision of other life-saving interventions such as bag and mask ventilation. The effect of low-cost, continuous HR monitoring to guide resuscitation in these settings is unknown.
NeoBeat is a low-cost, battery-operated device designed by Laerdal Global Health for the measurement of newborn HR. The device can be placed rapidly on a newborn by a single provider, and within 5 seconds, displays HR digitally. A preliminary trial of NeoBeat in 349 non-breathing newborns in Tanzania detected a HR in 67% of newborns classified as stillbirths, suggesting up to two thirds of fresh stillbirths may be misclassified in similar settings.
This trial will evaluate: 1) the effectiveness of HBB in combination with NeoBeat for vital status detection on reduction of reported stillbirths, and 2) the effectiveness of HR-guided HBB on effective breathing at 3 minutes.
The primary hypothesis is that implementation of HBB with measurement of HR using NeoBeat will decrease the reported total stillbirth rate by 15% compared to standard care. The secondary hypothesis is that implementation of HR-guided HBB will increase the proportion of newborns not breathing well at birth who are effectively breathing at 3 minutes by 50% compared to HBB with NeoBeat.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-09 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-03-31 |
Start Month Year | July 5, 2018 |
Primary Completion Month Year | July 30, 2020 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-03-31 |
Facilities
Sequence: | 200863498 | Sequence: | 200863499 | Sequence: | 200863500 |
Name | Binza-Delvaux Maternity Hospital | Name | Centre Hospital Kingasani | Name | Mother and Child Hospital Bumbu |
City | Kinshasa | City | Kinshasa | City | Kinshasa |
Country | Congo, The Democratic Republic of the | Country | Congo, The Democratic Republic of the | Country | Congo, The Democratic Republic of the |
Conditions
Sequence: | 52399526 | Sequence: | 52399524 | Sequence: | 52399525 | Sequence: | 52399527 |
Name | Neonatal Bradycardia | Name | Stillbirth | Name | Neonatal Respiratory Depression | Name | Neonatal Resuscitation |
Downcase Name | neonatal bradycardia | Downcase Name | stillbirth | Downcase Name | neonatal respiratory depression | Downcase Name | neonatal resuscitation |
Id Information
Sequence: | 40320674 |
Id Source | org_study_id |
Id Value | 7200AA18FA00010 |
Countries
Sequence: | 42743900 |
Name | Congo, The Democratic Republic of the |
Removed | False |
Design Groups
Sequence: | 55846561 | Sequence: | 55846562 | Sequence: | 55846563 |
Title | Epoch 1: Care prior to HBB training | Title | Epoch 2: HBB with NeoBeat | Title | Epoch 3: HR-guided HBB |
Description | A period of demographic and birth outcome data collection for a retrospective cohort of all infants born in the three study hospitals during the 18 months prior to the start of Epoch 2, reflecting care prior to HBB training. | Description | Implementation of Helping Babies Breathe training in combination with NeoBeat for detection of HR in non-breathing newborns, after which demographic and birth outcome data will be abstracted from the medical record along with observational data on resuscitation for prospective cohort of all infants born in the three study hospitals for a 9-month period. | Description | Implementation of HR-guided Helping Babies Breathe training with NeoBeat for measurement of HR throughout resuscitation of non-breathing newborns, after which demographic and birth outcome data will be abstracted from the medical record along with observational data on resuscitation for a prospective cohort of all infants born in the three study hospitals for a 9-month period. |
Interventions
Sequence: | 52708687 | Sequence: | 52708688 |
Intervention Type | Other | Intervention Type | Other |
Name | Epoch 2: HBB with NeoBeat | Name | Epoch 3: HR-guided HBB |
Description | At the beginning of Epoch 2, all birth attendants in each of the 3 maternity units will participate in a 2 day workshop in Kinshasa in French that will include instructions regarding use of NeoBeat and training in HBB 2.0. Participants will be introduced to NeoBeat, which will include practice with NeoBeat using the NeoNatalie newborn simulator. This training will be conducted in French using typical adapted training materials for this program that incorporate placement of NeoBeat at appropriate times in the algorithm, including a flipchart and NeoNatalie. Participants will complete the pre and post knowledge check questionnaire for the training as well as the Observed Standardized Clinical Exams (OSCEs) with the incorporation of use of NeoBeat into the OSCEs. | Description | At the beginning of Epoch 3, all birth attendants in each of the 3 maternity units will participate in a 1 day workshop in Kinshasa in French that will instruct them in an adapted, HR-guided HBB algorithm. This training will include simulation with NeoNatalie and NeoBeat. Participants will complete a pre and post knowledge check questionnaire for the training as well as the Observed Standardized Clinical Exams (OSCEs). |
Keywords
Sequence: | 80178385 | Sequence: | 80178386 | Sequence: | 80178387 | Sequence: | 80178388 |
Name | Neonatal Resuscitation | Name | Stillbirth | Name | Neonatal Respiratory Depression | Name | Neonatal Bradycardia |
Downcase Name | neonatal resuscitation | Downcase Name | stillbirth | Downcase Name | neonatal respiratory depression | Downcase Name | neonatal bradycardia |
Design Outcomes
Sequence: | 178223249 | Sequence: | 178223250 | Sequence: | 178223251 | Sequence: | 178223252 | Sequence: | 178223253 | Sequence: | 178223254 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Reported Total Stillbirth Rate | Measure | Effective, Spontaneous Breathing at 3 Minutes | Measure | Fresh Stillbirth Rate | Measure | Macerated Stillbirth Rate | Measure | Neonatal Death Prior to Discharge | Measure | Number of Providers Adhering to Resuscitation Algorithm |
Time Frame | At delivery | Time Frame | At 3 minutes of life | Time Frame | At delivery | Time Frame | At delivery | Time Frame | Up to 28 days of life | Time Frame | At delivery |
Description | The total number of stillborn infants (both fresh and macerated) at the facility per 1,000 births, with stillbirth as classified by the delivery attendant. | Description | Breathing without the assistance of stimulation or bag and mask ventilation at a respiratory rate ≥ 40 breaths per minute with a HR ≥ 100 beats per minute at 32 minutes of life. | Description | Total number of non-breathing newborns without a HR at the time of birth, and without signs of maceration, as determined by the delivery attendant, per 1,000 births. | Description | Total number of non-breathing newborns without a HR at the time of birth, with signs of maceration, as determined by the delivery attendant, per 1,000 births. | Description | Death of a live born infant during the birth hospitalization, where death occurs prior to discharge or transfer from the facility of birth. | Description | any number of provider actions to promote resuscitation of the non-breathing newborn such as suctioning, stimulation, bag and mask ventilation and corrective measures to improve bag and mask ventilation in response to newborn respiratory condition or HR as defined in the resuscitation algorithm. |
Browse Conditions
Sequence: | 194354564 | Sequence: | 194354565 | Sequence: | 194354566 | Sequence: | 194354567 | Sequence: | 194354568 | Sequence: | 194354569 | Sequence: | 194354570 | Sequence: | 194354571 | Sequence: | 194354572 | Sequence: | 194354573 | Sequence: | 194354574 | Sequence: | 194354575 | Sequence: | 194354576 | Sequence: | 194354577 | Sequence: | 194354578 | Sequence: | 194354579 |
Mesh Term | Respiratory Insufficiency | Mesh Term | Stillbirth | Mesh Term | Bradycardia | Mesh Term | Depression | Mesh Term | Behavioral Symptoms | Mesh Term | Arrhythmias, Cardiac | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Pathologic Processes | Mesh Term | Fetal Death | Mesh Term | Pregnancy Complications | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Death | Mesh Term | Respiration Disorders | Mesh Term | Respiratory Tract Diseases |
Downcase Mesh Term | respiratory insufficiency | Downcase Mesh Term | stillbirth | Downcase Mesh Term | bradycardia | Downcase Mesh Term | depression | Downcase Mesh Term | behavioral symptoms | Downcase Mesh Term | arrhythmias, cardiac | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | fetal death | Downcase Mesh Term | pregnancy complications | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | death | Downcase Mesh Term | respiration disorders | Downcase Mesh Term | respiratory tract diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48532042 | Sequence: | 48532043 | Sequence: | 48532044 | Sequence: | 48532045 | Sequence: | 48532046 | Sequence: | 48532047 | Sequence: | 48532048 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | American Academy of Pediatrics | Name | Kinshasa School of Public Health | Name | Laerdal Global Health | Name | RTI International | Name | Thrasher Research Fund | Name | University of North Carolina, Chapel Hill | Name | Saving Lives at Birth |
Overall Officials
Sequence: | 29404540 | Sequence: | 29404541 | Sequence: | 29404542 | Sequence: | 29404543 |
Role | Study Director | Role | Principal Investigator | Role | Study Chair | Role | Study Chair |
Name | Carl Bose, MD | Name | Jackie Patterson, MD, MPH | Name | Sara Berkelhamer, MD | Name | Nalini Singhal, MD |
Affiliation | University of North Carolina, Chapel Hill | Affiliation | University of North Carolina, Chapel Hill | Affiliation | University at Buffalo | Affiliation | University of Calgary |
Design Group Interventions
Sequence: | 68459037 | Sequence: | 68459038 |
Design Group Id | 55846562 | Design Group Id | 55846563 |
Intervention Id | 52708687 | Intervention Id | 52708688 |
Eligibilities
Sequence: | 30896967 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 28 Weeks |
Maximum Age | 45 Weeks |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | All newborns delivered at any of the following 3 maternity units in Kinshasa, DRC over 3 years: Bumbu, Kingasani and Binza-Delvaux. The first 18 months of patients enrolled in the study will be retrospective, while the subsequent 18 months will be prospective. The entire study population will include non-observed and observed deliveries. Observed deliveries will be a convenience sample of non-breathing newborns based on availability of study nurses. |
Criteria | Inclusion Criteria: all newborns delivered via vaginal, assisted or operative delivery at any of 3 participating maternity units in Kinshasa, Democratic Republic of Congo (DRC), during the study period will be enrolled. All newborns will be included, regardless of:
intrauterine fetal demise Exclusion Criteria: Newborns transferred to the maternity unit following delivery at a referral hospital or in the community |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254144501 |
Number Of Facilities | 3 |
Registered In Calendar Year | 2018 |
Actual Duration | 25 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 28 |
Maximum Age Num | 45 |
Minimum Age Unit | Weeks |
Maximum Age Unit | Weeks |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 4 |
Designs
Sequence: | 30642701 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 29009316 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799848
2018-06-12
https://zephyrnet.com/?p=NCT03799848
NCT03799848https://www.clinicaltrials.gov/study/NCT03799848?tab=tableNANANAThis is a Phase I open-label study to evaluate the pharmacokinetic (PK) profile of a single oral dose of vadadustat in subjects with hepatic impairment(HI) compared to healthy matched control subjects with normal hepatic function.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-27 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-03-22 |
Start Month Year | June 12, 2018 |
Primary Completion Month Year | October 18, 2018 |
Verification Month Year | March 2019 |
Verification Date | 2019-03-31 |
Last Update Posted Date | 2019-03-22 |
Detailed Descriptions
Sequence: | 20721591 |
Description | This is an open label, parallel-group, single dose, Phase 1 study to evaluate the PK profile, safety, and tolerability of a single oral 450 mg dose of vadadustat in subjects with hepatic impairment relative to control subjects with normal hepatic function. The study will enroll up to 24 subjects in 3 groups of 8 subjects at 2 study sites. Blood samples for vadadustat PK and its metabolites will be collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60, and 72 hours post-dose. |
Facilities
Sequence: | 200107899 | Sequence: | 200107900 |
Name | Prism Clinical Research | Name | American Research Corporation at the University of Texas Liver Institute |
City | Saint Paul | City | San Antonio |
State | Minnesota | State | Texas |
Zip | 55114 | Zip | 78215 |
Country | United States | Country | United States |
Conditions
Sequence: | 52171116 |
Name | Hepatic Impairment |
Downcase Name | hepatic impairment |
Id Information
Sequence: | 40158558 |
Id Source | org_study_id |
Id Value | AKB-6548-CI-0024 |
Countries
Sequence: | 42568862 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55593065 |
Group Type | Experimental |
Title | Vadadustat |
Description | Group 1: Subjects with moderately impaired hepatic function (Child-Pugh Class B) Group 2: Normal healthy volunteers Group 3: Subjects with mildly impaired hepatic function (Child-Pugh Class A) |
Interventions
Sequence: | 52485364 |
Intervention Type | Drug |
Name | Vadadustat |
Description | Oral tablet |
Keywords
Sequence: | 79868355 | Sequence: | 79868356 | Sequence: | 79868357 | Sequence: | 79868358 |
Name | Hepatic impairment | Name | Healthy subjects | Name | Child-pugh | Name | Vadadustat |
Downcase Name | hepatic impairment | Downcase Name | healthy subjects | Downcase Name | child-pugh | Downcase Name | vadadustat |
Design Outcomes
Sequence: | 177378459 | Sequence: | 177378460 | Sequence: | 177378461 | Sequence: | 177378462 | Sequence: | 177378463 | Sequence: | 177378464 | Sequence: | 177378465 | Sequence: | 177378466 | Sequence: | 177378467 | Sequence: | 177378468 | Sequence: | 177378469 | Sequence: | 177378470 | Sequence: | 177378471 | Sequence: | 177378472 | Sequence: | 177378473 | Sequence: | 177378474 | Sequence: | 177378475 | Sequence: | 177378476 | Sequence: | 177378477 | Sequence: | 177378478 | Sequence: | 177378479 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Area under the concentration-time curve from dosing to last measurable concentration (AUClast) | Measure | Area under the concentration-time curve from dosing to infinity (AUCinf) | Measure | Observed maximum concentration (Cmax). | Measure | Time to reach Cmax of vadadustat | Measure | Apparent total body clearance (CL/F) of vadadustat | Measure | Apparent volume of distribution (Vd/F) of vadadustat | Measure | Terminal half-life (t1/2) of vadadustat | Measure | Time to reach Tmax of vadadustat | Measure | Assessment of Treatment-Emergent Adverse Events (TEAEs) as reported by study subjects | Measure | Cmax related to free drug (Cmax, free) of Vadadustat Unbound | Measure | AUClast related to free drug (AUClast, free) of Vadadustat Unbound | Measure | AUCinf related to free drug (AUCinf, free) of Vadadustat Unbound | Measure | CL/F related to free drug (CL/Ffree) of Vadadustat Unbound | Measure | Terminal half-life (t1/2) of Vadadustat Unbound | Measure | The area under the concentration-time curve from dosing to last measurable concentration (AUClast) of Vadadustat metabolites | Measure | The area under the concentration-time curve from dosing to infinity (AUCinf) of Vadadustat metabolite | Measure | Time to reach Cmax of vadadustat metabolites | Measure | Terminal half-life (t1/2) of Vadadustat metabolites | Measure | Renal clearance (CLr) of Vadadustat/metabolite(s) Urine | Measure | Cumulative amount of drug excreted (Ae) of Vadadustat/metabolite(s) Urine | Measure | Cumulative fraction of drug excreted (Fe) of Vadadustat/metabolite(s) Urine |
Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Up to 9 Weeks | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 | Time Frame | Day 1, Day 4 |
Browse Conditions
Sequence: | 193486247 | Sequence: | 193486248 |
Mesh Term | Liver Diseases | Mesh Term | Digestive System Diseases |
Downcase Mesh Term | liver diseases | Downcase Mesh Term | digestive system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319190 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Akebia Therapeutics |
Overall Officials
Sequence: | 29285298 |
Role | Study Director |
Name | Akebia Therapeutics |
Affiliation | Akebia Therapeutics |
Design Group Interventions
Sequence: | 68148995 |
Design Group Id | 55593065 |
Intervention Id | 52485364 |
Eligibilities
Sequence: | 30765285 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria (All groups):
Male or female subjects between ≥18 years and ≤70 years of age Additional Group-Specific Inclusion Criteria: Group 1 (Moderate Hepatic Impairment Subjects): Presence of Moderate hepatic impairment (Child-Pugh Class B) Group 2 (Normal Hepatic Function Subjects): Normal hepatic function Group 3 (Mild Hepatic Impairment Subjects): Presence of mild hepatic impairment ( Child-Pugh Class A) Exclusion Criteria (all groups): Renal impairment ≥ Stage 3 (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) study equation) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253878068 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2018 |
Actual Duration | 4 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 18 |
Designs
Sequence: | 30511452 |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26673676 |
Intervention Id | 52485364 |
Name | AKB-6548 |
Responsible Parties
Sequence: | 28877746 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799835
2019-01-17
https://zephyrnet.com/?p=NCT03799835
NCT03799835https://www.clinicaltrials.gov/study/NCT03799835?tab=tableMaggy Chaussonm-chausson@unicancer.fr+33185343112This is an open-label, randomized, multicentric study in patients with high-risk non-muscle invasive bladder cancer who had never received BCG for this disease.
The objective is to evaluate the efficacy of atezolizumab as measured by recurrence-free survival.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-05-31 |
Start Month Year | January 17, 2019 |
Primary Completion Month Year | April 1, 2024 |
Verification Month Year | May 2022 |
Verification Date | 2022-05-31 |
Last Update Posted Date | 2022-05-31 |
Detailed Descriptions
Sequence: | 20795631 |
Description | ALBAN study will randomize 516 patients in 45 centers in Europe (France, Belgium and Spain), according to a ratio 1:1 in the following arms of treatment:
Arm A (control arm): BCG only The are two factors of stratifications (center and CIS). |
Facilities
Sequence: | 200760783 | Sequence: | 200760784 | Sequence: | 200760785 | Sequence: | 200760786 | Sequence: | 200760787 | Sequence: | 200760788 | Sequence: | 200760789 | Sequence: | 200760790 | Sequence: | 200760791 | Sequence: | 200760792 | Sequence: | 200760793 | Sequence: | 200760794 | Sequence: | 200760795 | Sequence: | 200760796 | Sequence: | 200760797 | Sequence: | 200760798 | Sequence: | 200760799 | Sequence: | 200760800 | Sequence: | 200760801 | Sequence: | 200760802 | Sequence: | 200760803 | Sequence: | 200760804 | Sequence: | 200760805 | Sequence: | 200760806 | Sequence: | 200760807 | Sequence: | 200760808 | Sequence: | 200760809 | Sequence: | 200760810 | Sequence: | 200760811 | Sequence: | 200760812 | Sequence: | 200760813 | Sequence: | 200760814 | Sequence: | 200760815 | Sequence: | 200760816 | Sequence: | 200760817 | Sequence: | 200760818 | Sequence: | 200760819 | Sequence: | 200760820 |
Status | Active, not recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Active, not recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Not yet recruiting | Status | Recruiting | Status | Recruiting | Status | Not yet recruiting | Status | Not yet recruiting | Status | Not yet recruiting |
Name | Groupe Jolimont – Hôpital de Jolimont | Name | AZ Delta – Campus Rumbeke | Name | Centre Hospitalier Universitaire Angers | Name | Centre Hospitalier Universitaire Bordeaux | Name | Hôpital G. Montpied | Name | Clinique Claude Bernard | Name | CHU Grenoble | Name | Hôpital privé Toulon – Sainte Marguerite | Name | Hôpital du Kremlin-Bicêtre | Name | Hôpital Saint Vincent | Name | Hôpital privé de la Louvière | Name | Hôpital Saint Philibert | Name | Insitut Paoli Calmette | Name | Centre Hospitalier Universitaire Marseille | Name | Centre Hospitalier Universitaire Nîmes | Name | Hôpital européen Georges Pompidou | Name | Hôpital Saint Louis | Name | Groupe Hospitalier Paris Saint Joseph | Name | Hôpital Cochin | Name | Institut Mutualiste Montsouris | Name | Centre Hospitalier Universitaire Tenon | Name | Hôpital Diaconesses- Croix Saint Simon | Name | Hôpital La Pitié Salpétrière | Name | Centre Hospitalier Universitaire Lyon Sud | Name | Centre CARIO-HPCA | Name | Centre Hospitalier Universitaire Rennes | Name | Hôpitaux d'instruction des armées Begin | Name | Hôpital Foch | Name | Hôpitaux Leman | Name | Institut Claudius Regaud | Name | Centre Hospitalier Universitaire Tours | Name | Institut Gustave Roussy | Name | Hospital Universitario A Coruña | Name | Hospital Universitario de Jerez de la Frontera | Name | Hospital Universitario Ramon y Cajal | Name | Hospital Universitario La Paz | Name | Hospital General Universitario Morales Meseguer | Name | Hospital Universitario de Canarias |
City | Haine Saint Paul | City | Roeselare | City | Angers | City | Bordeaux | City | Clermont-Ferrand | City | Ermont | City | Grenoble | City | Hyères | City | Le Kremlin-Bicêtre | City | Lille | City | Lille | City | Lomme | City | Marseille | City | Marseille | City | Nîmes | City | Paris | City | Paris | City | Paris | City | Paris | City | Paris | City | Paris | City | Paris | City | Paris | City | Pierre-Bénite | City | Plérin | City | Rennes | City | Saint-Mandé | City | Suresnes | City | Thonon-les-Bains | City | Toulouse | City | Tours | City | Villejuif | City | A Coruña | City | Cadiz | City | Madrid | City | Madrid | City | Murcia | City | Santa Cruz De Tenerife |
Zip | 7100 | Zip | 8800 | Zip | 49933 | Zip | 33000 | Zip | 63003 | Zip | 95120 | Zip | 38043 | Zip | 83400 | Zip | 94270 | Zip | 59020 | Zip | 59800 | Zip | 59462 | Zip | 13009 | Zip | 13354 | Zip | 30900 | Zip | 75010 | Zip | 75010 | Zip | 75014 | Zip | 75014 | Zip | 75014 | Zip | 75020 | Zip | 75020 | Zip | 75651 | Zip | 69130 | Zip | 22198 | Zip | 35033 | Zip | 94160 | Zip | 92150 | Zip | 74200 | Zip | 31059 | Zip | 3700 | Zip | 94805 | Zip | 15006 | Zip | 11009 | Zip | 28034 | Zip | 28046 | Zip | 30008 | Zip | 38320 |
Country | Belgium | Country | Belgium | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain |
Facility Contacts
Sequence: | 28213718 | Sequence: | 28213719 | Sequence: | 28213720 | Sequence: | 28213721 | Sequence: | 28213722 | Sequence: | 28213723 | Sequence: | 28213724 | Sequence: | 28213725 | Sequence: | 28213726 | Sequence: | 28213727 | Sequence: | 28213728 | Sequence: | 28213729 | Sequence: | 28213730 | Sequence: | 28213731 | Sequence: | 28213732 | Sequence: | 28213733 | Sequence: | 28213734 | Sequence: | 28213735 | Sequence: | 28213736 | Sequence: | 28213737 | Sequence: | 28213738 | Sequence: | 28213739 | Sequence: | 28213740 | Sequence: | 28213741 | Sequence: | 28213742 | Sequence: | 28213743 | Sequence: | 28213744 | Sequence: | 28213745 | Sequence: | 28213746 | Sequence: | 28213747 | Sequence: | 28213748 | Sequence: | 28213749 | Sequence: | 28213750 | Sequence: | 28213751 | Sequence: | 28213752 | Sequence: | 28213753 | Sequence: | 28213754 | Sequence: | 28213755 | Sequence: | 28213756 | Sequence: | 28213757 | Sequence: | 28213758 | Sequence: | 28213759 | Sequence: | 28213760 | Sequence: | 28213761 | Sequence: | 28213762 | Sequence: | 28213763 | Sequence: | 28213764 | Sequence: | 28213765 | Sequence: | 28213766 | Sequence: | 28213767 | Sequence: | 28213768 | Sequence: | 28213769 | Sequence: | 28213770 | Sequence: | 28213771 | Sequence: | 28213772 | Sequence: | 28213773 | Sequence: | 28213774 | Sequence: | 28213775 | Sequence: | 28213776 | Sequence: | 28213777 |
Facility Id | 200760784 | Facility Id | 200760785 | Facility Id | 200760785 | Facility Id | 200760786 | Facility Id | 200760786 | Facility Id | 200760787 | Facility Id | 200760787 | Facility Id | 200760788 | Facility Id | 200760788 | Facility Id | 200760789 | Facility Id | 200760789 | Facility Id | 200760790 | Facility Id | 200760790 | Facility Id | 200760791 | Facility Id | 200760792 | Facility Id | 200760792 | Facility Id | 200760793 | Facility Id | 200760793 | Facility Id | 200760794 | Facility Id | 200760794 | Facility Id | 200760795 | Facility Id | 200760795 | Facility Id | 200760796 | Facility Id | 200760796 | Facility Id | 200760797 | Facility Id | 200760797 | Facility Id | 200760798 | Facility Id | 200760798 | Facility Id | 200760799 | Facility Id | 200760799 | Facility Id | 200760800 | Facility Id | 200760801 | Facility Id | 200760801 | Facility Id | 200760802 | Facility Id | 200760802 | Facility Id | 200760803 | Facility Id | 200760803 | Facility Id | 200760804 | Facility Id | 200760804 | Facility Id | 200760805 | Facility Id | 200760805 | Facility Id | 200760806 | Facility Id | 200760806 | Facility Id | 200760807 | Facility Id | 200760807 | Facility Id | 200760808 | Facility Id | 200760809 | Facility Id | 200760809 | Facility Id | 200760810 | Facility Id | 200760812 | Facility Id | 200760813 | Facility Id | 200760813 | Facility Id | 200760814 | Facility Id | 200760815 | Facility Id | 200760816 | Facility Id | 200760817 | Facility Id | 200760818 | Facility Id | 200760819 | Facility Id | 200760819 | Facility Id | 200760820 |
Contact Type | primary | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | backup | Contact Type | primary |
Name | Lieven Goeman, MD | Name | Souhil Lebdai, MD | Name | MD | Name | Grégoire Robert, MD | Name | Marine Gross-Goupil, MD | Name | Laurent Guy, MD | Name | MD | Name | Laurent Thomas, MD | Name | Julie Giroud, MD | Name | Jean-Luc Descotes, MD-PHD | Name | Mathieu Laramas, MD | Name | Mael Martin, MD | Name | Philippe Bernard, MD | Name | Jacques Irani, MD | Name | Jean-Louis Bonnal | Name | Sylvie Berger | Name | Pierre Colin, MD | Name | Olvier Romano, MD | Name | Jean-Louis Bonnal | Name | Sylvie Berger | Name | Géraldine Pignot, MD | Name | Gwenaelle Gravis, MD | Name | Eric LECHEVALLIER, MD | Name | Jean-Laurent DEVILLE, MD | Name | Stéphane Droupy, MD | Name | Nadine Houédé, MD | Name | Marc-Olivier Timsit, MD | Name | Constance Thibault, MD | Name | Alexandra Masson-Lecomte, MD | Name | Hélène Gautier, MD | Name | Xavier Durand | Name | Nicolas Barry Delongchamps, MD | Name | Olivier Huillard | Name | Rafael Sanchez-Salas, MD | Name | Mostefa Bennamoun, MD | Name | Olivier Traxer, MD | Name | Ahmed Khalil, MD | Name | Philippe Sebe, MD | Name | Camille Serrate, MD | Name | Morgan Roupret, MD-PHD | Name | Baptiste Abbar, MD | Name | Alain Ruffion, MD | Name | Denis Maillet, MD | Name | Luc Corbel | Name | Dominique Besson | Name | Romain Mathieu, MD | Name | Hugo Picchi, MD | Name | Marie Dusaud, MD-PHD | Name | Yann Neuzillet, MD-PHD | Name | Damien Pouessel, MD | Name | Franck Bruyère, MD | Name | Claude Linassier, MD | Name | Yohann Loriot, MD | Name | Sara Martinez Breijo, MD | Name | Álvaro Juárez Soto, MD | Name | Álvaro Sánchez González, MD | Name | Mario Álvarez Maestro, MD | Name | Tomás Fernández Aparicio, MD | Name | Marta Zafra Poves, MD | Name | Ana Cristina Plata Bello, MD |
Browse Interventions
Sequence: | 96350077 | Sequence: | 96350076 | Sequence: | 96350078 | Sequence: | 96350079 | Sequence: | 96350080 | Sequence: | 96350081 | Sequence: | 96350082 | Sequence: | 96350083 | Sequence: | 96350084 |
Mesh Term | BCG Vaccine | Mesh Term | Atezolizumab | Mesh Term | Immune Checkpoint Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Antineoplastic Agents | Mesh Term | Adjuvants, Immunologic | Mesh Term | Immunologic Factors | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | bcg vaccine | Downcase Mesh Term | atezolizumab | Downcase Mesh Term | immune checkpoint inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | adjuvants, immunologic | Downcase Mesh Term | immunologic factors | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52361123 |
Name | Bladder Cancer |
Downcase Name | bladder cancer |
Id Information
Sequence: | 40294592 | Sequence: | 40294593 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | UC-0160/1717 | Id Value | 2017-004512-19 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42717658 | Sequence: | 42717659 | Sequence: | 42717660 |
Name | Belgium | Name | France | Name | Spain |
Removed | False | Removed | False | Removed | False |
Design Groups
Sequence: | 55804330 | Sequence: | 55804331 |
Group Type | Active Comparator | Group Type | Experimental |
Title | Arm A : control arm | Title | Arm B: experimental arm |
Description | BCG therapy only
BCG therapy will be administered in two phases: induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1) |
Description | BCG therapy + administration of atezolizumab
BCG therapy will be administered in two phases: induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1) |
Interventions
Sequence: | 52671928 | Sequence: | 52671929 |
Intervention Type | Drug | Intervention Type | Drug |
Name | BCG | Name | Atezolizumab |
Description | Intravesical administration OncoTice wil be used only under two conditions : BCG Medac® unavailable and the patient has received at minimum one instillation of BCG Medac® | Description | IV perfusion |
Design Outcomes
Sequence: | 178080901 | Sequence: | 178080902 | Sequence: | 178080903 | Sequence: | 178080904 | Sequence: | 178080905 | Sequence: | 178080906 | Sequence: | 178080907 | Sequence: | 178080908 | Sequence: | 178080909 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Recurrence-free survival | Measure | Progression-free survival | Measure | Disease-specific survival | Measure | Overall Survival | Measure | Disease worsening in each arm | Measure | Complete response in each arm | Measure | Complete response among patients with CIS | Measure | National Cancer Institute – Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 | Measure | Quality of life questionnaire (QLQ): QLQ-C30 questionnaire (EORTC) |
Time Frame | 2 years | Time Frame | From randomization to the date of progression, assessed up to 5 years | Time Frame | From randomization to the date of death, assessed up to 5 years | Time Frame | From randomization to the date of death, assessed up to 5 years | Time Frame | From randomization to the date of death, assessed up to 5 years | Time Frame | 6 weeks and 2 years after randomization | Time Frame | 6 weeks and 2 years after randomization | Time Frame | Throughout study completion, assessed up to 5 years | Time Frame | At randomization, every 12 weeks for years 1 and 2 after randomization, then every 24 weeks for years 3 to 5 after randomization |
Description | Recurrence is defined as reappearance of disease (local recurrence or occurrence of any metastasis) after the start of therapy. | Description | Progression- free survival defined as the time from randomization to the date of disease progression defined as increase of stage from Ta to T1 or from CIS to T1; progression to Muscle Invasive Bladder Cancer (T≥ 2) or to lymph node N+ or to distant disease M+; the date of progression being determined by the endoscopic resection (TURBT) for a local relapse or by CT scan in case of non-local relapse. | Description | Disease-specific survival defined as the time from randomization to the date of death from bladder cancer. | Description | Overall Survival defined as the time from randomization to the date of death from any cause. | Description | Disease worsening, defined as cystectomy or change in therapy indicative, including systemic chemotherapy or radiation therapy. The date of diagnosis (cystoscopy or CT scan) leading to cystectomy or chemotherapy will be considered as the time of disease worsening. | Description | Complete response is assessed by cystoscopy and cytology. | Description | Complete response is assessed by cystoscopy and cytology. | Description | The frequency, nature, and severity of adverse events graded according to NCI CTCAE v5.0 and according to the immune-related adverse event (irAE). | Description | This self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
Browse Conditions
Sequence: | 194209598 | Sequence: | 194209599 | Sequence: | 194209600 | Sequence: | 194209601 | Sequence: | 194209602 | Sequence: | 194209603 | Sequence: | 194209604 | Sequence: | 194209605 | Sequence: | 194209606 | Sequence: | 194209607 | Sequence: | 194209608 | Sequence: | 194209609 | Sequence: | 194209610 | Sequence: | 194209611 | Sequence: | 194209612 |
Mesh Term | Urinary Bladder Neoplasms | Mesh Term | Non-Muscle Invasive Bladder Neoplasms | Mesh Term | Urologic Neoplasms | Mesh Term | Urogenital Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Urinary Bladder Diseases | Mesh Term | Urologic Diseases | Mesh Term | Male Urogenital Diseases | Mesh Term | Carcinoma | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type |
Downcase Mesh Term | urinary bladder neoplasms | Downcase Mesh Term | non-muscle invasive bladder neoplasms | Downcase Mesh Term | urologic neoplasms | Downcase Mesh Term | urogenital neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | urinary bladder diseases | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | male urogenital diseases | Downcase Mesh Term | carcinoma | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48496039 | Sequence: | 48496040 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | UNICANCER | Name | Hoffmann-La Roche |
Overall Officials
Sequence: | 29385645 | Sequence: | 29385646 |
Role | Principal Investigator | Role | Principal Investigator |
Name | Morgan Roupret, MD-PHD | Name | Yohann Loriot, MD |
Affiliation | Hôpital Pitié-Salpétrière | Affiliation | Gustave Roussy, Cancer Campus, Grand Paris |
Central Contacts
Sequence: | 12056983 | Sequence: | 12056984 |
Contact Type | primary | Contact Type | backup |
Name | Soazig Nénan-Le Ficher | Name | Maggy Chausson |
Phone | +33185343113 | Phone | +33185343112 |
s-nenan@unicancer.fr | m-chausson@unicancer.fr | ||
Phone Extension | +33185343112 | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68408309 | Sequence: | 68408310 | Sequence: | 68408311 |
Design Group Id | 55804330 | Design Group Id | 55804331 | Design Group Id | 55804331 |
Intervention Id | 52671928 | Intervention Id | 52671928 | Intervention Id | 52671929 |
Eligibilities
Sequence: | 30874885 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Signed informed consent form after the last endoscopic surgery (TURBT) Any high risk non muscle invasive urothelial carcinoma histologically confirmed (mixed histology tumors allowed if urothelial carcinoma histology is predominant) defined on the TURBT as any of the following : T1 tumor and/or At least one additional (second) resection of the primary tumor has been performed in any of the following cases [without upstaging towards Muscle Invasive Bladder Cancer (EAU guidelines, 2017)] : T1 tumors at physician's discretion, Adequate hematologic and end-organ function, as defined by the following laboratory results obtained within 7 days prior to the first study treatment: absolute neutrophil count (ANC) ≥1500 cells/μL Exclusion Criteria: Patient having received previous BCG therapy for bladder cancer Malignancies other than urothelial cancer within 5 years prior to Day 1 of cycle 1 of treatment except the following: Patients with localized low risk prostate cancer (defined as Stage ≤T2b, Gleason score ≤7, and PSA at prostate cancer diagnosis ≤20 ng/mL [if measured]) treated with curative intent (radiotherapy and/or prostatectomy) and without prostate-specific antigen (PSA) recurrence are eligible. History of autoimmune disease or history of immunosuppression, or conditions associated with congenital or acquired immune deficiency , including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (see Appendix 6 for a more comprehensive list of autoimmune diseases) Patients with a history of autoimmune-related hypothyroidism/hyperthyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. Patients with active hepatitis B virus (HBV; chronic or acute; defined as having a positive hepatitis B surface antigen (HBsAg) test prior the randomisation) or hepatitis C. Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody (HBc Ab) and absence of HBsAg) are eligible. HBV DNA must be obtained in these patients prior to randomisation. Signs or symptoms of urinary infection and/or other signs and symptoms > grade 1 (NCI CTCAE v5.0) within 2 weeks prior to Cycle 1, Day 1 Patients receiving therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1 are not eligible Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months before Cycle1, Day 1, unstable arrhythmias, or unstable angina. – Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate. Major surgical procedure other than for diagnosis within 4 weeks prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation if such a live, attenuated vaccine will be required during the study – Influenza vaccination should be given during influenza season only (approximately October through May in the Northern Hemisphere and approximately April through September in the Southern Hemisphere). Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Cycle 1, Day 1, at randomization, during treatment or within 5 months following the last dose of atezolizumab (for patients randomized to atezolizumab). Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea, multiple doses for contrast allergy) may be enrolled in the study. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254059340 |
Number Of Facilities | 38 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30620677 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26769339 | Sequence: | 26769340 | Sequence: | 26769341 | Sequence: | 26769342 |
Intervention Id | 52671928 | Intervention Id | 52671928 | Intervention Id | 52671929 | Intervention Id | 52671929 |
Name | Bacillus Calmette Guerin (BCG) Medac® | Name | OncoTice | Name | MPDL3280A | Name | Tecentriq® |
Responsible Parties
Sequence: | 28987208 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799822
2017-05-01
https://zephyrnet.com/?p=NCT03799822
NCT03799822https://www.clinicaltrials.gov/study/NCT03799822?tab=tableNANANAThe investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.
After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-11-03 |
Start Month Year | May 1, 2017 |
Primary Completion Month Year | September 15, 2020 |
Verification Month Year | October 2020 |
Verification Date | 2020-10-31 |
Last Update Posted Date | 2020-11-03 |
Detailed Descriptions
Sequence: | 20709988 |
Description | The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.
After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done. Relevant endpoints like death, cardiovascular events and bleeding episodes will be registered. |
Facilities
Sequence: | 199965069 |
Name | OLV Hospital |
City | Aalst |
Zip | 9300 |
Country | Belgium |
Browse Interventions
Sequence: | 95996897 | Sequence: | 95996898 | Sequence: | 95996899 | Sequence: | 95996900 | Sequence: | 95996901 | Sequence: | 95996902 | Sequence: | 95996903 | Sequence: | 95996904 | Sequence: | 95996905 | Sequence: | 95996906 | Sequence: | 95996907 | Sequence: | 95996908 | Sequence: | 95996909 | Sequence: | 95996910 | Sequence: | 95996911 | Sequence: | 95996912 |
Mesh Term | Vitamin K | Mesh Term | Rivaroxaban | Mesh Term | Vitamins | Mesh Term | Micronutrients | Mesh Term | Physiological Effects of Drugs | Mesh Term | Factor Xa Inhibitors | Mesh Term | Antithrombins | Mesh Term | Serine Proteinase Inhibitors | Mesh Term | Protease Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Anticoagulants | Mesh Term | Antifibrinolytic Agents | Mesh Term | Fibrin Modulating Agents | Mesh Term | Hemostatics | Mesh Term | Coagulants |
Downcase Mesh Term | vitamin k | Downcase Mesh Term | rivaroxaban | Downcase Mesh Term | vitamins | Downcase Mesh Term | micronutrients | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | factor xa inhibitors | Downcase Mesh Term | antithrombins | Downcase Mesh Term | serine proteinase inhibitors | Downcase Mesh Term | protease inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | anticoagulants | Downcase Mesh Term | antifibrinolytic agents | Downcase Mesh Term | fibrin modulating agents | Downcase Mesh Term | hemostatics | Downcase Mesh Term | coagulants |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52139003 |
Name | Atrial Fibrillation |
Downcase Name | atrial fibrillation |
Id Information
Sequence: | 40135062 |
Id Source | org_study_id |
Id Value | OLV 2014/065 |
Countries
Sequence: | 42542686 |
Name | Belgium |
Removed | False |
Design Groups
Sequence: | 55559344 | Sequence: | 55559345 | Sequence: | 55559346 |
Group Type | Active Comparator | Group Type | Experimental | Group Type | Experimental |
Title | Control | Title | rivaroxaban | Title | rivaroxaban + K2 |
Description | Hemodialysis patients with non valvular atrial fibrillation receiving warfarin | Description | Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od | Description | Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements |
Interventions
Sequence: | 52454908 | Sequence: | 52454909 | Sequence: | 52454910 |
Intervention Type | Drug | Intervention Type | Dietary Supplement | Intervention Type | Drug |
Name | Rivaroxaban 10 MG Oral Tablet | Name | MK-7 2000µg thrice weekly | Name | Vitamin K Antagonist – Drug |
Description | replacement of warfarin by rivaroxaban | Description | dietary supplement of vitamin K2 MK-7 2000µg thrice weekly | Description | treatment with a vitamin K antagonist |
Keywords
Sequence: | 79822817 | Sequence: | 79822818 | Sequence: | 79822819 |
Name | hemodialysis | Name | rivaroxaban | Name | vitamin K2 |
Downcase Name | hemodialysis | Downcase Name | rivaroxaban | Downcase Name | vitamin k2 |
Design Outcomes
Sequence: | 177263638 | Sequence: | 177263639 | Sequence: | 177263640 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | composite of fatal and non-fatal stroke and other cardiovascular events | Measure | death rate | Measure | safety: incidence of life-threatening, major and minor bleeding |
Time Frame | through study completion, on average 3 years | Time Frame | through study completion, on average 3 years | Time Frame | through study completion, on average 3 years |
Description | composite of fatal and non-fatal stroke and other cardiovascular events | Description | cause of death | Description | incidence of life-threatening, major and minor bleeding |
Browse Conditions
Sequence: | 193366519 | Sequence: | 193366520 | Sequence: | 193366521 | Sequence: | 193366522 | Sequence: | 193366523 |
Mesh Term | Atrial Fibrillation | Mesh Term | Arrhythmias, Cardiac | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Pathologic Processes |
Downcase Mesh Term | atrial fibrillation | Downcase Mesh Term | arrhythmias, cardiac | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290708 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Onze Lieve Vrouw Hospital |
Overall Officials
Sequence: | 29268531 |
Role | Principal Investigator |
Name | Rogier Caluwe, MD |
Affiliation | OLV Hospital Aalst, Belgium |
Design Group Interventions
Sequence: | 68107453 | Sequence: | 68107454 | Sequence: | 68107455 | Sequence: | 68107456 |
Design Group Id | 55559345 | Design Group Id | 55559346 | Design Group Id | 55559346 | Design Group Id | 55559344 |
Intervention Id | 52454908 | Intervention Id | 52454908 | Intervention Id | 52454909 | Intervention Id | 52454910 |
Eligibilities
Sequence: | 30747722 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 100 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
inclusion in the trial with clinicaltrials.gov identifier NCT02610933 Exclusion Criteria: none |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121851 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 41 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 100 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30494005 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28860285 |
Responsible Party Type | Principal Investigator |
Name | Rogier Caluwe |
Title | Principal Investigator |
Affiliation | Onze Lieve Vrouw Hospital |
Study References
Sequence: | 52032730 |
Pmid | 33753537 |
Reference Type | derived |
Citation | De Vriese AS, Caluwe R, Van Der Meersch H, De Boeck K, De Bacquer D. Safety and Efficacy of Vitamin K Antagonists versus Rivaroxaban in Hemodialysis Patients with Atrial Fibrillation: A Multicenter Randomized Controlled Trial. J Am Soc Nephrol. 2021 Jun 1;32(6):1474-1483. doi: 10.1681/ASN.2020111566. Epub 2021 Mar 22. |
]]>
https://zephyrnet.com/NCT03799809
2016-12-01
https://zephyrnet.com/?p=NCT03799809
NCT03799809https://www.clinicaltrials.gov/study/NCT03799809?tab=tableSACHIN D, MDsachinmedico@gmail.com8129840208Pulmonary aspergillomas are a common cause of recurrent hemoptysis which may be moderate to severe in 2 to 50 % of cases and may be life threatening. Surgical resection, though curative, may not be feasible in significant number of patients and also associated significant post op complications. Bronchial artery embolisation (BAE) is effective for acute control of hemoptysis, however recurrences may occur in upto a quarter of subjects over a 1 year period.
Aspergilloma is caused by a fungus hence systemic antifungals seem appropriate choice. However the fungus only partially touch the walls of the cavities containing them and rarely come into contact with the bloodstream. This is the major reason why the systemic administration of antifungal agents is ineffective in eradicating the condition.
If surgical resection is not a treatment option to control recurrent hemoptysis, instillation of antifungal agents in an aspergilloma cavity could be considered(QoE II).The instillation of antifungal directly into the cavity (intra-cavitatory) containing aspergilloma brings the drug in contact with the fungus. Thus may lead to antifungal action and shrinkage or complete disappearance of aspergilloma. This can be achieved either by percutaneous route or bronchoscopically. Percutaneous approaches have been investigated however they can sometimes cause fungal spread in thoracic space resulting in fungal empyema which should be carefully avoided. Endobronchial instillation of antifungals have been investigated and found to be safe and effective in controlling hemoptysis, however published data comprise of case reports or small case series.
Recently we have published our experience of intrabronchial voriconazole in aspergilloma among 82 patients and found to be safe and effective in hemoptysis control, with transient post procedure cough as an adverse effect with no major serious adverse events. Multiple small studies and case reports have published the safety and efficacy of voriconazole. However, a quality data in the form of randomized controlled trial (RCT) is not there. Therefore, we planned this RCT to assess the efficacy of intrabronchial voriconazole in inoperable aspergilloma.
<![CDATA[
Studies
Study First Submitted Date | 2018-10-20 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | December 1, 2016 |
Primary Completion Month Year | December 30, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20727129 |
Description | Primary Objective : To compare the percentage of patients achieving reduction in hemoptysis in intrabronchial voriconazole with standard medical therapy group vs standard medical therapy alone for inoperable symptomatic pulmonary aspergilloma.
Secondary Objectives: To compare the percentage of patients who have complete cessation of hemoptysis after 3 months. Number of Patients: 30 patients in each arm (Intrabronchial voriconazole with Standard medical therapy vs Standard medical therapy alone) Study Design : Prospective Randomized control study Dosages of drug – 400 mg iv preparation of Voriconazole every week for 4 sessions Duration of follow-up – 3-6 months Brief Methodology: Patients with aspergilloma who presented with hemoptysis will be screened for inclusion in the study. Diagnosis of aspergilloma will be based on characteristic computed tomography (CT) features with microbiological or serological evidence of Aspergillus (Aspergillus specific Ig G). The patients fulfilling the inclusion criteria will be taken informed consent and randomized into one of the two arms of intervention. Arm 1: Will receive 400 mg of Intrabronchial Voriconazole every week for 4 weeks along with standard medical therapy. Arm 2: Will receive standard medical therapy alone (hemostatics, anti-tussive and others as deemed appropriate by treating physician) All subjects in arm 1 will undergo fiberoptic bronchoscopy (FOB) following standard protocol under local anesthesia with supplemental oxygen and continuous hemodynamic monitoring. After identifying the segmental/sub-segmental bronchus of interest (as identified by CT) or cavity (if visible) the study drug voriconazole, will be instilled. The bronchoscope will be kept wedged for 60 seconds to prevent back leakage of the solution and then slowly withdrawn without applying suction. The patient will be kept in right or left lateral position (depending on the side of involvement) for the next 20 minutes. Following this patients will be observed for 48 hours for cessation of hemoptysis before discharge. The procedure will be done on day 1 of each week for 4 weeks in arm 1. All patients will receive standard medical treatment for hemoptysis including appropriate positioning, airway protection, blood product transfusions, antitussives, tranexamic acid, and antimicrobial therapy as clinically indicated. BAE shall be offered to all patients if indicated. Mild hemoptysis shall be defined as < 50 ml in 24 hrs, moderate hemoptysis as 50-200 ml in 24 hrs and massive hemoptysis as 200-600 ml in 24 hrs or any amount causing hemodynamic compromise/threatening ventilation. Records will be reviewed regarding demographics, primary etiology leading to fibrocavitary disease, duration and severity of hemoptysis/ other constitutional symptoms, extent of disease (unilateral, bilateral, associated pleural or parenchymal changes), simple vs complex aspergilloma. Size of index aspergilloma. The number of patients requiring emergency or hospital admission due to recurrent hemoptysis, and subsequent treatment details will be recorded. All patients will be followed up for 3-6 months. During follow up patients will be assessed for symptoms and severity, successful cessation of hemoptysis, requirement of BAE due to persistent or increased hemoptysis, number of sessions required for symptomatic improvement/cessation of hemoptysis, hemoptysis-free interval, recurrence of hemoptysis will be noted. Pre and post procedure CT scans (low dose limited CT through aspergilloma) will be compared by an independent radiologist blinded to the clinical outcome. Size of index aspergilloma shall be determined by addition of maximum diameter of largest length and width of the visible lesion. CTs shall be compared for documenting change in the size of index aspergilloma and decrease/disappearance of the cavity. On the basis of these parameters, aspergillomas will be described as no interval change, increased or decreased aspergilloma size, or disappearance and emptying of the cavity. Outcomes in the form of reduction/cessation of hemoptysis, decrease in size of aspergilloma, overall symptomatic improvement and mortality shall be recorded. |
Facilities
Sequence: | 200159067 |
Status | Recruiting |
Name | All India Institute of Medical Sciences |
City | New Delhi |
State | Delhi |
Zip | 110029 |
Country | India |
Facility Contacts
Sequence: | 28113704 |
Facility Id | 200159067 |
Contact Type | primary |
Name | Sachin D, MD |
sachinmedico@gmail.com | |
Phone | 8129840208 |
Browse Interventions
Sequence: | 96074006 | Sequence: | 96074007 | Sequence: | 96074008 | Sequence: | 96074009 | Sequence: | 96074010 | Sequence: | 96074011 | Sequence: | 96074012 | Sequence: | 96074013 | Sequence: | 96074014 | Sequence: | 96074015 | Sequence: | 96074016 | Sequence: | 96074017 |
Mesh Term | Voriconazole | Mesh Term | Antifungal Agents | Mesh Term | Anti-Infective Agents | Mesh Term | 14-alpha Demethylase Inhibitors | Mesh Term | Cytochrome P-450 Enzyme Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Steroid Synthesis Inhibitors | Mesh Term | Hormone Antagonists | Mesh Term | Hormones, Hormone Substitutes, and Hormone Antagonists | Mesh Term | Physiological Effects of Drugs | Mesh Term | Cytochrome P-450 CYP3A Inhibitors |
Downcase Mesh Term | voriconazole | Downcase Mesh Term | antifungal agents | Downcase Mesh Term | anti-infective agents | Downcase Mesh Term | 14-alpha demethylase inhibitors | Downcase Mesh Term | cytochrome p-450 enzyme inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | steroid synthesis inhibitors | Downcase Mesh Term | hormone antagonists | Downcase Mesh Term | hormones, hormone substitutes, and hormone antagonists | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | cytochrome p-450 cyp3a inhibitors |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52185349 |
Name | Aspergilloma |
Downcase Name | aspergilloma |
Id Information
Sequence: | 40168982 |
Id Source | org_study_id |
Id Value | AIIMS SACHIN |
Countries
Sequence: | 42580592 |
Name | India |
Removed | False |
Design Groups
Sequence: | 55608992 | Sequence: | 55608993 |
Group Type | Active Comparator | Group Type | No Intervention |
Title | Voriconazole | Title | Control |
Description | Will receive 400 mg of Intrabronchial Voriconazole every week for 4 weeks along with standard medical therapy. | Description | Will receive standard medical therapy alone (hemostatics, anti-tussive and others as deemed appropriate by treating physician) |
Interventions
Sequence: | 52499315 |
Intervention Type | Drug |
Name | Intrabronchial Voriconazole instillation |
Description | Efficacy of intrabronchial voriconazole instillation for inoperable pulmonary aspergilloma |
Design Outcomes
Sequence: | 177431653 | Sequence: | 177431654 | Sequence: | 177431655 | Sequence: | 177431656 | Sequence: | 177431657 | Sequence: | 177431658 | Sequence: | 177431659 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | To compare the percentage of patients achieving reduction in hemoptysis in intrabronchial voriconazole with standard medical therapy group vs standard medical therapy alone for inoperable pulmonary aspergilloma at 3 months. | Measure | To compare the percentage of patients who have complete cessation of hemoptysis after 3 months. | Measure | To compare the percentage of patients having recurrence of hemoptysis during 3 months follow up. | Measure | To compare the severity of hemoptysis during recurrence in both groups. | Measure | To compare the change in size of aspergilloma after 3 months following last intrabronchial voriconazole instillation. | Measure | To compare the percentage of patients who need BAE during anytime till 3 months. | Measure | To compare the percentage of patients with symptomatic improvement in Dyspnea On Exertion, Cough and hemoptysis. |
Time Frame | 3 months follow up | Time Frame | 3 months follow up | Time Frame | 3 months follow up | Time Frame | 3 months follow up | Time Frame | 3 months follow up | Time Frame | 3 months follow up | Time Frame | 3 months follow up |
Description | Percentage of patients achieving reduction in hemoptysis in intrabronchial voriconazole with standard medical therapy group vs standard medical therapy alone for inoperable pulmonary aspergilloma at 3 months. | Description | percentage of patients who have complete cessation of hemoptysis after 3 months. | Description | percentage of patients having recurrence of hemoptysis during 3 months follow up. | Description | severity of hemoptysis during recurrence in both groups shall be compared with visual analogue scale. | Description | change in size of aspergilloma after 3 months following last intrabronchial voriconazole instillation. | Description | percentage of patients who need BAE during anytime till 3 months. | Description | percentage of patients with symptomatic improvement in Dyspnea On Exertion, Cough and hemoptysis. |
Sponsors
Sequence: | 48332215 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | All India Institute of Medical Sciences, New Delhi |
Central Contacts
Sequence: | 12012276 |
Contact Type | primary |
Name | SACHIN D, MD |
Phone | 8129840208 |
sachinmedico@gmail.com | |
Role | Contact |
Design Group Interventions
Sequence: | 68168032 |
Design Group Id | 55608992 |
Intervention Id | 52499315 |
Eligibilities
Sequence: | 30773509 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients with mild to moderate hemoptysis AND inoperable aspergilloma/ those unwilling for surgery. Exclusion Criteria: Patient who are not fit for FOB (e.g. hemodynamic instability) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952452 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30519640 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28885941 |
Responsible Party Type | Principal Investigator |
Name | DR SACHIN D |
Title | senior resident |
Affiliation | All India Institute of Medical Sciences, New Delhi |
]]>
https://zephyrnet.com/NCT03799796
2019-01-06
https://zephyrnet.com/?p=NCT03799796
NCT03799796https://www.clinicaltrials.gov/study/NCT03799796?tab=tableNANANACurrently, Hispanic Spanish-speaking individuals are not receiving culturally appropriate diabetes care. Lack of knowledge impacts several areas of type 2 diabetes (T2D) management, including healthy eating and being physically active in Hispanic Spanish-speaking individuals. Use of diabetes technology is on the rise, however, many technologies do not provide Spanish-language options. A flash glucose monitoring (FGM) system is now available in both English and Spanish. Research suggests that use of FGM results in improved clinical outcomes. Furthermore, increased number of FGM scans are associated with improved clinical outcomes such as decreased A1C and improvements in BG time in range. Our preliminary work indicates that Hispanics (1) are willing to use diabetes technology, such as FGM, if it supports Spanish language and (2) in English-speaking populations, but not specific to the Hispanic Spanish-speaking population, FGM supports biobehavioral change. Further, our work, and the work of others, indicate Hispanic individuals desire for peer interactions to relate and understand the variables that impact T2D. Interaction with online peer support communities is associated with increased knowledge, receipt of emotional support, and improved glycemic levels. These results suggest that education and support to increase use and understanding of FGM will lead to improved clinical and behavioral outcomes.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-09 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-10-22 |
Start Month Year | January 6, 2019 |
Primary Completion Month Year | July 27, 2020 |
Verification Month Year | October 2020 |
Verification Date | 2020-10-31 |
Last Update Posted Date | 2020-10-22 |
Detailed Descriptions
Sequence: | 20716258 |
Description | Currently, Hispanic Spanish-speaking individuals are not receiving culturally appropriate diabetes care. Lack of knowledge impacts several areas of type 2 diabetes (T2D) management, including healthy eating and being physically active in Hispanic Spanish-speaking individuals. Use of diabetes technology is on the rise, however, many technologies do not provide Spanish-language options. A flash glucose monitoring (FGM) system is now available in both English and Spanish. FGM involves wearing an interstitial glucose sensor that is placed on the upper arm and a reader. When an individual wants to check their glucose level, they waive or scan the reader over their sensor and a glucose history, current glucose level, and projected glucose trend is displayed. Research suggests that use of FGM results in improved clinical outcomes. Furthermore, increased number of FGM scans are associated with improved clinical outcomes such as decreased A1C and improvements in BG time in range. Our preliminary work indicates that Hispanics (1) are willing to use diabetes technology, such as FGM, if it supports Spanish language and (2) in English-speaking populations, but not specific to the Hispanic Spanish-speaking population, FGM supports biobehavioral change. Further, our work, and the work of others, indicate Hispanic individuals desire for peer interactions to relate and understand the variables that impact T2D. Interaction with online peer support communities is associated with increased knowledge, receipt of emotional support, and improved glycemic levels. These results suggest that education and support to increase use and understanding of FGM will lead to improved clinical and behavioral outcomes.
Little is known about the uses, benefits, and limitations of online peer support in the context of learning how to use diabetes technology, such as FGM. Hispanic, Spanish speaking individuals are at high risk for T2D and associated morbidity and mortality. Hispanics are more likely to die from diabetes compared to Caucasian counterparts. The investigators propose to address gaps in diabetes care for Hispanic individuals by conducting a pilot trial of an online peer support intervention using an online peer facilitator to augment the use of FGM. The online peer facilitator will be Hispanic and bilingual in English and Spanish with substantial knowledge of diabetes and FGM. Our intervention is culturally appropriate to address the biobehavioral and biopsychosocial needs of Hispanic individuals. The investigators anticipate the additional support provided by the online peer facilitator will encourage healthy eating habits and physical activity behaviors in Hispanic individuals with T2D. Our research team is experienced with community-based participatory research in both diabetes online peer support communities and Hispanic populations using technology to support T2D. Examining online peer support communities to augment diabetes care in Hispanic Spanish speaking individuals is a promising, exciting, and innovative area of research that has not yet been explored. This proposed study contains several novel components. First, using online peer support communities is low-cost and easily accessible, making this intervention more translatable in the clinical setting while adding to the toolkit that already exists for diabetes care. Second, using FGM in a population not using insulin is forward thinking. Empowering people with their own glucose data, early in the course of their diabetes, may change the trajectory of diabetes management. The research team received PCORI pipeline-to-proposal funding (tiers I-III) to develop a research question via a community advisory board (CAB) in partnership with the diabetes online peer support community. The CAB included researchers, clinicians, and people with diabetes, both English and Spanish speaking. This study will address important questions identified by people affected by diabetes. Aim 1 Explore the relationship between engagement in an online peer support intervention with clinical and behavioral outcomes in Hispanic, Spanish speaking individuals with T2D using flash glucose monitoring for 12 weeks Method. A one group, pre-post evaluation of Hispanic, Spanish speaking individuals (N=43) recruited from a health center in Utah. Primary outcome: Time-in-range (average glucose level and number of minutes in 70mg/dl-180mg/dl in last 10 days of the study minus average glucose level and number of minutes in 70mg/dl-180mg/dl for 10 days baseline) between baseline and 12 weeks. Secondary outcomes: Change in A1C from baseline to 12 weeks. Online peer support engagement (measured by survey and Facebook activity), Frequency of FGM scans. Change in self-reported self-management behaviors, self-efficacy and quality of life between baseline and 12 weeks. Hypothesis. Increased engagement in the online peer support intervention will be associated with improved clinical, behavioral and psychosocial outcomes after 12 weeks of FGM. Aim 2. Evaluate the acceptability and feasibility of an online peer support intervention for Hispanic Spanish speaking individuals with T2D to learn how to use flash glucose monitoring to make changes to meal and activity choices. Method. Qualitative and quantitative analysis for measures of use of and satisfaction with flash glucose sensors, eligible participant acceptance of flash glucose sensors, and dropout rates, including causes for drop out, and online peer support engagement through platform analytics. A semi-structured interview will be conducted with participants at the end of the intervention explore their experiences during engagement with the online peer support community. Hypothesis. Online peer support engagement will be associated with satisfaction with FGM and number of daily scans. |
Facilities
Sequence: | 200053118 |
Name | University of Utah College of Nursing |
City | Salt Lake City |
State | Utah |
Zip | 841112 |
Country | United States |
Conditions
Sequence: | 52156372 |
Name | Diabetes Mellitus, Type 2 |
Downcase Name | diabetes mellitus, type 2 |
Id Information
Sequence: | 40148147 |
Id Source | org_study_id |
Id Value | ADC-SRR-IIS-18-23 |
Countries
Sequence: | 42557673 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55577805 |
Group Type | Experimental |
Title | Flash Glucose Monitoring with Online Peer Support |
Description | Pre-Test-Post-Test |
Interventions
Sequence: | 52471915 |
Intervention Type | Behavioral |
Name | Flash Glucose Monitoring with Online Peer Support |
Description | Hispanic Adults who are Spanish-Speaking with type 2 diabetes who are not using insulin will be asked to use flash glucose monitoring and to sign up for an moderated online peer support group where they can ask questions and share progress. |
Keywords
Sequence: | 79847961 | Sequence: | 79847962 | Sequence: | 79847963 | Sequence: | 79847964 |
Name | flash glucose monitoring | Name | online peer support | Name | Hispanic | Name | Spanish-Speaking |
Downcase Name | flash glucose monitoring | Downcase Name | online peer support | Downcase Name | hispanic | Downcase Name | spanish-speaking |
Design Outcomes
Sequence: | 177327598 | Sequence: | 177327599 | Sequence: | 177327600 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Time-in-Range | Measure | A1C | Measure | Online peer support engagement |
Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks |
Description | Average glucose level and number of minutes spent between 70-180 mg/dL | Description | Glycosylated hemoglobin | Description | Survey, Activity in online peer support group |
Browse Conditions
Sequence: | 193431739 | Sequence: | 193431740 | Sequence: | 193431741 | Sequence: | 193431742 | Sequence: | 193431743 |
Mesh Term | Diabetes Mellitus | Mesh Term | Diabetes Mellitus, Type 2 | Mesh Term | Glucose Metabolism Disorders | Mesh Term | Metabolic Diseases | Mesh Term | Endocrine System Diseases |
Downcase Mesh Term | diabetes mellitus | Downcase Mesh Term | diabetes mellitus, type 2 | Downcase Mesh Term | glucose metabolism disorders | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | endocrine system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48305973 | Sequence: | 48305974 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Utah | Name | La Trobe University |
Overall Officials
Sequence: | 29277883 |
Role | Principal Investigator |
Name | Michelle L Litchman, PhD, FNP-BC |
Affiliation | University of Utah College of Nursing |
Design Group Interventions
Sequence: | 68130750 |
Design Group Id | 55577805 |
Intervention Id | 52471915 |
Eligibilities
Sequence: | 30757299 |
Gender | All |
Minimum Age | 21 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age ≥21 years Exclusion Criteria: Non-Spanish speaking |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254225709 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 18 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 21 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30503524 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26665857 |
Intervention Id | 52471915 |
Name | Abbott Freestyle Libre |
Responsible Parties
Sequence: | 28869802 |
Responsible Party Type | Principal Investigator |
Name | Michelle Litchman |
Title | Assistant Professor |
Affiliation | University of Utah |
Study References
Sequence: | 52049347 |
Pmid | 35200153 |
Reference Type | derived |
Citation | Ng AH, Greenwood DA, Iacob E, Allen NA, Ferrer M, Rodriguez B, Litchman ML. Examining a Continuous Glucose Monitoring Plus Online Peer Support Community Intervention to Support Hispanic Adults With Type 2 Diabetes: Protocol for a Mixed Methods Feasibility Study. JMIR Res Protoc. 2022 Feb 24;11(2):e31595. doi: 10.2196/31595. |
]]>
https://zephyrnet.com/NCT03799783
2018-03-01
https://zephyrnet.com/?p=NCT03799783
NCT03799783https://www.clinicaltrials.gov/study/NCT03799783?tab=tableNANANAChildren’s compliance during diagnostic or therapeutic procedures is a challenge, often requiring the use of sedative and/or analgesic drugs.
Electroencephalogram (EEG) needs stillness for a medium-long period but, at the same time, the use of any drug for sedation may affect the exam through an interference with EEG waves. Dexmedetomidine is a selective ∝2-adrenergic agonist with sedative and anxiolytic properties, with a long effect and which does not alter EEG pattern.
The aim of this interventional study is to evaluate the effectiveness, safety and feasibility of dexmedetomidine for sedation during EEG in children who are not cooperative.
Children affected by behavioral disorders and requiring sedation to perform EEG were considered. The protocol establishes to administer IV dexmedetomidine (loading dose and continued infusion) to reach a targeted level of sedation (Pediatric Sedation State Scale = 2). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before, during and after procedure until the offset.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-02-02 |
Start Month Year | March 1, 2018 |
Primary Completion Month Year | February 28, 2019 |
Verification Month Year | January 2021 |
Verification Date | 2021-01-31 |
Last Update Posted Date | 2021-02-02 |
Results First Posted Date | 2021-01-15 |
Detailed Descriptions
Sequence: | 20563345 |
Description | Compliance during diagnostic or therapeutic procedures is a very frequent challenge in children. Procedural sedation and analgesia represents an effective answer to this problem. Electroencephalogram (EEG) is a procedure which needs stillness for a medium-long period. Whereas the majority of children carry out this procedure without sedation, patients with behavioral problems, who frequently need to rule out the presence of seizures as associated symptoms or different disease, often show an insufficient compliance. Sedative drugs usually interfere with EEG cerebral waves pattern, so they can not be used. Dexmedetomidine is a selective ∝2-adrenergic agonist with prevalent sedative and anxiolytic properties, with a long effect and which does not alter EEG pattern.
The aim of this interventional study is to evaluate effectiveness, safety and feasibility of dexmedetomidine for sedation during EEG in children who are not cooperative. Children referred to the Pediatric Neurology Department of the Pediatric Hospital of Padova and required sedation to perform EEG were considered in the study. The protocol establishes to administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete. The loading dose can be repeated up to two times, if needed, to achieve the targeted level of Pediatric Sedation State Scale (PSSS) of 2 (quiet, asleep or awake, not moving during procedure, and no frown or brow furrow indicating pain or anxiety, no verbalization of any complaint). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before, during and after procedure until the complete awake of the patient. The quality of the EEG pattern was also evaluated. Occurrence and type of adverse events are registered during this period. Finally, the caregivers' opinion about the quality of the sedation and the presence of any sleep disturbance at home during the next 12 hours after the procedure were considered. |
Facilities
Sequence: | 198529678 |
Name | Pediatric Intensive Care Unit – Department of Woman's and Child's Health – Azienda Ospedaliera di Padova |
City | Padova |
State | PD |
Country | Italy |
Browse Interventions
Sequence: | 95247284 | Sequence: | 95247285 | Sequence: | 95247286 | Sequence: | 95247287 | Sequence: | 95247288 | Sequence: | 95247289 | Sequence: | 95247290 | Sequence: | 95247291 | Sequence: | 95247292 | Sequence: | 95247293 | Sequence: | 95247294 | Sequence: | 95247295 | Sequence: | 95247296 | Sequence: | 95247297 |
Mesh Term | Dexmedetomidine | Mesh Term | Hypnotics and Sedatives | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Analgesics, Non-Narcotic | Mesh Term | Analgesics | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Adrenergic alpha-2 Receptor Agonists | Mesh Term | Adrenergic alpha-Agonists | Mesh Term | Adrenergic Agonists | Mesh Term | Adrenergic Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | dexmedetomidine | Downcase Mesh Term | hypnotics and sedatives | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | analgesics, non-narcotic | Downcase Mesh Term | analgesics | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | adrenergic alpha-2 receptor agonists | Downcase Mesh Term | adrenergic alpha-agonists | Downcase Mesh Term | adrenergic agonists | Downcase Mesh Term | adrenergic agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51763891 | Sequence: | 51763892 |
Name | Procedural Sedation | Name | Behavior Disorders |
Downcase Name | procedural sedation | Downcase Name | behavior disorders |
Id Information
Sequence: | 39832893 |
Id Source | org_study_id |
Id Value | 4422/AO/18 |
Countries
Sequence: | 42232503 |
Name | Italy |
Removed | False |
Design Groups
Sequence: | 55184878 |
Group Type | Experimental |
Title | Dexmedetomidine |
Description | 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion |
Interventions
Sequence: | 52085223 |
Intervention Type | Drug |
Name | dexmedetomidine |
Description | To administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete |
Keywords
Sequence: | 79197219 | Sequence: | 79197220 |
Name | dexmedetomidine | Name | sedation |
Downcase Name | dexmedetomidine | Downcase Name | sedation |
Design Outcomes
Sequence: | 176067587 | Sequence: | 176067588 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale) | Measure | Number of Patients With Adverse Events |
Time Frame | 10 minutes | Time Frame | during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening) |
Description | the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine. | Description | any adverse event potentially related with DEX-administration |
Browse Conditions
Sequence: | 191843053 |
Mesh Term | Mental Disorders |
Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list |
Sponsors
Sequence: | 47940409 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Azienda Ospedaliera di Padova |
Overall Officials
Sequence: | 29046343 |
Role | Principal Investigator |
Name | angela amigoni, MD |
Affiliation | azienda Ospedaliera di Padova-Pediatric Intensive Care Unit |
Design Group Interventions
Sequence: | 67655734 |
Design Group Id | 55184878 |
Intervention Id | 52085223 |
Eligibilities
Sequence: | 30527023 |
Gender | All |
Minimum Age | 1 Month |
Maximum Age | 18 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
children affected by behavior disorders who underwent EEG procedure with sedation Exclusion Criteria: ASA > 2 |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254094507 |
Number Of Facilities | 1 |
Number Of Nsae Subjects | 10 |
Registered In Calendar Year | 2019 |
Actual Duration | 12 |
Were Results Reported | True |
Months To Report Results | 21 |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 1 |
Maximum Age Num | 18 |
Minimum Age Unit | Month |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30275912 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Drug administration by a loading dose followed by continuous infusion during a procedure |
Intervention Other Names
Sequence: | 26476415 |
Intervention Id | 52085223 |
Name | dexdor |
Milestones
Sequence: | 40755998 | Sequence: | 40755999 | Sequence: | 40756000 |
Result Group Id | 55828807 | Result Group Id | 55828807 | Result Group Id | 55828807 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG000 |
Title | STARTED | Title | COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 19 | Count | 19 | Count | 0 |
Participant Flows
Sequence: | 3898056 |
Outcome Counts
Sequence: | 73518951 | Sequence: | 73518952 |
Outcome Id | 30605227 | Outcome Id | 30605228 |
Result Group Id | 55828808 | Result Group Id | 55828808 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants |
Count | 19 | Count | 19 |
Provided Documents
Sequence: | 2566077 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2020-02-20 |
Url | https://ClinicalTrials.gov/ProvidedDocs/83/NCT03799783/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27772330 | Sequence: | 27772331 | Sequence: | 27772332 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 10 | Subjects Affected | 0 |
Subjects At Risk | 19 | Subjects At Risk | 19 | Subjects At Risk | 19 |
Created At | 2023-08-06 14:32:18.993223 | Created At | 2023-08-06 14:32:18.993223 | Created At | 2023-08-06 14:32:18.993223 |
Updated At | 2023-08-06 14:32:18.993223 | Updated At | 2023-08-06 14:32:18.993223 | Updated At | 2023-08-06 14:32:18.993223 |
Reported Events
Sequence: | 524310152 | Sequence: | 524310153 |
Result Group Id | 55828809 | Result Group Id | 55828809 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Time Frame | 90 minutes | Time Frame | 90 minutes |
Event Type | other | Event Type | other |
Subjects Affected | 6 | Subjects Affected | 4 |
Subjects At Risk | 19 | Subjects At Risk | 19 |
Description | Other (not including serious) adverse events | Description | Other (not including serious) adverse events |
Event Count | 6 | Event Count | 4 |
Organ System | Cardiac disorders | Organ System | Cardiac disorders |
Adverse Event Term | hypotension | Adverse Event Term | bradycardia |
Frequency Threshold | 0 | Frequency Threshold | 0 |
Assessment | Systematic Assessment | Assessment | Systematic Assessment |
Responsible Parties
Sequence: | 28655773 |
Responsible Party Type | Principal Investigator |
Name | angela amigoni |
Title | Principal Investigator |
Affiliation | Azienda Ospedaliera di Padova |
Result Agreements
Sequence: | 3828800 |
Pi Employee | Yes |
Result Contacts
Sequence: | 3828765 |
Organization | University Hospital Padova |
Name | Angela Amigoni, MD |
Phone | 339 8333765 |
Angela.amigoni@aopd.veneto.it | |
Extension | ++39 |
Outcomes
Sequence: | 30605227 | Sequence: | 30605228 |
Outcome Type | Primary | Outcome Type | Secondary |
Title | Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale) | Title | Number of Patients With Adverse Events |
Description | the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine. | Description | any adverse event potentially related with DEX-administration |
Time Frame | 10 minutes | Time Frame | during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening) |
Units | Participants | Units | Participants |
Param Type | Count of Participants | Param Type | Count of Participants |
Outcome Measurements
Sequence: | 234052032 | Sequence: | 234052033 |
Outcome Id | 30605227 | Outcome Id | 30605228 |
Result Group Id | 55828808 | Result Group Id | 55828808 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Title | Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale) | Title | Number of Patients With Adverse Events |
Description | the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine. | Description | any adverse event potentially related with DEX-administration |
Units | Participants | Units | Participants |
Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 13 | Param Value | 10 |
Param Value Num | 13.0 | Param Value Num | 10.0 |
Study References
Sequence: | 51656827 | Sequence: | 51656828 | Sequence: | 51656829 | Sequence: | 51656830 | Sequence: | 51656831 | Sequence: | 51656832 | Sequence: | 51656833 | Sequence: | 51656834 |
Pmid | 20017865 | Pmid | 28557732 | Pmid | 22536619 | Pmid | 27354454 | Pmid | 27516413 | Pmid | 25145661 | Pmid | 19589455 | Pmid | 16238552 |
Reference Type | background | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result |
Citation | Mason KP, O'Mahony E, Zurakowski D, Libenson MH. Effects of dexmedetomidine sedation on the EEG in children. Paediatr Anaesth. 2009 Dec;19(12):1175-83. doi: 10.1111/j.1460-9592.2009.03160.x. | Citation | Cravero JP, Askins N, Sriswasdi P, Tsze DS, Zurakowski D, Sinnott S. Validation of the Pediatric Sedation State Scale. Pediatrics. 2017 May;139(5):e20162897. doi: 10.1542/peds.2016-2897. | Citation | National Clinical Guideline Centre (UK). Sedation in Children and Young People: Sedation for Diagnostic and Therapeutic Procedures in Children and Young People [Internet]. London: Royal College of Physicians (UK); 2010 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK82237/ | Citation | Cote CJ, Wilson S; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016 Jul;138(1):e20161212. doi: 10.1542/peds.2016-1212. | Citation | Sulton C, McCracken C, Simon HK, Hebbar K, Reynolds J, Cravero J, Mallory M, Kamat P. Pediatric Procedural Sedation Using Dexmedetomidine: A Report From the Pediatric Sedation Research Consortium. Hosp Pediatr. 2016 Sep;6(9):536-44. doi: 10.1542/hpeds.2015-0280. Epub 2016 Aug 11. | Citation | Keidan I, Ben-Menachem E, Tzadok M, Ben-Zeev B, Berkenstadt H. Electroencephalography for children with autistic spectrum disorder: a sedation protocol. Paediatr Anaesth. 2015 Feb;25(2):200-5. doi: 10.1111/pan.12510. Epub 2014 Aug 22. | Citation | Lubisch N, Roskos R, Berkenbosch JW. Dexmedetomidine for procedural sedation in children with autism and other behavior disorders. Pediatr Neurol. 2009 Aug;41(2):88-94. doi: 10.1016/j.pediatrneurol.2009.02.006. | Citation | Zub D, Berkenbosch JW, Tobias JD. Preliminary experience with oral dexmedetomidine for procedural and anesthetic premedication. Paediatr Anaesth. 2005 Nov;15(11):932-8. doi: 10.1111/j.1460-9592.2005.01623.x. |
Baseline Counts
Sequence: | 11315437 |
Result Group Id | 55828806 |
Ctgov Group Code | BG000 |
Units | Participants |
Scope | overall |
Count | 19 |
Result Groups
Sequence: | 55828806 | Sequence: | 55828807 | Sequence: | 55828808 | Sequence: | 55828809 |
Ctgov Group Code | BG000 | Ctgov Group Code | FG000 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 |
Result Type | Baseline | Result Type | Participant Flow | Result Type | Outcome | Result Type | Reported Event |
Title | Dexmedetomidine | Title | Dexmedetomidine | Title | Dexmedetomidine | Title | Dexmedetomidine |
Description | 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete |
Description | 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete |
Description | 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete |
Description | 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete |
Baseline Measurements
Sequence: | 124860130 | Sequence: | 124860131 | Sequence: | 124860132 |
Result Group Id | 55828806 | Result Group Id | 55828806 | Result Group Id | 55828806 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 |
Category | Female | Category | Male | ||
Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male |
Units | years | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 7.3 | Param Value | 10 | Param Value | 9 |
Param Value Num | 7.3 | Param Value Num | 10.0 | Param Value Num | 9.0 |
Dispersion Type | Standard Deviation | ||||
Dispersion Value | 4 | ||||
Dispersion Value Num | 4.0 | ||||
Number Analyzed | 19 | Number Analyzed | 19 | Number Analyzed | 19 |
]]>
https://zephyrnet.com/NCT03799770
2019-01-01
https://zephyrnet.com/?p=NCT03799770
NCT03799770https://www.clinicaltrials.gov/study/NCT03799770?tab=tableNANANAThis is a diagnostic test accuracy study. The investigators measure optic nerve sheath diameter (ONSD) by ultrasound on the eye during living donor liver transplantation operation at 5 minutes after reperfusion to predict the occurrence of early tacrolimus neurotoxicity after liver transplantation.
We measured the ONSD at 4 timings: (T1) Post induction and before surgical incision, (T2) Portal vein clamping, (T3) 5 minutes after reperfusion, and (T4) 30 min after reperfusion.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-04-12 |
Start Month Year | January 1, 2019 |
Primary Completion Month Year | March 23, 2021 |
Verification Month Year | April 2022 |
Verification Date | 2022-04-30 |
Last Update Posted Date | 2022-04-12 |
Detailed Descriptions
Sequence: | 20675309 |
Description | Neurotoxicity is mainly associated with tacrolimus and cyclosporin, amounting to 10 – 30% for CS and up to 32% for tacrolimus.(2) . Sirolimus, everolimus, and mycophenolate mofetil lack the neurotoxicity of calcineurin inhibitors (3-4).
Neurotoxicity mostly occurs in the early postoperative period increasing morbidity, mortality and hospital and intensive care stay. Neurotoxicity has variable manifestations and mainly affects the CNS. They are usually divided into minor manifestations as tremor, headache, insomnia and paraesthesia or major encephalopathy, akinetic mutism, seizures, speech disorders, polyneuropathy, myopathy, pseudobulbar palsy and even stroke. (2) The main pathogenesis of calcinurin inhibitors neurotoxicity appears to be fluid extravasation (vasogenic edema) due to disruption of blood brain barrier, not cell destruction (cytotoxic edema).(5) During liver transplant operation there are changes in the intracranial pressure and cerebral perfusion pressure especially during reperfusion that may affect the integrity of blood brain barrier. (6) There are multiple methods for monitoring of intracranial pressure invasive or non -invasive. The invasive method remains the gold standard for monitoring of intracranial pressure but there is a controversy about its use in liver transplantation as it may be complicated by bleeding and infections (7). Also there are a multiple non-invasive methods for monitoring of ICP. Ultrasonographic measurement of the optic nerve sheath diameter (ONSD) was introduced recently as a useful noninvasive method for evaluating ICP. ONSD demonstrated a good correlation with the ICP level in many previously published studies. (8,9) Rajajee et al. found that the optimal cutoff of ONSD for the detection of an acutely increased ICP > 20 mm Hg was greater than 4.8 mm. (10) We hypothesize that the absolute value or the changes of ONSD during different stages of living donor liver transplantation operation may predict occurrence of early calcinurin inhibitor neurotoxicity (CNIN).We will investigate whether the absolute value or changes of ONSD during different stages of living donor liver transplantation operation may be a predictor of early calcinurin inhibitor neurotoxicity in the first month post liver transplantation. This is a prospective observational cohort study that will be conducted to all adult patients of both sex undergoing living donor liver transplantation operation at Gastro-Intestinal Surgical Centre (GISC), Mansoura university Hospitals, Mansoura, Egypt over the period covering more than 100 consecutive cases. After Institutional review board approval, we will secure informed consents from all included patients during the preoperative visits. Anesthesia and surgery techniques will be done according to our center's protocol.(11) Reperfusion: On portal vein declamping, we will start rapid 500 ml 4% albumin infusion or packed RBCs (according to the anhepatic hemoglobin level 5 min before declamping) through 14 Gauge peripheral venous cannula in all patients. For hypotension we will give norepinephrine and for resistant hypotension we will use adrenaline as rescue. Technique of ONSD: Sonographic measurement of ONSD was performed with the same manner of previous studies. Patients were placed in the supine position with their eyes closed, and a thick gel layer was applied to the closed upper eyelid. The 7.5-MHz linear probe was placed on the gel without excessive pressure and adjusted to the proper angle for displaying the entry of the optic nerve into the globe. The intensity of the ultrasound was adjusted to display optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band. An ultrasound beam was focused on the retrobulbar area using the lowest possible acoustic power that could measure ONSD. The ONSD was measured 3 mm behind the optic disc. Measurements were performed in the transverse and sagittal planes of both eyes, and the final ONSD value was calculated by averaging 4 measured values. (8) Immunosuppression: All patients will receive intravenous 0.5 gm methylprednisolone at the start of the warm ischemia. After hepatic artery anastomosis and declamping, we will administer 500 mg mycophenolate mofetil through the nasogastric tube and i.v. 20 mg basiliximab. In the ICU, patients will receive oral tacrolimus starting the day after the operation (adjusting the dose targeting serum level of 5-10 ng/ml) , mycophenolate mofetil 500 mg twice per day and basiliximab 20 mg iv 4 days after. |
Facilities
Sequence: | 199573623 |
Name | Gastroenerology Surgical Center – Liver transplantation program |
City | Mansourah |
State | Dakahlia |
Zip | 35516 |
Country | Egypt |
Conditions
Sequence: | 52049682 |
Name | Liver Transplant; Complications |
Downcase Name | liver transplant; complications |
Id Information
Sequence: | 40062482 |
Id Source | org_study_id |
Id Value | R.18.12.369 – 2018/12/16 |
Countries
Sequence: | 42460614 |
Name | Egypt |
Removed | False |
Interventions
Sequence: | 52361446 |
Intervention Type | Diagnostic Test |
Name | Optic nerve sheath diameter by ultrasound at 5 minutes post-reperfucion |
Description | Patients were placed in the supine position with their eyes closed, and a thick gel layer was applied to the closed upper eyelid. The 7.5-MHz linear probe was placed on the gel without excessive pressure and adjusted to the proper angle for displaying the entry of the optic nerve into the globe. The intensity of the ultrasound was adjusted to display optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band. An ultrasound beam was focused on the retrobulbar area using the lowest possible acoustic power that could measure ONSD. The ONSD was measured 3 mm behind the optic disc. Measurements were performed in the transverse and sagittal planes of both eyes, and the final ONSD value was calculated by average 4 measured values.
We measured the ONSD at 4 timings: (T1) Post induction and before surgical incision, (T2) Portal vein clamping, (T3) 5 minutes after reperfusion, and (T4) 30 min after reperfusion. |
Design Outcomes
Sequence: | 176959503 | Sequence: | 176959504 | Sequence: | 176959505 | Sequence: | 176959506 | Sequence: | 176959507 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Early tacrolimus neurotoxicity | Measure | Time and presentation of neurotoxicity | Measure | Intensive Care Unit stay | Measure | Hospital Length of stay | Measure | Mortality |
Time Frame | 28 days after transplantation | Time Frame | 28 days after transplantation | Time Frame | until discharge from ICU for 1 year | Time Frame | until discharge from the hospital for 1 year | Time Frame | three months after transplant |
Description | definition that will be considered when neurological events (visual disturbance, altered level of consciousness, confusion, psychosis, seizure, encephalopathy, tremors and/or coma or change in the pattern of the preexisting cirrhotic neurological changes ) appeared in the absence of central pontine myelinolysis, central nervous system infection, stroke, or hemorrhage within the first 4 weeks after LT and symptoms improved after dose modification of CNI therapy | Description | according to the 1ry outcome definition, the time (day) and presentation (clinically) reported | Description | reported in days | Description | Measured in days | Description | three-month all-cause mortality |
Browse Conditions
Sequence: | 193001016 | Sequence: | 193001017 | Sequence: | 193001018 | Sequence: | 193001019 |
Mesh Term | Neurotoxicity Syndromes | Mesh Term | Nervous System Diseases | Mesh Term | Poisoning | Mesh Term | Chemically-Induced Disorders |
Downcase Mesh Term | neurotoxicity syndromes | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | poisoning | Downcase Mesh Term | chemically-induced disorders |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48205598 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mansoura University |
Overall Officials
Sequence: | 29214169 | Sequence: | 29214170 |
Role | Principal Investigator | Role | Study Director |
Name | Mahmoud M. Elsedeiq, MD | Name | Amr M. Yassin, MD |
Affiliation | Lecturer of anaesthesia and intensive care | Affiliation | professor of anaesthesia and surgical intensive care |
Eligibilities
Sequence: | 30693802 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Population | Adult (>= 18 years) recipients undergoing living donor liver transplantation |
Criteria | Inclusion Criteria:
All adult patients of both sex undergoing living donor liver transplantation operation Exclusion Criteria: History of optic neuritis |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253904316 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 27 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30440476 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28806990 |
Responsible Party Type | Principal Investigator |
Name | Amr M. Yassen |
Title | professor of anaesthesia and surgical intensive care |
Affiliation | Mansoura University |
]]>
https://zephyrnet.com/NCT03799757
2016-01-31
https://zephyrnet.com/?p=NCT03799757
NCT03799757https://www.clinicaltrials.gov/study/NCT03799757?tab=tableNANANAin this study we are investigating the role of instillation of Bupivacaine through surgical drains at the end of mastectomy surgeries in controlling post operative pain and decreasing their pain killers requirement in the early postoperative period
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | January 2016 |
Primary Completion Month Year | November 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20741227 |
Description | patients were enrolled into 2 groups. in one group the wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.
in the other group the wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) patients and health care providers were blinded as regard the study group patients enrolled in. Visual Analog Pain Scale which is a score for detection of how much the patient is annoyed from the pain- was assessed two and four hours post-operative then every four hours thereafter. |
Facilities
Sequence: | 200280706 |
Name | Faculty of Medicine, Main Univeristy Hospital |
City | Alexandria |
Country | Egypt |
Browse Interventions
Sequence: | 96133373 | Sequence: | 96133374 | Sequence: | 96133375 | Sequence: | 96133376 | Sequence: | 96133377 | Sequence: | 96133378 | Sequence: | 96133379 |
Mesh Term | Bupivacaine | Mesh Term | Anesthetics, Local | Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents |
Downcase Mesh Term | bupivacaine | Downcase Mesh Term | anesthetics, local | Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52221670 | Sequence: | 52221671 |
Name | Pain, Postoperative | Name | Breast Cancer |
Downcase Name | pain, postoperative | Downcase Name | breast cancer |
Id Information
Sequence: | 40195726 |
Id Source | org_study_id |
Id Value | malhussini001 |
Countries
Sequence: | 42609723 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55649952 | Sequence: | 55649953 |
Group Type | Active Comparator | Group Type | Placebo Comparator |
Title | Bupivacaine | Title | Placebo |
Description | The wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. | Description | The wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) |
Interventions
Sequence: | 52535481 | Sequence: | 52535482 |
Intervention Type | Drug | Intervention Type | Drug |
Name | 40ml of 0.25% bupivacaine | Name | 40ml of 0.9% normal saline |
Keywords
Sequence: | 79941965 | Sequence: | 79941966 | Sequence: | 79941967 |
Name | bupivacaine | Name | Post-mastectomy acute pain | Name | Wound instillation |
Downcase Name | bupivacaine | Downcase Name | post-mastectomy acute pain | Downcase Name | wound instillation |
Design Outcomes
Sequence: | 177561975 | Sequence: | 177561976 | Sequence: | 177561977 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Visual analogue pain score | Measure | Number of demands for analgesic | Measure | Timing of first demand for analgesic |
Time Frame | first 24 hours | Time Frame | First 24 hours | Time Frame | First 24 hours |
Description | The intensity of pain will be assessed by the VAS score | Description | How many times the patient will require analgesics | Description | Time lapse between recovery from surgery and first demand for analgesic |
Browse Conditions
Sequence: | 193679043 | Sequence: | 193679041 | Sequence: | 193679042 | Sequence: | 193679044 | Sequence: | 193679045 |
Mesh Term | Pathologic Processes | Mesh Term | Pain, Postoperative | Mesh Term | Postoperative Complications | Mesh Term | Pain | Mesh Term | Neurologic Manifestations |
Downcase Mesh Term | pathologic processes | Downcase Mesh Term | pain, postoperative | Downcase Mesh Term | postoperative complications | Downcase Mesh Term | pain | Downcase Mesh Term | neurologic manifestations |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366555 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Alexandria University |
Overall Officials
Sequence: | 29312982 |
Role | Principal Investigator |
Name | Mahmoud A Alhussini, md |
Affiliation | faculty of medicine , univeristy of alexandria |
Design Group Interventions
Sequence: | 68217579 | Sequence: | 68217580 |
Design Group Id | 55649952 | Design Group Id | 55649953 |
Intervention Id | 52535481 | Intervention Id | 52535482 |
Eligibilities
Sequence: | 30794789 |
Gender | Female |
Minimum Age | 30 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
female patients with unilateral breast cancer candidates for total mastectomy and axillary dissection Exclusion Criteria: Male patients |
Gender Description | only females with breast cancer who were subjected to mastectomy with axillary nodal dissection were enrolled |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004454 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 34 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 30 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Designs
Sequence: | 30540829 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | Triple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28907149 |
Responsible Party Type | Principal Investigator |
Name | Mahmoud A. Alhussini |
Title | lecturer surgical oncology |
Affiliation | Alexandria University |
]]>
https://zephyrnet.com/NCT03799744
2019-03-20
https://zephyrnet.com/?p=NCT03799744
NCT03799744https://www.clinicaltrials.gov/study/NCT03799744?tab=tableNANANAThis is a Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of VCN-01 in Combination With Durvalumab (MEDI4736) in Subjects With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck.
VCN-01 is a genetically modified oncolytic adenovirus characterized by the presence of four independent genetic modifications on the backbone of the wild-type HAd5 adenovirus genome, encoding human PH20, that confer tumor selectivity and anti-tumor activity.
Durvalumab is a human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that inhibits binding of PD-L1.
The proposed mechanism of action (MOA) for durvalumab is interference in the interaction of PD-L1 with PD-1 and CD80 (B7.1). Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions releases the inhibition of immune responses, including those that may result in tumor elimination.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-09 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-03-28 |
Start Month Year | March 20, 2019 |
Primary Completion Month Year | January 31, 2023 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-03-28 |
Detailed Descriptions
Sequence: | 20690211 |
Description | Research Hypothesis The presence of VCN-01 into the tumor after systemic administration will help to overcome the observed resistance to durvalumab and other PD1/PD-L1 checkpoint inhibitors. Primary objectives To evaluate the safety and tolerability of a single intravenous injection of VCN-01 combined with durvalumab in two administration regimens (concomitant or durvalumab starting two weeks later "sequential schedule"), and to determine the recommended phase II dose (RP2D) of the combination. Study design This is a phase I trial, multicenter, open label, and dose escalation study. Patients will be entered at each dose level, according to a planned dose escalation schedule. Absence of unacceptable toxicity at the previous dose is required for entering a patient in the subsequent level. Number of Centers: up to 3 Number of Patients: 15-20 patients Study Population: Patients with metastatic squamous cell carcinoma of the head and neck who have progressed during or after treatment with immune-checkpoint inhibitors. |
Facilities
Sequence: | 199706505 | Sequence: | 199706506 |
Name | Institut Català D'Oncologia | Name | Hospital Universitari Vall D'Hebron |
City | Hospitalet de Llobregat | City | Barcelona |
State | Barcelona | ||
Zip | 08908 | Zip | 08035 |
Country | Spain | Country | Spain |
Browse Interventions
Sequence: | 95880969 | Sequence: | 95880970 | Sequence: | 95880971 |
Mesh Term | Durvalumab | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Antineoplastic Agents |
Downcase Mesh Term | durvalumab | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | antineoplastic agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52087309 | Sequence: | 52087310 | Sequence: | 52087311 | Sequence: | 52087312 |
Name | Head and Neck Neoplasms | Name | Carcinoma, Squamous Cell of Head and Neck | Name | Metastasis | Name | Recurrence |
Downcase Name | head and neck neoplasms | Downcase Name | carcinoma, squamous cell of head and neck | Downcase Name | metastasis | Downcase Name | recurrence |
Id Information
Sequence: | 40091806 | Sequence: | 40091807 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | ICO-VCN-H&N-2018 | Id Value | 2018-001095-38 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42491726 |
Name | Spain |
Removed | False |
Design Groups
Sequence: | 55501347 | Sequence: | 55501348 |
Group Type | Experimental | Group Type | Experimental |
Title | VCN-01 and Durvalumab; concomitant. | Title | VCN-01 and Durvalumab; sequential |
Description | Combination VCN-01 (single iv dose) with Durvalumab, Concomitant schedule; Dose Escalation of VCN-01 | Description | Combination VCN-01 (single iv dose) with Durvalumab, Delayed schedule (14 days); Dose Escalation of VCN-01 |
Interventions
Sequence: | 52400334 | Sequence: | 52400335 |
Intervention Type | Genetic | Intervention Type | Biological |
Name | VCN-01 | Name | Durvalumab |
Description | Dose level 1: 3.3×10^12 viral particles/patient and Dose level 2: 1×10^13 viral particles/patient | Description | Dose: 1500 mg Q4W |
Design Outcomes
Sequence: | 177091026 | Sequence: | 177091027 | Sequence: | 177091028 | Sequence: | 177091029 | Sequence: | 177091030 | Sequence: | 177091031 | Sequence: | 177091032 | Sequence: | 177091033 | Sequence: | 177091034 | Sequence: | 177091035 | Sequence: | 177091036 | Sequence: | 177091037 | Sequence: | 177091038 | Sequence: | 177091039 | Sequence: | 177091040 | Sequence: | 177091041 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Safety by means of Adverse Events (AEs) | Measure | Objective response rate (ORR) | Measure | Progression Free Survival (PFS) | Measure | Maximum Plasma Concentration (Cmax ) of VCN-01 | Measure | Tmax of VCN-01 | Measure | AUC of VCN-01 | Measure | Apparent Half-Life (t1/2) of VCN-01 | Measure | Elimination rate constant of VCN-01 | Measure | VCN-01 viral shedding in blood | Measure | anti-VCN-01 antibodies | Measure | VCN-01 viral shedding in stool and sputum | Measure | Immunological changes induced by the combination of VCN-01 and durvalumab. | Measure | Changes in Microbiome in stool (VCN-01 and Durvalumab concomitant arm) | Measure | Changes in Microbiome in stool (VCN-01 and Durvalumab sequential) | Measure | Circulating free DNA (cfDNA) in plasma analysis (VCN-01 and Durvalumab concomitant arm) | Measure | Circulating free DNA (cfDNA) in plasma analysis (VCN-01 and Durvalumab sequential) |
Time Frame | through study completion, an average of 2 years | Time Frame | On Cycle 3 (+/- 3 days, each cycle is 28 days), and then every 2 cycles (± 7 days) until disease progression or withdrawal (an average of 2 years) | Time Frame | On Cycle 3 (+/- 3 days, each cycle is 28 days), and then every 2 cycles (± 7 days) until disease progression or withdrawal (an average of 2 years) | Time Frame | For both arms: On day 1 pre-dose (within 15 minutes prior to VCN-01 infusion) and then 30 minutes, 1, 2, 4, 6, 24 and 48 hours post VCN-01 administration. | Time Frame | VCN-01 and Durvalumab concomitant arm: On day 1 pre-dose (within 15 minutes prior to VCN-01 infusion) and then 30 minutes, 1 hours, 2 hours, 4 hours, 6 hours, 24 hours and 48 hours post VCN-01 administration. VCN-01 and Durvalumab sequential: On day 1 | Time Frame | VCN-01 and Durvalumab concomitant arm: On day 1 pre-dose (within 15 minutes prior to VCN-01 infusion) and then 30 minutes, 1 hours, 2 hours, 4 hours, 6 hours, 24 hours and 48 hours post VCN-01 administration. VCN-01 and Durvalumab sequential: On day 1 | Time Frame | VCN-01 and Durvalumab concomitant arm: On day 1 pre-dose (within 15 minutes prior to VCN-01 infusion) and then 30 minutes, 1 hours, 2 hours, 4 hours, 6 hours, 24 hours and 48 hours post VCN-01 administration. VCN-01 and Durvalumab sequential: On day 1 | Time Frame | VCN-01 and Durvalumab concomitant arm: On day 1 pre-dose (within 15 minutes prior to VCN-01 infusion) and then 30 minutes, 1 hours, 2 hours, 4 hours, 6 hours, 24 hours and 48 hours post VCN-01 administration. VCN-01 and Durvalumab sequential: On day 1 | Time Frame | VCN-01 and Durvalumab concomitant arm: On day 1: pre-dose and then, 4 hours, 24 hours and 48 hours post dose, on day 8, day 15, day 22 of cycle 1 (each cycle is 28 days), then on day1 of subsequent durvalumab cycles and at the final visit. Arm II: On day | Time Frame | At screening, on day 1 pre-dose (within 15 minutes prior to VCN-01 ) in both arms. In concomitant arm: at day1 of subsequent durvalumab cycles (each cycle is 28 days), and at the final visit. In sequential arm: at day15 on cycle 1, at day1 of subsequent | Time Frame | VCN-01 and Durvalumab concomitant arm: at day 1, 8, 15 and 22 on cycle 1 (each cycle is 28 days) And at day1 of subsequent durvalumab cycles. VCN-01 and Durvalumab sequential: at day -14, -7, 1, 8, 15 on cycle 1 and at day 1 of subsequent durvalumab | Time Frame | VCN-01 and Durvalumab concomitant arm: On day 1: pre-dose, at 30 minutes, 6 hours, 24 hours, 48 hours, at day 8 on cycle 1 (each cycle is 28 days), at day 1of cycle 2 and at the final visit. VCN-01 and Durvalumab sequential: On day 1, 15 minutes before | Time Frame | On day 1: pre-dose and 1st deposition after-dose (the first deposition occurred from day 1 to day 7), day 8, day 15, day 22 on cycle 1 (each cycle is 28 days). | Time Frame | On day -14 (pre-dose and 1st deposition after-dose), day -7, Day 1, day 8 and day15 on cycle 1 (each cycle is 28 days). | Time Frame | Pre-dose on day 1 (within 15min prior to VCN-01 infusion) and at day 8 on cycle 1, at day 1 on cycle 2, at day 1 on cycle 3 and at day 1 on cycle 4 (within 15min prior durvalumab administration) (each cycle is 28 days). | Time Frame | On day -14 pre-dose and 1st deposition after-dose(the first deposition occurred from day -14 to day -8), day -7, day 1, day 8 and day15 on cycle 1 (each cycle is 28 days). |
Description | Incidence of Adverse Events as assessed by CTCAE v4.0 | Description | Proportion of patients with reduction in tumor burden of a predefined amount assessed by CT or MRI | Description | Time from study enrollment until disease progression or death assessed by CT or MRI | Description | The maximum (or peak) concentration that VCN-01 achieves in plasma after its administration. | Description | Time to Maximum Plasma Concentration of VCN-01 | Description | The definite integral in a plot of drug concentration in blood plasma vs. time. | Description | The time it takes for half to be removed | Description | The rate at which VCN-01 is removed from the body. | Description | Determination of VCN-01 levels in peripheral blood samples | Description | Assessment of Blood levels of neutralizing anti-VCN-01 antibodies | Description | Determination of VCN-01 levels in stool and sputum | Description | Study of the Immunological changes induced by the combination of VCN-01 and durvalumab by assessment of blood levels of circulating Interleukin 6 and Interleukin 10 | Description | Analyse the microbiome in stool, prior and after VCN-01 administration | Description | Analyse the microbiome in stool, prior and after VCN-01 administration | Description | To analyse the circulating free DNA (cfDNA) in plasma obtained from samples collected prior and post VCN-01 treatment. | Description | To analyse the circulating free DNA (cfDNA) in plasma obtained from samples collected prior and post VCN-01 treatment. |
Browse Conditions
Sequence: | 193153204 | Sequence: | 193153194 | Sequence: | 193153195 | Sequence: | 193153196 | Sequence: | 193153197 | Sequence: | 193153198 | Sequence: | 193153199 | Sequence: | 193153200 | Sequence: | 193153201 | Sequence: | 193153202 | Sequence: | 193153203 | Sequence: | 193153205 |
Mesh Term | Disease Attributes | Mesh Term | Carcinoma | Mesh Term | Carcinoma, Squamous Cell | Mesh Term | Head and Neck Neoplasms | Mesh Term | Squamous Cell Carcinoma of Head and Neck | Mesh Term | Recurrence | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Neoplasms, Squamous Cell | Mesh Term | Pathologic Processes | Mesh Term | Neoplasms by Site |
Downcase Mesh Term | disease attributes | Downcase Mesh Term | carcinoma | Downcase Mesh Term | carcinoma, squamous cell | Downcase Mesh Term | head and neck neoplasms | Downcase Mesh Term | squamous cell carcinoma of head and neck | Downcase Mesh Term | recurrence | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | neoplasms, squamous cell | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | neoplasms by site |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48241675 | Sequence: | 48241676 | Sequence: | 48241677 | Sequence: | 48241678 |
Agency Class | OTHER | Agency Class | INDUSTRY | Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Institut Català d'Oncologia | Name | Theriva Biologics SL | Name | BioClever 2005 S.L. | Name | AstraZeneca |
Design Group Interventions
Sequence: | 68037155 | Sequence: | 68037156 | Sequence: | 68037157 | Sequence: | 68037158 |
Design Group Id | 55501347 | Design Group Id | 55501348 | Design Group Id | 55501347 | Design Group Id | 55501348 |
Intervention Id | 52400334 | Intervention Id | 52400334 | Intervention Id | 52400335 | Intervention Id | 52400335 |
Eligibilities
Sequence: | 30716696 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Written informed consent and any locally-required authorization (e.g., Data Privacy Directive in the EU) obtained from the patient prior to performing any protocol-related procedures; including screening evaluations must be obtained. Adequate normal organ and marrow function as defined below (transfusions intended to elevate any parameters below solely for the intent of meeting study eligibility are not permitted): Leukocytes ≥3000 mcL Exclusion Criteria: Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolization, monoclonal antibodies) within 4 weeks (28 days) prior to the first dose of study treatment. Enrolment with a shorter period of time might be allowed upon discussion with the Study Physician/Medical Monitor according data of sufficient washout time form PK properties of the agent. Previous treatment PD1/PD-L1 inhibition (including Durvalumab) is a specific entry criterion, but patients:Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy. All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study. o Exception: Patients with endocrine AE of ≤Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic. Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. Presently has a second malignancy other than SCCHN, or history of treatment for invasive cancer other that SCCHN in the past 3 years except for: Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253951307 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 15 |
Designs
Sequence: | 30463233 |
Allocation | Non-Randomized |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | This is a phase I trial, multicenter, open label, and dose escalation study. Patients will be entered at each dose level, according to a planned dose escalation schedule. Absence of unacceptable toxicity at the previous dose is required for entering a patient in the subsequent level.
The investigational treatment will be a single i.v. VCN-01 dose combined with concomitant i.v. durvalumab (MEDI4736) 1500 mg Q4W (Arm I) or durvalumab starting two weeks after VCN-01 administration, "sequential schedule" (Arm II). Patient recruitment in Arm I and Arm II will be performed in parallel based on slot availability. Only one single dose of VCN-01 will be administered to each patient during the trial. Durvalumab will be administered Q4W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion. |
Responsible Parties
Sequence: | 28829693 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799731
2018-07-11
https://zephyrnet.com/?p=NCT03799731
NCT03799731https://www.clinicaltrials.gov/study/NCT03799731?tab=tableNANANAPhase 2A study, assessing the antitumor activity and the safety profile of GM102, a new compound (monoclonal antibody), administered alone or in combination with chemotherapy in patients with locally advanced or metastatic colorectal cancer. The primary objective of the study is to evaluate the antitumor activity of GM102 single agent and in combination with trifluridine/tipiracil.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-04-14 |
Start Month Year | July 11, 2018 |
Primary Completion Month Year | January 19, 2021 |
Verification Month Year | April 2022 |
Verification Date | 2022-04-30 |
Last Update Posted Date | 2022-04-14 |
Detailed Descriptions
Sequence: | 20848268 |
Description | GM102 is a humanized low fucose monoclonal antibody with a high affinity to AMHRII receptor (fetal receptor mediating the activity of AMH, reexpressed in a variety of solid tumors). GM102 acts through engagement of immune cells (macrophages, natural killer (NK) cells) to trigger ADCC (antibody dependent cellular cytotoxicity) and phagocytosis of tumor cells.
AMRHII expression was found in 73% of primary colorectal tumors tested. Advanced/metastatic colorectal cancer (CRC) remains an unmet need disease, with few therapeutic options beyond two or three lines of therapy. CRC is characterized by a tumor microenvironment (TME) particularly rich in macrophages and more specifically macrophages capable of tumor phagocytosis. The pattern of the TME remains a major prognostic factor in the metastatic setting. C201 consists in two parallel cohorts and an expansion of cohort II for patients with advanced or metastatic colorectal cancer in two different settings of the disease: Cohort I (GM102 as a single agent) in refractory patients, having exhausted all therapeutic options. Patients will receive GM102 alone at the dose of 7 mg/kg administered by intravenous infusion at Day 1, Day 8, Day 15 and Day 22 of each 28-day cycle Patients will be treated with GM102 (Cohort I) or GM102 and trifluridine/tipiracil (Cohort II and Cohort II expansion) until confirmed progression or toxicity. A Trial Steering Committee (TSC) will analyze and qualify GM102 activity and toxicities and will provide recommendations on the Investigational Medicinal Product (IMP) continuation. |
Facilities
Sequence: | 201251996 | Sequence: | 201251997 | Sequence: | 201251998 | Sequence: | 201251999 | Sequence: | 201252000 |
Name | Cliniques Universitaires Saint-Luc | Name | UZ Gasthuisberg | Name | UZ Leuven | Name | University Hopistal Olomouc | Name | University Hospital Motol |
City | Brussels | City | Gent | City | Leuven | City | Olomouc | City | Praha |
Country | Belgium | Country | Belgium | Country | Belgium | Country | Czechia | Country | Czechia |
Browse Interventions
Sequence: | 96578074 | Sequence: | 96578075 | Sequence: | 96578076 | Sequence: | 96578077 | Sequence: | 96578078 |
Mesh Term | Trifluridine | Mesh Term | Antimetabolites | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antiviral Agents | Mesh Term | Anti-Infective Agents |
Downcase Mesh Term | trifluridine | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antiviral agents | Downcase Mesh Term | anti-infective agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52496656 |
Name | Colorectal Cancer |
Downcase Name | colorectal cancer |
Id Information
Sequence: | 40391235 |
Id Source | org_study_id |
Id Value | C201 |
Countries
Sequence: | 42826780 | Sequence: | 42826781 |
Name | Belgium | Name | Czechia |
Removed | False | Removed | False |
Design Groups
Sequence: | 55952552 | Sequence: | 55952553 | Sequence: | 55952554 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | Cohort I: GM102 single agent | Title | Cohort II: GM102 + trifluridine/tipiracil | Title | Cohort II expansion: GM102 + trifluridine/tipiracil |
Description | GM102 will be intravenously administered at the dose of 7 mg/kg on Days 1, 8, 15 and 22 of each 28-day cycle | Description | GM102 will be intravenously administered at the dose of 7 mg/kg on Days 1, 8, 15 and 22, and trifluridine/tipiracil will be orally administered at the dose of 35 mg/m² twice daily on Days 1 to 5 and days 8 to 12 of each 28-day cycle | Description | GM102 will be intravenously administered at the dose of 7 mg/kg on Days 1, 8, 15 and 22, after a loading dose of 10 mg/kg q1w during 28-day cycle 1, and trifluridine/tipiracil will be orally administered at the dose of 35 mg/m² twice daily on Days 1 to 5 and days 8 to 12 of each 28-day cycle |
Interventions
Sequence: | 52804814 | Sequence: | 52804815 | Sequence: | 52804816 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | GM102 | Name | Trifluridine/Tipiracil | Name | GM102 expansion |
Description | GM102 7 mg/kg weekly | Description | Lonsurf 35 mg/m² twice daily during 10 days per cycle | Description | GM102 7 mg/kg weekly after a loading dose of 10 mg/kg q1w during 28-day cycle 1 |
Design Outcomes
Sequence: | 178594437 | Sequence: | 178594438 | Sequence: | 178594439 | Sequence: | 178594440 | Sequence: | 178594441 | Sequence: | 178594442 | Sequence: | 178594443 | Sequence: | 178594444 | Sequence: | 178594445 | Sequence: | 178594446 | Sequence: | 178594447 | Sequence: | 178594448 | Sequence: | 178594449 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Overall Response Rate (ORR) | Measure | Progression Free Survival (PFS) at 6 months | Measure | Immune Overall Response Rate (iORR) | Measure | Clinical Benefit Rate (CBR) | Measure | Tumor Growth Rate (TGR) before and under treatment | Measure | Progression Free Survival (PFS) | Measure | Overall Survival (OS) | Measure | Incidence of Serious Adverse Event (SAE) and Treatment Emergent Adverse Event (TEAE) | Measure | Pharmacodynamics evaluation | Measure | Exposure to murlentamab | Measure | Exposure to trifluridine | Measure | Evidence of anti-murlentamab antibodies (ADA) | Measure | AMHRII (Anti-Mullerian Hormone type II receptor) expression |
Time Frame | Through study completion, an average 1 year | Time Frame | 6 months after the first infusion | Time Frame | Through study completion, an average 1 year | Time Frame | up to 4 months | Time Frame | up to 2 months | Time Frame | Through study completion, an average 1 year | Time Frame | Through study completion, an average 1 year | Time Frame | Through study completion, an average 1 year | Time Frame | Up to 2 months | Time Frame | At days 1 and 15 of cycles 1, 2 (each cycle is 28 days) and End of Treatment for cohort I and II, an average of one year; days 1, 8,15 and 22 of cycles 1, 2 (each cycle is 28 days) and End of Treatment for cohort II expansion, an average of one year | Time Frame | At days 1 and 15 of cycles 1, 2 (each cycle is 28 days) and End of Treatment, an average of one year | Time Frame | Baseline, beginning of every even cycle in pre-dose (each cycle is 28 days) and at the End of Treatment, an average of one year | Time Frame | Up to 2 months |
Description | ORR from the end of cycle 2 and subsequently confirmed at least 4 weeks later using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 | Description | Proportion of patients without documented progression at 6 months | Description | ORR using immune Response Evaluation Criteria In Solid Tumors (iRECIST) | Description | CBR at 8 and 16 weeks defined as the number of non-progressors using RECIST 1.1 and iRECIST criteria | Description | Percentage of variation in TGR | Description | Time elapsed from the date of first infusion to the date of documented progression or death | Description | Time elapsed from the date of first infusion to the date of death | Description | Number of events | Description | Tumor Immune MicroEnvironment analysis and evolution changes: quantity/density and quality of immune cells | Description | PK parameters analysis | Description | Trifluridine plasma concentrations only for cohort II | Description | Presence of ADA | Description | AMHRII membrane expression in percentage |
Browse Conditions
Sequence: | 194727905 | Sequence: | 194727906 | Sequence: | 194727907 | Sequence: | 194727908 | Sequence: | 194727909 | Sequence: | 194727910 | Sequence: | 194727911 | Sequence: | 194727912 | Sequence: | 194727913 | Sequence: | 194727914 | Sequence: | 194727915 |
Mesh Term | Colorectal Neoplasms | Mesh Term | Intestinal Neoplasms | Mesh Term | Gastrointestinal Neoplasms | Mesh Term | Digestive System Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Digestive System Diseases | Mesh Term | Gastrointestinal Diseases | Mesh Term | Colonic Diseases | Mesh Term | Intestinal Diseases | Mesh Term | Rectal Diseases |
Downcase Mesh Term | colorectal neoplasms | Downcase Mesh Term | intestinal neoplasms | Downcase Mesh Term | gastrointestinal neoplasms | Downcase Mesh Term | digestive system neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | colonic diseases | Downcase Mesh Term | intestinal diseases | Downcase Mesh Term | rectal diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48621046 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | GamaMabs Pharma |
Overall Officials
Sequence: | 29455255 |
Role | Principal Investigator |
Name | Eric Van Cutsem, MD |
Affiliation | UZ Leuven, Belgium |
Design Group Interventions
Sequence: | 68592500 | Sequence: | 68592501 | Sequence: | 68592502 | Sequence: | 68592503 | Sequence: | 68592504 |
Design Group Id | 55952552 | Design Group Id | 55952553 | Design Group Id | 55952554 | Design Group Id | 55952553 | Design Group Id | 55952554 |
Intervention Id | 52804814 | Intervention Id | 52804814 | Intervention Id | 52804815 | Intervention Id | 52804815 | Intervention Id | 52804816 |
Eligibilities
Sequence: | 30951203 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Histologically confirmed metastatic or locally advanced colorectal adenocarcinoma. Exclusion Criteria: Age < 18 years old. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253858422 |
Number Of Facilities | 5 |
Registered In Calendar Year | 2019 |
Actual Duration | 30 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 11 |
Designs
Sequence: | 30696791 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26835264 |
Intervention Id | 52804815 |
Name | Lonsurf |
Responsible Parties
Sequence: | 29063548 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799718
2019-03-13
https://zephyrnet.com/?p=NCT03799718
NCT03799718https://www.clinicaltrials.gov/study/NCT03799718?tab=tableNANANAA multidose open-label study with autologous Mesenchymal Stromal Stem Cells Secreting Neurotrophic Factors (MSC-NTF cells) involving 20 participants with progressive MS at multiple investigational study sites.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-11-14 |
Start Month Year | March 13, 2019 |
Primary Completion Month Year | March 11, 2021 |
Verification Month Year | August 2021 |
Verification Date | 2021-08-31 |
Last Update Posted Date | 2022-11-14 |
Results First Posted Date | 2022-11-14 |
Detailed Descriptions
Sequence: | 20713085 |
Description | An open-label study with a single treatment arm involving 20 participants with progressive MS at multiple investigational study sites. After providing informed consent, participants meeting the inclusion and exclusion criteria will be randomized and approximately 4 weeks later will undergo a bone-marrow aspiration (BMA). Each participants will receive three Intrathecal cell transplantations within 16 weeks and will be followed for 12 weeks for safety and efficacy. |
Facilities
Sequence: | 200013922 | Sequence: | 200013923 | Sequence: | 200013924 | Sequence: | 200013925 |
Name | University of Southern California | Name | Stanford University School of Medicine | Name | The Mount Sinai Hospital | Name | Cleveland Clinic |
City | Los Angeles | City | Redwood City | City | New York | City | Cleveland |
State | California | State | California | State | New York | State | Ohio |
Zip | 90033 | Zip | 94305 | Zip | 10029 | Zip | 44195 |
Country | United States | Country | United States | Country | United States | Country | United States |
Conditions
Sequence: | 52147770 |
Name | Multiple Sclerosis, Chronic Progressive |
Downcase Name | multiple sclerosis, chronic progressive |
Id Information
Sequence: | 40141583 |
Id Source | org_study_id |
Id Value | BCT-101-US |
Countries
Sequence: | 42550783 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55568475 |
Group Type | Experimental |
Title | NurOwn (MSC-NTF cells) |
Description | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
Interventions
Sequence: | 52463579 |
Intervention Type | Biological |
Name | NurOwn (MSC-NTF cells) |
Description | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
Design Outcomes
Sequence: | 177297640 | Sequence: | 177297641 | Sequence: | 177297642 | Sequence: | 177297643 | Sequence: | 177297644 | Sequence: | 177297645 | Sequence: | 177297646 | Sequence: | 177297647 | Sequence: | 177297648 | Sequence: | 177297649 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Number of Participants With Treatment-emergent Adverse Events | Measure | Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) | Measure | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed | Measure | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT | Measure | Number of Participants Who Had >5.5 in Expanded Disability Status Scale (EDSS) at Baseline, With ≥0.5 Points Improvement From Baseline to Week 28 | Measure | Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) | Measure | Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level | Measure | Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score | Measure | Change in Concentration of Vascular Endothelial Growth Factor (VEGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following First NurOwn® Treatment | Measure | Change in Concentration of Hepatocyte Growth Factor (HGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following NurOwn® Treatment |
Time Frame | Up to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 16 weeks post first treatment | Time Frame | From Baseline (pre-first treatment) to 16 weeks post first treatment |
Description | Combined safety of all 3 intrathecal doses of NurOwn® (MSC-NTF cells) Number of participants who experienced Treatment-emergent Adverse Events during the study.
Treatment-emergent Adverse Event is an adverse event that occurs for the first time after initiation of first treatment or if it had occurred prior to initiation first treatment, it worsens in severity after initiation of first treatment. |
Description | 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT).
The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes. The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded. Higher values represent worse outcomes. |
Description | ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk.
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes |
Description | The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses.
The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome. |
Description | Expanded Disability Status Scale (EDSS) provides a total score on a scale that ranges from 0 (no disability) through 1 to 10 (death due to MS), in 0.5-point steps. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the sequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The higher score represents the worse outcome. | Description | The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks.
It contains 12 questions that assess the impact of MS on different aspects of walking function and quality. Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome. |
Description | The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels.
The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome. |
Description | Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed.
It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome. |
Description | Change from baseline (pre-first treatment) in the concentration of Vascular endothelial growth factor (VEGF) neuroprotective biomarker in the Cerebrospinal fluid (CSF) at 16 weeks following first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome | Description | Change from baseline in the concentration of Hepatocyte growth factor (HGF) neuroprotective biomarker in the Cerebrospinal Fluid (CSF) at 16 weeks following the first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome |
Browse Conditions
Sequence: | 193399231 | Sequence: | 193399232 | Sequence: | 193399233 | Sequence: | 193399234 | Sequence: | 193399235 | Sequence: | 193399236 | Sequence: | 193399237 | Sequence: | 193399238 | Sequence: | 193399239 | Sequence: | 193399240 | Sequence: | 193399241 |
Mesh Term | Multiple Sclerosis | Mesh Term | Multiple Sclerosis, Chronic Progressive | Mesh Term | Pathologic Processes | Mesh Term | Demyelinating Autoimmune Diseases, CNS | Mesh Term | Autoimmune Diseases of the Nervous System | Mesh Term | Nervous System Diseases | Mesh Term | Demyelinating Diseases | Mesh Term | Autoimmune Diseases | Mesh Term | Immune System Diseases | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes |
Downcase Mesh Term | multiple sclerosis | Downcase Mesh Term | multiple sclerosis, chronic progressive | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | demyelinating autoimmune diseases, cns | Downcase Mesh Term | autoimmune diseases of the nervous system | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | demyelinating diseases | Downcase Mesh Term | autoimmune diseases | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48298234 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Brainstorm-Cell Therapeutics |
Overall Officials
Sequence: | 29272860 |
Role | Principal Investigator |
Name | Jeffrey Cohen, MD |
Affiliation | The Cleveland Clinic |
Design Group Interventions
Sequence: | 68119632 |
Design Group Id | 55568475 |
Intervention Id | 52463579 |
Eligibilities
Sequence: | 30752363 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Males and females ages 18 to 65 years old, inclusive, at the Screening Visit. Exclusion Criteria: Prior stem cell therapy of any kind. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254175113 |
Number Of Facilities | 4 |
Number Of Nsae Subjects | 68 |
Number Of Sae Subjects | 2 |
Registered In Calendar Year | 2019 |
Actual Duration | 24 |
Were Results Reported | True |
Months To Report Results | 18 |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 9 |
Designs
Sequence: | 30498631 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Open label |
Drop Withdrawals
Sequence: | 28975619 |
Result Group Id | 56079294 |
Ctgov Group Code | FG000 |
Period | Overall Study |
Reason | Adverse Event |
Count | 2 |
Milestones
Sequence: | 40992027 | Sequence: | 40992028 | Sequence: | 40992029 |
Result Group Id | 56079294 | Result Group Id | 56079294 | Result Group Id | 56079294 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG000 |
Title | STARTED | Title | COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study |
Description | 20 participants underwent bone marrow aspiration. In two participants, autologous bone marrow culture failed to meet specific MSC-NTF cell product release criteria and they did not receive treatment | Description | Of the 20 participants enrolled, 18 were treated, 17 received all three treatments and one received two treatments. | ||
Count | 20 | Count | 18 | Count | 2 |
Count Units | 54 | Count Units | 53 | Count Units | 1 |
Participant Flows
Sequence: | 3920078 |
Pre Assignment Details | Not meeting inclusion exclusion criteria |
Units Analyzed | Treatments |
Outcome Counts
Sequence: | 73972415 | Sequence: | 73972416 | Sequence: | 73972417 | Sequence: | 73972418 | Sequence: | 73972419 | Sequence: | 73972420 | Sequence: | 73972421 | Sequence: | 73972422 | Sequence: | 73972423 | Sequence: | 73972424 |
Outcome Id | 30793057 | Outcome Id | 30793058 | Outcome Id | 30793059 | Outcome Id | 30793060 | Outcome Id | 30793061 | Outcome Id | 30793062 | Outcome Id | 30793063 | Outcome Id | 30793064 | Outcome Id | 30793065 | Outcome Id | 30793066 |
Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 18 | Count | 18 | Count | 18 | Count | 18 | Count | 10 | Count | 18 | Count | 18 | Count | 18 | Count | 17 | Count | 17 |
Provided Documents
Sequence: | 2577770 | Sequence: | 2577771 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2019-06-01 | Document Date | 2019-04-12 |
Url | https://ClinicalTrials.gov/ProvidedDocs/18/NCT03799718/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/18/NCT03799718/SAP_001.pdf |
Reported Event Totals
Sequence: | 27934087 | Sequence: | 27934088 | Sequence: | 27934089 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 2 | Subjects Affected | 18 | Subjects Affected | 0 |
Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 |
Created At | 2023-08-08 21:34:52.883141 | Created At | 2023-08-08 21:34:52.883141 | Created At | 2023-08-08 21:34:52.883141 |
Updated At | 2023-08-08 21:34:52.883141 | Updated At | 2023-08-08 21:34:52.883141 | Updated At | 2023-08-08 21:34:52.883141 |
Reported Events
Sequence: | 528025622 | Sequence: | 528025623 | Sequence: | 528025624 | Sequence: | 528025625 | Sequence: | 528025626 | Sequence: | 528025627 | Sequence: | 528025628 | Sequence: | 528025629 | Sequence: | 528025630 | Sequence: | 528025631 | Sequence: | 528025632 | Sequence: | 528025633 | Sequence: | 528025634 |
Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 | Result Group Id | 56079296 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks | Time Frame | 28 weeks |
Event Type | serious | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other |
Subjects Affected | 2 | Subjects Affected | 16 | Subjects Affected | 15 | Subjects Affected | 6 | Subjects Affected | 5 | Subjects Affected | 4 | Subjects Affected | 4 | Subjects Affected | 3 | Subjects Affected | 3 | Subjects Affected | 3 | Subjects Affected | 3 | Subjects Affected | 3 | Subjects Affected | 3 |
Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 |
Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) | Description | Adverse Events (AE) were collected over a period of 38 weeks from the time of informed consent at the screening visit through the last study visit (Visit 7 or an Early Termination visit) Treatment Emergent Adverse Events (TEAE) were collected over a period of 28 weeks from the time of the first treatment through the last study visit (Visit 7 or an Early Termination visit) |
Event Count | 2 | Event Count | 35 | Event Count | 29 | Event Count | 8 | Event Count | 5 | Event Count | 4 | Event Count | 5 | Event Count | 3 | Event Count | 4 | Event Count | 3 | Event Count | 4 | Event Count | 3 | Event Count | 4 |
Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Infections and infestations | Organ System | Musculoskeletal and connective tissue disorders | Organ System | General disorders | Organ System | General disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Injury, poisoning and procedural complications | Organ System | General disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders |
Adverse Event Term | Arachnoiditis | Adverse Event Term | Headache | Adverse Event Term | Back pain | Adverse Event Term | Urinary tract infection | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Injection site pain | Adverse Event Term | Pyrexia | Adverse Event Term | Arthralgia | Adverse Event Term | Fall | Adverse Event Term | Fatigue | Adverse Event Term | Muscular weakness | Adverse Event Term | Musculoskeletal stiffness | Adverse Event Term | Pain in extremity |
Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 |
Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment |
Responsible Parties
Sequence: | 28864905 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3850822 |
Pi Employee | No |
Restriction Type | GT60 |
Result Contacts
Sequence: | 3850787 |
Organization | Brainstorm Cell therapeutics |
Name | Ralph Kern, MD, Chief Medical Officer |
Phone | 201-488-0460 |
rkern@brainstorm-cell.com | |
Outcomes
Sequence: | 30793057 | Sequence: | 30793058 | Sequence: | 30793059 | Sequence: | 30793060 | Sequence: | 30793061 | Sequence: | 30793062 | Sequence: | 30793063 | Sequence: | 30793064 | Sequence: | 30793065 | Sequence: | 30793066 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Number of Participants With Treatment-emergent Adverse Events | Title | Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) | Title | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed | Title | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT | Title | Number of Participants Who Had >5.5 in Expanded Disability Status Scale (EDSS) at Baseline, With ≥0.5 Points Improvement From Baseline to Week 28 | Title | Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) | Title | Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level | Title | Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score | Title | Change in Concentration of Vascular Endothelial Growth Factor (VEGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following First NurOwn® Treatment | Title | Change in Concentration of Hepatocyte Growth Factor (HGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following NurOwn® Treatment |
Description | Combined safety of all 3 intrathecal doses of NurOwn® (MSC-NTF cells) Number of participants who experienced Treatment-emergent Adverse Events during the study.
Treatment-emergent Adverse Event is an adverse event that occurs for the first time after initiation of first treatment or if it had occurred prior to initiation first treatment, it worsens in severity after initiation of first treatment. |
Description | 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT).
The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes. The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded. Higher values represent worse outcomes. |
Description | ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk.
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes |
Description | The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses.
The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome. |
Description | Expanded Disability Status Scale (EDSS) provides a total score on a scale that ranges from 0 (no disability) through 1 to 10 (death due to MS), in 0.5-point steps. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the sequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The higher score represents the worse outcome. | Description | The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks.
It contains 12 questions that assess the impact of MS on different aspects of walking function and quality. Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome. |
Description | The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels.
The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome. |
Description | Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed.
It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome. |
Description | Change from baseline (pre-first treatment) in the concentration of Vascular endothelial growth factor (VEGF) neuroprotective biomarker in the Cerebrospinal fluid (CSF) at 16 weeks following first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome | Description | Change from baseline in the concentration of Hepatocyte growth factor (HGF) neuroprotective biomarker in the Cerebrospinal Fluid (CSF) at 16 weeks following the first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome |
Time Frame | Up to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 28 weeks post-first treatment | Time Frame | From Baseline (pre-first treatment) to 16 weeks post first treatment | Time Frame | From Baseline (pre-first treatment) to 16 weeks post first treatment |
Population | The primary, secondary, and exploratory efficacy endpoints were analyzed using the modified intent to treat (mITT) and Efficacy Evaluable (EE) populations The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3 | Population | The modified intent to treat (mITT) population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3 | Population | mITT population | Population | The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3. | Population | The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline.
Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3. The participants in mITT population whose EDSS Score was >5.5 at Baseline was analyzed. |
Population | The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3 | Population | The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3 | Population | The mITT population was defined in this study as all participants who received at least 1 treatment and had at least 1 T25FW or 9-HPT assessment post baseline. Baseline was defined as the most recent assessment prior to receiving the first transplantation on Day 0, at Visit 3. | Population | mITT Population with data available at week 16 | Population | mITT population with data available at week 16 |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Picograms per milliliter | Units | picograms per milliliter |
Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | ||||||||||||||||
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Geometric Mean | Param Type | Geometric Mean |
Outcome Measurements
Sequence: | 235564904 | Sequence: | 235564905 | Sequence: | 235564906 | Sequence: | 235564907 | Sequence: | 235564908 | Sequence: | 235564909 | Sequence: | 235564910 | Sequence: | 235564911 | Sequence: | 235564912 | Sequence: | 235564913 | Sequence: | 235564914 | Sequence: | 235564915 | Sequence: | 235564916 | Sequence: | 235564917 | Sequence: | 235564918 | Sequence: | 235564919 | Sequence: | 235564920 | Sequence: | 235564921 | Sequence: | 235564922 | Sequence: | 235564923 | Sequence: | 235564924 | Sequence: | 235564925 | Sequence: | 235564926 |
Outcome Id | 30793057 | Outcome Id | 30793058 | Outcome Id | 30793058 | Outcome Id | 30793058 | Outcome Id | 30793059 | Outcome Id | 30793059 | Outcome Id | 30793059 | Outcome Id | 30793060 | Outcome Id | 30793060 | Outcome Id | 30793060 | Outcome Id | 30793061 | Outcome Id | 30793061 | Outcome Id | 30793062 | Outcome Id | 30793062 | Outcome Id | 30793062 | Outcome Id | 30793063 | Outcome Id | 30793063 | Outcome Id | 30793063 | Outcome Id | 30793064 | Outcome Id | 30793064 | Outcome Id | 30793064 | Outcome Id | 30793065 | Outcome Id | 30793066 |
Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 | Result Group Id | 56079295 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Category | Number of Participants with 25% or greater improvement from Baseline inT25FW speed or 9-HPT | Category | Number of Participants with <25% improvement from Baseline inT25FW speed or 9-HPT | Category | Number of Participants with missing data at week 28 | Category | Number of participants with 25% or more improvement | Category | Number of participants without 25% or more improvement | Category | Number of participants with missing values at week 28 | Category | Number of Participants with 25% or greater improvement from Baseline to Week 28 in 9-HPT | Category | Number of Participants with less than 25% improvement from Baseline to Week 28 in 9-HPT | Category | Number of participants with missing values at week 28 | Category | No of Participants with >5.5 in EDSS at Baseline with ≥0.5 Points Improvement from Baseline to Wk 28 | Category | No of Participants with >5.5 in EDSS at Baseline with <0.5 Points Improvement from Baseline to Wk 28 | Category | Number of Participants with ≥10 Points Improvement from Baseline to Week 28 in MSWS-12 | Category | Number of Participants with <10 Points Improvement from Baseline to Week 28 in MSWS-12 | Category | Number of Participants with missing data at week 28 | Category | No. of participants with ≥8 Letter improvement at Week 28 in LCLA Binocular 2.5% Contrast Level | Category | No. of Participants with <8 Letter Improvement at week 28 in LCLA Binocular 2.5% Contrast Level | Category | Number of Participants with missing data at week 28 | Category | Number of Participants with ≥ 3 points Improvement from Baseline to Week 28 in SDMT Score | Category | Number of Participants with < 3 points Improvement from Baseline to Week 28 in SDMT Score | Category | Number of Participants with missing data at week 28 | ||||||
Title | Number of Participants With Treatment-emergent Adverse Events | Title | Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) | Title | Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) | Title | Number of Participants With 25% or Greater Improvement From Baseline in Time 25 Foot Walk (T25FW) Speed or Nine-Hole Peg Test (9-HPT) | Title | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed | Title | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed | Title | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in Timed 25 Foot Walk (T25FW) Speed | Title | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT | Title | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT | Title | Number of Participants With 25% or Greater Improvement From Baseline to Week 28 in 9-HPT | Title | Number of Participants Who Had >5.5 in Expanded Disability Status Scale (EDSS) at Baseline, With ≥0.5 Points Improvement From Baseline to Week 28 | Title | Number of Participants Who Had >5.5 in Expanded Disability Status Scale (EDSS) at Baseline, With ≥0.5 Points Improvement From Baseline to Week 28 | Title | Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) | Title | Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) | Title | Number of Participants With ≥10 Points Improvement From Baseline to Week 28 in Multiple Sclerosis Walking Scale (MSWS-12) | Title | Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level | Title | Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level | Title | Number of Participants With ≥8 Letter Improvement From Baseline to Week 28 in LCLA Binocular 2.5% Contrast Level | Title | Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score | Title | Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score | Title | Number of Participants With ≥ 3 Points Improvement From Baseline to Week 28 in Symbol Digit Modalities Test (SDMT) Score | Title | Change in Concentration of Vascular Endothelial Growth Factor (VEGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following First NurOwn® Treatment | Title | Change in Concentration of Hepatocyte Growth Factor (HGF) Neuroprotective Biomarker From Baseline in the Cerebrospinal Fluid (CSF) 16 Weeks Following NurOwn® Treatment |
Description | Combined safety of all 3 intrathecal doses of NurOwn® (MSC-NTF cells) Number of participants who experienced Treatment-emergent Adverse Events during the study.
Treatment-emergent Adverse Event is an adverse event that occurs for the first time after initiation of first treatment or if it had occurred prior to initiation first treatment, it worsens in severity after initiation of first treatment. |
Description | 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT).
The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes. The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded. Higher values represent worse outcomes. |
Description | 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT).
The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes. The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded. Higher values represent worse outcomes. |
Description | 25% or greater improvement at 28 weeks from Baseline in Time 25 Foot Walk (T25FW) speed or 9 Hole Peg Test (9-HPT).
The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. T25FW is the average of the two successive trials. Higher values represent better outcomes. The 9HPT is used to measure upper extremity function in patients with various neurological diagnoses. The participant is asked to pick up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded. Higher values represent worse outcomes. |
Description | ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk.
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes |
Description | ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk.
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes |
Description | ≥25% improvement in T25FW speed over 28 weeks The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk.
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes |
Description | The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses.
The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome. |
Description | The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses.
The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome. |
Description | The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses.
The participant is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the participant picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. The higher values represent a worse outcome. |
Description | Expanded Disability Status Scale (EDSS) provides a total score on a scale that ranges from 0 (no disability) through 1 to 10 (death due to MS), in 0.5-point steps. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the sequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The higher score represents the worse outcome. | Description | Expanded Disability Status Scale (EDSS) provides a total score on a scale that ranges from 0 (no disability) through 1 to 10 (death due to MS), in 0.5-point steps. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the sequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The higher score represents the worse outcome. | Description | The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks.
It contains 12 questions that assess the impact of MS on different aspects of walking function and quality. Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome. |
Description | The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks.
It contains 12 questions that assess the impact of MS on different aspects of walking function and quality. Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome. |
Description | The Multiple Sclerosis Walking Scale (MSWS)-12 is a patient-reported outcome measure of the walking limitations due to MS during the past 2 weeks.
It contains 12 questions that assess the impact of MS on different aspects of walking function and quality. Total administration time should be approximately 5 minutes. Activities are rated by participant from min. 1 (not at all) to max. 5 (extremely) and summed to calculate a total score using a scale from 0 to 60 (ranging from low to high impact on walking). This score is then divided by 60 and multiplied by 100 to get a score between 0 and 100 A higher score represents a worse outcome. |
Description | The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels.
The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome. |
Description | The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels.
The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome. |
Description | The Low contrast letter acuity (LCLA) is a leading outcome measure to assess visual disability in multiple sclerosis (MS) research Total administration time, for a typical MS patient, is approximately 10-15 minutes to complete, when testing each eye individually and binocular vision for two different contrast levels.
The score for each chart is quantified as the number of letters identified correctly with a minimum scrore of 0 letter and a maximum score of 70 letters. The higher score represents the better outcome. |
Description | Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed.
It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome. |
Description | Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed.
It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome. |
Description | Symbol Digit Modalities test (SDMT) is a commonly used test to assess psychomotor speed, which measures processing speed as well as motor speed.
It is a paper-pencil measure which requires an individual to substitute digits for abstract symbols using a reference key Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110) Minimum score is 0 and maximum score 110. The higher score represents the better outcome. |
Description | Change from baseline (pre-first treatment) in the concentration of Vascular endothelial growth factor (VEGF) neuroprotective biomarker in the Cerebrospinal fluid (CSF) at 16 weeks following first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome | Description | Change from baseline in the concentration of Hepatocyte growth factor (HGF) neuroprotective biomarker in the Cerebrospinal Fluid (CSF) at 16 weeks following the first NurOwn® treatment The concentration of the biomarker is measured as Picogram per milliliter (pg/ml). A higher concentration of neuroprotective biomarkers suggests a better outcome |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Picograms per milliliter | Units | picograms per milliliter |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Geometric Mean | Param Type | Geometric Mean |
Param Value | 18 | Param Value | 3 | Param Value | 13 | Param Value | 2 | Param Value | 2 | Param Value | 12 | Param Value | 4 | Param Value | 2 | Param Value | 13 | Param Value | 3 | Param Value | 3 | Param Value | 7 | Param Value | 6 | Param Value | 10 | Param Value | 2 | Param Value | 4 | Param Value | 11 | Param Value | 3 | Param Value | 10 | Param Value | 5 | Param Value | 3 | Param Value | 90.17 | Param Value | 15.16 |
Param Value Num | 18.0 | Param Value Num | 3.0 | Param Value Num | 13.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 12.0 | Param Value Num | 4.0 | Param Value Num | 2.0 | Param Value Num | 13.0 | Param Value Num | 3.0 | Param Value Num | 3.0 | Param Value Num | 7.0 | Param Value Num | 6.0 | Param Value Num | 10.0 | Param Value Num | 2.0 | Param Value Num | 4.0 | Param Value Num | 11.0 | Param Value Num | 3.0 | Param Value Num | 10.0 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 90.17 | Param Value Num | 15.16 |
Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | ||||||||||||||||||||||||||||||||||||||||||
Dispersion Lower Limit | -9.16 | Dispersion Lower Limit | 0.2 | ||||||||||||||||||||||||||||||||||||||||||
Dispersion Upper Limit | 124.8 | Dispersion Upper Limit | 19.44 | ||||||||||||||||||||||||||||||||||||||||||
Baseline Counts
Sequence: | 11379734 |
Result Group Id | 56079293 |
Ctgov Group Code | BG000 |
Units | Participants |
Scope | overall |
Count | 18 |
Result Groups
Sequence: | 56079293 | Sequence: | 56079294 | Sequence: | 56079295 | Sequence: | 56079296 |
Ctgov Group Code | BG000 | Ctgov Group Code | FG000 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 |
Result Type | Baseline | Result Type | Participant Flow | Result Type | Outcome | Result Type | Reported Event |
Title | NurOwn (MSC-NTF Cells) | Title | NurOwn (MSC-NTF Cells) | Title | NurOwn (MSC-NTF Cells) | Title | NurOwn (MSC-NTF Cells) |
Description | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
Description | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors NurOwn (MSC-NTF cells). Study drug was supplied in one 5 mL syringe containing 4 mL of NurOwn (MSC-NTF cells) suspension at a dose of 100-125 x106 cells for IT administration. 3 doses of NurOwn (MSC-NTF cells) were transplanted intrathecally at 8-week intervals (Day 0-1, week 8, and week 16) | Description | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
Description | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
NurOwn (MSC-NTF cells): Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
Baseline Measurements
Sequence: | 125540031 | Sequence: | 125540032 | Sequence: | 125540033 | Sequence: | 125540034 | Sequence: | 125540035 | Sequence: | 125540036 | Sequence: | 125540037 | Sequence: | 125540038 | Sequence: | 125540039 | Sequence: | 125540040 | Sequence: | 125540041 | Sequence: | 125540042 | Sequence: | 125540043 | Sequence: | 125540044 | Sequence: | 125540045 | Sequence: | 125540046 |
Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 | Result Group Id | 56079293 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 |
Classification | United States | ||||||||||||||||||||||||||||||
Category | Female | Category | Male | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Unknown or Not Reported | Category | American Indian or Alaska Native | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | White | Category | More than one race | Category | Unknown or Not Reported | ||||||||
Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Region of Enrollment | Title | Timed 25-foot walk speed | Title | Nine-Hole Peg Test (9HPT) |
Description | The T25FW is a quantitative mobility and leg function performance test based on a timed 25-feet walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Baseline T25FW is the average of the two successive trials. Higher values represent better outcomes | Description | The Nine-Hole Peg Test (9HPT) is used to measure upper extremity function in patients with various neurological diagnoses The participant is seated at a table with a container holding nine pegs and a block with 9 empty holes. On a start command, the participant picks up the nine pegs, puts them in the nine holes, and, once completed, removes them again as quickly as possible, replacing them into the container. The total time to complete the task is recorded.
Baseline 9HPT is the average of 2 trials of dominant hand and nondominant hand. Higher values represent a worse outcome. |
||||||||||||||||||||||||||||
Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Feet/seconds | Units | Seconds |
Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean |
Param Value | 47.4 | Param Value | 10 | Param Value | 8 | Param Value | 0 | Param Value | 18 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 2 | Param Value | 15 | Param Value | 0 | Param Value | 0 | Param Value | 18 | Param Value | 2.4 | Param Value | 35.2 |
Param Value Num | 47.4 | Param Value Num | 10.0 | Param Value Num | 8.0 | Param Value Num | 0.0 | Param Value Num | 18.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 15.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 18.0 | Param Value Num | 2.4 | Param Value Num | 35.2 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||
Dispersion Value | 9.6 | Dispersion Value | 1.6 | Dispersion Value | 15.7 | ||||||||||||||||||||||||||
Dispersion Value Num | 9.6 | Dispersion Value Num | 1.6 | Dispersion Value Num | 15.7 | ||||||||||||||||||||||||||
Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 | Number Analyzed | 18 |
]]>
https://zephyrnet.com/NCT03799705
2019-12-01
https://zephyrnet.com/?p=NCT03799705
NCT03799705https://www.clinicaltrials.gov/study/NCT03799705?tab=tableNANANAResearchers are trying to identify versions of genes as well as factors in subjects blood associated with certain types of congenital malformations(CMs). This study will help the researchers to better understand family traits that contribute to CMs.
<![CDATA[
Studies
Study First Submitted Date | 2018-08-29 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-01-12 |
Start Month Year | December 1, 2019 |
Primary Completion Month Year | December 29, 2022 |
Verification Month Year | January 2023 |
Verification Date | 2023-01-31 |
Last Update Posted Date | 2023-01-12 |
Facilities
Sequence: | 200307683 |
Name | Mayo Clinic |
City | Rochester |
State | Minnesota |
Zip | 55905 |
Country | United States |
Conditions
Sequence: | 52232513 | Sequence: | 52232514 |
Name | Vacterl Association | Name | Congenital Malformation |
Downcase Name | vacterl association | Downcase Name | congenital malformation |
Id Information
Sequence: | 40203470 |
Id Source | org_study_id |
Id Value | 18-001135 |
Countries
Sequence: | 42617551 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55662294 |
Title | History of VACTERL or congenital malformations |
Description | 1) Adults with VACTERL association; 2) adults with a history of congenital malformations resembling VACTERL association; 3) gravid and non-gravid women with a history of recurrent miscarriage, their surviving offspring, and the biological father of offspring; 4) newly diagnosed VACTERL patients identified by healthcare providers. |
Design Outcomes
Sequence: | 177602129 | Sequence: | 177602130 |
Outcome Type | primary | Outcome Type | primary |
Measure | Genetic variants | Measure | Targeted metabolomics |
Time Frame | 2 years | Time Frame | 2 years |
Description | Identification of genetic variants which may be associated with VACTERL association or other congenital malformations. | Description | Identification of changes in metabolic pathways which may provide functional insight into the presence of genetic variants in patients with VACTERL association |
Browse Conditions
Sequence: | 193720423 |
Mesh Term | Congenital Abnormalities |
Downcase Mesh Term | congenital abnormalities |
Mesh Type | mesh-list |
Sponsors
Sequence: | 48376931 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mayo Clinic |
Overall Officials
Sequence: | 29318892 |
Role | Principal Investigator |
Name | Myra Wick, MD PhD |
Affiliation | Mayo Clinic |
Eligibilities
Sequence: | 30801282 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 0 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | A US population consisting of adults with VACTERL, adults and offspring with a family history of VACTERL, and women with a history of miscarriage and/or congenital malformations. |
Criteria | Inclusion Criteria:
Adults with confirmed or putative diagnosis of VACTERL association; Exclusion Criteria: 1) Parents of non-biological children 3) Children with congenital malformations associated with an identifiable environmental or lifestyle exposure 4) Children with congenital malformations associated with confirmed chromosomal disorders 5) Failure to abstain from red meat, meat products, chicken, peanuts, or brewer's yeast (including beer) at least 24 hours prior to blood and urine collection. |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254016371 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 37 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 0 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Designs
Sequence: | 30547302 |
Observational Model | Family-Based |
Time Perspective | Other |
Links
Sequence: | 4392923 |
Url | https://www.mayo.edu/research/clinical-trials |
Description | Mayo Clinic Clinical Trials |
Responsible Parties
Sequence: | 28913638 |
Responsible Party Type | Principal Investigator |
Name | Myra J. Wick |
Title | Principal Investigator |
Affiliation | Mayo Clinic |
]]>
https://zephyrnet.com/NCT03799692
2018-11-19
https://zephyrnet.com/?p=NCT03799692
NCT03799692https://www.clinicaltrials.gov/study/NCT03799692?tab=tableYin Liuliuyinfudan@163.com13818051895This is an open-label, single arm, two-stage Simon Design study for women with LuminalB/HER-2 Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin.
The primary objective of the trial is to evaluate of the efficacy and safety of Nanoparticle Albumin-Bound Paclitaxel Combined with Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 Negative Breast Cancer.
The primary endpoint of the study is to assess Pathological complete response rate(pCR)using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
The total number of patients to be included in this study is 78 patients.
The duration of the study, from first patient visit to last patient visit will be approximately 12 months.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | November 19, 2018 |
Primary Completion Month Year | March 30, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Facilities
Sequence: | 200107904 | Sequence: | 200107905 |
Status | Recruiting | Status | Recruiting |
Name | Fudan University Shanghai Cancer Center | Name | Department of Breast Surgery, Cancer Hospital, Fudan University |
City | Shanghai | City | Shanghai |
State | Shanghai | ||
Zip | 200032 | Zip | 200032 |
Country | China | Country | China |
Facility Contacts
Sequence: | 28106390 | Sequence: | 28106391 |
Facility Id | 200107904 | Facility Id | 200107905 |
Contact Type | primary | Contact Type | primary |
Name | Zhi-Min Shao, MD.PhD. | Name | Zhimin Shao |
zhimingshao@yahoo.com | zhimingshao@yahoo.com | ||
Phone | 13601637369 | Phone | 86(21)64175590 |
Phone Extension | 88807 |
Facility Investigators
Sequence: | 18332487 | Sequence: | 18332488 |
Facility Id | 200107904 | Facility Id | 200107905 |
Role | Principal Investigator | Role | Principal Investigator |
Name | Zhi-Min Shao, MD.PhD. | Name | Zhimin Shao |
Conditions
Sequence: | 52171119 |
Name | HER-2 Negative Breast Cancer |
Downcase Name | her-2 negative breast cancer |
Id Information
Sequence: | 40158561 |
Id Source | org_study_id |
Id Value | 1808189-8 |
Countries
Sequence: | 42568865 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55593069 |
Group Type | Experimental |
Title | Chemotherapy |
Description | Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, Carboplatin AUC=2, iv, d1, 8, 15, 4 cycles (21 days per cycle). |
Interventions
Sequence: | 52485368 |
Intervention Type | Drug |
Name | Chemotherapy |
Description | Drug: Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1, 8, 15.
Drug: Carboplatin AUC=2 iv, d1, 8, 15. |
Keywords
Sequence: | 79868364 |
Name | Neoadjuvant Chemotherapy |
Downcase Name | neoadjuvant chemotherapy |
Design Outcomes
Sequence: | 177378485 | Sequence: | 177378486 | Sequence: | 177378487 | Sequence: | 177378488 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The primary endpoint is pathological complete remission (pCR) | Measure | Objective response rate (ORR) | Measure | Breast conserving surgery (BCS) rate | Measure | Adverse events (AE) |
Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months |
Description | Histopathological examination of breast and axillary lymph node specimens without invasive cancer cell remnants. Complete pathological response is also considered to be achieved if only in situ cancer cell remnants are present in the surgical specimens. | Description | The second endpoint ORR composed of tumor response classifications of complete response (CR) and partial response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases. | Description | Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy as a whole evaluable. | Description | Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly. |
Browse Conditions
Sequence: | 193486256 | Sequence: | 193486257 | Sequence: | 193486258 | Sequence: | 193486259 | Sequence: | 193486260 |
Mesh Term | Breast Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Breast Diseases | Mesh Term | Skin Diseases |
Downcase Mesh Term | breast neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | breast diseases | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319195 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Fudan University |
Overall Officials
Sequence: | 29285300 |
Role | Principal Investigator |
Name | Zhimin Shao |
Affiliation | Fudan University |
Central Contacts
Sequence: | 12008851 | Sequence: | 12008852 |
Contact Type | primary | Contact Type | backup |
Name | Zhimin Shao | Name | Yin Liu |
Phone | 18017312288 | Phone | 13818051895 |
szm@163.com | liuyinfudan@163.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68148999 |
Design Group Id | 55593069 |
Intervention Id | 52485368 |
Eligibilities
Sequence: | 30765288 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
1.Age: from 18 to 70 years old, female. Exclusion Criteria: 1.Any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation therapy. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253878248 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30511455 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28877749 |
Responsible Party Type | Principal Investigator |
Name | Zhimin Shao |
Title | professor |
Affiliation | Fudan University |
]]>
https://zephyrnet.com/NCT03799679
2018-11-26
https://zephyrnet.com/?p=NCT03799679
NCT03799679https://www.clinicaltrials.gov/study/NCT03799679?tab=tableYin LiuNA13818051895This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin.
The primary objective of the trial is to evaluate of the efficacy and safety of weekly Nanoparticle Albumin-Bound Paclitaxel(Nab-P) Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer.
The primary endpoint of the study is to to assess Pathological complete response rate(pCR)using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)..
The total number of patients to be included in this study is 60 patients.
The duration of the study, from first patient visit to last patient visit will be approximately 19 months.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | November 26, 2018 |
Primary Completion Month Year | November 30, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Facilities
Sequence: | 200280207 |
Status | Recruiting |
Name | Cancer Hospital/ Institute, Fudan University |
City | Shanghai |
State | Shanghai |
Zip | 200032 |
Country | China |
Facility Contacts
Sequence: | 28132832 |
Facility Id | 200280207 |
Contact Type | primary |
Name | Zhimin Shao, M.D. |
zhimingshao@yahoo.com | |
Phone | 862164175590 |
Phone Extension | 8808 |
Browse Interventions
Sequence: | 96132746 |
Mesh Term | Antineoplastic Agents |
Downcase Mesh Term | antineoplastic agents |
Mesh Type | mesh-list |
Conditions
Sequence: | 52221385 |
Name | Triple Negative Breast Cancer |
Downcase Name | triple negative breast cancer |
Id Information
Sequence: | 40195538 |
Id Source | org_study_id |
Id Value | 1808189-7 |
Countries
Sequence: | 42609534 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55649654 |
Group Type | Experimental |
Title | Chemotherapy |
Description | Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1* 12 cycles ( weekly), followed by epirubicin 90mg/m2, iv, d1 + cyclophosphamide 600mg/m2, iv, d1 * 4 cycles (14 days per cycle) |
Interventions
Sequence: | 52535179 |
Intervention Type | Drug |
Name | Chemotherapeutic Agent |
Description | Drug: Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1. Patients will receive this as a single-agent for the first twelve weeks, then followed by epirubicin in combination with cyclophosphamide.
Drug: Epirubicin 90 mg/m² given IV Drug: Cyclophosphamide 600 mg/m² given IV |
Keywords
Sequence: | 79941581 |
Name | Neoadjuvant Chemotherapy |
Downcase Name | neoadjuvant chemotherapy |
Design Outcomes
Sequence: | 177560887 | Sequence: | 177560888 | Sequence: | 177560889 | Sequence: | 177560890 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The primary endpoint is pathological complete remission (pCR) | Measure | The second endpoint includes the objective response rate (ORR) | Measure | Breast conserving surgery(BCS) rate | Measure | Adverse events (AE) |
Time Frame | 2 months | Time Frame | 2 months | Time Frame | 2 months | Time Frame | 2 months |
Description | Histopathological examination of breast and axillary lymph node specimens without invasive cancer cell remnants. Complete pathological response is also considered to be achieved if only in situ cancer cell remnants are present in the surgical specimens. | Description | The second endpoint ORR composed of tumor response classifications of complete response (CR) and partial response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases. | Description | Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy as a whole evaluable. | Description | Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly. |
Browse Conditions
Sequence: | 193677956 | Sequence: | 193677957 | Sequence: | 193677958 | Sequence: | 193677959 | Sequence: | 193677960 | Sequence: | 193677961 |
Mesh Term | Breast Neoplasms | Mesh Term | Triple Negative Breast Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Breast Diseases | Mesh Term | Skin Diseases |
Downcase Mesh Term | breast neoplasms | Downcase Mesh Term | triple negative breast neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | breast diseases | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366296 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Fudan University |
Overall Officials
Sequence: | 29312849 |
Role | Principal Investigator |
Name | Zhimin Shao |
Affiliation | Fudan University |
Central Contacts
Sequence: | 12020554 | Sequence: | 12020555 |
Contact Type | primary | Contact Type | backup |
Name | Zhimin Shao | Name | Yin Liu |
Phone | 18017312288 | Phone | 13818051895 |
szm@163.com | |||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68217189 |
Design Group Id | 55649654 |
Intervention Id | 52535179 |
Eligibilities
Sequence: | 30794629 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age: from 18 to 70 years old, female. Exclusion Criteria: Any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation therapy. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004176 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30540669 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer. Patients will treated by Nanoparticle Albumin-Bound Paclitaxel Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide. |
Responsible Parties
Sequence: | 28906989 |
Responsible Party Type | Principal Investigator |
Name | Zhimin Shao |
Title | professor |
Affiliation | Fudan University |
]]>
https://zephyrnet.com/NCT03799666
2019-01-07
https://zephyrnet.com/?p=NCT03799666
NCT03799666https://www.clinicaltrials.gov/study/NCT03799666?tab=tableNANANA3R aims to increase the access of patients with chronic respiratory diseases (CRD) to pulmonary rehabilitation (PR) in Portugal. The main goals of 3R are: i) design and implement an innovative community-based PR programme; ii) assess the cost-benefit of the community-based PR programme; iii) disseminate and perform knowledge transfer about PR across the country.
PR is an evidence-based intervention for the management of CRD and offering PR has been defined as a priority by national/international organizations. However, in Portugal PR is practically inexistent (<1% of “candidate” patients have access). Currently, PR programmes are hospital-based and directed to patients with advanced disease. One of the recommendations to enhance the implementation of PR is the development on novel models of programme delivery. It is hypothesised that community-based programs, direct to patients at all grades of the disease, and involving all stakeholders (health professionals, patients, society, policy makers) may turn PR more accessible.
The plan is to implement community-based PR programs in 4 primary care centres of 2 ACES of the centre region of Portugal and assess the impact of such intervention in several domains using surrogate and patient-/family-centered outcomes. A cost-benefit analysis will be performed on acute exacerbations and healthcare utilization. Dissemination will include one conference, activities with the community, courses and an online PR toolkit. Four schools of 2 polytechnics, 2 city councils, the Health Regional Administration-Centre (ARS-Centro) and all respiratory professional and civic national associations are partners.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-14 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-07-08 |
Start Month Year | January 7, 2019 |
Primary Completion Month Year | December 30, 2019 |
Verification Month Year | July 2020 |
Verification Date | 2020-07-31 |
Last Update Posted Date | 2020-07-08 |
Detailed Descriptions
Sequence: | 20709994 |
Description | More than 1 billion people suffer from chronic respiratory diseases worldwide and, in Europe, the total annual cost of respiratory diseases amounts to more than €380 billion. In Portugal, respiratory diseases are the 3rd leading cause of death and direct costs related to hospitalizations (in 2013 – €213 millions). Management of chronic respiratory diseases are high priorities for the National Health Service, and particularly, for the Center Health Regional Administration.
Pulmonary rehabilitation (PR) is an evidence-based intervention for the management of patients with chronic respiratory diseases (grade A). Offering PR has long been defined as a priority by several national and international organizations. Despite this firm recommendation and the knowhow on the provision of PR, in Portugal, PR is practically inexistent, with <1% of "candidate" patients having access to this standard care. Therefore, the need for a National Network on PR has been acknowledged as a priority. It is hypothesised that community-based programmes, direct to patients at all grades of the disease, and involving all stakeholders (health professionals, patients/family, society, policy makers) may turn PR more accessible. Thus, the main goal of this project is to increase the access of patients with chronic respiratory diseases, namely COPD, to PR in the center region of Portugal and disseminate this intervention nationally. 3R aims to implement and disseminate community-based PR programs in Portugal. Specifically, it will: Implement 4 community-based PR programmes (Task 1); To bring PR from bench to Portuguese common practice, 3R brings together a strong consortium composed of 4 schools of 2 Polytechnic Institutions, 2 City Councils, Health Regional Administration – Centre and all respiratory national associations (Sociedade, Portuguesa do Pulmão – SPP, RESPIRA and Fundação Portuguesa do Pulmão – FPP). This consortium involves an experienced team with complementary backgrounds and integrates students from the several institutions during all activities. It is strongly believed that jointly this multidisciplinary team has the experience and complementary skills, as well as the means, to guarantee the success and outreach of the project. It is estimated that 73 patients will be required to detect significant differences in patients' health-related quality of life (HRQOL), based on a previous study. Stable patients with CRD and their family members will be recruited from Primary Care Centres (PCCs) of the ACES of Baixo Vouga and Baixo Mondego (ACES-BV & BM). Family doctors from PCCs will provide a list of eligible individuals. Individuals/families will be contacted and those interested will meet with researchers to receive further information about the study and sign the informed consents. Participants will be divided in two groups: experimental (EG) and control (CG). The EG will include participants/families wanting to participate in a 12-week community-based PR programme and the CG will include those willing to collaborate in data collection but not in the PR programmes (Task 1). The PR programme will include exercise training (endurance, strength and balance training) twice a week and psychoeducational sessions every two weeks performed by a multidisciplinary team. Data will be collected at baseline, at 12 weeks (i.e., immediately post-PR), 3 and 6 months post-PR. Data analysis will be undertaken using Statistical Package for the Social Sciences (SPSS) software and will include descriptive and inferential statistics. To analyse changes in outcome measures, data from baseline and after treatment assessments will be compared. Moreover, between groups comparisons will also be performed for baseline, after intervention and follow-ups assessments. Effect sizes for the interventions will also be calculated. |
Facilities
Sequence: | 199965088 |
Name | University of Aveiro |
City | Aveiro |
Zip | 3810-193 |
Country | Portugal |
Conditions
Sequence: | 52139020 |
Name | Chronic Respiratory Disease |
Downcase Name | chronic respiratory disease |
Id Information
Sequence: | 40135076 |
Id Source | org_study_id |
Id Value | SAICT-POL/23926/2016 |
Countries
Sequence: | 42542700 |
Name | Portugal |
Removed | False |
Design Groups
Sequence: | 55559374 | Sequence: | 55559375 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Pulmonary Rehabilitation Group | Title | Standard Care Group |
Description | Patients will participate in a 12-week community-based pulmonary rehabilitation programme. | Description | Patients will continue to receive the standard care, which means the daily medication prescribed by the pshysician from the primary care centre team. |
Interventions
Sequence: | 52454925 | Sequence: | 52454926 |
Intervention Type | Other | Intervention Type | Other |
Name | Pulmonary Rehabilitation | Name | Daily medication |
Description | Patients will be treated with daily medication prescribed by the physician. Additionally patients will participate in a 12-w.eek community-based pulmonary rehabilitation programme, with two exercise training sessions per week and six psycho-education sessions, managed by a multidisciplinary team, once every two weeks. Patient's families will be invited to participate in the psychoeducational component | Description | Patients will be treated with daily medication prescribed by the physician and will continue to receive the standard care from the primary care centre team. |
Keywords
Sequence: | 79822843 | Sequence: | 79822844 | Sequence: | 79822845 | Sequence: | 79822846 |
Name | Pulmonary rehabilitation | Name | Community-based | Name | Chronic Respiratory Diseases | Name | Cost-benefit analysis |
Downcase Name | pulmonary rehabilitation | Downcase Name | community-based | Downcase Name | chronic respiratory diseases | Downcase Name | cost-benefit analysis |
Design Outcomes
Sequence: | 177263841 | Sequence: | 177263842 | Sequence: | 177263843 | Sequence: | 177263844 | Sequence: | 177263845 | Sequence: | 177263846 | Sequence: | 177263847 | Sequence: | 177263848 | Sequence: | 177263849 | Sequence: | 177263850 | Sequence: | 177263851 | Sequence: | 177263852 | Sequence: | 177263853 | Sequence: | 177263854 | Sequence: | 177263855 | Sequence: | 177263856 | Sequence: | 177263857 | Sequence: | 177263858 | Sequence: | 177263859 | Sequence: | 177263860 | Sequence: | 177263861 | Sequence: | 177263862 | Sequence: | 177263863 | Sequence: | 177263864 | Sequence: | 177263865 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other |
Measure | Change in Health Related quality-of-life: St. George Respiratory Questionnaire | Measure | Change in airflow obstruction | Measure | Change in exercise capacity | Measure | Change in functionality | Measure | Change in quadriceps muscle strength | Measure | Change in biceps muscle strength | Measure | Change in muscle cross sectional area | Measure | Change in upper limb muscle strength | Measure | Change in respiratory muscle strength | Measure | Change in frequency of exacerbations | Measure | Change in Healthcare utilization | Measure | Change in family adaptability/cohesion | Measure | Change in balance | Measure | Change in Physical activity | Measure | Change in Physical activity | Measure | Change in Diaphragm excursion | Measure | Change in Dyspnoea | Measure | Change in symptom's impact in patients life | Measure | Change in Emotional state | Measure | Change in Fatigue symptoms | Measure | Change in Fatigue | Measure | Change in cough-related quality of life: Leicester Cough Questionnaire | Measure | Change in cough and sputum symptoms | Measure | Digital Technology access | Measure | Change in Body Mass Index |
Time Frame | Up to 9 months | Time Frame | Up to 9 months | Time Frame | Up to 9 months | Time Frame | Up to 9 months | Time Frame | Up to 9 months | Time Frame | Up to 3 months | Time Frame | Up to 3 months | Time Frame | Up to 9 months | Time Frame | Up to 3 months | Time Frame | Up to 9 months | Time Frame | Up to 9 months | Time Frame | Up to 3 months | Time Frame | Up to 3 months | Time Frame | Up to 3 months | Time Frame | Up to 9 months | Time Frame | Up to 3 months | Time Frame | Up to 9 months | Time Frame | Up to 9 months | Time Frame | Up to 9 months | Time Frame | Up to 3 months | Time Frame | Up to 3 months | Time Frame | Up to 3 months | Time Frame | Up to 3 months | Time Frame | At baseline | Time Frame | Up to 9 months |
Description | St. George Respiratory Questionnaire (SGRQ) will be used to assess Health Related quality-of-life. The SGRQ is a comprehensive well-established 50-item questionnaire to measure health status in patients with chronic respiratory diseases. Scores can be provided for each domain and as a total score, ranging from 0 (no impairment) to 100 (worst possible health status). | Description | Forced expiratory volume in one second and forced vital capacity will be measured with a portable spirometer to assess the degree of airflow obstruction. Results will be expressed in liters and percentage of predicted. We will calculate the ratio between the forced expiratory volume in one second and the forced vital capacity. | Description | Exercise capacity will be tested in a 6-minute walk test, since it allows exercise prescription. The test results will be presented as the walked distance (meters). | Description | Functionality will be tested with the 1-minute sit-to-stand, with the results presented as number of sit-to-stand repetitions. | Description | Quadriceps muscle strength will be measured using a handheld dynamometer (kilogram/force). | Description | Biceps muscle strength will be measured using a handheld dynamometer (kilogram/force). | Description | Cross-sectional will be measured with ultrasound of the lower (quadriceps) and upper (biceps) limb muscles. | Description | Upper limb strength will be measured with Handgrip (kg) | Description | Respiratory muscle strength will be measured through a respiratory pressure meter to assess inspiratory and expiratory muscle strength (cm/H20) | Description | Number of exacerbations in the previous year, healthcare utilization, such as emergency department visits or hospital admissions, in the previous year, which are related to COPD decline | Description | Healthcare utilization will be assessed through the number of participants that visit emergency department and the number of visits of each participant in the previous year. The number and duration of hospital admissions in the previous year will also be assessed. | Description | Family function was assessed with the family adaptability and cohesion evaluation scale (FACES-IV). The FACES-IV is a 62 items subdivided in: cohesion and flexibility dimensions, and family communication and family satisfaction scales. The cohesion and flexibility dimensions provide six family scales, two balanced scales (Balanced cohesion and balanced flexibility, with percentile scores ranging from 16 to 85) and four unbalanced scales (Disengaged, Enmeshed, Rigid and Chaotic, with percentile scores ranging from 10 to 99). The six family types (Balanced, Rigidly Cohesive, Midrange, Flexibly unbalanced, chaotically unbalanced and unbalanced) can be plotted onto the Circumplex Model. The family communications and Satisfaction scales are composed of 10 items each, with percentile scores ranging from 10 to 99. In all FACES-IV subscales higher scores indicate better family cohesion, flexibility, communication or satisfaction. | Description | Balance will be assessed with the Brief-Best tests. | Description | Accelerometry will be used to assess physical activity. | Description | The Brief Physical Activity questionnaire will be used to assess physical activity. It a 2 items questionnaire, with scores ranging from 0 to 8. If the sum of the two items score is above or equal 4 the subject will be considered physically active. | Description | Ultrasound will be used to assess the diaphragm excursion, only volunteer from patients who agree to come to ESSUA and will be seen previously by a physician | Description | Medical Research Council scale will be used to assess functional dyspnoea related to respiratory impairment. It is a 5-point scale, rated from 0 to 4, with higher scores denoting greater breathlessness severity. | Description | COPD Assessment Test (CAT) will be used to assess burdensome symptoms in patients' life with 8 items (cough, sputum, dyspnoea, chest tightness, capacity of exercise and home daily activities, confidence leaving home, sleep and energy levels).he scores range from 0-40, organised in 4 categories, namely <10 low impact, 10-20 medium, 21-30 high and >30 very high impact, with 5 representing the upper limit of normal in healthy non-smokers | Description | Hospital Anxiety and Depression Scale will be used to assess symptoms of anxiety and depression. It is a 14 item questionnaire that can be subdivided in two subscales: anxiety and depression. Scores are provided for each subscale and range from 0 to 21, with higher scores meaning more symptoms of anxiety and depression. | Description | The fatigue subscale of the Checklist of Individual Strength (CIS-20) will be used to assess fatigue.The subscale of subjective fatigue is a 8-item questionnaire, with higher scores indicating higher levels of fatigue. The total scores range from 8 to 56. | Description | The Functional Assessment of Cancer Therapy – Fatigue subscale (FACIT-F) will be used to assess fatigue levels. It is multi-dimensional 13-item questionnaire assessing tiredness, weakness and difficulty in handling daily activities due to fatigue. Scores range from 0 to 52, with higher scores indicating less fatigue. | Description | Cough-related quality of life will be assessed with the Leicester Cough Questionnaire, which is a 19 items scale organised in 3 domains (physical, psychological and social). Each domain has a score ranging from 1 to 7 and the LCQ total score varies from 3 to 21. Higher scores express a better quality of life and less impact of cough. | Description | The Cough and Sputum Assessment Questionnaire (CASA-Q) will be used to assess cough and sputum symptoms, based on their reported frequency and severity, and their impact on daily activities. t is a 20-item questionnaire containing 4 domains: cough symptoms, cough impact, sputum symptoms and sputum impact. All items are rescored and summed, achieving a score ranging from 0 to 100 for each domain, with higher scores indicating fewer symptoms or less cough and sputum impact. | Description | A survey asking about the use of internet and access to computers, smartphones (combination of mobile phone, web browser and computer capabilities)/tablets and cell phones (simple devices mainly for voice calls and text messages) will be used to assess digital technology access. Confidence in using these technologies will be assessed using a numerical scale from 0 (not at all confident) to 10 (completely confident). | Description | Patients' body mass index will be assessed in kg/m^2 based on patients' height and weight. |
Browse Conditions
Sequence: | 193366592 | Sequence: | 193366593 |
Mesh Term | Respiratory Tract Diseases | Mesh Term | Respiration Disorders |
Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | respiration disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list |
Sponsors
Sequence: | 48290727 | Sequence: | 48290728 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Aveiro University | Name | Fundação para a Ciência e a Tecnologia |
Overall Officials
Sequence: | 29268537 |
Role | Principal Investigator |
Name | Alda S. Marques, PhD |
Affiliation | School of Health Sciences of the University of Aveiro (ESSUA) |
Design Group Interventions
Sequence: | 68107484 | Sequence: | 68107485 |
Design Group Id | 55559374 | Design Group Id | 55559375 |
Intervention Id | 52454925 | Intervention Id | 52454926 |
Eligibilities
Sequence: | 30747735 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
clinical diagnosis of a chronic respiratory disease Exclusion Criteria: cognitive impairments |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121947 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 11 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 23 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30494018 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28860298 |
Responsible Party Type | Principal Investigator |
Name | Alda Sofia Pires de Dias Marques |
Title | Senior Lecturer |
Affiliation | Aveiro University |
Study References
Sequence: | 52032743 | Sequence: | 52032744 | Sequence: | 52032745 |
Pmid | 34499161 | Pmid | 32184112 | Pmid | 31151409 |
Reference Type | derived | Reference Type | derived | Reference Type | derived |
Citation | Paixao C, Rebelo P, Oliveira A, Jacome C, Cruz J, Martins V, Simao P, Marques A. Responsiveness and Minimal Clinically Important Difference of the Brief-BESTest in People With COPD After Pulmonary Rehabilitation. Phys Ther. 2021 Nov 1;101(11):pzab209. doi: 10.1093/ptj/pzab209. | Citation | Rebelo P, Oliveira A, Andrade L, Valente C, Marques A. Minimal Clinically Important Differences for Patient-Reported Outcome Measures of Fatigue in Patients With COPD Following Pulmonary Rehabilitation. Chest. 2020 Aug;158(2):550-561. doi: 10.1016/j.chest.2020.02.045. Epub 2020 Mar 14. | Citation | Marques A, Jacome C, Rebelo P, Paixao C, Oliveira A, Cruz J, Freitas C, Rua M, Loureiro H, Peguinho C, Marques F, Simoes A, Santos M, Martins P, Andre A, De Francesco S, Martins V, Brooks D, Simao P. Improving access to community-based pulmonary rehabilitation: 3R protocol for real-world settings with cost-benefit analysis. BMC Public Health. 2019 May 31;19(1):676. doi: 10.1186/s12889-019-7045-1. |
]]>
https://zephyrnet.com/NCT03799653
2019-03-20
https://zephyrnet.com/?p=NCT03799653
NCT03799653https://www.clinicaltrials.gov/study/NCT03799653?tab=tableHaihua Zhu, MasterNA86592-2137278The Nurse Cohort Study Xiamen (NCSX) is an open-ended prospective cohort study with very broad research aims. The primary objectives of the NCSX is planned to examine genetic, epigenetic, biological, psychological, social, lifestyle and other environmental factors of nurses in relation to incidence and progression of the common chronic diseases, such as hypertension, ischemic heart disease, stroke, diabetes, chronic kidney disease and some cancers, which are emerging with economic development in Xiamen, China. Specifically, we intend to test whether empirically driven hypothesis and emerging risk factors mainly developed in response to observations in economically developed Western societies apply in a population living in a rapid changing lifestyle in China now.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-04-13 |
Start Month Year | March 20, 2019 |
Primary Completion Month Year | December 31, 2023 |
Verification Month Year | April 2022 |
Verification Date | 2022-04-30 |
Last Update Posted Date | 2022-04-13 |
Detailed Descriptions
Sequence: | 20695742 |
Description | Objectives: To establish a cohort of about 10,000 registered nurses (aged 20 or over) in Xiamen, China; to describe the baseline major risk factors; to analyze their interrelationships; and to examine the risks of incidence and progression of major chronic diseases, such as hypertension, stroke, CKD and cancers, and all-cause and cause-specific mortality by different levels of the risk factors after about 5 years follow-up.
Design: A prospective cohort study. Setting: 7 public hospitals in Xiamen, China. Participants: About 10,000 registered nurses (aged 20 or over) who work in public hospitals in Xiamen, China. Main outcome: Incidences of common chronic diseases, such as CVD, diabetes, chronic kidney disease, and cancers; progression of these diseases; all cause and specific-cause mortality. Hypothesis: Relative risks of major risk factors. Results of the study should have strong impact on prevention and control of these diseases and promoting nurses'health in the local population. |
Facilities
Sequence: | 199774612 |
Status | Recruiting |
Name | The First Affiliated Hospital of Xiamen University |
City | Xiamen |
State | Fujian |
Zip | 361003 |
Country | China |
Facility Contacts
Sequence: | 28074247 |
Facility Id | 199774612 |
Contact Type | primary |
Name | Zhibin Li, Ph.D. |
zhibinli33@hotmail.com | |
Phone | 86592-2137364 |
Conditions
Sequence: | 52101405 |
Name | Hypertension |
Downcase Name | hypertension |
Id Information
Sequence: | 40103879 |
Id Source | org_study_id |
Id Value | KYH2019-002 |
Countries
Sequence: | 42506278 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55517395 |
Title | Nurses |
Description | All subjects are registered nurses in Xiamen, China |
Interventions
Sequence: | 52415405 |
Intervention Type | Other |
Name | No intervention |
Description | This is a prospective observational study, and there is no intervention. |
Design Outcomes
Sequence: | 177137644 | Sequence: | 177137645 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Incidence rate | Measure | Mortality |
Time Frame | 2019.1.21-2024.12.31 | Time Frame | 2019.1.21-2024.12.31 |
Description | The incidence rates of common chronic diseases, such as hypertension, The stroke, CKD and cancers | Description | All-cause and cause-specific mortality |
Browse Conditions
Sequence: | 193212086 | Sequence: | 193212087 | Sequence: | 193212088 |
Mesh Term | Hypertension | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases |
Downcase Mesh Term | hypertension | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48255196 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | The First Affiliated Hospital of Xiamen University |
Overall Officials
Sequence: | 29245217 |
Role | Study Chair |
Name | Weihua Li, Ph.D. |
Affiliation | The First Affiliated Hospital of Xiamen University |
Central Contacts
Sequence: | 11993860 | Sequence: | 11993861 |
Contact Type | primary | Contact Type | backup |
Name | Zhibin Li, Ph.D. | Name | Haihua Zhu, Master |
Phone | 86592-2137364 | Phone | 86592-2137278 |
zhibinli33@hotmail.com | |||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68056445 |
Design Group Id | 55517395 |
Intervention Id | 52415405 |
Eligibilities
Sequence: | 30725386 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 20 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | Registered nurses in public hospitals in Xiamen, China; Aged 20 years or over and living in Xiamen for at least 1 year and will not move out of Xiamen for at least 5 years; |
Criteria | Inclusion Criteria:
Registered nurses of public hospitals in Xiamen, China; Exclusion Criteria: who are unambulatory; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253974151 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 20 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30471834 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28838265 |
Responsible Party Type | Principal Investigator |
Name | Zhibin LI |
Title | Director |
Affiliation | The First Affiliated Hospital of Xiamen University |
]]>
https://zephyrnet.com/NCT03799640
2018-12-05
https://zephyrnet.com/?p=NCT03799640
NCT03799640https://www.clinicaltrials.gov/study/NCT03799640?tab=tableNANANAOlder individuals, 60-90, will be provided regular or cognitively based yoga training. They will then be evaluated using standard cognitive testing devices.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-09-10 |
Start Month Year | December 5, 2018 |
Primary Completion Month Year | August 15, 2019 |
Verification Month Year | September 2019 |
Verification Date | 2019-09-30 |
Last Update Posted Date | 2019-09-10 |
Detailed Descriptions
Sequence: | 20716261 |
Description | Reductions in executive function are common with age. Along with these declines come reductions in simple functional patterns of daily living such as crossing a street, walking in a crowded area, or performing any functions that occurs in an open (changing) environment. This study will use a newly developed yoga program incorporating multi-directional movements, cognitive challenges and visuomotor disturbances to improve executive function and associated movements in persons over 60 years of age. |
Facilities
Sequence: | 200053121 | Sequence: | 200053122 |
Name | Max Orovitz Laboratories | Name | Laboratory of Neruomuscular Research and Active Aging |
City | Coral Gables | City | Coral Gables |
State | Florida | State | Florida |
Zip | 33146-2416 | Zip | 33147 |
Country | United States | Country | United States |
Conditions
Sequence: | 52156381 | Sequence: | 52156382 | Sequence: | 52156383 |
Name | Standard Yoga | Name | Multi-directional Yoga | Name | Educational Control |
Downcase Name | standard yoga | Downcase Name | multi-directional yoga | Downcase Name | educational control |
Id Information
Sequence: | 40148150 |
Id Source | org_study_id |
Id Value | 20180704 |
Countries
Sequence: | 42557676 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55577810 | Sequence: | 55577811 | Sequence: | 55577812 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | Standard Yoga | Title | Multi-directional Yoga | Title | Educational Control |
Description | Yoga will be performed using linear forward and backward movements. | Description | The multidirectional yoga training program will use both simple and complex movement sequences (asana or postures) that include a cognitive component. For example, participants will be taught a movement sequence that includes 16-20 yoga postures that increase in difficulty as the training progresses. . | Description | Lectures on Health and Wellness |
Interventions
Sequence: | 52471920 | Sequence: | 52471921 | Sequence: | 52471922 |
Intervention Type | Other | Intervention Type | Other | Intervention Type | Other |
Name | Standard Yoga | Name | Multi-directional Yoga | Name | Educational Control |
Description | Yoga using standard poses and linear movements | Description | The multidirectional yoga training program will use both simple and complex movement sequences (asana or postures) that include a cognitive component. For example, participants will be taught a movement sequence that includes 16-20 yoga postures that increase in difficulty as the training progresses. | Description | Lectures on health and fitness |
Design Outcomes
Sequence: | 177327613 | Sequence: | 177327608 | Sequence: | 177327609 | Sequence: | 177327610 | Sequence: | 177327611 | Sequence: | 177327612 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Timed up-and-go | Measure | NIH Toolbox: Picture Sequence Memory Test | Measure | NIH Toolbox Flanker test | Measure | NIH Toolbox List Sorting test | Measure | NIH Toolbox Pattern Comparison Processing Speed test | Measure | Walking Executive Function Tests |
Time Frame | 5 minutes | Time Frame | 5 minutes | Time Frame | 5 minutes | Time Frame | 5 minutes | Time Frame | 5 minutes | Time Frame | 10 minutes |
Description | Rising from a chair, circumventing a cone and returning to the chair. | Description | Measures episodic memory. Participants are asked to reproduce a sequence of pictures that is shown on the screen. | Description | Measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it. | Description | Measures working memory. Participant recalls and sequences different visually and orally presented stimuli. | Description | Measures speed of processing. Participants discern whether two side-by-side pictures are the same or not, with 85 seconds to respond to as many items as possible. Items are simple so as to purely measure processing speed. | Description | Walking and responding to visual cues presented on a 60 inch monitor. |
Sponsors
Sequence: | 48305978 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Miami |
Overall Officials
Sequence: | 29277886 |
Role | Principal Investigator |
Name | Joseph Signorile, PhD |
Affiliation | University of Miami |
Design Group Interventions
Sequence: | 68130757 | Sequence: | 68130758 | Sequence: | 68130759 | Sequence: | 68130760 | Sequence: | 68130761 | Sequence: | 68130762 |
Design Group Id | 55577812 | Design Group Id | 55577811 | Design Group Id | 55577812 | Design Group Id | 55577810 | Design Group Id | 55577811 | Design Group Id | 55577810 |
Intervention Id | 52471920 | Intervention Id | 52471920 | Intervention Id | 52471921 | Intervention Id | 52471921 | Intervention Id | 52471922 | Intervention Id | 52471922 |
Eligibilities
Sequence: | 30757302 |
Gender | All |
Minimum Age | 60 Years |
Maximum Age | 90 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
60-90 years of age Exclusion Criteria: Regularly participating in yoga or other balance training program |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254225747 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2019 |
Actual Duration | 8 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 60 |
Maximum Age Num | 90 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 6 |
Designs
Sequence: | 30503527 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Masking Description | Tests will not be performed by the investigators providing the interventions.. |
Intervention Model Description | Comparison of Yoga Interventions |
Investigator Masked | True |
Responsible Parties
Sequence: | 28869805 |
Responsible Party Type | Principal Investigator |
Name | Joseph Signorile |
Title | Professor |
Affiliation | University of Miami |
]]>
https://zephyrnet.com/NCT03799627
2019-01-31
https://zephyrnet.com/?p=NCT03799627
NCT03799627https://www.clinicaltrials.gov/study/NCT03799627?tab=tableNANANAThis is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-03 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-09-29 |
Start Month Year | January 31, 2019 |
Primary Completion Month Year | June 5, 2020 |
Verification Month Year | September 2022 |
Verification Date | 2022-09-30 |
Last Update Posted Date | 2022-09-29 |
Results First Posted Date | 2022-09-29 |
Detailed Descriptions
Sequence: | 20730274 |
Description | This is a Phase 2, randomized, open-label study to evaluate efficacy and safety of oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy. The study will be conducted in two parts running in parallel: Part 1, Main Study in a hemodialysis population on maintenance treatment with Epoetin Alfa; Part 2 is in a hemodialysis population that are erythropoiesis-stimulating agent (ESA) hyporesponders on maintenance treatment with Epoetin Alfa. For all participants (Main and ESA hyporesponder parallel study), the study will include a Screening Period, a Treatment Period, and a Safety Follow-Up Period. PK and PD sampling will be done throughout the study. The aim is to achieve and maintain hemoglobin (Hb) levels within the target range of 10.0 to 11.0 grams per deciliter (g/dL), inclusive, while targeting the middle of the range and minimizing excursions outside the target range. |
Facilities
Sequence: | 200189835 | Sequence: | 200189836 | Sequence: | 200189837 | Sequence: | 200189838 | Sequence: | 200189839 | Sequence: | 200189840 | Sequence: | 200189841 | Sequence: | 200189842 | Sequence: | 200189843 | Sequence: | 200189844 | Sequence: | 200189845 | Sequence: | 200189846 | Sequence: | 200189847 | Sequence: | 200189848 | Sequence: | 200189849 | Sequence: | 200189850 | Sequence: | 200189851 | Sequence: | 200189852 | Sequence: | 200189853 | Sequence: | 200189854 | Sequence: | 200189855 | Sequence: | 200189856 | Sequence: | 200189857 | Sequence: | 200189858 | Sequence: | 200189859 | Sequence: | 200189860 | Sequence: | 200189861 | Sequence: | 200189862 | Sequence: | 200189863 | Sequence: | 200189864 | Sequence: | 200189865 | Sequence: | 200189866 | Sequence: | 200189867 | Sequence: | 200189868 | Sequence: | 200189869 | Sequence: | 200189870 | Sequence: | 200189871 | Sequence: | 200189872 | Sequence: | 200189873 | Sequence: | 200189874 | Sequence: | 200189875 |
Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site #1 | Name | Research Site #2 | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site #1 | Name | Research Site #2 | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site |
City | Fresno | City | Granada Hills | City | Los Angeles | City | Northridge | City | Riverside | City | San Dimas | City | San Dimas | City | San Gabriel | City | Tarzana | City | Vacaville | City | Victorville | City | Denver | City | Bridgeport | City | Hartford | City | Coral Gables | City | Hollywood | City | Miami | City | Miami | City | Miami | City | Tampa | City | Tampa | City | Winter Park | City | Augusta | City | Statesboro | City | Roseville | City | Minneapolis | City | Minneapolis | City | Kansas City | City | Las Vegas | City | Bronx | City | Asheville | City | Wilmington | City | Canton | City | Oklahoma City | City | El Paso | City | Houston | City | San Antonio | City | San Antonio | City | Chesapeake | City | Norfolk | City | Wauwatosa |
State | California | State | California | State | California | State | California | State | California | State | California | State | California | State | California | State | California | State | California | State | California | State | Colorado | State | Connecticut | State | Connecticut | State | Florida | State | Florida | State | Florida | State | Florida | State | Florida | State | Florida | State | Florida | State | Florida | State | Georgia | State | Georgia | State | Michigan | State | Minnesota | State | Minnesota | State | Missouri | State | Nevada | State | New York | State | North Carolina | State | North Carolina | State | Ohio | State | Oklahoma | State | Texas | State | Texas | State | Texas | State | Texas | State | Virginia | State | Virginia | State | Wisconsin |
Zip | 93720 | Zip | 91344 | Zip | 90022 | Zip | 91324 | Zip | 92501 | Zip | 91773 | Zip | 91773 | Zip | 91776 | Zip | 91356 | Zip | 95688 | Zip | 92394 | Zip | 80230 | Zip | 06606 | Zip | 06762 | Zip | 33134 | Zip | 33024 | Zip | 33126 | Zip | 33134 | Zip | 33150 | Zip | 33607 | Zip | 33614 | Zip | 32789 | Zip | 30909 | Zip | 30458 | Zip | 48066 | Zip | 55404 | Zip | 55404 | Zip | 64111 | Zip | 89107 | Zip | 10461 | Zip | 28801 | Zip | 28401 | Zip | 44718 | Zip | 73116 | Zip | 79915 | Zip | 77004 | Zip | 78229 | Zip | 78258 | Zip | 23320 | Zip | 23510 | Zip | 53226 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States |
Browse Interventions
Sequence: | 96089741 | Sequence: | 96089742 | Sequence: | 96089743 | Sequence: | 96089744 | Sequence: | 96089745 | Sequence: | 96089746 | Sequence: | 96089747 |
Mesh Term | Epoetin Alfa | Mesh Term | Glycine | Mesh Term | Hematinics | Mesh Term | Glycine Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | epoetin alfa | Downcase Mesh Term | glycine | Downcase Mesh Term | hematinics | Downcase Mesh Term | glycine agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52193549 | Sequence: | 52193550 |
Name | Anemia | Name | Dialysis-dependent Chronic Kidney Disease |
Downcase Name | anemia | Downcase Name | dialysis-dependent chronic kidney disease |
Id Information
Sequence: | 40175451 |
Id Source | org_study_id |
Id Value | AKB-6548-CI-0025 |
Countries
Sequence: | 42587798 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55618914 | Sequence: | 55618915 | Sequence: | 55618916 |
Group Type | Experimental | Group Type | Experimental | Group Type | Active Comparator |
Title | Vadadustat | Title | Vadadustat TIW | Title | Epoetin Alfa |
Description | The initial dose of Vadadustat (300, 450, or 600 milligrams [mg]) will be based upon the dose of Epoetin Alfa dose participants had received prior to Vadadustat treatment | Description | Participants randomized to Vadadustat (Main and erythropoiesis-stimulating agent [ESA] hyporesponder parallel studies) who complete a once-daily dosing regimen treatment period and meet eligibility criteria for transition to three times weekly (TIW) dosing will switch to TIW dosing | Description | Epoetin Alfa |
Interventions
Sequence: | 52508185 | Sequence: | 52508186 | Sequence: | 52508187 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Vadadustat | Name | Epoetin Alfa | Name | Vadadustat TIW |
Description | Vadadustat Tablets 150 mg | Description | Epoetin Alfa | Description | Oral Vadadustat |
Keywords
Sequence: | 79901507 | Sequence: | 79901508 | Sequence: | 79901509 | Sequence: | 79901510 | Sequence: | 79901511 |
Name | Vadadustat | Name | AKB-6548 | Name | Anemia | Name | Chronic kidney disease (CKD) | Name | erythropoietin |
Downcase Name | vadadustat | Downcase Name | akb-6548 | Downcase Name | anemia | Downcase Name | chronic kidney disease (ckd) | Downcase Name | erythropoietin |
Design Outcomes
Sequence: | 177461945 | Sequence: | 177461946 | Sequence: | 177461947 | Sequence: | 177461948 | Sequence: | 177461949 | Sequence: | 177461950 | Sequence: | 177461951 | Sequence: | 177461952 | Sequence: | 177461953 | Sequence: | 177461954 | Sequence: | 177461955 | Sequence: | 177461956 | Sequence: | 177461957 | Sequence: | 177461958 | Sequence: | 177461959 | Sequence: | 177461960 | Sequence: | 177461961 | Sequence: | 177461962 | Sequence: | 177461963 | Sequence: | 177461964 | Sequence: | 177461965 | Sequence: | 177461966 | Sequence: | 177461967 | Sequence: | 177461968 | Sequence: | 177461969 | Sequence: | 177461970 | Sequence: | 177461971 | Sequence: | 177461972 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Measure | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Measure | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Measure | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Measure | Number of Participants Classified as Hb Outliers | Measure | Number of Participants With Hb Values Within the Target Range at the PEP | Measure | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Measure | Mean Change in Hb Between Baseline and the SEP | Measure | Number of Participants With Hb Values Within the Target Range at the SEP | Measure | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Measure | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Measure | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Measure | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Measure | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Measure | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Measure | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Measure | Mean Change From Baseline in Reticulocyte Count | Measure | Mean Change From Baseline in Iron Concentration | Measure | Mean Change From Baseline in Ferritin Concentration | Measure | Mean Change From Baseline in Total Iron Binding Capacity | Measure | Mean Change From Baseline in Hepcidin Concentration | Measure | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Measure | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Measure | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Measure | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Measure | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Measure | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Measure | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose |
Time Frame | Baseline; Week 10 to Week 12 | Time Frame | Up to Week 24 | Time Frame | Up to Week 24 | Time Frame | Up to Week 24 | Time Frame | Weeks 13 – 20 | Time Frame | Week 10 to Week 12 | Time Frame | Week 10 to Week 12; Week 18 to Week 20 | Time Frame | Baseline; Week 18 to Week 20 | Time Frame | Week 18 to Week 20 | Time Frame | Week 18 to Week 20 | Time Frame | Week 10 to Week 12 | Time Frame | Week 18 to Week 20 | Time Frame | Up to Week 20 | Time Frame | Up to Week 20 | Time Frame | Up to Week 20 | Time Frame | Baseline; Week 1 (pre-dose), Week 1 +1 (Day 8; pre-dose), Week 11 (pre-dose), and Week 13 (pre-dose) | Time Frame | Baseline; Week 1, Week 4, Week 8, Week 11, Week 12, Week 13, Week 16, and Week 20 | Time Frame | Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 | Time Frame | Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 | Time Frame | Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 | Time Frame | Baseline; Week 12 and Week 20 | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose |
Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. |
Browse Conditions
Sequence: | 193571852 | Sequence: | 193571853 | Sequence: | 193571854 | Sequence: | 193571855 | Sequence: | 193571856 | Sequence: | 193571860 | Sequence: | 193571861 | Sequence: | 193571862 | Sequence: | 193571863 | Sequence: | 193571864 | Sequence: | 193571857 | Sequence: | 193571858 | Sequence: | 193571859 |
Mesh Term | Kidney Diseases | Mesh Term | Renal Insufficiency, Chronic | Mesh Term | Anemia | Mesh Term | Hematologic Diseases | Mesh Term | Urologic Diseases | Mesh Term | Male Urogenital Diseases | Mesh Term | Renal Insufficiency | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases |
Downcase Mesh Term | kidney diseases | Downcase Mesh Term | renal insufficiency, chronic | Downcase Mesh Term | anemia | Downcase Mesh Term | hematologic diseases | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | male urogenital diseases | Downcase Mesh Term | renal insufficiency | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48340187 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Akebia Therapeutics |
Overall Officials
Sequence: | 29297915 |
Role | Study Director |
Name | Chief Medical Officer |
Affiliation | Akebia Therapeutics Inc. |
Design Group Interventions
Sequence: | 68180082 | Sequence: | 68180083 | Sequence: | 68180084 |
Design Group Id | 55618914 | Design Group Id | 55618916 | Design Group Id | 55618915 |
Intervention Id | 52508185 | Intervention Id | 52508186 | Intervention Id | 52508187 |
Eligibilities
Sequence: | 30778529 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 99 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
≥18 years of age, providing informed consent Eligibility in the Main study and erythropoiesis-stimulating agent (ESA) hyporesponder parallel study is based on the following mean weekly Epoetin Alfa doses: Main study: Mean weekly Epoetin Alfa dose <300 Units per kilogram per week (U/kg/week) for 8 weeks prior to SV2; Two Hb values measured by the central laboratory at least 4 days apart between Screening Visit 1 (SV1) and SV2 as indicated:. Main study: 2 Hb values between 8.5 and 11.0 g/dL, inclusive; Exclusion Criteria: Anemia due to a cause other than chronic kidney disease (e.g., sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia) For female participants of non-childbearing potential: inability to confirm surgical sterility (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy) at least 1 month prior to Screening; For female participants of childbearing potential: lack of confirmation of the use of acceptable forms of contraception* for a minimum of one complete menstrual cycle prior to Screening; Any other reason, which in the opinion of the Investigator, would make the participant not suitable for participation in the study Acceptable forms of contraception include: Established use of oral, injected or implanted hormonal methods of contraception; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253971225 |
Number Of Facilities | 41 |
Number Of Nsae Subjects | 192 |
Number Of Sae Subjects | 96 |
Registered In Calendar Year | 2018 |
Actual Duration | 16 |
Were Results Reported | True |
Months To Report Results | 23 |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 99 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 5 |
Number Of Secondary Outcomes To Measure | 23 |
Designs
Sequence: | 30524632 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Randomized, Open-Label, Active-Controlled |
Drop Withdrawals
Sequence: | 29004199 | Sequence: | 29004200 | Sequence: | 29004201 | Sequence: | 29004202 | Sequence: | 29004203 | Sequence: | 29004204 | Sequence: | 29004205 | Sequence: | 29004206 | Sequence: | 29004207 | Sequence: | 29004208 | Sequence: | 29004209 | Sequence: | 29004210 | Sequence: | 29004211 | Sequence: | 29004212 | Sequence: | 29004213 | Sequence: | 29004214 | Sequence: | 29004215 | Sequence: | 29004216 | Sequence: | 29004217 | Sequence: | 29004218 | Sequence: | 29004219 | Sequence: | 29004220 | Sequence: | 29004221 | Sequence: | 29004222 | Sequence: | 29004223 | Sequence: | 29004224 | Sequence: | 29004225 | Sequence: | 29004226 | Sequence: | 29004227 | Sequence: | 29004228 | Sequence: | 29004229 | Sequence: | 29004230 | Sequence: | 29004231 | Sequence: | 29004232 | Sequence: | 29004233 | Sequence: | 29004234 | Sequence: | 29004235 | Sequence: | 29004236 | Sequence: | 29004237 | Sequence: | 29004238 | Sequence: | 29004239 | Sequence: | 29004240 | Sequence: | 29004241 | Sequence: | 29004242 | Sequence: | 29004243 | Sequence: | 29004244 | Sequence: | 29004245 | Sequence: | 29004246 | Sequence: | 29004247 | Sequence: | 29004248 | Sequence: | 29004249 | Sequence: | 29004250 | Sequence: | 29004251 | Sequence: | 29004252 | Sequence: | 29004253 | Sequence: | 29004254 | Sequence: | 29004255 | Sequence: | 29004256 | Sequence: | 29004257 | Sequence: | 29004258 | Sequence: | 29004259 | Sequence: | 29004260 | Sequence: | 29004261 | Sequence: | 29004262 | Sequence: | 29004263 | Sequence: | 29004264 | Sequence: | 29004265 | Sequence: | 29004266 | Sequence: | 29004267 | Sequence: | 29004268 | Sequence: | 29004269 | Sequence: | 29004270 | Sequence: | 29004271 | Sequence: | 29004272 | Sequence: | 29004273 | Sequence: | 29004274 | Sequence: | 29004275 | Sequence: | 29004276 | Sequence: | 29004277 | Sequence: | 29004278 | Sequence: | 29004279 | Sequence: | 29004280 | Sequence: | 29004281 | Sequence: | 29004282 | Sequence: | 29004283 | Sequence: | 29004284 | Sequence: | 29004285 | Sequence: | 29004286 | Sequence: | 29004287 | Sequence: | 29004288 | Sequence: | 29004289 | Sequence: | 29004290 | Sequence: | 29004291 | Sequence: | 29004292 | Sequence: | 29004293 | Sequence: | 29004294 | Sequence: | 29004295 | Sequence: | 29004296 | Sequence: | 29004297 | Sequence: | 29004298 | Sequence: | 29004299 | Sequence: | 29004300 | Sequence: | 29004301 | Sequence: | 29004302 | Sequence: | 29004303 | Sequence: | 29004304 | Sequence: | 29004305 | Sequence: | 29004306 | Sequence: | 29004307 | Sequence: | 29004308 | Sequence: | 29004309 | Sequence: | 29004310 | Sequence: | 29004311 | Sequence: | 29004312 | Sequence: | 29004313 | Sequence: | 29004314 | Sequence: | 29004315 | Sequence: | 29004316 | Sequence: | 29004317 | Sequence: | 29004318 | Sequence: | 29004319 | Sequence: | 29004320 | Sequence: | 29004321 | Sequence: | 29004322 | Sequence: | 29004323 | Sequence: | 29004324 | Sequence: | 29004325 | Sequence: | 29004326 | Sequence: | 29004327 | Sequence: | 29004328 | Sequence: | 29004329 | Sequence: | 29004330 | Sequence: | 29004331 | Sequence: | 29004332 | Sequence: | 29004333 | Sequence: | 29004334 | Sequence: | 29004335 | Sequence: | 29004336 | Sequence: | 29004337 | Sequence: | 29004338 | Sequence: | 29004339 | Sequence: | 29004340 | Sequence: | 29004341 | Sequence: | 29004342 | Sequence: | 29004343 | Sequence: | 29004344 | Sequence: | 29004345 | Sequence: | 29004346 | Sequence: | 29004347 | Sequence: | 29004348 | Sequence: | 29004349 | Sequence: | 29004350 | Sequence: | 29004351 | Sequence: | 29004352 | Sequence: | 29004353 | Sequence: | 29004354 | Sequence: | 29004355 | Sequence: | 29004356 | Sequence: | 29004357 | Sequence: | 29004358 | Sequence: | 29004359 | Sequence: | 29004360 |
Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Lack of Efficacy | Reason | Lack of Efficacy | Reason | Lack of Efficacy | Reason | Lack of Efficacy | Reason | Lack of Efficacy | Reason | Lack of Efficacy | Reason | Lack of Efficacy | Reason | Lack of Efficacy | Reason | Lack of Efficacy | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Death | Reason | Death | Reason | Death | Reason | Death | Reason | Death | Reason | Death | Reason | Death | Reason | Death | Reason | Death | Reason | Study Drug Put on Hold | Reason | Study Drug Put on Hold | Reason | Study Drug Put on Hold | Reason | Study Drug Put on Hold | Reason | Study Drug Put on Hold | Reason | Study Drug Put on Hold | Reason | Study Drug Put on Hold | Reason | Study Drug Put on Hold | Reason | Study Drug Put on Hold | Reason | Due to Urgent Safety Measures Letter | Reason | Due to Urgent Safety Measures Letter | Reason | Due to Urgent Safety Measures Letter | Reason | Due to Urgent Safety Measures Letter | Reason | Due to Urgent Safety Measures Letter | Reason | Due to Urgent Safety Measures Letter | Reason | Due to Urgent Safety Measures Letter | Reason | Due to Urgent Safety Measures Letter | Reason | Due to Urgent Safety Measures Letter | Reason | Kidney Transplantation | Reason | Kidney Transplantation | Reason | Kidney Transplantation | Reason | Kidney Transplantation | Reason | Kidney Transplantation | Reason | Kidney Transplantation | Reason | Kidney Transplantation | Reason | Kidney Transplantation | Reason | Kidney Transplantation | Reason | Participant Was on Rescue Epogen | Reason | Participant Was on Rescue Epogen | Reason | Participant Was on Rescue Epogen | Reason | Participant Was on Rescue Epogen | Reason | Participant Was on Rescue Epogen | Reason | Participant Was on Rescue Epogen | Reason | Participant Was on Rescue Epogen | Reason | Participant Was on Rescue Epogen | Reason | Participant Was on Rescue Epogen | Reason | Placed on Dose Hold Until End of Treatment | Reason | Placed on Dose Hold Until End of Treatment | Reason | Placed on Dose Hold Until End of Treatment | Reason | Placed on Dose Hold Until End of Treatment | Reason | Placed on Dose Hold Until End of Treatment | Reason | Placed on Dose Hold Until End of Treatment | Reason | Placed on Dose Hold Until End of Treatment | Reason | Placed on Dose Hold Until End of Treatment | Reason | Placed on Dose Hold Until End of Treatment | Reason | Met Exclusion Criteria | Reason | Met Exclusion Criteria | Reason | Met Exclusion Criteria | Reason | Met Exclusion Criteria | Reason | Met Exclusion Criteria | Reason | Met Exclusion Criteria | Reason | Met Exclusion Criteria | Reason | Met Exclusion Criteria | Reason | Met Exclusion Criteria | Reason | Investigational Product Noncompliance | Reason | Investigational Product Noncompliance | Reason | Investigational Product Noncompliance | Reason | Investigational Product Noncompliance | Reason | Investigational Product Noncompliance | Reason | Investigational Product Noncompliance | Reason | Investigational Product Noncompliance | Reason | Investigational Product Noncompliance | Reason | Investigational Product Noncompliance | Reason | Participant Relocation | Reason | Participant Relocation | Reason | Participant Relocation | Reason | Participant Relocation | Reason | Participant Relocation | Reason | Participant Relocation | Reason | Participant Relocation | Reason | Participant Relocation | Reason | Participant Relocation | Reason | Eurofin Issue | Reason | Eurofin Issue | Reason | Eurofin Issue | Reason | Eurofin Issue | Reason | Eurofin Issue | Reason | Eurofin Issue | Reason | Eurofin Issue | Reason | Eurofin Issue | Reason | Eurofin Issue | Reason | Noncompliance with Site Instructions | Reason | Noncompliance with Site Instructions | Reason | Noncompliance with Site Instructions | Reason | Noncompliance with Site Instructions | Reason | Noncompliance with Site Instructions | Reason | Noncompliance with Site Instructions | Reason | Noncompliance with Site Instructions | Reason | Noncompliance with Site Instructions | Reason | Noncompliance with Site Instructions | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Participant's Last Dose Prior to End of Treatment | Reason | Changes In Hemoglobin Values | Reason | Changes In Hemoglobin Values | Reason | Changes In Hemoglobin Values | Reason | Changes In Hemoglobin Values | Reason | Changes In Hemoglobin Values | Reason | Changes In Hemoglobin Values | Reason | Changes In Hemoglobin Values | Reason | Changes In Hemoglobin Values | Reason | Changes In Hemoglobin Values |
Count | 1 | Count | 2 | Count | 0 | Count | 0 | Count | 2 | Count | 5 | Count | 0 | Count | 2 | Count | 0 | Count | 2 | Count | 2 | Count | 0 | Count | 0 | Count | 2 | Count | 2 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 1 | Count | 0 | Count | 2 | Count | 0 | Count | 3 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 2 | Count | 0 | Count | 2 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 1 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 1 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 2 | Count | 1 | Count | 0 | Count | 0 | Count | 2 | Count | 1 | Count | 0 | Count | 1 |
Intervention Other Names
Sequence: | 26684156 | Sequence: | 26684157 | Sequence: | 26684158 |
Intervention Id | 52508185 | Intervention Id | 52508186 | Intervention Id | 52508186 |
Name | AKB-6548 | Name | Procrit | Name | Epogen |
Milestones
Sequence: | 41027678 | Sequence: | 41027679 | Sequence: | 41027680 | Sequence: | 41027681 | Sequence: | 41027682 | Sequence: | 41027683 | Sequence: | 41027684 | Sequence: | 41027685 | Sequence: | 41027686 | Sequence: | 41027687 | Sequence: | 41027688 | Sequence: | 41027689 | Sequence: | 41027690 | Sequence: | 41027691 | Sequence: | 41027692 | Sequence: | 41027693 | Sequence: | 41027694 | Sequence: | 41027695 | Sequence: | 41027696 | Sequence: | 41027697 | Sequence: | 41027698 | Sequence: | 41027699 | Sequence: | 41027700 | Sequence: | 41027701 | Sequence: | 41027702 | Sequence: | 41027703 | Sequence: | 41027704 |
Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 | Result Group Id | 56112532 | Result Group Id | 56112533 | Result Group Id | 56112534 | Result Group Id | 56112535 | Result Group Id | 56112536 | Result Group Id | 56112537 | Result Group Id | 56112538 | Result Group Id | 56112539 | Result Group Id | 56112540 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 |
Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 35 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 27 | Count | 23 | Count | 22 | Count | 8 | Count | 12 | Count | 8 | Count | 10 | Count | 3 | Count | 2 | Count | 8 | Count | 11 | Count | 1 | Count | 10 | Count | 9 | Count | 13 | Count | 3 | Count | 2 | Count | 3 |
Participant Flows
Sequence: | 3922864 |
Pre Assignment Details | A total of 540 participants were screened, of which 175 participants were enrolled and randomized into the 2 parts of this study (Main Study; n=165; Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study: n=10). A total of 365 participants failed screening. Participants were randomized to either a Vadadustat or Epoetin Alfa treatment group, and randomization was stratified by mean weekly Epoetin Alfa dose calculated over a period of 8 weeks prior to Screening Visit 2. |
Outcome Counts
Sequence: | 74039013 | Sequence: | 74039014 | Sequence: | 74039015 | Sequence: | 74039016 | Sequence: | 74039017 | Sequence: | 74039018 | Sequence: | 74039019 | Sequence: | 74039020 | Sequence: | 74039021 | Sequence: | 74039022 | Sequence: | 74039023 | Sequence: | 74039024 | Sequence: | 74039025 | Sequence: | 74039026 | Sequence: | 74039027 | Sequence: | 74039028 | Sequence: | 74039029 | Sequence: | 74039030 | Sequence: | 74039031 | Sequence: | 74039032 | Sequence: | 74039033 | Sequence: | 74039034 | Sequence: | 74039035 | Sequence: | 74039036 | Sequence: | 74039037 | Sequence: | 74039038 | Sequence: | 74039039 | Sequence: | 74039040 | Sequence: | 74039041 | Sequence: | 74039042 | Sequence: | 74039043 | Sequence: | 74039044 | Sequence: | 74039045 | Sequence: | 74039046 | Sequence: | 74039047 | Sequence: | 74039048 | Sequence: | 74039049 | Sequence: | 74039050 | Sequence: | 74039051 | Sequence: | 74039052 | Sequence: | 74039053 | Sequence: | 74039054 | Sequence: | 74039055 | Sequence: | 74039056 | Sequence: | 74039057 | Sequence: | 74039058 | Sequence: | 74039059 | Sequence: | 74039060 | Sequence: | 74039061 | Sequence: | 74039062 | Sequence: | 74039063 | Sequence: | 74039064 | Sequence: | 74039065 | Sequence: | 74039066 | Sequence: | 74039067 | Sequence: | 74039068 | Sequence: | 74039069 | Sequence: | 74039070 | Sequence: | 74039071 | Sequence: | 74039072 | Sequence: | 74039073 | Sequence: | 74039074 | Sequence: | 74039075 | Sequence: | 74039076 | Sequence: | 74039077 | Sequence: | 74039078 | Sequence: | 74039079 | Sequence: | 74039080 | Sequence: | 74039081 | Sequence: | 74039082 | Sequence: | 74039083 | Sequence: | 74039084 | Sequence: | 74039085 | Sequence: | 74039086 | Sequence: | 74039087 | Sequence: | 74039088 | Sequence: | 74039089 | Sequence: | 74039090 | Sequence: | 74039091 | Sequence: | 74039092 | Sequence: | 74039093 | Sequence: | 74039094 | Sequence: | 74039095 | Sequence: | 74039096 | Sequence: | 74039097 | Sequence: | 74039098 | Sequence: | 74039099 | Sequence: | 74039100 | Sequence: | 74039101 | Sequence: | 74039102 | Sequence: | 74039103 | Sequence: | 74039104 | Sequence: | 74039105 | Sequence: | 74039106 | Sequence: | 74039107 | Sequence: | 74039108 | Sequence: | 74039109 | Sequence: | 74039110 | Sequence: | 74039111 | Sequence: | 74039112 | Sequence: | 74039113 | Sequence: | 74039114 | Sequence: | 74039115 | Sequence: | 74039116 | Sequence: | 74039117 | Sequence: | 74039118 | Sequence: | 74039119 | Sequence: | 74039120 | Sequence: | 74039121 | Sequence: | 74039122 | Sequence: | 74039123 | Sequence: | 74039124 | Sequence: | 74039125 | Sequence: | 74039126 | Sequence: | 74039127 | Sequence: | 74039128 | Sequence: | 74039129 | Sequence: | 74039130 | Sequence: | 74039131 | Sequence: | 74039132 | Sequence: | 74039133 | Sequence: | 74039134 | Sequence: | 74039135 | Sequence: | 74039136 | Sequence: | 74039137 | Sequence: | 74039138 | Sequence: | 74039139 | Sequence: | 74039140 | Sequence: | 74039141 | Sequence: | 74039142 | Sequence: | 74039143 | Sequence: | 74039144 | Sequence: | 74039145 | Sequence: | 74039146 | Sequence: | 74039147 | Sequence: | 74039148 | Sequence: | 74039149 | Sequence: | 74039150 | Sequence: | 74039151 | Sequence: | 74039152 | Sequence: | 74039153 | Sequence: | 74039154 | Sequence: | 74039155 | Sequence: | 74039156 | Sequence: | 74039157 | Sequence: | 74039158 | Sequence: | 74039159 | Sequence: | 74039160 | Sequence: | 74039161 | Sequence: | 74039162 | Sequence: | 74039163 | Sequence: | 74039164 | Sequence: | 74039165 | Sequence: | 74039166 | Sequence: | 74039167 | Sequence: | 74039168 | Sequence: | 74039169 | Sequence: | 74039170 | Sequence: | 74039171 | Sequence: | 74039172 | Sequence: | 74039173 | Sequence: | 74039174 | Sequence: | 74039175 | Sequence: | 74039176 | Sequence: | 74039177 | Sequence: | 74039178 | Sequence: | 74039179 | Sequence: | 74039180 | Sequence: | 74039181 | Sequence: | 74039182 | Sequence: | 74039183 | Sequence: | 74039184 | Sequence: | 74039185 | Sequence: | 74039186 | Sequence: | 74039187 | Sequence: | 74039188 | Sequence: | 74039189 | Sequence: | 74039190 | Sequence: | 74039191 | Sequence: | 74039192 | Sequence: | 74039193 | Sequence: | 74039194 | Sequence: | 74039195 | Sequence: | 74039196 | Sequence: | 74039197 | Sequence: | 74039198 | Sequence: | 74039199 | Sequence: | 74039200 | Sequence: | 74039201 | Sequence: | 74039202 | Sequence: | 74039203 | Sequence: | 74039204 | Sequence: | 74039205 | Sequence: | 74039206 | Sequence: | 74039207 | Sequence: | 74039208 | Sequence: | 74039209 | Sequence: | 74039210 | Sequence: | 74039211 | Sequence: | 74039212 | Sequence: | 74039213 | Sequence: | 74039214 | Sequence: | 74039215 | Sequence: | 74039216 | Sequence: | 74039217 | Sequence: | 74039218 | Sequence: | 74039219 | Sequence: | 74039220 | Sequence: | 74039221 | Sequence: | 74039222 | Sequence: | 74039223 | Sequence: | 74039224 | Sequence: | 74039225 | Sequence: | 74039226 | Sequence: | 74039227 | Sequence: | 74039228 | Sequence: | 74039229 | Sequence: | 74039230 | Sequence: | 74039231 | Sequence: | 74039232 | Sequence: | 74039233 | Sequence: | 74039234 |
Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 |
Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112551 | Result Group Id | 56112552 | Result Group Id | 56112553 | Result Group Id | 56112554 | Result Group Id | 56112555 | Result Group Id | 56112556 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112551 | Result Group Id | 56112552 | Result Group Id | 56112553 | Result Group Id | 56112554 | Result Group Id | 56112555 | Result Group Id | 56112557 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112558 | Result Group Id | 56112559 | Result Group Id | 56112560 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112561 | Result Group Id | 56112562 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112567 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112567 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112567 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112567 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112568 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | 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Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 35 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 34 | Count | 35 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 34 | Count | 35 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 34 | Count | 35 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 30 | Count | 27 | Count | 23 | Count | 10 | Count | 16 | Count | 13 | Count | 12 | Count | 3 | Count | 5 | Count | 30 | Count | 30 | Count | 23 | Count | 12 | Count | 18 | Count | 14 | Count | 12 | Count | 4 | Count | 5 | Count | 1 | Count | 4 | Count | 7 | Count | 5 | Count | 17 | Count | 0 | Count | 26 | Count | 24 | Count | 23 | Count | 7 | Count | 14 | Count | 10 | Count | 12 | Count | 3 | Count | 4 | Count | 26 | Count | 24 | Count | 23 | Count | 7 | Count | 14 | Count | 10 | Count | 12 | Count | 3 | Count | 4 | Count | 1 | Count | 4 | Count | 7 | Count | 5 | Count | 17 | Count | 0 | Count | 30 | Count | 30 | Count | 23 | Count | 12 | Count | 18 | Count | 14 | Count | 12 | Count | 4 | Count | 5 | Count | 26 | Count | 24 | Count | 23 | Count | 7 | Count | 14 | Count | 10 | Count | 12 | Count | 3 | Count | 4 | Count | 35 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 35 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 35 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 33 | Count | 30 | Count | 15 | Count | 21 | Count | 15 | Count | 5 | Count | 30 | Count | 32 | Count | 21 | Count | 18 | Count | 20 | Count | 21 | Count | 11 | Count | 5 | Count | 5 | Count | 35 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 34 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 35 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 35 | Count | 34 | Count | 21 | Count | 17 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 32 | Count | 30 | Count | 14 | Count | 21 | Count | 17 | Count | 5 | Count | 29 | Count | 28 | Count | 13 | Count | 21 | Count | 13 | Count | 5 | Count | 17 | Count | 17 | Count | 8 | Count | 8 | Count | 6 | Count | 2 | Count | 32 | Count | 30 | Count | 14 | Count | 21 | Count | 17 | Count | 5 | Count | 17 | Count | 17 | Count | 8 | Count | 8 | Count | 6 | Count | 2 | Count | 29 | Count | 28 | Count | 13 | Count | 21 | Count | 13 | Count | 5 | Count | 16 | Count | 15 | Count | 8 | Count | 8 | Count | 6 | Count | 2 |
Provided Documents
Sequence: | 2581571 | Sequence: | 2581572 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2018-06-27 | Document Date | 2020-07-02 |
Url | https://ClinicalTrials.gov/ProvidedDocs/27/NCT03799627/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/27/NCT03799627/SAP_001.pdf |
Reported Event Totals
Sequence: | 27955798 | Sequence: | 27955799 | Sequence: | 27955800 | Sequence: | 27955801 | Sequence: | 27955802 | Sequence: | 27955803 | Sequence: | 27955804 | Sequence: | 27955805 | Sequence: | 27955806 | Sequence: | 27955807 | Sequence: | 27955808 | Sequence: | 27955809 | Sequence: | 27955810 | Sequence: | 27955811 | Sequence: | 27955812 | Sequence: | 27955813 | Sequence: | 27955814 | Sequence: | 27955815 | Sequence: | 27955816 | Sequence: | 27955817 | Sequence: | 27955818 | Sequence: | 27955819 | Sequence: | 27955820 | Sequence: | 27955821 | Sequence: | 27955822 | Sequence: | 27955823 | Sequence: | 27955824 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG003 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG004 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG005 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG006 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG007 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG008 | Ctgov Group Code | EG008 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 9 | Subjects Affected | 11 | Subjects Affected | 0 | Subjects Affected | 7 | Subjects Affected | 20 | Subjects Affected | 0 | Subjects Affected | 5 | Subjects Affected | 10 | Subjects Affected | 0 | Subjects Affected | 8 | Subjects Affected | 9 | Subjects Affected | 1 | Subjects Affected | 6 | Subjects Affected | 9 | Subjects Affected | 1 | Subjects Affected | 10 | Subjects Affected | 10 | Subjects Affected | 1 | Subjects Affected | 5 | Subjects Affected | 8 | Subjects Affected | 1 | Subjects Affected | 4 | Subjects Affected | 4 | Subjects Affected | 0 | Subjects Affected | 3 | Subjects Affected | 2 | Subjects Affected | 0 |
Subjects At Risk | 34 | Subjects At Risk | 34 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 35 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 23 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 13 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 5 |
Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 | Created At | 2023-08-09 03:55:44.020012 |
Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 | Updated At | 2023-08-09 03:55:44.020012 |
Reported Events
Sequence: | 528504815 | Sequence: | 528504736 | Sequence: | 528504737 | Sequence: | 528504738 | Sequence: | 528504816 | Sequence: | 528504817 | Sequence: | 528504818 | Sequence: | 528504819 | Sequence: | 528504739 | Sequence: | 528504820 | Sequence: | 528504740 | Sequence: | 528504741 | Sequence: | 528504742 | Sequence: | 528504743 | Sequence: | 528504733 | Sequence: | 528504734 | Sequence: | 528504735 | Sequence: | 528504744 | Sequence: | 528504745 | Sequence: | 528504746 | Sequence: | 528504747 | Sequence: | 528504748 | Sequence: | 528504749 | Sequence: | 528504750 | Sequence: | 528504751 | Sequence: | 528504752 | Sequence: | 528504753 | Sequence: | 528504754 | Sequence: | 528504755 | Sequence: | 528504756 | Sequence: | 528504757 | Sequence: | 528504758 | Sequence: | 528504759 | Sequence: | 528504760 | Sequence: | 528504761 | Sequence: | 528504762 | Sequence: | 528504763 | Sequence: | 528504764 | Sequence: | 528504765 | Sequence: | 528504766 | Sequence: | 528504767 | Sequence: | 528504768 | Sequence: | 528504769 | Sequence: | 528504770 | Sequence: | 528504771 | Sequence: | 528504772 | Sequence: | 528504773 | Sequence: | 528504774 | Sequence: | 528504775 | Sequence: | 528504776 | Sequence: | 528504777 | Sequence: | 528504778 | Sequence: | 528504779 | Sequence: | 528504780 | Sequence: | 528504781 | Sequence: | 528504782 | Sequence: | 528504783 | Sequence: | 528504784 | Sequence: | 528504785 | Sequence: | 528504786 | Sequence: | 528504787 | Sequence: | 528504788 | Sequence: | 528504789 | Sequence: | 528504790 | Sequence: | 528504791 | Sequence: | 528504792 | Sequence: | 528504793 | Sequence: | 528504794 | Sequence: | 528504795 | Sequence: | 528504796 | Sequence: | 528504797 | Sequence: | 528504798 | Sequence: | 528504799 | Sequence: | 528504800 | Sequence: | 528504801 | Sequence: | 528504802 | Sequence: | 528504803 | Sequence: | 528504804 | Sequence: | 528504805 | Sequence: | 528504806 | Sequence: | 528504807 | Sequence: | 528504808 | Sequence: | 528504809 | Sequence: | 528504810 | Sequence: | 528504811 | Sequence: | 528504812 | Sequence: | 528504813 | Sequence: | 528504814 | Sequence: | 528504821 | Sequence: | 528504822 | Sequence: | 528504823 | Sequence: | 528504824 | Sequence: | 528504825 | Sequence: | 528504826 | Sequence: | 528504827 | Sequence: | 528504828 | Sequence: | 528504829 | Sequence: | 528504830 | Sequence: | 528504831 | Sequence: | 528504832 | Sequence: | 528504833 | Sequence: | 528504834 | Sequence: | 528504835 | Sequence: | 528504836 | Sequence: | 528504837 | Sequence: | 528504838 | Sequence: | 528504839 | Sequence: | 528504840 | Sequence: | 528504841 | Sequence: | 528504842 | Sequence: | 528504843 | Sequence: | 528504844 | Sequence: | 528504845 | Sequence: | 528504846 | Sequence: | 528504847 | Sequence: | 528504848 | Sequence: | 528504849 | Sequence: | 528504850 | Sequence: | 528504851 | Sequence: | 528504852 | Sequence: | 528504853 | Sequence: | 528504854 | Sequence: | 528504855 | Sequence: | 528504856 | Sequence: | 528504857 | Sequence: | 528504858 | Sequence: | 528504859 | Sequence: | 528504860 | Sequence: | 528504861 | Sequence: | 528504862 | Sequence: | 528504863 | Sequence: | 528504864 | Sequence: | 528504865 | Sequence: | 528504866 | Sequence: | 528504867 | Sequence: | 528504868 | Sequence: | 528504869 | Sequence: | 528504870 | Sequence: | 528504871 | Sequence: | 528504872 | Sequence: | 528504873 | Sequence: | 528504874 | Sequence: | 528504875 | Sequence: | 528504876 | Sequence: | 528504877 | Sequence: | 528504878 | Sequence: | 528504879 | Sequence: | 528504880 | Sequence: | 528504881 | Sequence: | 528504882 | Sequence: | 528504883 | Sequence: | 528504884 | Sequence: | 528504885 | Sequence: | 528504886 | Sequence: | 528504887 | Sequence: | 528504888 | Sequence: | 528504889 | Sequence: | 528504890 | Sequence: | 528504891 | Sequence: | 528504892 | Sequence: | 528504893 | Sequence: | 528504894 | Sequence: | 528504895 | Sequence: | 528504896 | Sequence: | 528504897 | Sequence: | 528504898 | Sequence: | 528504899 | Sequence: | 528504900 | Sequence: | 528504901 | Sequence: | 528504902 | Sequence: | 528504903 | Sequence: | 528504904 | Sequence: | 528504905 | Sequence: | 528504906 | Sequence: | 528504907 | Sequence: | 528504908 | Sequence: | 528504909 | Sequence: | 528504910 | Sequence: | 528504911 | Sequence: | 528504912 | Sequence: | 528504913 | Sequence: | 528504914 | Sequence: | 528504915 | Sequence: | 528504916 | Sequence: | 528504917 | Sequence: | 528504918 | Sequence: | 528504919 | Sequence: | 528504920 | Sequence: | 528504921 | Sequence: | 528504922 | Sequence: | 528504923 | Sequence: | 528504924 | Sequence: | 528504925 | Sequence: | 528504926 | Sequence: | 528504927 | Sequence: | 528504928 | Sequence: | 528504929 | Sequence: | 528504930 | Sequence: | 528504931 | Sequence: | 528504932 | Sequence: | 528504933 | Sequence: | 528504934 | Sequence: | 528504935 | Sequence: | 528504936 | Sequence: | 528504937 | Sequence: | 528504938 | Sequence: | 528504939 | Sequence: | 528504940 | Sequence: | 528504941 | Sequence: | 528504942 | Sequence: | 528504943 | Sequence: | 528504944 | Sequence: | 528504945 | Sequence: | 528504946 | Sequence: | 528504947 | Sequence: | 528504948 | Sequence: | 528504949 | Sequence: | 528504950 | Sequence: | 528504951 | Sequence: | 528504952 | Sequence: | 528504953 | Sequence: | 528504954 | Sequence: | 528504955 | Sequence: | 528504956 | Sequence: | 528504957 | Sequence: | 528504958 | Sequence: | 528504959 | Sequence: | 528504960 | Sequence: | 528504961 | Sequence: | 528504962 | Sequence: | 528504963 | Sequence: | 528504964 | Sequence: | 528504965 | Sequence: | 528504966 | Sequence: | 528504967 | Sequence: | 528504968 | Sequence: | 528504969 | Sequence: | 528504970 | Sequence: | 528504971 | Sequence: | 528504972 | Sequence: | 528504973 | Sequence: | 528504974 | Sequence: | 528504975 | Sequence: | 528504976 | Sequence: | 528504977 | Sequence: | 528504978 | Sequence: | 528504979 | Sequence: | 528504980 | Sequence: | 528504981 | Sequence: | 528504982 | Sequence: | 528504983 | Sequence: | 528504984 | Sequence: | 528504985 | Sequence: | 528504986 | Sequence: | 528504987 | Sequence: | 528504988 | Sequence: | 528504989 | Sequence: | 528504990 | Sequence: | 528504991 | Sequence: | 528504992 | Sequence: | 528504993 | Sequence: | 528504994 | Sequence: | 528504995 | Sequence: | 528504996 | Sequence: | 528504997 | Sequence: | 528504998 | Sequence: | 528504999 | Sequence: | 528505000 | Sequence: | 528505001 | Sequence: | 528505002 | Sequence: | 528505003 | Sequence: | 528505004 | Sequence: | 528505005 | Sequence: | 528505006 | Sequence: | 528505007 | Sequence: | 528505008 | Sequence: | 528505009 | Sequence: | 528505010 | Sequence: | 528505011 | Sequence: | 528505012 | Sequence: | 528505013 | Sequence: | 528505014 | Sequence: | 528505015 | Sequence: | 528505016 | Sequence: | 528505017 | Sequence: | 528505018 | Sequence: | 528505019 | Sequence: | 528505020 | Sequence: | 528505021 | Sequence: | 528505022 | Sequence: | 528505023 | Sequence: | 528505024 | Sequence: | 528505025 | Sequence: | 528505026 | Sequence: | 528505027 | Sequence: | 528505028 | Sequence: | 528505029 | Sequence: | 528505030 | Sequence: | 528505031 | Sequence: | 528505032 | Sequence: | 528505033 | Sequence: | 528505034 | Sequence: | 528505035 | Sequence: | 528505036 | Sequence: | 528505037 | Sequence: | 528505038 | Sequence: | 528505039 | Sequence: | 528505040 | Sequence: | 528505041 | Sequence: | 528505042 | Sequence: | 528505043 | Sequence: | 528505044 | Sequence: | 528505045 | Sequence: | 528505046 | Sequence: | 528505047 | Sequence: | 528505048 | Sequence: | 528505049 | Sequence: | 528505050 | Sequence: | 528505051 | Sequence: | 528505052 | Sequence: | 528505053 | Sequence: | 528505054 | Sequence: | 528505055 | Sequence: | 528505056 | Sequence: | 528505057 | Sequence: | 528505058 | Sequence: | 528505059 | Sequence: | 528505060 | Sequence: | 528505061 | Sequence: | 528505062 | Sequence: | 528505063 | Sequence: | 528505064 | Sequence: | 528505065 | Sequence: | 528505066 | Sequence: | 528505067 | Sequence: | 528505068 | Sequence: | 528505069 | Sequence: | 528505070 | Sequence: | 528505071 | Sequence: | 528505072 | Sequence: | 528505073 | Sequence: | 528505074 | Sequence: | 528505075 | Sequence: | 528505076 | Sequence: | 528505077 | Sequence: | 528505078 | Sequence: | 528505079 | Sequence: | 528505080 | Sequence: | 528505081 | Sequence: | 528505082 | Sequence: | 528505083 | Sequence: | 528505084 | Sequence: | 528505085 | Sequence: | 528505086 | Sequence: | 528505087 | Sequence: | 528505088 | Sequence: | 528505089 | Sequence: | 528505090 | Sequence: | 528505091 | Sequence: | 528505092 | Sequence: | 528505093 | Sequence: | 528505094 | Sequence: | 528505095 | Sequence: | 528505096 | Sequence: | 528505097 | Sequence: | 528505098 | Sequence: | 528505099 | Sequence: | 528505100 | Sequence: | 528505101 | Sequence: | 528505102 | Sequence: | 528505103 | Sequence: | 528505104 | Sequence: | 528505105 | Sequence: | 528505106 | Sequence: | 528505107 | Sequence: | 528505108 | Sequence: | 528505109 | Sequence: | 528505110 | Sequence: | 528505111 | Sequence: | 528505112 | Sequence: | 528505113 | Sequence: | 528505114 | Sequence: | 528505115 | Sequence: | 528505116 | Sequence: | 528505117 | Sequence: | 528505118 | Sequence: | 528505119 | Sequence: | 528505120 | Sequence: | 528505121 | Sequence: | 528505122 | Sequence: | 528505123 | Sequence: | 528505124 | Sequence: | 528505125 | Sequence: | 528505126 | Sequence: | 528505127 | Sequence: | 528505128 | Sequence: | 528505129 | Sequence: | 528505130 | Sequence: | 528505131 | Sequence: | 528505132 | Sequence: | 528505133 | Sequence: | 528505134 | Sequence: | 528505135 | Sequence: | 528505136 | Sequence: | 528505137 | Sequence: | 528505138 | Sequence: | 528505139 | Sequence: | 528505140 | Sequence: | 528505141 | Sequence: | 528505142 | Sequence: | 528505143 | Sequence: | 528505144 | Sequence: | 528505145 | Sequence: | 528505146 | Sequence: | 528505147 | Sequence: | 528505148 | Sequence: | 528505149 | Sequence: | 528505150 | Sequence: | 528505151 | Sequence: | 528505152 | Sequence: | 528505153 | Sequence: | 528505154 | Sequence: | 528505155 | Sequence: | 528505156 | Sequence: | 528505157 | Sequence: | 528505158 | Sequence: | 528505159 | Sequence: | 528505160 | Sequence: | 528505161 | Sequence: | 528505162 | Sequence: | 528505163 | Sequence: | 528505164 | Sequence: | 528505165 | Sequence: | 528505166 | Sequence: | 528505167 | Sequence: | 528505168 | Sequence: | 528505169 | Sequence: | 528505170 | Sequence: | 528505171 | Sequence: | 528505172 | Sequence: | 528505173 | Sequence: | 528505174 | Sequence: | 528505175 | Sequence: | 528505176 | Sequence: | 528505177 | Sequence: | 528505178 | Sequence: | 528505179 | Sequence: | 528505180 | Sequence: | 528505181 | Sequence: | 528505182 | Sequence: | 528505183 | Sequence: | 528505184 | Sequence: | 528505185 | Sequence: | 528505186 | Sequence: | 528505187 | Sequence: | 528505188 | Sequence: | 528505189 | Sequence: | 528505190 | Sequence: | 528505191 | Sequence: | 528505192 | Sequence: | 528505193 | Sequence: | 528505194 | Sequence: | 528505195 | Sequence: | 528505196 | Sequence: | 528505197 | Sequence: | 528505198 | Sequence: | 528505199 | Sequence: | 528505200 | Sequence: | 528505201 | Sequence: | 528505202 | Sequence: | 528505203 | Sequence: | 528505204 | Sequence: | 528505205 | Sequence: | 528505206 | Sequence: | 528505207 | Sequence: | 528505208 | Sequence: | 528505209 | Sequence: | 528505210 | Sequence: | 528505211 | Sequence: | 528505212 | Sequence: | 528505213 | Sequence: | 528505214 | Sequence: | 528505215 | Sequence: | 528505216 | Sequence: | 528505217 | Sequence: | 528505218 | Sequence: | 528505219 | Sequence: | 528505220 | Sequence: | 528505221 | Sequence: | 528505222 | Sequence: | 528505223 | Sequence: | 528505224 | Sequence: | 528505225 | Sequence: | 528505226 | Sequence: | 528505227 | Sequence: | 528505228 | Sequence: | 528505229 | Sequence: | 528505230 | Sequence: | 528505231 | Sequence: | 528505232 | Sequence: | 528505233 | Sequence: | 528505234 | Sequence: | 528505235 | Sequence: | 528505236 | Sequence: | 528505237 | Sequence: | 528505238 | Sequence: | 528505239 | Sequence: | 528505240 | Sequence: | 528505241 | Sequence: | 528505242 | Sequence: | 528505243 | Sequence: | 528505244 | Sequence: | 528505245 | Sequence: | 528505246 | Sequence: | 528505247 | Sequence: | 528505248 | Sequence: | 528505249 | Sequence: | 528505250 | Sequence: | 528505251 | Sequence: | 528505252 | Sequence: | 528505253 | Sequence: | 528505254 | Sequence: | 528505255 | Sequence: | 528505256 | Sequence: | 528505257 | Sequence: | 528505258 | Sequence: | 528505259 | Sequence: | 528505260 | Sequence: | 528505261 | Sequence: | 528505262 | Sequence: | 528505263 | Sequence: | 528505264 | Sequence: | 528505265 | Sequence: | 528505266 | Sequence: | 528505267 | Sequence: | 528505268 | Sequence: | 528505269 | Sequence: | 528505270 | Sequence: | 528505271 | Sequence: | 528505272 | Sequence: | 528505273 | Sequence: | 528505274 | Sequence: | 528505275 | Sequence: | 528505276 | Sequence: | 528505277 | Sequence: | 528505278 | Sequence: | 528505279 | Sequence: | 528505280 | Sequence: | 528505281 | Sequence: | 528505282 | Sequence: | 528505283 | Sequence: | 528505284 | Sequence: | 528505285 | Sequence: | 528505286 | Sequence: | 528505287 | Sequence: | 528505288 | Sequence: | 528505289 | Sequence: | 528505290 | Sequence: | 528505291 | Sequence: | 528505292 | Sequence: | 528505293 | Sequence: | 528505294 | Sequence: | 528505295 | Sequence: | 528505296 | Sequence: | 528505297 | Sequence: | 528505298 | Sequence: | 528505299 | Sequence: | 528505300 | Sequence: | 528505301 | Sequence: | 528505302 | Sequence: | 528505303 | Sequence: | 528505304 | Sequence: | 528505305 | Sequence: | 528505306 | Sequence: | 528505307 | Sequence: | 528505308 | Sequence: | 528505309 | Sequence: | 528505310 | Sequence: | 528505311 | Sequence: | 528505312 | Sequence: | 528505313 | Sequence: | 528505314 | Sequence: | 528505315 | Sequence: | 528505316 | Sequence: | 528505317 | Sequence: | 528505318 | Sequence: | 528505319 | Sequence: | 528505320 | Sequence: | 528505321 | Sequence: | 528505322 | Sequence: | 528505323 | Sequence: | 528505324 | Sequence: | 528505325 | Sequence: | 528505326 | Sequence: | 528505327 | Sequence: | 528505328 | Sequence: | 528505329 | Sequence: | 528505330 | Sequence: | 528505331 | Sequence: | 528505332 | Sequence: | 528505333 | Sequence: | 528505334 | Sequence: | 528505335 | Sequence: | 528505336 | Sequence: | 528505337 | Sequence: | 528505338 | Sequence: | 528505339 | Sequence: | 528505340 | Sequence: | 528505341 | Sequence: | 528505342 | Sequence: | 528505343 | Sequence: | 528505344 | Sequence: | 528505345 | Sequence: | 528505346 | Sequence: | 528505347 | Sequence: | 528505348 | Sequence: | 528505349 | Sequence: | 528505350 | Sequence: | 528505351 | Sequence: | 528505352 | Sequence: | 528505353 | Sequence: | 528505354 | Sequence: | 528505355 | Sequence: | 528505356 | Sequence: | 528505357 | Sequence: | 528505358 | Sequence: | 528505359 | Sequence: | 528505360 | Sequence: | 528505361 | Sequence: | 528505362 | Sequence: | 528505363 | Sequence: | 528505364 | Sequence: | 528505365 | Sequence: | 528505366 | Sequence: | 528505367 | Sequence: | 528505368 | Sequence: | 528505369 | Sequence: | 528505370 | Sequence: | 528505371 | Sequence: | 528505372 | Sequence: | 528505373 | Sequence: | 528505374 | Sequence: | 528505375 | Sequence: | 528505376 | Sequence: | 528505377 | Sequence: | 528505378 | Sequence: | 528505379 | Sequence: | 528505380 | Sequence: | 528505381 | Sequence: | 528505382 | Sequence: | 528505383 | Sequence: | 528505384 | Sequence: | 528505385 | Sequence: | 528505386 | Sequence: | 528505387 | Sequence: | 528505388 | Sequence: | 528505389 | Sequence: | 528505390 | Sequence: | 528505391 | Sequence: | 528505392 | Sequence: | 528505393 | Sequence: | 528505394 | Sequence: | 528505395 | Sequence: | 528505396 | Sequence: | 528505397 | Sequence: | 528505398 | Sequence: | 528505399 | Sequence: | 528505400 | Sequence: | 528505401 | Sequence: | 528505402 | Sequence: | 528505403 | Sequence: | 528505404 | Sequence: | 528505405 | Sequence: | 528505406 | Sequence: | 528505407 | Sequence: | 528505408 | Sequence: | 528505409 | Sequence: | 528505410 | Sequence: | 528505411 | Sequence: | 528505412 | Sequence: | 528505413 | Sequence: | 528505414 | Sequence: | 528505415 | Sequence: | 528505416 | Sequence: | 528505417 | Sequence: | 528505418 | Sequence: | 528505419 | Sequence: | 528505420 | Sequence: | 528505421 | Sequence: | 528505422 | Sequence: | 528505423 | Sequence: | 528505424 | Sequence: | 528505425 | Sequence: | 528505426 | Sequence: | 528505427 | Sequence: | 528505428 | Sequence: | 528505429 | Sequence: | 528505430 | Sequence: | 528505431 | Sequence: | 528505432 | Sequence: | 528505433 | Sequence: | 528505434 | Sequence: | 528505435 | Sequence: | 528505436 | Sequence: | 528505437 | Sequence: | 528505438 | Sequence: | 528505439 | Sequence: | 528505440 | Sequence: | 528505441 | Sequence: | 528505442 | Sequence: | 528505443 | Sequence: | 528505444 | Sequence: | 528505445 | Sequence: | 528505446 | Sequence: | 528505447 | Sequence: | 528505448 | Sequence: | 528505449 | Sequence: | 528505450 | Sequence: | 528505451 | Sequence: | 528505452 | Sequence: | 528505453 | Sequence: | 528505454 | Sequence: | 528505455 | Sequence: | 528505456 | Sequence: | 528505457 | Sequence: | 528505458 | Sequence: | 528505459 | Sequence: | 528505460 | Sequence: | 528505461 | Sequence: | 528505462 | Sequence: | 528505463 | Sequence: | 528505464 | Sequence: | 528505465 | Sequence: | 528505466 | Sequence: | 528505467 | Sequence: | 528505468 | Sequence: | 528505469 | Sequence: | 528505470 | Sequence: | 528505471 | Sequence: | 528505472 | Sequence: | 528505473 | Sequence: | 528505474 | Sequence: | 528505475 | Sequence: | 528505476 | Sequence: | 528505477 | Sequence: | 528505478 | Sequence: | 528505479 | Sequence: | 528505480 | Sequence: | 528505481 | Sequence: | 528505482 | Sequence: | 528505483 | Sequence: | 528505484 | Sequence: | 528505485 | Sequence: | 528505486 | Sequence: | 528505487 | Sequence: | 528505488 | Sequence: | 528505489 | Sequence: | 528505490 | Sequence: | 528505491 | Sequence: | 528505492 | Sequence: | 528505493 | Sequence: | 528505494 | Sequence: | 528505495 | Sequence: | 528505496 | Sequence: | 528505497 | Sequence: | 528505498 | Sequence: | 528505499 | Sequence: | 528505500 | Sequence: | 528505501 | Sequence: | 528505502 | Sequence: | 528505503 | Sequence: | 528505504 | Sequence: | 528505505 | Sequence: | 528505506 | Sequence: | 528505507 | Sequence: | 528505508 | Sequence: | 528505509 | Sequence: | 528505510 | Sequence: | 528505511 | Sequence: | 528505512 | Sequence: | 528505513 | Sequence: | 528505514 | Sequence: | 528505515 | Sequence: | 528505516 | Sequence: | 528505517 | Sequence: | 528505518 | Sequence: | 528505519 | Sequence: | 528505520 | Sequence: | 528505521 | Sequence: | 528505522 | Sequence: | 528505523 | Sequence: | 528505524 | Sequence: | 528505525 | Sequence: | 528505526 | Sequence: | 528505527 | Sequence: | 528505528 | Sequence: | 528505529 | Sequence: | 528505530 | Sequence: | 528505531 | Sequence: | 528505532 | Sequence: | 528505533 | Sequence: | 528505534 | Sequence: | 528505535 | Sequence: | 528505536 | Sequence: | 528505537 | Sequence: | 528505538 | Sequence: | 528505539 | Sequence: | 528505540 | Sequence: | 528505541 | Sequence: | 528505542 | Sequence: | 528505543 | Sequence: | 528505544 | Sequence: | 528505545 | Sequence: | 528505546 | Sequence: | 528505547 | Sequence: | 528505548 | Sequence: | 528505549 | Sequence: | 528505550 | Sequence: | 528505551 | Sequence: | 528505552 | Sequence: | 528505553 | Sequence: | 528505554 | Sequence: | 528505555 | Sequence: | 528505556 | Sequence: | 528505557 | Sequence: | 528505558 | Sequence: | 528505559 | Sequence: | 528505560 | Sequence: | 528505561 | Sequence: | 528505562 | Sequence: | 528505563 | Sequence: | 528505564 | Sequence: | 528505565 | Sequence: | 528505566 | Sequence: | 528505567 | Sequence: | 528505568 | Sequence: | 528505569 | Sequence: | 528505570 | Sequence: | 528505571 | Sequence: | 528505572 | Sequence: | 528505573 | Sequence: | 528505574 | Sequence: | 528505575 | Sequence: | 528505576 | Sequence: | 528505577 | Sequence: | 528505578 | Sequence: | 528505579 | Sequence: | 528505580 | Sequence: | 528505581 | Sequence: | 528505582 | Sequence: | 528505583 | Sequence: | 528505584 | Sequence: | 528505585 | Sequence: | 528505586 | Sequence: | 528505587 | Sequence: | 528505588 | Sequence: | 528505589 | Sequence: | 528505590 | Sequence: | 528505591 | Sequence: | 528505592 | Sequence: | 528505593 | Sequence: | 528505594 | Sequence: | 528505595 | Sequence: | 528505596 | Sequence: | 528505597 | Sequence: | 528505598 | Sequence: | 528505599 | Sequence: | 528505600 | Sequence: | 528505601 | Sequence: | 528505602 | Sequence: | 528505603 | Sequence: | 528505604 | Sequence: | 528505605 | Sequence: | 528505606 | Sequence: | 528505607 | Sequence: | 528505608 | Sequence: | 528505609 | Sequence: | 528505610 | Sequence: | 528505611 | Sequence: | 528505612 | Sequence: | 528505613 | Sequence: | 528505614 | Sequence: | 528505615 | Sequence: | 528505616 | Sequence: | 528505617 | Sequence: | 528505618 | Sequence: | 528505619 | Sequence: | 528505620 | Sequence: | 528505621 | Sequence: | 528505622 | Sequence: | 528505623 | Sequence: | 528505624 | Sequence: | 528505625 | Sequence: | 528505626 | Sequence: | 528505627 | Sequence: | 528505628 | Sequence: | 528505629 | Sequence: | 528505630 | Sequence: | 528505631 | Sequence: | 528505632 | Sequence: | 528505633 | Sequence: | 528505634 | Sequence: | 528505635 | Sequence: | 528505636 | Sequence: | 528505637 | Sequence: | 528505638 | Sequence: | 528505639 | Sequence: | 528505640 | Sequence: | 528505641 | Sequence: | 528505642 | Sequence: | 528505643 | Sequence: | 528505644 | Sequence: | 528505645 | Sequence: | 528505646 | Sequence: | 528505647 | Sequence: | 528505648 | Sequence: | 528505649 | Sequence: | 528505650 | Sequence: | 528505651 | Sequence: | 528505652 | Sequence: | 528505653 | Sequence: | 528505654 | Sequence: | 528505655 | Sequence: | 528505656 | Sequence: | 528505657 | Sequence: | 528505658 | Sequence: | 528505659 | Sequence: | 528505660 | Sequence: | 528505661 | Sequence: | 528505662 | Sequence: | 528505663 | Sequence: | 528505664 | Sequence: | 528505665 | Sequence: | 528505666 | Sequence: | 528505667 | Sequence: | 528505668 | Sequence: | 528505669 | Sequence: | 528505670 | Sequence: | 528505671 | Sequence: | 528505672 | Sequence: | 528505673 | Sequence: | 528505674 | Sequence: | 528505675 | Sequence: | 528505676 | Sequence: | 528505677 | Sequence: | 528505678 | Sequence: | 528505679 | Sequence: | 528505680 | Sequence: | 528505681 | Sequence: | 528505682 | Sequence: | 528505683 | Sequence: | 528505684 | Sequence: | 528505685 | Sequence: | 528505686 | Sequence: | 528505687 | Sequence: | 528505688 | Sequence: | 528505689 | Sequence: | 528505690 | Sequence: | 528505691 | Sequence: | 528505692 | Sequence: | 528505693 | Sequence: | 528505694 | Sequence: | 528505695 | Sequence: | 528505696 | Sequence: | 528505697 | Sequence: | 528505698 | Sequence: | 528505699 | Sequence: | 528505700 | Sequence: | 528505701 | Sequence: | 528505702 | Sequence: | 528505703 | Sequence: | 528505704 | Sequence: | 528505705 | Sequence: | 528505706 | Sequence: | 528505707 | Sequence: | 528505708 | Sequence: | 528505709 | Sequence: | 528505710 | Sequence: | 528505711 | Sequence: | 528505712 | Sequence: | 528505713 | Sequence: | 528505714 | Sequence: | 528505715 | Sequence: | 528505716 | Sequence: | 528505717 | Sequence: | 528505718 | Sequence: | 528505719 | Sequence: | 528505720 | Sequence: | 528505721 | Sequence: | 528505722 | Sequence: | 528505723 | Sequence: | 528505724 | Sequence: | 528505725 | Sequence: | 528505726 | Sequence: | 528505727 | Sequence: | 528505728 | Sequence: | 528505729 | Sequence: | 528505730 | Sequence: | 528505731 | Sequence: | 528505732 | Sequence: | 528505733 | Sequence: | 528505734 | Sequence: | 528505735 | Sequence: | 528505736 | Sequence: | 528505737 | Sequence: | 528505738 | Sequence: | 528505739 | Sequence: | 528505740 | Sequence: | 528505741 | Sequence: | 528505742 | Sequence: | 528505743 | Sequence: | 528505744 | Sequence: | 528505745 | Sequence: | 528505746 | Sequence: | 528505747 | Sequence: | 528505748 | Sequence: | 528505749 | Sequence: | 528505750 | Sequence: | 528505751 | Sequence: | 528505752 | Sequence: | 528505753 | Sequence: | 528505754 | Sequence: | 528505755 | Sequence: | 528505756 | Sequence: | 528505757 | Sequence: | 528505758 | Sequence: | 528505759 | Sequence: | 528505760 | Sequence: | 528505761 | Sequence: | 528505762 | Sequence: | 528505763 | Sequence: | 528505764 | Sequence: | 528505765 | Sequence: | 528505766 | Sequence: | 528505767 | Sequence: | 528505768 | Sequence: | 528505769 | Sequence: | 528505770 | Sequence: | 528505771 | Sequence: | 528505772 | Sequence: | 528505773 | Sequence: | 528505774 | Sequence: | 528505775 | Sequence: | 528505776 | Sequence: | 528505777 | Sequence: | 528505778 | Sequence: | 528505779 | Sequence: | 528505780 | Sequence: | 528505781 | Sequence: | 528505782 | Sequence: | 528505783 | Sequence: | 528505784 | Sequence: | 528505785 | Sequence: | 528505786 | Sequence: | 528505787 | Sequence: | 528505788 | Sequence: | 528505789 | Sequence: | 528505790 | Sequence: | 528505791 | Sequence: | 528505792 | Sequence: | 528505793 | Sequence: | 528505794 | Sequence: | 528505795 | Sequence: | 528505796 | Sequence: | 528505797 | Sequence: | 528505798 | Sequence: | 528505799 | Sequence: | 528505800 | Sequence: | 528505801 | Sequence: | 528505802 | Sequence: | 528505803 | Sequence: | 528505804 | Sequence: | 528505805 | Sequence: | 528505806 | Sequence: | 528505807 | Sequence: | 528505808 | Sequence: | 528505809 | Sequence: | 528505810 | Sequence: | 528505811 | Sequence: | 528505812 | Sequence: | 528505813 | Sequence: | 528505814 | Sequence: | 528505815 | Sequence: | 528505816 | Sequence: | 528505817 | Sequence: | 528505818 | Sequence: | 528505819 | Sequence: | 528505820 | Sequence: | 528505821 | Sequence: | 528505822 | Sequence: | 528505823 | Sequence: | 528505824 | Sequence: | 528505825 | Sequence: | 528505826 | Sequence: | 528505827 | Sequence: | 528505828 | Sequence: | 528505829 | Sequence: | 528505830 | Sequence: | 528505831 | Sequence: | 528505832 | Sequence: | 528505833 | Sequence: | 528505834 | Sequence: | 528505835 | Sequence: | 528505836 | Sequence: | 528505837 | Sequence: | 528505838 | Sequence: | 528505839 | Sequence: | 528505840 | Sequence: | 528505841 | Sequence: | 528505842 | Sequence: | 528505843 | Sequence: | 528505844 | Sequence: | 528505845 | Sequence: | 528505846 | Sequence: | 528505847 | Sequence: | 528505848 | Sequence: | 528505849 | Sequence: | 528505850 | Sequence: | 528505851 | Sequence: | 528505852 | Sequence: | 528505853 | Sequence: | 528505854 | Sequence: | 528505855 | Sequence: | 528505856 | Sequence: | 528505857 | Sequence: | 528505858 | Sequence: | 528505859 | Sequence: | 528505860 | Sequence: | 528505861 | Sequence: | 528505862 | Sequence: | 528505863 | Sequence: | 528505864 | Sequence: | 528505865 | Sequence: | 528505866 | Sequence: | 528505867 | Sequence: | 528505868 | Sequence: | 528505869 | Sequence: | 528505870 | Sequence: | 528505871 | Sequence: | 528505872 | Sequence: | 528505873 | Sequence: | 528505874 | Sequence: | 528505875 | Sequence: | 528505876 | Sequence: | 528505877 | Sequence: | 528505878 | Sequence: | 528505879 | Sequence: | 528505880 | Sequence: | 528505881 | Sequence: | 528505882 | Sequence: | 528505883 | Sequence: | 528505884 | Sequence: | 528505885 | Sequence: | 528505886 | Sequence: | 528505887 | Sequence: | 528505888 | Sequence: | 528505889 | Sequence: | 528505890 | Sequence: | 528505891 | Sequence: | 528505892 | Sequence: | 528505893 | Sequence: | 528505894 | Sequence: | 528505895 | Sequence: | 528505896 | Sequence: | 528505897 | Sequence: | 528505898 | Sequence: | 528505899 | Sequence: | 528505900 | Sequence: | 528505901 | Sequence: | 528505902 | Sequence: | 528505903 | Sequence: | 528505904 | Sequence: | 528505905 | Sequence: | 528505906 | Sequence: | 528505907 | Sequence: | 528505908 | Sequence: | 528505909 | Sequence: | 528505910 | Sequence: | 528505911 | Sequence: | 528505912 | Sequence: | 528505913 | Sequence: | 528505914 | Sequence: | 528505915 | Sequence: | 528505916 | Sequence: | 528505917 | Sequence: | 528505918 | Sequence: | 528505919 | Sequence: | 528505920 | Sequence: | 528505921 | Sequence: | 528505922 | Sequence: | 528505923 | Sequence: | 528505924 | Sequence: | 528505925 | Sequence: | 528505926 | Sequence: | 528505927 | Sequence: | 528505928 | Sequence: | 528505929 | Sequence: | 528505930 | Sequence: | 528505931 | Sequence: | 528505932 | Sequence: | 528505933 | Sequence: | 528505934 | Sequence: | 528505935 | Sequence: | 528505936 | Sequence: | 528505937 | Sequence: | 528505938 | Sequence: | 528505939 | Sequence: | 528505940 | Sequence: | 528505941 | Sequence: | 528505942 | Sequence: | 528505943 | Sequence: | 528505944 | Sequence: | 528505945 | Sequence: | 528505946 | Sequence: | 528505947 | Sequence: | 528505948 | Sequence: | 528505949 | Sequence: | 528505950 | Sequence: | 528505951 | Sequence: | 528505952 | Sequence: | 528505953 | Sequence: | 528505954 | Sequence: | 528505955 | Sequence: | 528505956 | Sequence: | 528505957 | Sequence: | 528505958 | Sequence: | 528505959 | Sequence: | 528505960 | Sequence: | 528505961 | Sequence: | 528505962 | Sequence: | 528505963 | Sequence: | 528505964 | Sequence: | 528505965 | Sequence: | 528505966 | Sequence: | 528505967 | Sequence: | 528505968 | Sequence: | 528505969 | Sequence: | 528505970 | Sequence: | 528505971 | Sequence: | 528505972 | Sequence: | 528505973 | Sequence: | 528505974 | Sequence: | 528505975 | Sequence: | 528505976 | Sequence: | 528505977 | Sequence: | 528505978 | Sequence: | 528505979 | Sequence: | 528505980 | Sequence: | 528505981 | Sequence: | 528505982 | Sequence: | 528505983 | Sequence: | 528505984 | Sequence: | 528505985 | Sequence: | 528505986 | Sequence: | 528505987 | Sequence: | 528505988 | Sequence: | 528505989 | Sequence: | 528505990 | Sequence: | 528505991 | Sequence: | 528505992 | Sequence: | 528505993 | Sequence: | 528505994 | Sequence: | 528505995 | Sequence: | 528505996 | Sequence: | 528505997 | Sequence: | 528505998 | Sequence: | 528505999 | Sequence: | 528506000 | Sequence: | 528506001 | Sequence: | 528506002 | Sequence: | 528506003 | Sequence: | 528506004 | Sequence: | 528506005 | Sequence: | 528506006 | Sequence: | 528506007 | Sequence: | 528506008 | Sequence: | 528506009 | Sequence: | 528506010 | Sequence: | 528506011 | Sequence: | 528506012 | Sequence: | 528506013 | Sequence: | 528506014 | Sequence: | 528506015 | Sequence: | 528506016 | Sequence: | 528506017 | Sequence: | 528506018 | Sequence: | 528506019 | Sequence: | 528506020 | Sequence: | 528506021 | Sequence: | 528506022 | Sequence: | 528506023 | Sequence: | 528506024 | Sequence: | 528506025 | Sequence: | 528506026 | Sequence: | 528506027 | Sequence: | 528506028 | Sequence: | 528506029 | Sequence: | 528506030 | Sequence: | 528506031 | Sequence: | 528506032 | Sequence: | 528506033 | Sequence: | 528506034 | Sequence: | 528506035 | Sequence: | 528506036 | Sequence: | 528506037 | Sequence: | 528506038 | Sequence: | 528506039 | Sequence: | 528506040 | Sequence: | 528506041 | Sequence: | 528506042 | Sequence: | 528506043 | Sequence: | 528506044 | Sequence: | 528506045 | Sequence: | 528506046 | Sequence: | 528506047 | Sequence: | 528506048 | Sequence: | 528506049 | Sequence: | 528506050 | Sequence: | 528506051 | Sequence: | 528506052 | Sequence: | 528506053 | Sequence: | 528506054 | Sequence: | 528506055 | Sequence: | 528506056 | Sequence: | 528506057 | Sequence: | 528506058 | Sequence: | 528506059 | Sequence: | 528506060 | Sequence: | 528506061 | Sequence: | 528506062 | Sequence: | 528506063 | Sequence: | 528506064 | Sequence: | 528506065 | Sequence: | 528506066 | Sequence: | 528506067 | Sequence: | 528506068 | Sequence: | 528506069 | Sequence: | 528506070 | Sequence: | 528506071 | Sequence: | 528506072 | Sequence: | 528506073 | Sequence: | 528506074 | Sequence: | 528506075 | Sequence: | 528506076 | Sequence: | 528506077 | Sequence: | 528506078 | Sequence: | 528506079 | Sequence: | 528506080 | Sequence: | 528506081 | Sequence: | 528506082 | Sequence: | 528506083 | Sequence: | 528506084 | Sequence: | 528506085 | Sequence: | 528506086 | Sequence: | 528506087 | Sequence: | 528506088 | Sequence: | 528506089 | Sequence: | 528506090 | Sequence: | 528506091 | Sequence: | 528506092 | Sequence: | 528506093 | Sequence: | 528506094 | Sequence: | 528506095 | Sequence: | 528506096 | Sequence: | 528506097 | Sequence: | 528506098 | Sequence: | 528506099 | Sequence: | 528506100 | Sequence: | 528506101 | Sequence: | 528506102 | Sequence: | 528506103 | Sequence: | 528506104 | Sequence: | 528506105 | Sequence: | 528506106 | Sequence: | 528506107 | Sequence: | 528506108 | Sequence: | 528506109 | Sequence: | 528506110 | Sequence: | 528506111 | Sequence: | 528506112 | Sequence: | 528506113 | Sequence: | 528506114 | Sequence: | 528506115 | Sequence: | 528506116 | Sequence: | 528506117 | Sequence: | 528506118 | Sequence: | 528506119 | Sequence: | 528506120 | Sequence: | 528506121 | Sequence: | 528506122 | Sequence: | 528506123 | Sequence: | 528506124 | Sequence: | 528506125 | Sequence: | 528506126 | Sequence: | 528506127 |
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| Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 | Result Group Id | 56112569 | Result Group Id | 56112570 | Result Group Id | 56112571 | Result Group Id | 56112572 | Result Group Id | 56112573 | Result Group Id | 56112574 | Result Group Id | 56112575 | Result Group Id | 56112576 | Result Group Id | 56112577 |
Ctgov Group Code | EG001 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | 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Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 |
Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) | Time Frame | Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up) |
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Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 | Subjects At Risk | 34 | Subjects At Risk | 35 | Subjects At Risk | 23 | Subjects At Risk | 18 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 13 | Subjects At Risk | 5 | Subjects At Risk | 5 |
Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Description | TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. |
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| Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 2 | Event Count | 2 | Event Count | 2 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event 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| Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 3 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 3 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 0 |
Organ System | Cardiac disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Blood and lymphatic system disorders | Organ System | Cardiac disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections 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infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Eye disorders | Organ System | Eye disorders | Organ System | Eye disorders | Organ System | Eye disorders | Organ System | Eye disorders | Organ System | Eye disorders | Organ System | Eye disorders | Organ System | Eye disorders | Organ System | Eye disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders |
Adverse Event Term | Tachycardia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Tachycardia | Adverse Event Term | Tachycardia | Adverse Event Term | Tachycardia | Adverse Event Term | Tachycardia | Adverse Event Term | Anaemia | Adverse Event Term | Tachycardia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute coronary syndrome | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute left ventricular failure | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Acute myocardial infarction | Adverse Event Term | Atrial flutter | Adverse Event Term | Atrial flutter | Adverse Event Term | Atrial flutter | Adverse Event Term | Atrial flutter | Adverse Event Term | Atrial flutter | Adverse Event Term | Atrial flutter | Adverse Event Term | Atrial flutter | Adverse Event Term | Atrial flutter | Adverse Event Term | Atrial flutter | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac arrest | Adverse Event Term | Cardiac failure | Adverse Event Term | Cardiac failure | Adverse Event Term | Cardiac failure | Adverse Event Term | Cardiac failure | Adverse Event Term | Cardiac failure | Adverse Event Term | Cardiac failure | Adverse Event Term | Cardiac failure | Adverse Event Term | Cardiac failure | Adverse Event Term | Cardiac failure | Adverse Event Term | Tachycardia | Adverse Event Term | Tachycardia | Adverse Event Term | Tachycardia | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrointestinal haemorrhage | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated inguinal hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Incarcerated umbilical hernia | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Pancreatitis | Adverse Event Term | Pancreatitis | Adverse Event Term | Pancreatitis | Adverse Event Term | Pancreatitis | Adverse Event Term | Pancreatitis | Adverse Event Term | Pancreatitis | Adverse Event Term | Pancreatitis | Adverse Event Term | Pancreatitis | Adverse Event Term | Pancreatitis | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Catheter site thrombosis | Adverse Event Term | Death | Adverse Event Term | Death | Adverse Event Term | Death | Adverse Event Term | Death | Adverse Event Term | Death | Adverse Event Term | Death | Adverse Event Term | Death | Adverse Event Term | Death | Adverse Event Term | Death | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Non-cardiac chest pain | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Cholecystitis acute | Adverse Event Term | Liver injury | Adverse Event Term | Liver injury | Adverse Event Term | Liver injury | Adverse Event Term | Liver injury | Adverse Event Term | Liver injury | Adverse Event Term | Liver injury | Adverse Event Term | Liver injury | Adverse Event Term | Liver injury | Adverse Event Term | Liver injury | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Gangrene | Adverse Event Term | Gangrene | Adverse Event Term | Gangrene | Adverse Event Term | Gangrene | Adverse Event Term | Gangrene | Adverse Event Term | Gangrene | Adverse Event Term | Gangrene | Adverse Event Term | Gangrene | Adverse Event Term | Gangrene | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Osteomyelitis | Adverse Event Term | Osteomyelitis | Adverse Event Term | Osteomyelitis | Adverse Event Term | Osteomyelitis | Adverse Event Term | Osteomyelitis | Adverse Event Term | Osteomyelitis | Adverse Event Term | Osteomyelitis | Adverse Event Term | Osteomyelitis | Adverse Event Term | Osteomyelitis | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Pneumonia bacterial | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Staphylococcal bacteraemia | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula site complication | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Arteriovenous graft thrombosis | Adverse Event Term | Facial bones fracture | Adverse Event Term | Facial bones fracture | Adverse Event Term | Facial bones fracture | Adverse Event Term | Facial bones fracture | Adverse Event Term | Facial bones fracture | Adverse Event Term | Facial bones fracture | Adverse Event Term | Facial bones fracture | Adverse Event Term | Facial bones fracture | Adverse Event Term | Facial bones fracture | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Humerus fracture | Adverse Event Term | Humerus fracture | Adverse Event Term | Humerus fracture | Adverse Event Term | Humerus fracture | Adverse Event Term | Humerus fracture | Adverse Event Term | Humerus fracture | Adverse Event Term | Humerus fracture | Adverse Event Term | Humerus fracture | Adverse Event Term | Humerus fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Rib fracture | Adverse Event Term | Subdural haematoma | Adverse Event Term | Subdural haematoma | Adverse Event Term | Subdural haematoma | Adverse Event Term | Subdural haematoma | Adverse Event Term | Subdural haematoma | Adverse Event Term | Subdural haematoma | Adverse Event Term | Subdural haematoma | Adverse Event Term | Subdural haematoma | Adverse Event Term | Subdural haematoma | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Vascular pseudoaneurysm | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Hypoglycaemia | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Intervertebral disc protrusion | Adverse Event Term | Osteoarthritis | Adverse Event Term | Osteoarthritis | Adverse Event Term | Osteoarthritis | Adverse Event Term | Osteoarthritis | Adverse Event Term | Osteoarthritis | Adverse Event Term | Osteoarthritis | Adverse Event Term | Osteoarthritis | Adverse Event Term | Osteoarthritis | Adverse Event Term | Osteoarthritis | Adverse Event Term | Facial paralysis | Adverse Event Term | Facial paralysis | Adverse Event Term | Facial paralysis | Adverse Event Term | Facial paralysis | Adverse Event Term | Facial paralysis | Adverse Event Term | Facial paralysis | Adverse Event Term | Facial paralysis | Adverse Event Term | Facial paralysis | Adverse Event Term | Facial paralysis | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Hypertensive encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Metabolic encephalopathy | Adverse Event Term | Seizure | Adverse Event Term | Seizure | Adverse Event Term | Seizure | Adverse Event Term | Seizure | Adverse Event Term | Seizure | Adverse Event Term | Seizure | Adverse Event Term | Seizure | Adverse Event Term | Seizure | Adverse Event Term | Seizure | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Subarachnoid haemorrhage | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Transient ischaemic attack | Adverse Event Term | Haematuria | Adverse Event Term | Haematuria | Adverse Event Term | Haematuria | Adverse Event Term | Haematuria | Adverse Event Term | Haematuria | Adverse Event Term | Haematuria | Adverse Event Term | Haematuria | Adverse Event Term | Haematuria | Adverse Event Term | Haematuria | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Subcapsular renal haematoma | Adverse Event Term | Nipple pain | Adverse Event Term | Nipple pain | Adverse Event Term | Nipple pain | Adverse Event Term | Nipple pain | Adverse Event Term | Nipple pain | Adverse Event Term | Nipple pain | Adverse Event Term | Nipple pain | Adverse Event Term | Nipple pain | Adverse Event Term | Nipple pain | Adverse Event Term | Uterine mass | Adverse Event Term | Uterine mass | Adverse Event Term | Uterine mass | Adverse Event Term | Uterine mass | Adverse Event Term | Uterine mass | Adverse Event Term | Uterine mass | Adverse Event Term | Uterine mass | Adverse Event Term | Uterine mass | Adverse Event Term | Uterine mass | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Acute pulmonary oedema | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Pulmonary embolism | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Petechiae | Adverse Event Term | Petechiae | Adverse Event Term | Petechiae | Adverse Event Term | Petechiae | Adverse Event Term | Petechiae | Adverse Event Term | Petechiae | Adverse Event Term | Petechiae | Adverse Event Term | Petechiae | Adverse Event Term | Petechiae | Adverse Event Term | Pancreas transplant | Adverse Event Term | Pancreas transplant | Adverse Event Term | Pancreas transplant | Adverse Event Term | Pancreas transplant | Adverse Event Term | Pancreas transplant | Adverse Event Term | Pancreas transplant | Adverse Event Term | Pancreas transplant | Adverse Event Term | Pancreas transplant | Adverse Event Term | Pancreas transplant | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Accelerated hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive crisis | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypertensive urgency | Adverse Event Term | Hypotension | Adverse Event Term | Hypotension | Adverse Event Term | Hypotension | Adverse Event Term | Hypotension | Adverse Event Term | Hypotension | Adverse Event Term | Hypotension | Adverse Event Term | Hypotension | Adverse Event Term | Hypotension | Adverse Event Term | Hypotension | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Subclavian artery stenosis | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Nephrogenic anaemia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Thrombocytopenia | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Arteriosclerosis coronary artery | Adverse Event Term | Bundle branch block right | Adverse Event Term | Bundle branch block right | Adverse Event Term | Bundle branch block right | Adverse Event Term | Bundle branch block right | Adverse Event Term | Bundle branch block right | Adverse Event Term | Bundle branch block right | Adverse Event Term | Bundle branch block right | Adverse Event Term | Bundle branch block right | Adverse Event Term | Bundle branch block right | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Diastolic dysfunction | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Left atrial enlargement | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Mitral valve incompetence | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Right atrial enlargement | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Sinus tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Supraventricular tachycardia | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Systolic dysfunction | Adverse Event Term | Tinnitus | Adverse Event Term | Tinnitus | Adverse Event Term | Tinnitus | Adverse Event Term | Tinnitus | Adverse Event Term | Tinnitus | Adverse Event Term | Tinnitus | Adverse Event Term | Tinnitus | Adverse Event Term | Tinnitus | Adverse Event Term | Tinnitus | Adverse Event Term | Cataract | Adverse Event Term | Cataract | Adverse Event Term | Cataract | Adverse Event Term | Cataract | Adverse Event Term | Cataract | Adverse Event Term | Cataract | Adverse Event Term | Cataract | Adverse Event Term | Cataract | Adverse Event Term | Cataract | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal discomfort | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Haematemesis | Adverse Event Term | Haematemesis | Adverse Event Term | Haematemesis | Adverse Event Term | Haematemesis | Adverse Event Term | Haematemesis | Adverse Event Term | Haematemesis | Adverse Event Term | Haematemesis | Adverse Event Term | Haematemesis | Adverse Event Term | Haematemesis | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Toothache | Adverse Event Term | Toothache | Adverse Event Term | Toothache | Adverse Event Term | Toothache | Adverse Event Term | Toothache | Adverse Event Term | Toothache | Adverse Event Term | Toothache | Adverse Event Term | Toothache | Adverse Event Term | Toothache | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Vomiting | Adverse Event Term | Asthenia | Adverse Event Term | Asthenia | Adverse Event Term | Asthenia | Adverse Event Term | Asthenia | Adverse Event Term | Asthenia | Adverse Event Term | Asthenia | Adverse Event Term | Asthenia | Adverse Event Term | Asthenia | Adverse Event Term | Asthenia | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Fatigue | Adverse Event Term | Pain | Adverse Event Term | Pain | Adverse Event Term | Pain | Adverse Event Term | Pain | Adverse Event Term | Pain | Adverse Event Term | Pain | Adverse Event Term | Pain | Adverse Event Term | Pain | Adverse Event Term | Pain | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Ulcer haemorrhage | Adverse Event Term | Acarodermatitis | Adverse Event Term | Acarodermatitis | Adverse Event Term | Acarodermatitis | Adverse Event Term | Acarodermatitis | Adverse Event Term | Acarodermatitis | Adverse Event Term | Acarodermatitis | Adverse Event Term | Acarodermatitis | Adverse Event Term | Acarodermatitis | Adverse Event Term | Acarodermatitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Clostridium difficile infection | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Localised infection | Adverse Event Term | Nail infection | Adverse Event Term | Nail infection | Adverse Event Term | Nail infection | Adverse Event Term | Nail infection | Adverse Event Term | Nail infection | Adverse Event Term | Nail infection | Adverse Event Term | Nail infection | Adverse Event Term | Nail infection | Adverse Event Term | Nail infection | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Pneumonia | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urosepsis | Adverse Event Term | Urosepsis | Adverse Event Term | Urosepsis | Adverse Event Term | Urosepsis | Adverse Event Term | Urosepsis | Adverse Event Term | Urosepsis | Adverse Event Term | Urosepsis | Adverse Event Term | Urosepsis | Adverse Event Term | Urosepsis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Arteriovenous fistula thrombosis | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Contusion | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Fall | Adverse Event Term | Graft thrombosis | Adverse Event Term | Graft thrombosis | Adverse Event Term | Graft thrombosis | Adverse Event Term | Graft thrombosis | Adverse Event Term | Graft thrombosis | Adverse Event Term | Graft thrombosis | Adverse Event Term | Graft thrombosis | Adverse Event Term | Graft thrombosis | Adverse Event Term | Graft thrombosis | Adverse Event Term | Joint injury | Adverse Event Term | Joint injury | Adverse Event Term | Joint injury | Adverse Event Term | Joint injury | Adverse Event Term | Joint injury | Adverse Event Term | Joint injury | Adverse Event Term | Joint injury | Adverse Event Term | Joint injury | Adverse Event Term | Joint injury | Adverse Event Term | Transfusion reaction | Adverse Event Term | Transfusion reaction | Adverse Event Term | Transfusion reaction | Adverse Event Term | Transfusion reaction | Adverse Event Term | Transfusion reaction | Adverse Event Term | Transfusion reaction | Adverse Event Term | Transfusion reaction | Adverse Event Term | Transfusion reaction | Adverse Event Term | Transfusion reaction | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular access complication | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Vascular pseudoaneurysm ruptured | Adverse Event Term | Weight decreased | Adverse Event Term | Weight decreased | Adverse Event Term | Weight decreased | Adverse Event Term | Weight decreased | Adverse Event Term | Weight decreased | Adverse Event Term | Weight decreased | Adverse Event Term | Weight decreased | Adverse Event Term | Weight decreased | Adverse Event Term | Weight decreased | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Fluid overload | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hyperkalaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Hypovolaemia | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Type 2 diabetes mellitus | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Intervertebral disc degeneration | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Muscle spasms | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Loss of consciousness | Adverse Event Term | Loss of consciousness | Adverse Event Term | Loss of consciousness | Adverse Event Term | Loss of consciousness | Adverse Event Term | Loss of consciousness | Adverse Event Term | Loss of consciousness | Adverse Event Term | Loss of consciousness | Adverse Event Term | Loss of consciousness | Adverse Event Term | Loss of consciousness | Adverse Event Term | Presyncope | Adverse Event Term | Presyncope | Adverse Event Term | Presyncope | Adverse Event Term | Presyncope | Adverse Event Term | Presyncope | Adverse Event Term | Presyncope | Adverse Event Term | Presyncope | Adverse Event Term | Presyncope | Adverse Event Term | Presyncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Mental status changes | Adverse Event Term | Mental status changes | Adverse Event Term | Mental status changes | Adverse Event Term | Mental status changes | Adverse Event Term | Mental status changes | Adverse Event Term | Mental status changes | Adverse Event Term | Mental status changes | Adverse Event Term | Mental status changes | Adverse Event Term | Mental status changes | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Costovertebral angle tenderness | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary retention | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Urinary tract obstruction | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Uterine haemorrhage | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Acute respiratory failure | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Chronic obstructive pulmonary disease | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Epistaxis | Adverse Event Term | Epistaxis | Adverse Event Term | Epistaxis | Adverse Event Term | Epistaxis | Adverse Event Term | Epistaxis | Adverse Event Term | Epistaxis | Adverse Event Term | Epistaxis | Adverse Event Term | Epistaxis | Adverse Event Term | Epistaxis | Adverse Event Term | Hypoxia | Adverse Event Term | Hypoxia | Adverse Event Term | Hypoxia | Adverse Event Term | Hypoxia | Adverse Event Term | Hypoxia | Adverse Event Term | Hypoxia | Adverse Event Term | Hypoxia | Adverse Event Term | Hypoxia | Adverse Event Term | Hypoxia | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pleural effusion | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary hypertension | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Pulmonary oedema | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Diabetic foot | Adverse Event Term | Pruritus | Adverse Event Term | Pruritus | Adverse Event Term | Pruritus | Adverse Event Term | Pruritus | Adverse Event Term | Pruritus | Adverse Event Term | Pruritus | Adverse Event Term | Pruritus | Adverse Event Term | Pruritus | Adverse Event Term | Pruritus | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Uraemic pruritus | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Deep vein thrombosis | Adverse Event Term | Haematoma | Adverse Event Term | Haematoma | Adverse Event Term | Haematoma | Adverse Event Term | Haematoma | Adverse Event Term | Haematoma | Adverse Event Term | Haematoma | Adverse Event Term | Haematoma | Adverse Event Term | Haematoma | Adverse Event Term | Haematoma | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypertension | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Hypovolaemic shock | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Shock haemorrhagic | Adverse Event Term | Vascular calcification | Adverse Event Term | Vascular calcification | Adverse Event Term | Vascular calcification | Adverse Event Term | Vascular calcification | Adverse Event Term | Vascular calcification | Adverse Event Term | Vascular calcification | Adverse Event Term | Vascular calcification | Adverse Event Term | Vascular calcification | Adverse Event Term | Vascular calcification |
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Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 5 | Frequency Threshold | 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Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | 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23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | 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Responsible Parties
Sequence: | 28890942 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3853608 |
Pi Employee | No |
Result Contacts
Sequence: | 3853573 |
Organization | Akebia Therapeutics, Inc |
Name | Akebia Therapeutics, Inc |
Phone | 617-844-6128 |
trials@akebia.com | |
Outcomes
Sequence: | 30820453 | Sequence: | 30820437 | Sequence: | 30820438 | Sequence: | 30820439 | Sequence: | 30820440 | Sequence: | 30820441 | Sequence: | 30820442 | Sequence: | 30820443 | Sequence: | 30820444 | Sequence: | 30820445 | Sequence: | 30820446 | Sequence: | 30820447 | Sequence: | 30820448 | Sequence: | 30820449 | Sequence: | 30820450 | Sequence: | 30820451 | Sequence: | 30820452 | Sequence: | 30820454 | Sequence: | 30820455 | Sequence: | 30820456 | Sequence: | 30820457 | Sequence: | 30820458 | Sequence: | 30820459 | Sequence: | 30820460 | Sequence: | 30820461 | Sequence: | 30820462 | Sequence: | 30820463 | Sequence: | 30820464 |
Outcome Type | Secondary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Title | Mean Change in Hb Between Baseline and the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose |
Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. |
Time Frame | Baseline; Week 1, Week 4, Week 8, Week 11, Week 12, Week 13, Week 16, and Week 20 | Time Frame | Baseline; Week 10 to Week 12 | Time Frame | Up to Week 24 | Time Frame | Up to Week 24 | Time Frame | Up to Week 24 | Time Frame | Weeks 13 – 20 | Time Frame | Week 10 to Week 12 | Time Frame | Week 10 to Week 12; Week 18 to Week 20 | Time Frame | Baseline; Week 18 to Week 20 | Time Frame | Week 18 to Week 20 | Time Frame | Week 18 to Week 20 | Time Frame | Week 10 to Week 12 | Time Frame | Week 18 to Week 20 | Time Frame | Up to Week 20 | Time Frame | Up to Week 20 | Time Frame | Up to Week 20 | Time Frame | Baseline; Week 1 (pre-dose), Week 1 +1 (Day 8; pre-dose), Week 11 (pre-dose), and Week 13 (pre-dose) | Time Frame | Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 | Time Frame | Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 | Time Frame | Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 | Time Frame | Baseline; Week 12 and Week 20 | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose | Time Frame | Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose |
Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population: All randomized participants. Analysis of this population was based on the randomized treatment. | Population | Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Population | Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Population | Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Population | Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. Only participants with available data were included in the analysis. The rows presenting data for HB > 12.0 g/dL, HB > 13.0 g/dL and HB > 14.0 g/dL are mutually exclusive. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study). | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study). | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Pharmacokinetic (PK) Population: all randomized participants who received study drug and had enough drug concentrations to estimate AUC and Cmax. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with concentrations below the limit of quantitation (BLQ) for all the time points were excluded from the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Population | PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. | Population | PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. | Population | PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. | Population | PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. | Population | PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. | Population | PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. | Population | PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis. |
Units | 10^3 cells/microliter (µL) | Units | grams per deciliter (g/dL) | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | g/dL | Units | g/dL | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Milliunits per milliliter | Units | micrograms per deciliter (µg/dL) | Units | micrograms per liter (µg/L) | Units | µg/dL | Units | nanograms per milliliter (ng/mL) | Units | Micrograms per milliliter (μg/mL) | Units | hours*µg/mL | Units | Hours | Units | Hours | Units | 1/hour | Units | liters per hour | Units | Liters |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | ||||||||||||||||||||||||
Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Geometric Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Median | Param Type | Median | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean |
Outcome Measurements
Sequence: | 235800598 | Sequence: | 235800699 | Sequence: | 235800539 | Sequence: | 235800700 | Sequence: | 235800674 | Sequence: | 235800531 | Sequence: | 235800532 | Sequence: | 235800533 | Sequence: | 235800534 | Sequence: | 235800535 | Sequence: | 235800536 | Sequence: | 235800537 | Sequence: | 235800538 | Sequence: | 235800540 | Sequence: | 235800541 | Sequence: | 235800542 | Sequence: | 235800543 | Sequence: | 235800544 | Sequence: | 235800545 | Sequence: | 235800546 | Sequence: | 235800547 | Sequence: | 235800548 | Sequence: | 235800549 | Sequence: | 235800550 | Sequence: | 235800558 | Sequence: | 235800551 | Sequence: | 235800552 | Sequence: | 235800553 | Sequence: | 235800554 | Sequence: | 235800555 | Sequence: | 235800556 | Sequence: | 235800557 | Sequence: | 235800559 | Sequence: | 235800560 | Sequence: | 235800561 | Sequence: | 235800562 | Sequence: | 235800563 | Sequence: | 235800564 | Sequence: | 235800565 | Sequence: | 235800566 | Sequence: | 235800567 | Sequence: | 235800568 | Sequence: | 235800569 | Sequence: | 235800570 | Sequence: | 235800571 | Sequence: | 235800572 | Sequence: | 235800573 | Sequence: | 235800574 | Sequence: | 235800575 | Sequence: | 235800576 | Sequence: | 235800577 | Sequence: | 235800578 | Sequence: | 235800579 | Sequence: | 235800580 | Sequence: | 235800581 | Sequence: | 235800582 | Sequence: | 235800583 | Sequence: | 235800584 | Sequence: | 235800585 | Sequence: | 235800586 | Sequence: | 235800587 | Sequence: | 235800588 | Sequence: | 235800589 | Sequence: | 235800590 | Sequence: | 235800591 | Sequence: | 235800592 | Sequence: | 235800593 | Sequence: | 235800594 | Sequence: | 235800595 | Sequence: | 235800596 | Sequence: | 235800597 | Sequence: | 235800675 | Sequence: | 235800599 | Sequence: | 235800600 | Sequence: | 235800601 | Sequence: | 235800602 | Sequence: | 235800603 | Sequence: | 235800604 | Sequence: | 235800605 | Sequence: | 235800606 | Sequence: | 235800607 | Sequence: | 235800608 | Sequence: | 235800609 | Sequence: | 235800610 | Sequence: | 235800611 | Sequence: | 235800612 | Sequence: | 235800613 | Sequence: | 235800614 | Sequence: | 235800615 | Sequence: | 235800616 | Sequence: | 235800617 | Sequence: | 235800618 | Sequence: | 235800619 | Sequence: | 235800620 | Sequence: | 235800621 | Sequence: | 235800622 | Sequence: | 235800623 | Sequence: | 235800624 | Sequence: | 235800625 | Sequence: | 235800626 | Sequence: | 235800627 | Sequence: | 235800628 | Sequence: | 235800629 | Sequence: | 235800630 | Sequence: | 235800631 | Sequence: | 235800632 | Sequence: | 235800633 | Sequence: | 235800634 | Sequence: | 235800635 | Sequence: | 235800636 | Sequence: | 235800637 | Sequence: | 235800638 | Sequence: | 235800639 | Sequence: | 235800676 | Sequence: | 235800640 | Sequence: | 235800641 | Sequence: | 235800642 | Sequence: | 235800643 | Sequence: | 235800644 | Sequence: | 235800645 | Sequence: | 235800646 | Sequence: | 235800647 | Sequence: | 235800648 | Sequence: | 235800649 | Sequence: | 235800650 | Sequence: | 235800651 | Sequence: | 235800652 | Sequence: | 235800653 | Sequence: | 235800654 | Sequence: | 235800655 | Sequence: | 235800656 | Sequence: | 235800657 | Sequence: | 235800658 | Sequence: | 235800659 | Sequence: | 235800660 | Sequence: | 235800661 | Sequence: | 235800662 | Sequence: | 235800663 | Sequence: | 235800664 | Sequence: | 235800665 | Sequence: | 235800666 | Sequence: | 235800667 | Sequence: | 235800668 | Sequence: | 235800669 | Sequence: | 235800670 | Sequence: | 235800671 | Sequence: | 235800672 | Sequence: | 235800673 | Sequence: | 235800677 | Sequence: | 235800678 | Sequence: | 235800679 | Sequence: | 235800680 | Sequence: | 235800681 | Sequence: | 235800682 | Sequence: | 235800683 | Sequence: | 235800684 | Sequence: | 235800685 | Sequence: | 235800686 | Sequence: | 235800687 | Sequence: | 235800688 | Sequence: | 235800689 | Sequence: | 235800690 | Sequence: | 235800691 | Sequence: | 235800692 | Sequence: | 235800693 | Sequence: | 235800694 | Sequence: | 235800695 | Sequence: | 235800696 | Sequence: | 235800697 | Sequence: | 235800698 | Sequence: | 235800701 | Sequence: | 235800702 | Sequence: | 235800703 | Sequence: | 235800704 | Sequence: | 235800705 | Sequence: | 235800706 | Sequence: | 235800707 | Sequence: | 235800708 | Sequence: | 235800709 | Sequence: | 235800710 | Sequence: | 235800711 | Sequence: | 235800712 | Sequence: | 235800713 | Sequence: | 235800714 | Sequence: | 235800715 | Sequence: | 235800716 | Sequence: | 235800717 | Sequence: | 235800718 | Sequence: | 235800719 | Sequence: | 235800720 | Sequence: | 235800721 | Sequence: | 235800722 | Sequence: | 235800723 | Sequence: | 235800724 | Sequence: | 235800725 | Sequence: | 235800726 | Sequence: | 235800727 | Sequence: | 235800728 | Sequence: | 235800729 | Sequence: | 235800730 | Sequence: | 235800731 | Sequence: | 235800732 | Sequence: | 235800733 | Sequence: | 235800734 | Sequence: | 235800735 | Sequence: | 235800736 | Sequence: | 235800737 | Sequence: | 235800738 | Sequence: | 235800739 | Sequence: | 235800740 | Sequence: | 235800741 | Sequence: | 235800742 | Sequence: | 235800743 | Sequence: | 235800744 | Sequence: | 235800745 | Sequence: | 235800746 | Sequence: | 235800747 | Sequence: | 235800748 | Sequence: | 235800749 | Sequence: | 235800750 | Sequence: | 235800751 | Sequence: | 235800752 | Sequence: | 235800753 | Sequence: | 235800754 | Sequence: | 235800755 | Sequence: | 235800756 | Sequence: | 235800757 | Sequence: | 235800758 | Sequence: | 235800759 | Sequence: | 235800760 | Sequence: | 235800761 | Sequence: | 235800762 | Sequence: | 235800763 | Sequence: | 235800764 | Sequence: | 235800765 | Sequence: | 235800766 | Sequence: | 235800767 | Sequence: | 235800768 | Sequence: | 235800769 | Sequence: | 235800770 | Sequence: | 235800771 | Sequence: | 235800772 | Sequence: | 235800773 | Sequence: | 235800774 | Sequence: | 235800775 | Sequence: | 235800776 | Sequence: | 235800777 | Sequence: | 235800778 | Sequence: | 235800779 | Sequence: | 235800780 | Sequence: | 235800781 | Sequence: | 235800782 | Sequence: | 235800783 | Sequence: | 235800784 | Sequence: | 235801049 | Sequence: | 235800785 | Sequence: | 235800786 | Sequence: | 235800787 | Sequence: | 235800788 | Sequence: | 235800789 | Sequence: | 235800790 | Sequence: | 235800791 | Sequence: | 235800792 | Sequence: | 235800793 | Sequence: | 235800794 | Sequence: | 235800795 | Sequence: | 235800796 | Sequence: | 235800797 | Sequence: | 235800798 | Sequence: | 235800799 | Sequence: | 235800800 | Sequence: | 235800801 | Sequence: | 235800802 | Sequence: | 235800803 | Sequence: | 235800804 | Sequence: | 235800805 | Sequence: | 235800806 | Sequence: | 235800807 | Sequence: | 235800808 | Sequence: | 235800809 | Sequence: | 235800810 | Sequence: | 235800811 | Sequence: | 235800812 | Sequence: | 235800813 | Sequence: | 235800814 | Sequence: | 235800815 | Sequence: | 235800816 | Sequence: | 235800817 | Sequence: | 235800818 | Sequence: | 235800819 | Sequence: | 235800820 | Sequence: | 235800821 | Sequence: | 235800822 | Sequence: | 235800823 | Sequence: | 235800824 | Sequence: | 235800825 | Sequence: | 235800826 | Sequence: | 235800827 | Sequence: | 235800828 | Sequence: | 235800829 | Sequence: | 235800830 | Sequence: | 235800831 | Sequence: | 235800832 | Sequence: | 235800833 | Sequence: | 235800834 | Sequence: | 235800835 | Sequence: | 235800836 | Sequence: | 235800837 | Sequence: | 235800838 | Sequence: | 235800839 | Sequence: | 235800840 | Sequence: | 235800841 | Sequence: | 235800842 | Sequence: | 235800843 | Sequence: | 235800844 | Sequence: | 235800845 | Sequence: | 235800846 | Sequence: | 235800847 | Sequence: | 235800848 | Sequence: | 235800849 | Sequence: | 235800850 | Sequence: | 235800851 | Sequence: | 235800852 | Sequence: | 235800853 | Sequence: | 235800854 | Sequence: | 235800855 | Sequence: | 235800856 | Sequence: | 235800857 | Sequence: | 235800858 | Sequence: | 235800859 | Sequence: | 235800860 | Sequence: | 235800861 | Sequence: | 235800862 | Sequence: | 235800863 | Sequence: | 235800864 | Sequence: | 235800865 | Sequence: | 235800866 | Sequence: | 235800867 | Sequence: | 235800868 | Sequence: | 235800869 | Sequence: | 235800870 | Sequence: | 235800871 | Sequence: | 235800872 | Sequence: | 235800873 | Sequence: | 235800874 | Sequence: | 235800875 | Sequence: | 235800876 | Sequence: | 235800877 | Sequence: | 235800878 | Sequence: | 235800879 | Sequence: | 235800880 | Sequence: | 235800881 | Sequence: | 235800882 | Sequence: | 235800883 | Sequence: | 235800884 | Sequence: | 235800885 | Sequence: | 235800886 | Sequence: | 235800887 | Sequence: | 235800888 | Sequence: | 235800889 | Sequence: | 235800890 | Sequence: | 235800891 | Sequence: | 235800892 | Sequence: | 235800893 | Sequence: | 235800894 | Sequence: | 235800895 | Sequence: | 235800896 | Sequence: | 235800897 | Sequence: | 235800898 | Sequence: | 235800899 | Sequence: | 235800900 | Sequence: | 235800901 | Sequence: | 235800902 | Sequence: | 235800903 | Sequence: | 235800904 | Sequence: | 235801050 | Sequence: | 235800905 | Sequence: | 235800906 | Sequence: | 235800907 | Sequence: | 235800908 | Sequence: | 235800909 | Sequence: | 235800910 | Sequence: | 235800911 | Sequence: | 235800912 | Sequence: | 235800913 | Sequence: | 235800914 | Sequence: | 235800915 | Sequence: | 235800916 | Sequence: | 235800917 | Sequence: | 235800918 | Sequence: | 235800919 | Sequence: | 235801051 | Sequence: | 235800920 | Sequence: | 235800921 | Sequence: | 235800922 | Sequence: | 235800923 | Sequence: | 235800924 | Sequence: | 235800925 | Sequence: | 235800926 | Sequence: | 235800927 | Sequence: | 235800928 | Sequence: | 235800929 | Sequence: | 235800930 | Sequence: | 235800931 | Sequence: | 235800932 | Sequence: | 235800933 | Sequence: | 235800934 | Sequence: | 235800935 | Sequence: | 235800936 | Sequence: | 235800937 | Sequence: | 235800938 | Sequence: | 235800939 | Sequence: | 235800940 | Sequence: | 235800941 | Sequence: | 235800942 | Sequence: | 235800943 | Sequence: | 235800944 | Sequence: | 235800945 | Sequence: | 235800946 | Sequence: | 235800947 | Sequence: | 235800948 | Sequence: | 235800949 | Sequence: | 235800950 | Sequence: | 235800951 | Sequence: | 235800952 | Sequence: | 235800953 | Sequence: | 235800954 | Sequence: | 235800955 | Sequence: | 235800956 | Sequence: | 235800957 | Sequence: | 235800976 | Sequence: | 235800958 | Sequence: | 235800959 | Sequence: | 235800960 | Sequence: | 235800961 | Sequence: | 235801047 | Sequence: | 235800962 | Sequence: | 235800963 | Sequence: | 235800964 | Sequence: | 235800965 | Sequence: | 235800966 | Sequence: | 235800967 | Sequence: | 235800968 | Sequence: | 235800969 | Sequence: | 235800970 | Sequence: | 235800971 | Sequence: | 235800972 | Sequence: | 235800973 | Sequence: | 235800974 | Sequence: | 235800975 | Sequence: | 235800977 | Sequence: | 235800978 | Sequence: | 235800979 | Sequence: | 235800980 | Sequence: | 235800981 | Sequence: | 235800982 | Sequence: | 235800983 | Sequence: | 235800984 | Sequence: | 235800985 | Sequence: | 235800986 | Sequence: | 235800987 | Sequence: | 235800988 | Sequence: | 235800989 | Sequence: | 235800990 | Sequence: | 235800991 | Sequence: | 235800992 | Sequence: | 235800993 | Sequence: | 235800994 | Sequence: | 235800995 | Sequence: | 235800996 | Sequence: | 235800997 | Sequence: | 235800998 | Sequence: | 235800999 | Sequence: | 235801000 | Sequence: | 235801001 | Sequence: | 235801002 | Sequence: | 235801003 | Sequence: | 235801004 | Sequence: | 235801005 | Sequence: | 235801006 | Sequence: | 235801007 | Sequence: | 235801008 | Sequence: | 235801009 | Sequence: | 235801010 | Sequence: | 235801011 | Sequence: | 235801012 | Sequence: | 235801013 | Sequence: | 235801014 | Sequence: | 235801015 | Sequence: | 235801016 | Sequence: | 235801017 | Sequence: | 235801018 | Sequence: | 235801019 | Sequence: | 235801020 | Sequence: | 235801021 | Sequence: | 235801022 | Sequence: | 235801023 | Sequence: | 235801024 | Sequence: | 235801025 | Sequence: | 235801026 | Sequence: | 235801027 | Sequence: | 235801028 | Sequence: | 235801048 | Sequence: | 235801029 | Sequence: | 235801030 | Sequence: | 235801031 | Sequence: | 235801032 | Sequence: | 235801033 | Sequence: | 235801034 | Sequence: | 235801035 | Sequence: | 235801036 | Sequence: | 235801037 | Sequence: | 235801038 | Sequence: | 235801039 | Sequence: | 235801040 | Sequence: | 235801041 | Sequence: | 235801042 | Sequence: | 235801043 | Sequence: | 235801044 | Sequence: | 235801045 | Sequence: | 235801046 | Sequence: | 235801052 | Sequence: | 235801053 | Sequence: | 235801054 | Sequence: | 235801055 | Sequence: | 235801056 | Sequence: | 235801057 | Sequence: | 235801058 | Sequence: | 235801059 | Sequence: | 235801060 | Sequence: | 235801061 | Sequence: | 235801062 | Sequence: | 235801063 | Sequence: | 235801064 | Sequence: | 235801065 | Sequence: | 235801066 | Sequence: | 235801067 | Sequence: | 235801068 | Sequence: | 235801069 | Sequence: | 235801070 | Sequence: | 235801071 | Sequence: | 235801072 | Sequence: | 235801073 | Sequence: | 235801074 | Sequence: | 235801075 | Sequence: | 235801076 | Sequence: | 235801077 | Sequence: | 235801078 | Sequence: | 235801079 | Sequence: | 235801080 | Sequence: | 235801081 | Sequence: | 235801082 | Sequence: | 235801083 | Sequence: | 235801084 | Sequence: | 235801085 | Sequence: | 235801086 | Sequence: | 235801087 | Sequence: | 235801088 | Sequence: | 235801089 | Sequence: | 235801105 | Sequence: | 235801090 | Sequence: | 235801091 | Sequence: | 235801092 | Sequence: | 235801093 | Sequence: | 235801094 | Sequence: | 235801095 | Sequence: | 235801096 | Sequence: | 235801097 | Sequence: | 235801098 | Sequence: | 235801099 | Sequence: | 235801100 | Sequence: | 235801101 | Sequence: | 235801102 | Sequence: | 235801103 | Sequence: | 235801104 | Sequence: | 235801106 | Sequence: | 235801107 | Sequence: | 235801108 | Sequence: | 235801109 | Sequence: | 235801110 | Sequence: | 235801111 | Sequence: | 235801112 | Sequence: | 235801113 | Sequence: | 235801114 | Sequence: | 235801115 | Sequence: | 235801116 | Sequence: | 235801117 | Sequence: | 235801118 | Sequence: | 235801119 | Sequence: | 235801120 | Sequence: | 235801121 | Sequence: | 235801122 | Sequence: | 235801123 | Sequence: | 235801124 | Sequence: | 235801125 | Sequence: | 235801126 | Sequence: | 235801127 |
Outcome Id | 30820441 | Outcome Id | 30820451 | Outcome Id | 30820437 | Outcome Id | 30820451 | Outcome Id | 30820448 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820437 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820439 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820438 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820439 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820440 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820448 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820441 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820442 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820443 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820449 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820444 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820445 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820446 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820447 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820448 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820449 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820450 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820451 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820452 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820460 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820453 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820454 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820460 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820455 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820460 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820457 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820460 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820456 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820457 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820458 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820460 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820459 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820460 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820461 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820463 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820462 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820463 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 | Outcome Id | 30820464 |
Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112549 | Result Group Id | 56112547 | Result Group Id | 56112561 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112541 | Result Group Id | 56112543 | Result Group Id | 56112544 | Result Group Id | 56112545 | Result Group Id | 56112546 | Result Group Id | 56112547 | Result Group Id | 56112548 | Result Group Id | 56112549 | Result Group Id | 56112542 | Result Group Id | 56112550 | Result Group 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| Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112565 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112541 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112565 | Result Group Id | 56112542 | Result Group Id | 56112565 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112565 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112566 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112542 | Result Group Id | 56112565 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 | Result Group Id | 56112566 | Result Group Id | 56112541 | Result Group Id | 56112542 | Result Group Id | 56112563 | Result Group Id | 56112564 | Result Group Id | 56112565 |
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Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG008 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG002 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG003 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG005 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG000 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG004 | Ctgov Group Code | OG001 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG005 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG001 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 |
Classification | Hb >14.0 g/dL | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Change from Baseline at PEP | Classification | Change from Baseline at PEP | Classification | Change from Baseline at PEP | Classification | Change from Baseline at PEP | Classification | Change from Baseline at PEP | Classification | Change from Baseline at PEP | Classification | Change from Baseline at PEP | Classification | Change from Baseline at PEP | Classification | Change from Baseline at PEP | Classification | Hb >12.0 g/dL | Classification | Hb >12.0 g/dL | Classification | Hb >12.0 g/dL | Classification | Hb >12.0 g/dL | Classification | Hb >12.0 g/dL | Classification | Hb >12.0 g/dL | Classification | Hb >12.0 g/dL | Classification | Hb >12.0 g/dL | Classification | Hb >12.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >13.0 g/dL | Classification | Hb >14.0 g/dL | Classification | Hb >14.0 g/dL | Classification | Hb >14.0 g/dL | Classification | Hb >14.0 g/dL | Classification | Hb >14.0 g/dL | Classification | Hb >14.0 g/dL | Classification | Hb >14.0 g/dL | Classification | Hb >14.0 g/dL | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Hb increase >1.0 g/dL within any 2-week interval | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 13 | Classification | Week 13 | Classification | Week 13 | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 13 | Classification | Week 13 | Classification | Week 11 | Classification | Week 13 | Classification | Week 13 | Classification | Week 13 | Classification | Week 13 | Classification | Week 13 | Classification | Week 13 | Classification | Week 13 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 11 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Baseline | Classification | Baseline | Classification | Week 11 | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 4 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 8 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Baseline | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 16 | Classification | Week 1 +1 (Day 8) | Classification | Week 16 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Baseline | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 12 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 20 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 13 | Classification | Week 13 | Classification | Week 13 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 13 | Classification | Week 13 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 13 | Classification | Week 13 | Classification | Week 13 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 11 | Classification | Week 13 | Classification | Week 13 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 1 +1 (Day 8) | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | Classification | Week 11 | ||||||||||||||||||||||||
Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants Classified as Hb Outliers | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Number of Participants With Hb Values Within the Target Range at the PEP | Title | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Title | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Title | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Title | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Title | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Title | Mean Change in Hb Between Baseline and the SEP | Title | Mean Change in Hb Between Baseline and the SEP | Title | Mean Change in Hb Between Baseline and the SEP | Title | Mean Change in Hb Between Baseline and the SEP | Title | Mean Change in Hb Between Baseline and the SEP | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Mean Change in Hb Between Baseline and the SEP | Title | Mean Change in Hb Between Baseline and the SEP | Title | Mean Change in Hb Between Baseline and the SEP | Title | Mean Change in Hb Between Baseline and the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP | Title | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Title | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Title | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Title | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Title | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Reticulocyte Count | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Iron Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Ferritin Concentration | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Total Iron Binding Capacity | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Mean Change From Baseline in Hepcidin Concentration | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose | Title | Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose |
Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12. | Description | Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. | Description | Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose. |
Units | Participants | Units | Participants | Units | grams per deciliter (g/dL) | Units | Participants | Units | Participants | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | grams per deciliter (g/dL) | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | g/dL | Units | g/dL | Units | g/dL | Units | g/dL | Units | g/dL | Units | g/dL | Units | g/dL | Units | g/dL | Units | g/dL | Units | g/dL | Units | Participants | Units | g/dL | Units | g/dL | Units | g/dL | Units | g/dL | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | Milliunits per milliliter | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | Hours | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | 10^3 cells/microliter (µL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per deciliter (µg/dL) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | Hours | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | micrograms per liter (µg/L) | Units | µg/dL | Units | µg/dL | Units | Hours | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | nanograms per milliliter (ng/mL) | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | Hours | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | µg/dL | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | nanograms per milliliter (ng/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | Micrograms per milliliter (μg/mL) | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | Hours | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | hours*µg/mL | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | Hours | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | liters per hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | 1/hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | liters per hour | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters | Units | Liters |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Median | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Median | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Median | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Median | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Median | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean | Param Type | Geometric Mean |
Param Value | 0 | Param Value | 2 | Param Value | 9.620 | Param Value | 0 | Param Value | 1 | Param Value | 10.223 | Param Value | 10.059 | Param Value | 10.165 | Param Value | 9.778 | Param Value | 10.288 | Param Value | 10.095 | Param Value | 9.950 | Param Value | 9.530 | Param Value | -0.371 | Param Value | 0.072 | Param Value | 0.160 | Param Value | -0.911 | Param Value | -0.284 | Param Value | -0.418 | Param Value | 0.268 | Param Value | -0.671 | Param Value | -0.290 | Param Value | 18 | Param Value | 27 | Param Value | 0 | Param Value | 13 | Param Value | 12 | Param Value | 14 | Param Value | 13 | Param Value | 9 | Param Value | 5 | Param Value | 3 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 2 | Param Value | 3 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 2 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 2 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 3 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 4 | Param Value | 8 | Param Value | 4 | Param Value | 4 | Param Value | 2 | Param Value | 3 | Param Value | 6 | Param Value | 0 | Param Value | 2 | Param Value | 12 | Param Value | 13 | Param Value | 15 | Param Value | 1 | Param Value | 4 | Param Value | 4 | Param Value | 6 | Param Value | 0 | Param Value | 0 | Param Value | -0.050 | Param Value | -1.021 | Param Value | -0.360 | Param Value | -0.103 | Param Value | -0.422 | Param Value | -0.197 | Param Value | -0.186 | Param Value | 0.070 | Param Value | 0.114 | Param Value | -0.421 | Param Value | 23 | Param Value | -0.545 | Param Value | 0.343 | Param Value | -0.283 | Param Value | -0.400 | Param Value | 6 | Param Value | 7 | Param Value | 9 | Param Value | 2 | Param Value | 3 | Param Value | 2 | Param Value | 6 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 2 | Param Value | 2 | Param Value | 3 | Param Value | 7 | Param Value | 14 | Param Value | 19 | Param Value | 18 | Param Value | 1 | Param Value | 6 | Param Value | 6 | Param Value | 8 | Param Value | 0 | Param Value | 1 | Param Value | 10 | Param Value | 11 | Param Value | 14 | Param Value | 3 | Param Value | 5 | Param Value | 2 | Param Value | 8 | Param Value | 21 | Param Value | 16 | Param Value | 10 | Param Value | 14 | Param Value | 18 | Param Value | 10 | Param Value | 4 | Param Value | 5 | Param Value | 2 | Param Value | 8 | Param Value | 3 | Param Value | 5 | Param Value | 5 | Param Value | 3 | Param Value | 1 | Param Value | 3 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 3 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 7.33 | Param Value | 9.53 | Param Value | 9.93 | Param Value | 8.77 | Param Value | 6.98 | Param Value | 8.03 | Param Value | 12.1 | Param Value | 17.5 | Param Value | 15.3 | Param Value | 14.1 | Param Value | 20.2 | Param Value | 12.9 | Param Value | 15.6 | Param Value | 18.9 | Param Value | 16.1 | Param Value | 18.0 | Param Value | 17.4 | Param Value | 9.49 | Param Value | 14.2 | Param Value | 14.9 | Param Value | 19.4 | Param Value | 20.6 | Param Value | 17.3 | Param Value | 15.7 | Param Value | 39.2 | Param Value | 10.5 | Param Value | 51.9 | Param Value | 47.2 | Param Value | 48.8 | Param Value | 59.3 | Param Value | 48.4 | Param Value | 51.5 | Param Value | 62.6 | Param Value | 77.6 | Param Value | 83.0 | Param Value | 3.1 | Param Value | 6.9 | Param Value | 1.0 | Param Value | -18.1 | Param Value | -3.9 | Param Value | -6.6 | Param Value | 20.4 | Param Value | -35.8 | Param Value | -25.2 | Param Value | 14.6 | Param Value | 14.9 | Param Value | 0.8 | Param Value | -5.6 | Param Value | 2.9 | Param Value | 6.1 | Param Value | 22.5 | Param Value | -26.8 | Param Value | 17.5 | Param Value | 14.0 | Param Value | 23.9 | Param Value | 23.1 | Param Value | 9.1 | Param Value | 20.4 | Param Value | 23.1 | Param Value | 14.0 | Param Value | -3.3 | Param Value | -21.8 | Param Value | 11.7 | Param Value | 20.2 | Param Value | 21.0 | Param Value | 26.2 | Param Value | 32.5 | Param Value | 9.2 | Param Value | 3.9 | Param Value | -6.7 | Param Value | -27.2 | Param Value | 16.1 | Param Value | 16.3 | Param Value | 22.2 | Param Value | 47.7 | Param Value | 20.3 | Param Value | 26.9 | Param Value | 4.6 | Param Value | 3.8 | Param Value | -17.3 | Param Value | 16.7 | Param Value | 12.1 | Param Value | 10.4 | Param Value | 16.4 | Param Value | 46.3 | Param Value | 15.9 | Param Value | 10.5 | Param Value | 0.1 | Param Value | 2.0 | Param Value | 16.3 | Param Value | 13.9 | Param Value | 19.6 | Param Value | 8.3 | Param Value | -2.2 | Param Value | 9.7 | Param Value | 0.2 | Param Value | 26.6 | Param Value | -31.5 | Param Value | 4.0 | Param Value | 14.5 | Param Value | 13.2 | Param Value | 23.8 | Param Value | 10.3 | Param Value | 16.4 | Param Value | 10.9 | Param Value | 38.5 | Param Value | -3.3 | Param Value | 40.0 | Param Value | 87.4 | Param Value | 93.9 | Param Value | 90.1 | Param Value | 57.7 | Param Value | 80.9 | Param Value | 73.1 | Param Value | 65.7 | Param Value | 81.6 | Param Value | 58.4 | Param Value | -8.0 | Param Value | -11.2 | Param Value | -18.3 | Param Value | 3.3 | Param Value | 9.6 | Param Value | 1.7 | Param Value | -6.6 | Param Value | 8.6 | Param Value | 3.8 | Param Value | -5.5 | Param Value | -15.0 | Param Value | -8.6 | Param Value | 4.5 | Param Value | -5.9 | Param Value | 11.7 | Param Value | -12.6 | Param Value | 0.3 | Param Value | 2.0 | Param Value | -2.7 | Param Value | -22.2 | Param Value | -26.0 | Param Value | -2.8 | Param Value | -0.4 | Param Value | -5.1 | Param Value | -16.1 | Param Value | -2.5 | Param Value | -12.6 | Param Value | -22.8 | Param Value | -18.3 | Param Value | -17.9 | Param Value | -0.7 | Param Value | 5.2 | Param Value | -4.6 | Param Value | -13.9 | Param Value | 19.5 | Param Value | -12.0 | Param Value | -14.2 | Param Value | -9.5 | Param Value | -16.6 | Param Value | 28.7 | Param Value | -3.1 | Param Value | 13.4 | Param Value | -8.4 | Param Value | -15.3 | Param Value | -10.3 | Param Value | 939.3 | Param Value | 1043.6 | Param Value | 919.3 | Param Value | 910.2 | Param Value | 745.2 | Param Value | 739.5 | Param Value | 723.6 | Param Value | 1182.2 | Param Value | 449.6 | Param Value | -30.1 | Param Value | -101.9 | Param Value | -23.7 | Param Value | 41.4 | Param Value | 152.9 | Param Value | 45.5 | Param Value | -145.6 | Param Value | 34.8 | Param Value | -61.5 | Param Value | -120.8 | Param Value | -185.4 | Param Value | 24.9 | Param Value | 29.4 | Param Value | -5.6 | Param Value | -87.8 | Param Value | -78.3 | Param Value | 111.3 | Param Value | 397.8 | Param Value | -118.5 | Param Value | -194.8 | Param Value | -42.4 | Param Value | -68.0 | Param Value | -23.8 | Param Value | -30.1 | Param Value | -195.3 | Param Value | -0.5 | Param Value | -35.0 | Param Value | -92.0 | Param Value | -70.9 | Param Value | 99.5 | Param Value | -144.0 | Param Value | 27.8 | Param Value | 6.49 | Param Value | -97.2 | Param Value | -81.8 | Param Value | 80.0 | Param Value | 62.3 | Param Value | -113.6 | Param Value | -166.6 | Param Value | 26.5 | Param Value | -199.4 | Param Value | 4.8 | Param Value | -51.6 | Param Value | -104.8 | Param Value | 249.0 | Param Value | 607.0 | Param Value | 237.8 | Param Value | 230.7 | Param Value | 3.95 | Param Value | 234.8 | Param Value | 210.1 | Param Value | 235.7 | Param Value | 223.6 | Param Value | 218.2 | Param Value | 211.0 | Param Value | 225.6 | Param Value | 35.9 | Param Value | 27.7 | Param Value | -13.4 | Param Value | 27.6 | Param Value | 41.0 | Param Value | 48.2 | Param Value | -0.5 | Param Value | 44.2 | Param Value | 7.8 | Param Value | 30.3 | Param Value | 37.0 | Param Value | -1.1 | Param Value | 26.3 | Param Value | 49.4 | Param Value | 58.8 | Param Value | -7.4 | Param Value | 56.0 | Param Value | -24.8 | Param Value | 42.4 | Param Value | 37.2 | Param Value | -9.9 | Param Value | 25.1 | Param Value | 41.0 | Param Value | 54.5 | Param Value | -3.8 | Param Value | 58.0 | Param Value | -0.6 | Param Value | 35.0 | Param Value | 27.8 | Param Value | -3.0 | Param Value | 55.3 | Param Value | 215.608 | Param Value | 53.1 | Param Value | 60.9 | Param Value | -13.7 | Param Value | 42.5 | Param Value | 11.7 | Param Value | -2.5 | Param Value | 38.0 | Param Value | 44.9 | Param Value | -9.5 | Param Value | 51.7 | Param Value | 68.4 | Param Value | 67.9 | Param Value | -5.4 | Param Value | 66.7 | Param Value | -6.0 | Param Value | 194.870 | Param Value | 208.816 | Param Value | 259.161 | Param Value | 185.852 | Param Value | 160.760 | Param Value | 143.519 | Param Value | 239.958 | Param Value | 74.748 | Param Value | -50.565 | Param Value | -53.675 | Param Value | -66.646 | Param Value | -55.283 | Param Value | -34.868 | Param Value | -74.797 | Param Value | -62.787 | Param Value | -128.587 | Param Value | -1.062 | Param Value | -86.025 | Param Value | -38.627 | Param Value | -83.685 | Param Value | -93.412 | Param Value | -83.012 | Param Value | -43.701 | Param Value | -80.680 | Param Value | -152.243 | Param Value | -9.023 | Param Value | 26.0 | Param Value | 40.8 | Param Value | 26.5 | Param Value | 47.0 | Param Value | 56.5 | Param Value | 44.2 | Param Value | 20.1 | Param Value | 37.6 | Param Value | 23.8 | Param Value | 44.2 | Param Value | 60.1 | Param Value | 31.6 | Param Value | 28.6 | Param Value | 24.4 | Param Value | 32.4 | Param Value | 38.1 | Param Value | 41.2 | Param Value | 30.6 | Param Value | 11.5 | Param Value | 60.2 | Param Value | 338 | Param Value | 518 | Param Value | 342 | Param Value | 605 | Param Value | 786 | Param Value | 464 | Param Value | 289 | Param Value | 465 | Param Value | 310 | Param Value | 566 | Param Value | 6.73 | Param Value | 847 | Param Value | 388 | Param Value | 344 | Param Value | 338 | Param Value | 402 | Param Value | 450 | Param Value | 588 | Param Value | 8.53 | Param Value | 10.5 | Param Value | 12.5 | Param Value | 10.3 | Param Value | 11.0 | Param Value | 9.01 | Param Value | 8.82 | Param Value | 8.83 | Param Value | 10.1 | Param Value | 12.4 | Param Value | 14.6 | Param Value | 5.65 | Param Value | 11.0 | Param Value | 5.01 | Param Value | 2.08 | Param Value | 2.72 | Param Value | 3.48 | Param Value | 3.50 | Param Value | 2.00 | Param Value | 3.28 | Param Value | 3.28 | Param Value | 2.11 | Param Value | 3.33 | Param Value | 3.30 | Param Value | 2.17 | Param Value | 3.42 | Param Value | 3.23 | Param Value | 3.50 | Param Value | 3.50 | Param Value | 2.03 | Param Value | 2.11 | Param Value | 1.98 | Param Value | 4.25 | Param Value | 2.04 | Param Value | 0.0797 | Param Value | 0.0665 | Param Value | 0.0560 | Param Value | 0.0681 | Param Value | 0.0608 | Param Value | 0.0771 | Param Value | 0.0720 | Param Value | 0.0615 | Param Value | 0.0714 | Param Value | 0.0469 | Param Value | 0.0469 | Param Value | 0.0594 | Param Value | 0.0925 | Param Value | 0.0687 | Param Value | 0.124 | Param Value | 1.55 | Param Value | 0.175 | Param Value | 0.116 | Param Value | 0.0632 | Param Value | 0.138 | Param Value | 0.888 | Param Value | 0.869 | Param Value | 0.877 | Param Value | 0.744 | Param Value | 0.763 | Param Value | 1.29 | Param Value | 1.04 | Param Value | 0.967 | Param Value | 0.968 | Param Value | 0.795 | Param Value | 0.708 | Param Value | 0.872 | Param Value | 1.33 | Param Value | 0.747 | Param Value | 1.00 | Param Value | 1.02 | Param Value | 10.9 | Param Value | 14.3 | Param Value | 13.7 | Param Value | 12.1 | Param Value | 13.8 | Param Value | 15.8 | Param Value | 12.5 | Param Value | 13.7 | Param Value | 17.4 | Param Value | 15.3 | Param Value | 15.6 | Param Value | 12.4 | Param Value | 10.2 | Param Value | 10.7 | Param Value | 10.1 | Param Value | 8.24 | Param Value | 8.76 |
Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 9.62 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 10.223 | Param Value Num | 10.059 | Param Value Num | 10.165 | Param Value Num | 9.778 | Param Value Num | 10.288 | Param Value Num | 10.095 | Param Value Num | 9.95 | Param Value Num | 9.53 | Param Value Num | -0.371 | Param Value Num | 0.072 | Param Value Num | 0.16 | Param Value Num | -0.911 | Param Value Num | -0.284 | Param Value Num | -0.418 | Param Value Num | 0.268 | Param Value Num | -0.671 | Param Value Num | -0.29 | Param Value Num | 18.0 | Param Value Num | 27.0 | Param Value Num | 0.0 | Param Value Num | 13.0 | Param Value Num | 12.0 | Param Value Num | 14.0 | Param Value Num | 13.0 | Param Value Num | 9.0 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 4.0 | Param Value Num | 8.0 | Param Value Num | 4.0 | Param Value Num | 4.0 | Param Value Num | 2.0 | Param Value Num | 3.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 12.0 | Param Value Num | 13.0 | Param Value Num | 15.0 | Param Value Num | 1.0 | Param Value Num | 4.0 | Param Value Num | 4.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | -0.05 | Param Value Num | -1.021 | Param Value Num | -0.36 | Param Value Num | -0.103 | Param Value Num | -0.422 | Param Value Num | -0.197 | Param Value Num | -0.186 | Param Value Num | 0.07 | Param Value Num | 0.114 | Param Value Num | -0.421 | Param Value Num | 23.0 | Param Value Num | -0.545 | Param Value Num | 0.343 | Param Value Num | -0.283 | Param Value Num | -0.4 | Param Value Num | 6.0 | Param Value Num | 7.0 | Param Value Num | 9.0 | Param Value Num | 2.0 | Param Value Num | 3.0 | Param Value Num | 2.0 | Param Value Num | 6.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 3.0 | Param Value Num | 7.0 | Param Value Num | 14.0 | Param Value Num | 19.0 | Param Value Num | 18.0 | Param Value Num | 1.0 | Param Value Num | 6.0 | Param Value Num | 6.0 | Param Value Num | 8.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 10.0 | Param Value Num | 11.0 | Param Value Num | 14.0 | Param Value Num | 3.0 | Param Value Num | 5.0 | Param Value Num | 2.0 | Param Value Num | 8.0 | Param Value Num | 21.0 | Param Value Num | 16.0 | Param Value Num | 10.0 | Param Value Num | 14.0 | Param Value Num | 18.0 | Param Value Num | 10.0 | Param Value Num | 4.0 | Param Value Num | 5.0 | Param Value Num | 2.0 | Param Value Num | 8.0 | Param Value Num | 3.0 | Param Value Num | 5.0 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 3.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 7.33 | Param Value Num | 9.53 | Param Value Num | 9.93 | Param Value Num | 8.77 | Param Value Num | 6.98 | Param Value Num | 8.03 | Param Value Num | 12.1 | Param Value Num | 17.5 | Param Value Num | 15.3 | Param Value Num | 14.1 | Param Value Num | 20.2 | Param Value Num | 12.9 | Param Value Num | 15.6 | Param Value Num | 18.9 | Param Value Num | 16.1 | Param Value Num | 18.0 | Param Value Num | 17.4 | Param Value Num | 9.49 | Param Value Num | 14.2 | Param Value Num | 14.9 | Param Value Num | 19.4 | Param Value Num | 20.6 | Param Value Num | 17.3 | Param Value Num | 15.7 | Param Value Num | 39.2 | Param Value Num | 10.5 | Param Value Num | 51.9 | Param Value Num | 47.2 | Param Value Num | 48.8 | Param Value Num | 59.3 | Param Value Num | 48.4 | Param Value Num | 51.5 | Param Value Num | 62.6 | Param Value Num | 77.6 | Param Value Num | 83.0 | Param Value Num | 3.1 | Param Value Num | 6.9 | Param Value Num | 1.0 | Param Value Num | -18.1 | Param Value Num | -3.9 | Param Value Num | -6.6 | Param Value Num | 20.4 | Param Value Num | -35.8 | Param Value Num | -25.2 | Param Value Num | 14.6 | Param Value Num | 14.9 | Param Value Num | 0.8 | Param Value Num | -5.6 | Param Value Num | 2.9 | Param Value Num | 6.1 | Param Value Num | 22.5 | Param Value Num | -26.8 | Param Value Num | 17.5 | Param Value Num | 14.0 | Param Value Num | 23.9 | Param Value Num | 23.1 | Param Value Num | 9.1 | Param Value Num | 20.4 | Param Value Num | 23.1 | Param Value Num | 14.0 | Param Value Num | -3.3 | Param Value Num | -21.8 | Param Value Num | 11.7 | Param Value Num | 20.2 | Param Value Num | 21.0 | Param Value Num | 26.2 | Param Value Num | 32.5 | Param Value Num | 9.2 | Param Value Num | 3.9 | Param Value Num | -6.7 | Param Value Num | -27.2 | Param Value Num | 16.1 | Param Value Num | 16.3 | Param Value Num | 22.2 | Param Value Num | 47.7 | Param Value Num | 20.3 | Param Value Num | 26.9 | Param Value Num | 4.6 | Param Value Num | 3.8 | Param Value Num | -17.3 | Param Value Num | 16.7 | Param Value Num | 12.1 | Param Value Num | 10.4 | Param Value Num | 16.4 | Param Value Num | 46.3 | Param Value Num | 15.9 | Param Value Num | 10.5 | Param Value Num | 0.1 | Param Value Num | 2.0 | Param Value Num | 16.3 | Param Value Num | 13.9 | Param Value Num | 19.6 | Param Value Num | 8.3 | Param Value Num | -2.2 | Param Value Num | 9.7 | Param Value Num | 0.2 | Param Value Num | 26.6 | Param Value Num | -31.5 | Param Value Num | 4.0 | Param Value Num | 14.5 | Param Value Num | 13.2 | Param Value Num | 23.8 | Param Value Num | 10.3 | Param Value Num | 16.4 | Param Value Num | 10.9 | Param Value Num | 38.5 | Param Value Num | -3.3 | Param Value Num | 40.0 | Param Value Num | 87.4 | Param Value Num | 93.9 | Param Value Num | 90.1 | Param Value Num | 57.7 | Param Value Num | 80.9 | Param Value Num | 73.1 | Param Value Num | 65.7 | Param Value Num | 81.6 | Param Value Num | 58.4 | Param Value Num | -8.0 | Param Value Num | -11.2 | Param Value Num | -18.3 | Param Value Num | 3.3 | Param Value Num | 9.6 | Param Value Num | 1.7 | Param Value Num | -6.6 | Param Value Num | 8.6 | Param Value Num | 3.8 | Param Value Num | -5.5 | Param Value Num | -15.0 | Param Value Num | -8.6 | Param Value Num | 4.5 | Param Value Num | -5.9 | Param Value Num | 11.7 | Param Value Num | -12.6 | Param Value Num | 0.3 | Param Value Num | 2.0 | Param Value Num | -2.7 | Param Value Num | -22.2 | Param Value Num | -26.0 | Param Value Num | -2.8 | Param Value Num | -0.4 | Param Value Num | -5.1 | Param Value Num | -16.1 | Param Value Num | -2.5 | Param Value Num | -12.6 | Param Value Num | -22.8 | Param Value Num | -18.3 | Param Value Num | -17.9 | Param Value Num | -0.7 | Param Value Num | 5.2 | Param Value Num | -4.6 | Param Value Num | -13.9 | Param Value Num | 19.5 | Param Value Num | -12.0 | Param Value Num | -14.2 | Param Value Num | -9.5 | Param Value Num | -16.6 | Param Value Num | 28.7 | Param Value Num | -3.1 | Param Value Num | 13.4 | Param Value Num | -8.4 | Param Value Num | -15.3 | Param Value Num | -10.3 | Param Value Num | 939.3 | Param Value Num | 1043.6 | Param Value Num | 919.3 | Param Value Num | 910.2 | Param Value Num | 745.2 | Param Value Num | 739.5 | Param Value Num | 723.6 | Param Value Num | 1182.2 | Param Value Num | 449.6 | Param Value Num | -30.1 | Param Value Num | -101.9 | Param Value Num | -23.7 | Param Value Num | 41.4 | Param Value Num | 152.9 | Param Value Num | 45.5 | Param Value Num | -145.6 | Param Value Num | 34.8 | Param Value Num | -61.5 | Param Value Num | -120.8 | Param Value Num | -185.4 | Param Value Num | 24.9 | Param Value Num | 29.4 | Param Value Num | -5.6 | Param Value Num | -87.8 | Param Value Num | -78.3 | Param Value Num | 111.3 | Param Value Num | 397.8 | Param Value Num | -118.5 | Param Value Num | -194.8 | Param Value Num | -42.4 | Param Value Num | -68.0 | Param Value Num | -23.8 | Param Value Num | -30.1 | Param Value Num | -195.3 | Param Value Num | -0.5 | Param Value Num | -35.0 | Param Value Num | -92.0 | Param Value Num | -70.9 | Param Value Num | 99.5 | Param Value Num | -144.0 | Param Value Num | 27.8 | Param Value Num | 6.49 | Param Value Num | -97.2 | Param Value Num | -81.8 | Param Value Num | 80.0 | Param Value Num | 62.3 | Param Value Num | -113.6 | Param Value Num | -166.6 | Param Value Num | 26.5 | Param Value Num | -199.4 | Param Value Num | 4.8 | Param Value Num | -51.6 | Param Value Num | -104.8 | Param Value Num | 249.0 | Param Value Num | 607.0 | Param Value Num | 237.8 | Param Value Num | 230.7 | Param Value Num | 3.95 | Param Value Num | 234.8 | Param Value Num | 210.1 | Param Value Num | 235.7 | Param Value Num | 223.6 | Param Value Num | 218.2 | Param Value Num | 211.0 | Param Value Num | 225.6 | Param Value Num | 35.9 | Param Value Num | 27.7 | Param Value Num | -13.4 | Param Value Num | 27.6 | Param Value Num | 41.0 | Param Value Num | 48.2 | Param Value Num | -0.5 | Param Value Num | 44.2 | Param Value Num | 7.8 | Param Value Num | 30.3 | Param Value Num | 37.0 | Param Value Num | -1.1 | Param Value Num | 26.3 | Param Value Num | 49.4 | Param Value Num | 58.8 | Param Value Num | -7.4 | Param Value Num | 56.0 | Param Value Num | -24.8 | Param Value Num | 42.4 | Param Value Num | 37.2 | Param Value Num | -9.9 | Param Value Num | 25.1 | Param Value Num | 41.0 | Param Value Num | 54.5 | Param Value Num | -3.8 | Param Value Num | 58.0 | Param Value Num | -0.6 | Param Value Num | 35.0 | Param Value Num | 27.8 | Param Value Num | -3.0 | Param Value Num | 55.3 | Param Value Num | 215.608 | Param Value Num | 53.1 | Param Value Num | 60.9 | Param Value Num | -13.7 | Param Value Num | 42.5 | Param Value Num | 11.7 | Param Value Num | -2.5 | Param Value Num | 38.0 | Param Value Num | 44.9 | Param Value Num | -9.5 | Param Value Num | 51.7 | Param Value Num | 68.4 | Param Value Num | 67.9 | Param Value Num | -5.4 | Param Value Num | 66.7 | Param Value Num | -6.0 | Param Value Num | 194.87 | Param Value Num | 208.816 | Param Value Num | 259.161 | Param Value Num | 185.852 | Param Value Num | 160.76 | Param Value Num | 143.519 | Param Value Num | 239.958 | Param Value Num | 74.748 | Param Value Num | -50.565 | Param Value Num | -53.675 | Param Value Num | -66.646 | Param Value Num | -55.283 | Param Value Num | -34.868 | Param Value Num | -74.797 | Param Value Num | -62.787 | Param Value Num | -128.587 | Param Value Num | -1.062 | Param Value Num | -86.025 | Param Value Num | -38.627 | Param Value Num | -83.685 | Param Value Num | -93.412 | Param Value Num | -83.012 | Param Value Num | -43.701 | Param Value Num | -80.68 | Param Value Num | -152.243 | Param Value Num | -9.023 | Param Value Num | 26.0 | Param Value Num | 40.8 | Param Value Num | 26.5 | Param Value Num | 47.0 | Param Value Num | 56.5 | Param Value Num | 44.2 | Param Value Num | 20.1 | Param Value Num | 37.6 | Param Value Num | 23.8 | Param Value Num | 44.2 | Param Value Num | 60.1 | Param Value Num | 31.6 | Param Value Num | 28.6 | Param Value Num | 24.4 | Param Value Num | 32.4 | Param Value Num | 38.1 | Param Value Num | 41.2 | Param Value Num | 30.6 | Param Value Num | 11.5 | Param Value Num | 60.2 | Param Value Num | 338.0 | Param Value Num | 518.0 | Param Value Num | 342.0 | Param Value Num | 605.0 | Param Value Num | 786.0 | Param Value Num | 464.0 | Param Value Num | 289.0 | Param Value Num | 465.0 | Param Value Num | 310.0 | Param Value Num | 566.0 | Param Value Num | 6.73 | Param Value Num | 847.0 | Param Value Num | 388.0 | Param Value Num | 344.0 | Param Value Num | 338.0 | Param Value Num | 402.0 | Param Value Num | 450.0 | Param Value Num | 588.0 | Param Value Num | 8.53 | Param Value Num | 10.5 | Param Value Num | 12.5 | Param Value Num | 10.3 | Param Value Num | 11.0 | Param Value Num | 9.01 | Param Value Num | 8.82 | Param Value Num | 8.83 | Param Value Num | 10.1 | Param Value Num | 12.4 | Param Value Num | 14.6 | Param Value Num | 5.65 | Param Value Num | 11.0 | Param Value Num | 5.01 | Param Value Num | 2.08 | Param Value Num | 2.72 | Param Value Num | 3.48 | Param Value Num | 3.5 | Param Value Num | 2.0 | Param Value Num | 3.28 | Param Value Num | 3.28 | Param Value Num | 2.11 | Param Value Num | 3.33 | Param Value Num | 3.3 | Param Value Num | 2.17 | Param Value Num | 3.42 | Param Value Num | 3.23 | Param Value Num | 3.5 | Param Value Num | 3.5 | Param Value Num | 2.03 | Param Value Num | 2.11 | Param Value Num | 1.98 | Param Value Num | 4.25 | Param Value Num | 2.04 | Param Value Num | 0.0797 | Param Value Num | 0.0665 | Param Value Num | 0.056 | Param Value Num | 0.0681 | Param Value Num | 0.0608 | Param Value Num | 0.0771 | Param Value Num | 0.072 | Param Value Num | 0.0615 | Param Value Num | 0.0714 | Param Value Num | 0.0469 | Param Value Num | 0.0469 | Param Value Num | 0.0594 | Param Value Num | 0.0925 | Param Value Num | 0.0687 | Param Value Num | 0.124 | Param Value Num | 1.55 | Param Value Num | 0.175 | Param Value Num | 0.116 | Param Value Num | 0.0632 | Param Value Num | 0.138 | Param Value Num | 0.888 | Param Value Num | 0.869 | Param Value Num | 0.877 | Param Value Num | 0.744 | Param Value Num | 0.763 | Param Value Num | 1.29 | Param Value Num | 1.04 | Param Value Num | 0.967 | Param Value Num | 0.968 | Param Value Num | 0.795 | Param Value Num | 0.708 | Param Value Num | 0.872 | Param Value Num | 1.33 | Param Value Num | 0.747 | Param Value Num | 1.0 | Param Value Num | 1.02 | Param Value Num | 10.9 | Param Value Num | 14.3 | Param Value Num | 13.7 | Param Value Num | 12.1 | Param Value Num | 13.8 | Param Value Num | 15.8 | Param Value Num | 12.5 | Param Value Num | 13.7 | Param Value Num | 17.4 | Param Value Num | 15.3 | Param Value Num | 15.6 | Param Value Num | 12.4 | Param Value Num | 10.2 | Param Value Num | 10.7 | Param Value Num | 10.1 | Param Value Num | 8.24 | Param Value Num | 8.76 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Full Range | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Full Range | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Full Range | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Full Range | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Full Range | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Full Range | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | Dispersion Type | Geometric Coefficient of Variation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 0.6925 | Dispersion Value | 0.5805 | Dispersion Value | 0.6769 | Dispersion Value | 0.6806 | Dispersion Value | 0.6832 | Dispersion Value | 0.5445 | Dispersion Value | 0.7150 | Dispersion Value | 0.7950 | Dispersion Value | 0.2864 | Dispersion Value | 0.8920 | Dispersion Value | 1.1353 | Dispersion Value | 0.7519 | Dispersion Value | 1.3515 | Dispersion Value | 1.0383 | Dispersion Value | 1.2752 | Dispersion Value | 1.0087 | Dispersion Value | 0.7643 | Dispersion Value | 1.7730 | Dispersion Value | NA | Dispersion Value | 1.0961 | Dispersion Value | 0.4894 | Dispersion Value | 1.9225 | Dispersion Value | 1.1708 | Dispersion Value | 1.1597 | Dispersion Value | 0.8703 | Dispersion Value | 0.9545 | Dispersion Value | 1.0242 | Dispersion Value | 0.8370 | Dispersion Value | 0.9771 | Dispersion Value | 0.8897 | Dispersion Value | 0.7371 | Dispersion Value | 1.0157 | Dispersion Value | 57.3 | Dispersion Value | 54.0 | Dispersion Value | 83.6 | Dispersion Value | 48.2 | Dispersion Value | 61.6 | Dispersion Value | 53.2 | Dispersion Value | 94.3 | Dispersion Value | 97.0 | Dispersion Value | 72.6 | Dispersion Value | 86.4 | Dispersion Value | 90.8 | Dispersion Value | 54.2 | Dispersion Value | 76.3 | Dispersion Value | 98.2 | Dispersion Value | 76.0 | Dispersion Value | 49.8 | Dispersion Value | 104.8 | Dispersion Value | 37.1 | Dispersion Value | 55.9 | Dispersion Value | 106.2 | Dispersion Value | 78.0 | Dispersion Value | 169.6 | Dispersion Value | 53.4 | Dispersion Value | 107.2 | Dispersion Value | NA | Dispersion Value | 47.1 | Dispersion Value | 27.57 | Dispersion Value | 17.81 | Dispersion Value | 27.27 | Dispersion Value | 42.02 | Dispersion Value | 33.45 | Dispersion Value | 25.14 | Dispersion Value | 25.88 | Dispersion Value | 51.04 | Dispersion Value | 45.34 | Dispersion Value | 24.09 | Dispersion Value | 30.60 | Dispersion Value | 22.42 | Dispersion Value | 24.81 | Dispersion Value | 28.51 | Dispersion Value | 33.80 | Dispersion Value | 48.64 | Dispersion Value | 45.06 | Dispersion Value | 29.73 | Dispersion Value | 32.25 | Dispersion Value | 29.45 | Dispersion Value | 40.68 | Dispersion Value | 37.38 | Dispersion Value | 39.68 | Dispersion Value | 33.24 | Dispersion Value | 50.53 | Dispersion Value | 55.44 | Dispersion Value | 26.21 | Dispersion Value | 31.40 | Dispersion Value | 39.26 | Dispersion Value | 38.98 | Dispersion Value | 46.38 | Dispersion Value | 49.42 | Dispersion Value | 20.33 | Dispersion Value | 54.60 | Dispersion Value | 67.56 | Dispersion Value | 69.36 | Dispersion Value | 25.06 | Dispersion Value | 25.80 | Dispersion Value | 35.12 | Dispersion Value | 26.2 | Dispersion Value | 70.42 | Dispersion Value | 41.30 | Dispersion Value | 46.15 | Dispersion Value | 76.89 | Dispersion Value | 71.36 | Dispersion Value | 32.60 | Dispersion Value | 34.27 | Dispersion Value | 26.72 | Dispersion Value | 66.66 | Dispersion Value | 44.30 | Dispersion Value | 52.64 | Dispersion Value | 39.53 | Dispersion Value | 52.72 | Dispersion Value | 67.06 | Dispersion Value | 27.07 | Dispersion Value | 43.12 | Dispersion Value | 26.53 | Dispersion Value | 57.25 | Dispersion Value | 43.79 | Dispersion Value | 28.80 | Dispersion Value | 46.05 | Dispersion Value | 83.44 | Dispersion Value | 11.93 | Dispersion Value | 35.40 | Dispersion Value | 37.61 | Dispersion Value | 34.16 | Dispersion Value | 57.32 | Dispersion Value | 30.17 | Dispersion Value | 22.08 | Dispersion Value | 55.82 | Dispersion Value | 86.97 | Dispersion Value | 16.21 | Dispersion Value | 25.74 | Dispersion Value | 24.50 | Dispersion Value | 26.49 | Dispersion Value | 41.33 | Dispersion Value | 35.54 | Dispersion Value | 29.81 | Dispersion Value | 44.11 | Dispersion Value | 52.58 | Dispersion Value | 7.07 | Dispersion Value | 38.46 | Dispersion Value | 36.56 | Dispersion Value | 35.09 | Dispersion Value | 26.71 | Dispersion Value | 36.94 | Dispersion Value | 22.23 | Dispersion Value | 23.93 | Dispersion Value | 37.01 | Dispersion Value | 18.77 | Dispersion Value | 34.49 | Dispersion Value | 33.59 | Dispersion Value | 22.83 | Dispersion Value | 35.23 | Dispersion Value | 29.67 | Dispersion Value | 23.37 | Dispersion Value | 32.86 | Dispersion Value | 17.36 | Dispersion Value | 25.79 | Dispersion Value | 45.04 | Dispersion Value | 40.51 | Dispersion Value | 44.30 | Dispersion Value | 24.06 | Dispersion Value | 36.91 | Dispersion Value | 40.33 | Dispersion Value | 26.55 | Dispersion Value | 11.09 | Dispersion Value | 20.33 | Dispersion Value | 38.24 | Dispersion Value | 43.14 | Dispersion Value | 33.03 | Dispersion Value | 40.49 | Dispersion Value | 40.20 | Dispersion Value | 27.54 | Dispersion Value | 22.88 | Dispersion Value | 43.94 | Dispersion Value | 28.99 | Dispersion Value | 39.39 | Dispersion Value | 39.85 | Dispersion Value | 53.89 | Dispersion Value | 10.26 | Dispersion Value | 30.27 | Dispersion Value | 30.31 | Dispersion Value | 44.05 | Dispersion Value | 53.03 | Dispersion Value | 24.06 | Dispersion Value | 41.11 | Dispersion Value | 27.87 | Dispersion Value | 46.49 | Dispersion Value | 67.73 | Dispersion Value | 32.43 | Dispersion Value | 16.03 | Dispersion Value | 28.94 | Dispersion Value | 43.19 | Dispersion Value | 21.57 | Dispersion Value | 478.64 | Dispersion Value | 359.10 | Dispersion Value | 298.27 | Dispersion Value | 408.03 | Dispersion Value | 362.98 | Dispersion Value | 329.66 | Dispersion Value | 484.29 | Dispersion Value | 508.67 | Dispersion Value | 423.44 | Dispersion Value | 185.45 | Dispersion Value | 204.51 | Dispersion Value | 274.39 | Dispersion Value | 335.00 | Dispersion Value | 347.97 | Dispersion Value | 320.50 | Dispersion Value | 211.10 | Dispersion Value | 470.43 | Dispersion Value | 17.37 | Dispersion Value | 273.28 | Dispersion Value | 298.19 | Dispersion Value | 334.28 | Dispersion Value | 361.29 | Dispersion Value | 255.10 | Dispersion Value | 285.30 | Dispersion Value | 254.98 | Dispersion Value | 609.61 | Dispersion Value | 453.76 | Dispersion Value | 220.40 | Dispersion Value | 288.47 | Dispersion Value | 356.19 | Dispersion Value | 275.11 | Dispersion Value | 303.39 | Dispersion Value | 386.24 | Dispersion Value | 304.63 | Dispersion Value | 237.99 | Dispersion Value | 157.46 | Dispersion Value | 309.88 | Dispersion Value | 288.34 | Dispersion Value | 567.19 | Dispersion Value | 358.78 | Dispersion Value | 244.67 | Dispersion Value | 188.15 | Dispersion Value | 447.01 | Dispersion Value | 243.24 | Dispersion Value | 186.15 | Dispersion Value | 327.06 | Dispersion Value | 298.67 | Dispersion Value | 497.52 | Dispersion Value | 370.32 | Dispersion Value | 331.76 | Dispersion Value | 253.07 | Dispersion Value | 347.53 | Dispersion Value | 636.33 | Dispersion Value | 607.0 | Dispersion Value | 39.28 | Dispersion Value | 39.09 | Dispersion Value | 44.76 | Dispersion Value | 33.33 | Dispersion Value | 38.80 | Dispersion Value | 34.31 | Dispersion Value | 33.80 | Dispersion Value | 42.99 | Dispersion Value | 98.15 | Dispersion Value | 27.11 | Dispersion Value | 33.58 | Dispersion Value | 26.02 | Dispersion Value | 28.49 | Dispersion Value | 26.22 | Dispersion Value | 37.78 | Dispersion Value | 21.44 | Dispersion Value | 53.58 | Dispersion Value | 14.38 | Dispersion Value | 28.42 | Dispersion Value | 40.99 | Dispersion Value | 18.38 | Dispersion Value | 23.98 | Dispersion Value | 27.34 | Dispersion Value | 24.54 | Dispersion Value | 19.26 | Dispersion Value | 58.15 | Dispersion Value | 58.79 | Dispersion Value | 27.10 | Dispersion Value | 43.09 | Dispersion Value | 25.85 | Dispersion Value | 33.90 | Dispersion Value | 39.05 | Dispersion Value | 44.05 | Dispersion Value | 25.42 | Dispersion Value | 14.45 | Dispersion Value | 15.32 | Dispersion Value | 43.00 | Dispersion Value | 35.16 | Dispersion Value | 25.44 | Dispersion Value | 28.63 | Dispersion Value | 130.7350 | Dispersion Value | 58.33 | Dispersion Value | 70.50 | Dispersion Value | 31.46 | Dispersion Value | 62.93 | Dispersion Value | 18.52 | Dispersion Value | 28.15 | Dispersion Value | 30.71 | Dispersion Value | 29.29 | Dispersion Value | 37.50 | Dispersion Value | 43.40 | Dispersion Value | 58.44 | Dispersion Value | 29.78 | Dispersion Value | 35.22 | Dispersion Value | 21.79 | Dispersion Value | 113.9348 | Dispersion Value | 85.1667 | Dispersion Value | 134.9995 | Dispersion Value | 105.6611 | Dispersion Value | 102.6261 | Dispersion Value | 124.6749 | Dispersion Value | 151.3859 | Dispersion Value | 40.2119 | Dispersion Value | 57.6474 | Dispersion Value | 92.1185 | Dispersion Value | 152.3178 | Dispersion Value | 77.1648 | Dispersion Value | 89.7176 | Dispersion Value | 126.1667 | Dispersion Value | 96.1842 | Dispersion Value | 262.6300 | Dispersion Value | 30.4842 | Dispersion Value | 100.4382 | Dispersion Value | 75.0555 | Dispersion Value | 95.7049 | Dispersion Value | 115.2839 | Dispersion Value | 98.7521 | Dispersion Value | 80.8411 | Dispersion Value | 125.2481 | Dispersion Value | 218.9284 | Dispersion Value | 80.4001 | Dispersion Value | 87.9 | Dispersion Value | 54.8 | Dispersion Value | 59.3 | Dispersion Value | 38.2 | Dispersion Value | 39.2 | Dispersion Value | 73.1 | Dispersion Value | 174.4 | Dispersion Value | 78.9 | Dispersion Value | 69.0 | Dispersion Value | 29.6 | Dispersion Value | 41.6 | Dispersion Value | 151.6 | Dispersion Value | 49.3 | Dispersion Value | 350.6 | Dispersion Value | 26.9 | Dispersion Value | 99.0 | Dispersion Value | 77.7 | Dispersion Value | 102.7 | Dispersion Value | NA | Dispersion Value | 9.2 | Dispersion Value | 63.8 | Dispersion Value | 71.1 | Dispersion Value | 81.7 | Dispersion Value | 54.5 | Dispersion Value | 36.6 | Dispersion Value | 80.9 | Dispersion Value | 76.6 | Dispersion Value | 80.8 | Dispersion Value | 94.7 | Dispersion Value | 41.1 | Dispersion Value | 54.8 | Dispersion Value | 112.4 | Dispersion Value | 53.5 | Dispersion Value | 282.0 | Dispersion Value | 70.8 | Dispersion Value | 68.2 | Dispersion Value | 52.5 | Dispersion Value | 38.7 | Dispersion Value | 50.5 | Dispersion Value | 41.6 | Dispersion Value | 32.7 | Dispersion Value | 46.9 | Dispersion Value | 8.9 | Dispersion Value | 44.2 | Dispersion Value | 70.0 | Dispersion Value | 53.9 | Dispersion Value | 72.2 | Dispersion Value | 74.4 | Dispersion Value | 4.5 | Dispersion Value | 65.5 | Dispersion Value | 26.5 | Dispersion Value | 92.0 | Dispersion Value | 112.4 | Dispersion Value | NA | Dispersion Value | 15.9 | Dispersion Value | NA | Dispersion Value | NA | Dispersion Value | 63.8 | Dispersion Value | 71.1 | Dispersion Value | 81.7 | Dispersion Value | 54.5 | Dispersion Value | 36.6 | Dispersion Value | 80.9 | Dispersion Value | 76.6 | Dispersion Value | 80.8 | Dispersion Value | 94.7 | Dispersion Value | 41.1 | Dispersion Value | 54.8 | Dispersion Value | 53.5 | Dispersion Value | 282.0 | Dispersion Value | 70.8 | Dispersion Value | 68.2 | Dispersion Value | 52.5 | Dispersion Value | 36.2 | Dispersion Value | 53.4 | Dispersion Value | 69.7 | Dispersion Value | 38.6 | Dispersion Value | 16.7 | Dispersion Value | 56.9 | Dispersion Value | 36.6 | Dispersion Value | 41.0 | Dispersion Value | 50.4 | Dispersion Value | 67.4 | Dispersion Value | 27.2 | Dispersion Value | 35.8 | Dispersion Value | 28.7 | Dispersion Value | 37.6 | Dispersion Value | 10.3 | Dispersion Value | NA | Dispersion Value | 18.9 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 0.6925 | Dispersion Value Num | 0.5805 | Dispersion Value Num | 0.6769 | Dispersion Value Num | 0.6806 | Dispersion Value Num | 0.6832 | Dispersion Value Num | 0.5445 | Dispersion Value Num | 0.715 | Dispersion Value Num | 0.795 | Dispersion Value Num | 0.2864 | Dispersion Value Num | 0.892 | Dispersion Value Num | 1.1353 | Dispersion Value Num | 0.7519 | Dispersion Value Num | 1.3515 | Dispersion Value Num | 1.0383 | Dispersion Value Num | 1.2752 | Dispersion Value Num | 1.0087 | Dispersion Value Num | 0.7643 | Dispersion Value Num | 1.773 | Dispersion Value Num | 1.0961 | Dispersion Value Num | 0.4894 | Dispersion Value Num | 1.9225 | Dispersion Value Num | 1.1708 | Dispersion Value Num | 1.1597 | Dispersion Value Num | 0.8703 | Dispersion Value Num | 0.9545 | Dispersion Value Num | 1.0242 | Dispersion Value Num | 0.837 | Dispersion Value Num | 0.9771 | Dispersion Value Num | 0.8897 | Dispersion Value Num | 0.7371 | Dispersion Value Num | 1.0157 | Dispersion Value Num | 57.3 | Dispersion Value Num | 54.0 | Dispersion Value Num | 83.6 | Dispersion Value Num | 48.2 | Dispersion Value Num | 61.6 | Dispersion Value Num | 53.2 | Dispersion Value Num | 94.3 | Dispersion Value Num | 97.0 | Dispersion Value Num | 72.6 | Dispersion Value Num | 86.4 | Dispersion Value Num | 90.8 | Dispersion Value Num | 54.2 | Dispersion Value Num | 76.3 | Dispersion Value Num | 98.2 | Dispersion Value Num | 76.0 | Dispersion Value Num | 49.8 | Dispersion Value Num | 104.8 | Dispersion Value Num | 37.1 | Dispersion Value Num | 55.9 | Dispersion Value Num | 106.2 | Dispersion Value Num | 78.0 | Dispersion Value Num | 169.6 | Dispersion Value Num | 53.4 | Dispersion Value Num | 107.2 | Dispersion Value Num | 47.1 | Dispersion Value Num | 27.57 | Dispersion Value Num | 17.81 | Dispersion Value Num | 27.27 | Dispersion Value Num | 42.02 | Dispersion Value Num | 33.45 | Dispersion Value Num | 25.14 | Dispersion Value Num | 25.88 | Dispersion Value Num | 51.04 | Dispersion Value Num | 45.34 | Dispersion Value Num | 24.09 | Dispersion Value Num | 30.6 | Dispersion Value Num | 22.42 | Dispersion Value Num | 24.81 | Dispersion Value Num | 28.51 | Dispersion Value Num | 33.8 | Dispersion Value Num | 48.64 | Dispersion Value Num | 45.06 | Dispersion Value Num | 29.73 | Dispersion Value Num | 32.25 | Dispersion Value Num | 29.45 | Dispersion Value Num | 40.68 | Dispersion Value Num | 37.38 | Dispersion Value Num | 39.68 | Dispersion Value Num | 33.24 | Dispersion Value Num | 50.53 | Dispersion Value Num | 55.44 | Dispersion Value Num | 26.21 | Dispersion Value Num | 31.4 | Dispersion Value Num | 39.26 | Dispersion Value Num | 38.98 | Dispersion Value Num | 46.38 | Dispersion Value Num | 49.42 | Dispersion Value Num | 20.33 | Dispersion Value Num | 54.6 | Dispersion Value Num | 67.56 | Dispersion Value Num | 69.36 | Dispersion Value Num | 25.06 | Dispersion Value Num | 25.8 | Dispersion Value Num | 35.12 | Dispersion Value Num | 26.2 | Dispersion Value Num | 70.42 | Dispersion Value Num | 41.3 | Dispersion Value Num | 46.15 | Dispersion Value Num | 76.89 | Dispersion Value Num | 71.36 | Dispersion Value Num | 32.6 | Dispersion Value Num | 34.27 | Dispersion Value Num | 26.72 | Dispersion Value Num | 66.66 | Dispersion Value Num | 44.3 | Dispersion Value Num | 52.64 | Dispersion Value Num | 39.53 | Dispersion Value Num | 52.72 | Dispersion Value Num | 67.06 | Dispersion Value Num | 27.07 | Dispersion Value Num | 43.12 | Dispersion Value Num | 26.53 | Dispersion Value Num | 57.25 | Dispersion Value Num | 43.79 | Dispersion Value Num | 28.8 | Dispersion Value Num | 46.05 | Dispersion Value Num | 83.44 | Dispersion Value Num | 11.93 | Dispersion Value Num | 35.4 | Dispersion Value Num | 37.61 | Dispersion Value Num | 34.16 | Dispersion Value Num | 57.32 | Dispersion Value Num | 30.17 | Dispersion Value Num | 22.08 | Dispersion Value Num | 55.82 | Dispersion Value Num | 86.97 | Dispersion Value Num | 16.21 | Dispersion Value Num | 25.74 | Dispersion Value Num | 24.5 | Dispersion Value Num | 26.49 | Dispersion Value Num | 41.33 | Dispersion Value Num | 35.54 | Dispersion Value Num | 29.81 | Dispersion Value Num | 44.11 | Dispersion Value Num | 52.58 | Dispersion Value Num | 7.07 | Dispersion Value Num | 38.46 | Dispersion Value Num | 36.56 | Dispersion Value Num | 35.09 | Dispersion Value Num | 26.71 | Dispersion Value Num | 36.94 | Dispersion Value Num | 22.23 | Dispersion Value Num | 23.93 | Dispersion Value Num | 37.01 | Dispersion Value Num | 18.77 | Dispersion Value Num | 34.49 | Dispersion Value Num | 33.59 | Dispersion Value Num | 22.83 | Dispersion Value Num | 35.23 | Dispersion Value Num | 29.67 | Dispersion Value Num | 23.37 | Dispersion Value Num | 32.86 | Dispersion Value Num | 17.36 | Dispersion Value Num | 25.79 | Dispersion Value Num | 45.04 | Dispersion Value Num | 40.51 | Dispersion Value Num | 44.3 | Dispersion Value Num | 24.06 | Dispersion Value Num | 36.91 | Dispersion Value Num | 40.33 | Dispersion Value Num | 26.55 | Dispersion Value Num | 11.09 | Dispersion Value Num | 20.33 | Dispersion Value Num | 38.24 | Dispersion Value Num | 43.14 | Dispersion Value Num | 33.03 | Dispersion Value Num | 40.49 | Dispersion Value Num | 40.2 | Dispersion Value Num | 27.54 | Dispersion Value Num | 22.88 | Dispersion Value Num | 43.94 | Dispersion Value Num | 28.99 | Dispersion Value Num | 39.39 | Dispersion Value Num | 39.85 | Dispersion Value Num | 53.89 | Dispersion Value Num | 10.26 | Dispersion Value Num | 30.27 | Dispersion Value Num | 30.31 | Dispersion Value Num | 44.05 | Dispersion Value Num | 53.03 | Dispersion Value Num | 24.06 | Dispersion Value Num | 41.11 | Dispersion Value Num | 27.87 | Dispersion Value Num | 46.49 | Dispersion Value Num | 67.73 | Dispersion Value Num | 32.43 | Dispersion Value Num | 16.03 | Dispersion Value Num | 28.94 | Dispersion Value Num | 43.19 | Dispersion Value Num | 21.57 | Dispersion Value Num | 478.64 | Dispersion Value Num | 359.1 | Dispersion Value Num | 298.27 | Dispersion Value Num | 408.03 | Dispersion Value Num | 362.98 | Dispersion Value Num | 329.66 | Dispersion Value Num | 484.29 | Dispersion Value Num | 508.67 | Dispersion Value Num | 423.44 | Dispersion Value Num | 185.45 | Dispersion Value Num | 204.51 | Dispersion Value Num | 274.39 | Dispersion Value Num | 335.0 | Dispersion Value Num | 347.97 | Dispersion Value Num | 320.5 | Dispersion Value Num | 211.1 | Dispersion Value Num | 470.43 | Dispersion Value Num | 17.37 | Dispersion Value Num | 273.28 | Dispersion Value Num | 298.19 | Dispersion Value Num | 334.28 | Dispersion Value Num | 361.29 | Dispersion Value Num | 255.1 | Dispersion Value Num | 285.3 | Dispersion Value Num | 254.98 | Dispersion Value Num | 609.61 | Dispersion Value Num | 453.76 | Dispersion Value Num | 220.4 | Dispersion Value Num | 288.47 | Dispersion Value Num | 356.19 | Dispersion Value Num | 275.11 | Dispersion Value Num | 303.39 | Dispersion Value Num | 386.24 | Dispersion Value Num | 304.63 | Dispersion Value Num | 237.99 | Dispersion Value Num | 157.46 | Dispersion Value Num | 309.88 | Dispersion Value Num | 288.34 | Dispersion Value Num | 567.19 | Dispersion Value Num | 358.78 | Dispersion Value Num | 244.67 | Dispersion Value Num | 188.15 | Dispersion Value Num | 447.01 | Dispersion Value Num | 243.24 | Dispersion Value Num | 186.15 | Dispersion Value Num | 327.06 | Dispersion Value Num | 298.67 | Dispersion Value Num | 497.52 | Dispersion Value Num | 370.32 | Dispersion Value Num | 331.76 | Dispersion Value Num | 253.07 | Dispersion Value Num | 347.53 | Dispersion Value Num | 636.33 | Dispersion Value Num | 607.0 | Dispersion Value Num | 39.28 | Dispersion Value Num | 39.09 | Dispersion Value Num | 44.76 | Dispersion Value Num | 33.33 | Dispersion Value Num | 38.8 | Dispersion Value Num | 34.31 | Dispersion Value Num | 33.8 | Dispersion Value Num | 42.99 | Dispersion Value Num | 98.15 | Dispersion Value Num | 27.11 | Dispersion Value Num | 33.58 | Dispersion Value Num | 26.02 | Dispersion Value Num | 28.49 | Dispersion Value Num | 26.22 | Dispersion Value Num | 37.78 | Dispersion Value Num | 21.44 | Dispersion Value Num | 53.58 | Dispersion Value Num | 14.38 | Dispersion Value Num | 28.42 | Dispersion Value Num | 40.99 | Dispersion Value Num | 18.38 | Dispersion Value Num | 23.98 | Dispersion Value Num | 27.34 | Dispersion Value Num | 24.54 | Dispersion Value Num | 19.26 | Dispersion Value Num | 58.15 | Dispersion Value Num | 58.79 | Dispersion Value Num | 27.1 | Dispersion Value Num | 43.09 | Dispersion Value Num | 25.85 | Dispersion Value Num | 33.9 | Dispersion Value Num | 39.05 | Dispersion Value Num | 44.05 | Dispersion Value Num | 25.42 | Dispersion Value Num | 14.45 | Dispersion Value Num | 15.32 | Dispersion Value Num | 43.0 | Dispersion Value Num | 35.16 | Dispersion Value Num | 25.44 | Dispersion Value Num | 28.63 | Dispersion Value Num | 130.735 | Dispersion Value Num | 58.33 | Dispersion Value Num | 70.5 | Dispersion Value Num | 31.46 | Dispersion Value Num | 62.93 | Dispersion Value Num | 18.52 | Dispersion Value Num | 28.15 | Dispersion Value Num | 30.71 | Dispersion Value Num | 29.29 | Dispersion Value Num | 37.5 | Dispersion Value Num | 43.4 | Dispersion Value Num | 58.44 | Dispersion Value Num | 29.78 | Dispersion Value Num | 35.22 | Dispersion Value Num | 21.79 | Dispersion Value Num | 113.9348 | Dispersion Value Num | 85.1667 | Dispersion Value Num | 134.9995 | Dispersion Value Num | 105.6611 | Dispersion Value Num | 102.6261 | Dispersion Value Num | 124.6749 | Dispersion Value Num | 151.3859 | Dispersion Value Num | 40.2119 | Dispersion Value Num | 57.6474 | Dispersion Value Num | 92.1185 | Dispersion Value Num | 152.3178 | Dispersion Value Num | 77.1648 | Dispersion Value Num | 89.7176 | Dispersion Value Num | 126.1667 | Dispersion Value Num | 96.1842 | Dispersion Value Num | 262.63 | Dispersion Value Num | 30.4842 | Dispersion Value Num | 100.4382 | Dispersion Value Num | 75.0555 | Dispersion Value Num | 95.7049 | Dispersion Value Num | 115.2839 | Dispersion Value Num | 98.7521 | Dispersion Value Num | 80.8411 | Dispersion Value Num | 125.2481 | Dispersion Value Num | 218.9284 | Dispersion Value Num | 80.4001 | Dispersion Value Num | 87.9 | Dispersion Value Num | 54.8 | Dispersion Value Num | 59.3 | Dispersion Value Num | 38.2 | Dispersion Value Num | 39.2 | Dispersion Value Num | 73.1 | Dispersion Value Num | 174.4 | Dispersion Value Num | 78.9 | Dispersion Value Num | 69.0 | Dispersion Value Num | 29.6 | Dispersion Value Num | 41.6 | Dispersion Value Num | 151.6 | Dispersion Value Num | 49.3 | Dispersion Value Num | 350.6 | Dispersion Value Num | 26.9 | Dispersion Value Num | 99.0 | Dispersion Value Num | 77.7 | Dispersion Value Num | 102.7 | Dispersion Value Num | 9.2 | Dispersion Value Num | 63.8 | Dispersion Value Num | 71.1 | Dispersion Value Num | 81.7 | Dispersion Value Num | 54.5 | Dispersion Value Num | 36.6 | Dispersion Value Num | 80.9 | Dispersion Value Num | 76.6 | Dispersion Value Num | 80.8 | Dispersion Value Num | 94.7 | Dispersion Value Num | 41.1 | Dispersion Value Num | 54.8 | Dispersion Value Num | 112.4 | Dispersion Value Num | 53.5 | Dispersion Value Num | 282.0 | Dispersion Value Num | 70.8 | Dispersion Value Num | 68.2 | Dispersion Value Num | 52.5 | Dispersion Value Num | 38.7 | Dispersion Value Num | 50.5 | Dispersion Value Num | 41.6 | Dispersion Value Num | 32.7 | Dispersion Value Num | 46.9 | Dispersion Value Num | 8.9 | Dispersion Value Num | 44.2 | Dispersion Value Num | 70.0 | Dispersion Value Num | 53.9 | Dispersion Value Num | 72.2 | Dispersion Value Num | 74.4 | Dispersion Value Num | 4.5 | Dispersion Value Num | 65.5 | Dispersion Value Num | 26.5 | Dispersion Value Num | 92.0 | Dispersion Value Num | 112.4 | Dispersion Value Num | 15.9 | Dispersion Value Num | 63.8 | Dispersion Value Num | 71.1 | Dispersion Value Num | 81.7 | Dispersion Value Num | 54.5 | Dispersion Value Num | 36.6 | Dispersion Value Num | 80.9 | Dispersion Value Num | 76.6 | Dispersion Value Num | 80.8 | Dispersion Value Num | 94.7 | Dispersion Value Num | 41.1 | Dispersion Value Num | 54.8 | Dispersion Value Num | 53.5 | Dispersion Value Num | 282.0 | Dispersion Value Num | 70.8 | Dispersion Value Num | 68.2 | Dispersion Value Num | 52.5 | Dispersion Value Num | 36.2 | Dispersion Value Num | 53.4 | Dispersion Value Num | 69.7 | Dispersion Value Num | 38.6 | Dispersion Value Num | 16.7 | Dispersion Value Num | 56.9 | Dispersion Value Num | 36.6 | Dispersion Value Num | 41.0 | Dispersion Value Num | 50.4 | Dispersion Value Num | 67.4 | Dispersion Value Num | 27.2 | Dispersion Value Num | 35.8 | Dispersion Value Num | 28.7 | Dispersion Value Num | 37.6 | Dispersion Value Num | 10.3 | Dispersion Value Num | 18.9 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Lower Limit | 6.46 | Dispersion Lower Limit | 3.22 | Dispersion Lower Limit | 3.95 | Dispersion Lower Limit | 11.3 | Dispersion Lower Limit | 3.55 | Dispersion Lower Limit | 5.36 | Dispersion Lower Limit | 3.26 | Dispersion Lower Limit | 7.33 | Dispersion Lower Limit | 6.33 | Dispersion Lower Limit | 6.51 | Dispersion Lower Limit | 8.45 | Dispersion Lower Limit | 5.8 | Dispersion Lower Limit | 4.98 | Dispersion Lower Limit | 4.79 | Dispersion Lower Limit | 5.73 | Dispersion Lower Limit | 5.61 | Dispersion Lower Limit | 5.26 | Dispersion Lower Limit | 11.0 | Dispersion Lower Limit | 5.01 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 1.83 | Dispersion Lower Limit | 1.92 | Dispersion Lower Limit | 1.58 | Dispersion Lower Limit | 1.75 | Dispersion Lower Limit | 1.83 | Dispersion Lower Limit | 1.75 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 1.8 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 1.75 | Dispersion Lower Limit | 1.8 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 1.75 | Dispersion Lower Limit | 2.0 | Dispersion Lower Limit | 1.75 | Dispersion Lower Limit | 1.8 | Dispersion Lower Limit | 1.75 | Dispersion Lower Limit | 4.25 | Dispersion Lower Limit | 1.97 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Upper Limit | 13.8 | Dispersion Upper Limit | 9.75 | Dispersion Upper Limit | 3.95 | Dispersion Upper Limit | 12.0 | Dispersion Upper Limit | 22.1 | Dispersion Upper Limit | 26.6 | Dispersion Upper Limit | 21.1 | Dispersion Upper Limit | 20.7 | Dispersion Upper Limit | 18.3 | Dispersion Upper Limit | 18.0 | Dispersion Upper Limit | 9.58 | Dispersion Upper Limit | 22.9 | Dispersion Upper Limit | 70.0 | Dispersion Upper Limit | 17.9 | Dispersion Upper Limit | 47.8 | Dispersion Upper Limit | 31.3 | Dispersion Upper Limit | 7.12 | Dispersion Upper Limit | 11.0 | Dispersion Upper Limit | 5.01 | Dispersion Upper Limit | 11.5 | Dispersion Upper Limit | 5.03 | Dispersion Upper Limit | 10.5 | Dispersion Upper Limit | 9.0 | Dispersion Upper Limit | 5.03 | Dispersion Upper Limit | 4.5 | Dispersion Upper Limit | 6.75 | Dispersion Upper Limit | 5.23 | Dispersion Upper Limit | 5.0 | Dispersion Upper Limit | 5.0 | Dispersion Upper Limit | 5.05 | Dispersion Upper Limit | 4.5 | Dispersion Upper Limit | 4.5 | Dispersion Upper Limit | 10.83 | Dispersion Upper Limit | 4.67 | Dispersion Upper Limit | 3.63 | Dispersion Upper Limit | 5.0 | Dispersion Upper Limit | 5.0 | Dispersion Upper Limit | 4.25 | Dispersion Upper Limit | 2.12 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Explanation Of Na | Standard deviation cannot be calculated due to only one participant with data | Explanation Of Na | Dispersion data are not available for a single participant. | Explanation Of Na | Dispersion data are not available for a single participant | Explanation Of Na | Dispersion data are not available for a single participant | Explanation Of Na | Dispersion data are not available for a single participant | Explanation Of Na | Dispersion data are not available for a single participant | Explanation Of Na | Dispersion data are not available for a single participant |
Study References
Sequence: | 52087708 |
Pmid | 36005278 |
Reference Type | derived |
Citation | Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2. |
Baseline Counts
Sequence: | 11388349 | Sequence: | 11388350 | Sequence: | 11388351 | Sequence: | 11388352 | Sequence: | 11388353 | Sequence: | 11388354 | Sequence: | 11388355 | Sequence: | 11388356 | Sequence: | 11388357 | Sequence: | 11388358 |
Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall |
Count | 35 | Count | 34 | Count | 23 | Count | 18 | Count | 21 | Count | 21 | Count | 13 | Count | 5 | Count | 5 | Count | 175 |
Result Groups
Sequence: | 56112522 | Sequence: | 56112523 | Sequence: | 56112524 | Sequence: | 56112525 | Sequence: | 56112526 | Sequence: | 56112527 | Sequence: | 56112528 | Sequence: | 56112529 | Sequence: | 56112530 | Sequence: | 56112531 | Sequence: | 56112554 | Sequence: | 56112532 | Sequence: | 56112533 | Sequence: | 56112534 | Sequence: | 56112535 | Sequence: | 56112536 | Sequence: | 56112537 | Sequence: | 56112538 | Sequence: | 56112539 | Sequence: | 56112540 | Sequence: | 56112541 | Sequence: | 56112542 | Sequence: | 56112543 | Sequence: | 56112544 | Sequence: | 56112545 | Sequence: | 56112546 | Sequence: | 56112547 | Sequence: | 56112548 | Sequence: | 56112549 | Sequence: | 56112550 | Sequence: | 56112551 | Sequence: | 56112552 | Sequence: | 56112553 | Sequence: | 56112555 | Sequence: | 56112556 | Sequence: | 56112557 | Sequence: | 56112558 | Sequence: | 56112559 | Sequence: | 56112560 | Sequence: | 56112561 | Sequence: | 56112562 | Sequence: | 56112563 | Sequence: | 56112564 | Sequence: | 56112565 | Sequence: | 56112566 | Sequence: | 56112567 | Sequence: | 56112568 | Sequence: | 56112569 | Sequence: | 56112570 | Sequence: | 56112571 | Sequence: | 56112572 | Sequence: | 56112573 | Sequence: | 56112574 | Sequence: | 56112575 | Sequence: | 56112576 | Sequence: | 56112577 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | OG003 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG006 | Ctgov Group Code | FG007 | Ctgov Group Code | FG008 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG006 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG007 | Ctgov Group Code | OG008 | Ctgov Group Code | OG002 | Ctgov Group Code | OG003 | Ctgov Group Code | OG004 | Ctgov Group Code | OG005 | Ctgov Group Code | OG008 | Ctgov Group Code | OG008 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG003 | Ctgov Group Code | EG004 | Ctgov Group Code | EG005 | Ctgov Group Code | EG006 | Ctgov Group Code | EG007 | Ctgov Group Code | EG008 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Outcome | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event |
Title | Low Dose of Epoetin Alfa: Vadadustat 300 mg | Title | Low Dose of Epoetin Alfa: Vadadustat 450 mg | Title | Low Dose of Epoetin Alfa: Epoetin Alfa | Title | High Dose of Epoetin Alfa: Vadadustat 300 mg | Title | High Dose of Epoetin Alfa: Vadadustat 450 mg | Title | High Dose of Epoetin Alfa: Vadadustat 600 mg | Title | High Dose of Epoetin Alfa: Epoetin Alfa | Title | ESA Hyporesponder: Vadadustat 600 mg | Title | ESA Hyporesponder: Epoetin Alfa | Title | Total | Title | Vadadustat 750 mg (Starting Dose in TIW Dosing Regimen) | Title | Low Dose of Epoetin Alfa: Vadadustat 300 mg | Title | Low Dose of Epoetin Alfa: Vadadustat 450 mg | Title | Low Dose of Epoetin Alfa: Epoetin Alfa | Title | High Dose of Epoetin Alfa: Vadadustat 300 mg | Title | High Dose of Epoetin Alfa: Vadadustat 450 mg | Title | High Dose of Epoetin Alfa: Vadadustat 600 mg | Title | High Dose of Epoetin Alfa: Epoetin Alfa | Title | ESA Hyporesponder: Vadadustat 600 mg | Title | ESA Hyporesponder: Epoetin Alfa | Title | Low Dose of Epoetin Alfa: Vadadustat 300 mg | Title | Low Dose of Epoetin Alfa: Vadadustat 450 mg | Title | Low Dose of Epoetin Alfa: Epoetin Alfa | Title | High Dose of Epoetin Alfa: Vadadustat 300 mg | Title | High Dose of Epoetin Alfa: Vadadustat 450 mg | Title | High Dose of Epoetin Alfa: Vadadustat 600 mg | Title | High Dose of Epoetin Alfa: Epoetin Alfa | Title | ESA Hyporesponder: Vadadustat 600 mg | Title | ESA Hyporesponder: Epoetin Alfa | Title | Low Dose of Epoetin Alfa: Epoetin Alfa | Title | Vadadustat 300 mg (Starting Dose in TIW Dosing Regimen) | Title | Vadadustat 450 mg (Starting Dose in TIW Dosing Regimen) | Title | Vadadustat 600 mg (Starting Dose in TIW Dosing Regimen) | Title | Vadadustat Total (TIW Dosing Regimen) | Title | ESA Hyporesponder Parallel Study: Vadadustat ≤ 750 mg (TIW Dosing Regimen) | Title | ESA Hyporesponder Parallel Study: Vadadustat ≤ 750 mg (TIW Dosing Regimen) | Title | Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Vadadustat 300 mg | Title | Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Vadadustat 450 mg | Title | Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Epoetin Alfa | Title | ESA Hyporesponder (Epoetin Alfa ≥300 U/kg/Week): Vadadustat 600 mg | Title | ESA Hyporesponder (Epoetin Alfa ≥300 U/kg/Week): Epoetin Alfa | Title | High Dose of Epoetin Alfa: Vadadustat 300 mg | Title | High Dose of Epoetin Alfa: Vadadustat 450 mg | Title | High Dose of Epoetin Alfa: Vadadustat 600 mg | Title | ESA Hyporesponder: Vadadustat 600 mg | Title | ESA Hyporesponder: Epoetin Alfa | Title | ESA Hyporesponder: Epoetin Alfa | Title | Low Dose of Epoetin Alfa: Vadadustat 300 mg | Title | Low Dose of Epoetin Alfa: Vadadustat 450 mg | Title | Low Dose of Epoetin Alfa: Epoetin Alfa | Title | High Dose of Epoetin Alfa: Vadadustat 300 mg | Title | High Dose of Epoetin Alfa: Vadadustat 450 mg | Title | High Dose of Epoetin Alfa: Vadadustat 600 mg | Title | High Dose of Epoetin Alfa: Epoetin Alfa | Title | ESA Hyporesponder: Vadadustat 600 mg | Title | ESA Hyporesponder: Epoetin Alfa |
Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | Total of all reporting groups | Description | After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [600 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive. | Description | After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 300 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [150 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 450 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [300 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 600 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [450 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 1 tablet greater (150 mg) than final dose in QD dosing regimen. Vadadustat Total comprises all participants who switched from Vadadustat QD to TIW dosing regimen in the Main Study (i.e., combined arm for starting doses of 300mg, 450 mg, 600 mg and 750 mg). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat ≤ 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat ≤ 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive. | Description | In the erythropoiesis-stimulating agent (ESA) hyporesponder parallel study participants who were maintained on ≥300 U/kg/week dose of Epoetin Alfa prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with an oral dose of Vadadustat 600 mg tablet per day. | Description | In the ESA hyporesponder parallel study participants who were maintained on ≥300 U/kg/week dose of Epoetin Alfa prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three TIW dose of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive | Description | In the ESA hyporesponder parallel study participants who were maintained on ≥300 U/kg/week dose of Epoetin Alfa prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three TIW dose of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.(US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive" | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. | Description | In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20. | Description | In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive. |
Baseline Measurements
Sequence: | 125654974 | Sequence: | 125654975 | Sequence: | 125654976 | Sequence: | 125654977 | Sequence: | 125654978 | Sequence: | 125654979 | Sequence: | 125654980 | Sequence: | 125654981 | Sequence: | 125654982 | Sequence: | 125654983 | Sequence: | 125654984 | Sequence: | 125654985 | Sequence: | 125654986 | Sequence: | 125654987 | Sequence: | 125654988 | Sequence: | 125654989 | Sequence: | 125654990 | Sequence: | 125654991 | Sequence: | 125654992 | Sequence: | 125654993 | Sequence: | 125654994 | Sequence: | 125654995 | Sequence: | 125654996 | Sequence: | 125654997 | Sequence: | 125654998 | Sequence: | 125654999 | Sequence: | 125655000 | Sequence: | 125655001 | Sequence: | 125655002 | Sequence: | 125655003 | Sequence: | 125655004 | Sequence: | 125655005 | Sequence: | 125655006 | Sequence: | 125655007 | Sequence: | 125655008 | Sequence: | 125655009 | Sequence: | 125655010 | Sequence: | 125655011 | Sequence: | 125655012 | Sequence: | 125655013 | Sequence: | 125655014 | Sequence: | 125655015 | Sequence: | 125655016 | Sequence: | 125655017 | Sequence: | 125655018 | Sequence: | 125655019 | Sequence: | 125655020 | Sequence: | 125655021 | Sequence: | 125655022 | Sequence: | 125655023 | Sequence: | 125655024 | Sequence: | 125655025 | Sequence: | 125655026 | Sequence: | 125655027 | Sequence: | 125655028 | Sequence: | 125655029 | Sequence: | 125655030 | Sequence: | 125655031 | Sequence: | 125655032 | Sequence: | 125655033 | Sequence: | 125655034 | Sequence: | 125655035 | Sequence: | 125655036 | Sequence: | 125655037 | Sequence: | 125655038 | Sequence: | 125655039 | Sequence: | 125655040 | Sequence: | 125655041 | Sequence: | 125655042 | Sequence: | 125655043 | Sequence: | 125655044 | Sequence: | 125655045 | Sequence: | 125655046 | Sequence: | 125655047 | Sequence: | 125655048 | Sequence: | 125655049 | Sequence: | 125655050 | Sequence: | 125655051 | Sequence: | 125655052 | Sequence: | 125655053 | Sequence: | 125655054 | Sequence: | 125655055 | Sequence: | 125655056 | Sequence: | 125655057 | Sequence: | 125655058 | Sequence: | 125655059 | Sequence: | 125655060 | Sequence: | 125655061 | Sequence: | 125655062 | Sequence: | 125655063 | Sequence: | 125655064 | Sequence: | 125655065 | Sequence: | 125655066 | Sequence: | 125655067 | Sequence: | 125655068 | Sequence: | 125655069 | Sequence: | 125655070 | Sequence: | 125655071 | Sequence: | 125655072 | Sequence: | 125655073 | Sequence: | 125655074 | Sequence: | 125655075 | Sequence: | 125655076 | Sequence: | 125655077 | Sequence: | 125655078 | Sequence: | 125655079 | Sequence: | 125655080 | Sequence: | 125655081 | Sequence: | 125655082 | Sequence: | 125655083 |
Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 | Result Group Id | 56112522 | Result Group Id | 56112523 | Result Group Id | 56112524 | Result Group Id | 56112525 | Result Group Id | 56112526 | Result Group Id | 56112527 | Result Group Id | 56112528 | Result Group Id | 56112529 | Result Group Id | 56112530 | Result Group Id | 56112531 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG007 | Ctgov Group Code | BG008 | Ctgov Group Code | BG009 |
Classification | <65 years | Classification | <65 years | Classification | <65 years | Classification | <65 years | Classification | <65 years | Classification | <65 years | Classification | <65 years | Classification | <65 years | Classification | <65 years | Classification | <65 years | Classification | >=65 years | Classification | >=65 years | Classification | >=65 years | Classification | >=65 years | Classification | >=65 years | Classification | >=65 years | Classification | >=65 years | Classification | >=65 years | Classification | >=65 years | Classification | >=65 years | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | White | Category | White | Category | White | Category | White | Category | White | Category | White | Category | White | Category | White | Category | White | Category | White | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | More than one race | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | ||||||||||||||||||||||||||||||||||||||||
Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Age, Customized | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 20 | Param Value | 22 | Param Value | 15 | Param Value | 11 | Param Value | 18 | Param Value | 13 | Param Value | 7 | Param Value | 4 | Param Value | 3 | Param Value | 113 | Param Value | 15 | Param Value | 12 | Param Value | 8 | Param Value | 7 | Param Value | 3 | Param Value | 8 | Param Value | 6 | Param Value | 1 | Param Value | 2 | Param Value | 62 | Param Value | 14 | Param Value | 13 | Param Value | 4 | Param Value | 7 | Param Value | 7 | Param Value | 9 | Param Value | 6 | Param Value | 4 | Param Value | 3 | Param Value | 67 | Param Value | 21 | Param Value | 21 | Param Value | 19 | Param Value | 11 | Param Value | 14 | Param Value | 12 | Param Value | 7 | Param Value | 1 | Param Value | 2 | Param Value | 108 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 2 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 4 | Param Value | 2 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 9 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 4 | Param Value | 18 | Param Value | 19 | Param Value | 7 | Param Value | 8 | Param Value | 13 | Param Value | 14 | Param Value | 6 | Param Value | 2 | Param Value | 2 | Param Value | 89 | Param Value | 10 | Param Value | 9 | Param Value | 13 | Param Value | 5 | Param Value | 6 | Param Value | 5 | Param Value | 5 | Param Value | 3 | Param Value | 0 | Param Value | 56 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 4 | Param Value | 4 | Param Value | 1 | Param Value | 2 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 13 |
Param Value Num | 20.0 | Param Value Num | 22.0 | Param Value Num | 15.0 | Param Value Num | 11.0 | Param Value Num | 18.0 | Param Value Num | 13.0 | Param Value Num | 7.0 | Param Value Num | 4.0 | Param Value Num | 3.0 | Param Value Num | 113.0 | Param Value Num | 15.0 | Param Value Num | 12.0 | Param Value Num | 8.0 | Param Value Num | 7.0 | Param Value Num | 3.0 | Param Value Num | 8.0 | Param Value Num | 6.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 62.0 | Param Value Num | 14.0 | Param Value Num | 13.0 | Param Value Num | 4.0 | Param Value Num | 7.0 | Param Value Num | 7.0 | Param Value Num | 9.0 | Param Value Num | 6.0 | Param Value Num | 4.0 | Param Value Num | 3.0 | Param Value Num | 67.0 | Param Value Num | 21.0 | Param Value Num | 21.0 | Param Value Num | 19.0 | Param Value Num | 11.0 | Param Value Num | 14.0 | Param Value Num | 12.0 | Param Value Num | 7.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 108.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 4.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 9.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 4.0 | Param Value Num | 18.0 | Param Value Num | 19.0 | Param Value Num | 7.0 | Param Value Num | 8.0 | Param Value Num | 13.0 | Param Value Num | 14.0 | Param Value Num | 6.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 89.0 | Param Value Num | 10.0 | Param Value Num | 9.0 | Param Value Num | 13.0 | Param Value Num | 5.0 | Param Value Num | 6.0 | Param Value Num | 5.0 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 56.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 4.0 | Param Value Num | 4.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 13.0 |
Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 | Number Analyzed | 35 | Number Analyzed | 34 | Number Analyzed | 23 | Number Analyzed | 18 | Number Analyzed | 21 | Number Analyzed | 21 | Number Analyzed | 13 | Number Analyzed | 5 | Number Analyzed | 5 | Number Analyzed | 175 |
]]>
https://zephyrnet.com/NCT03799614
2019-02-26
https://zephyrnet.com/?p=NCT03799614
NCT03799614https://www.clinicaltrials.gov/study/NCT03799614?tab=tableNANANAThe primary purpose of this study is to test the safety, tolerability and efficacy of vibration (delivered by an experimental device called RMBand that is worn on the subject’s arm) on parkinsonian tremor. The RMBand was developed by Resonate Forward, LLC (RF). This RMBand is designed to administer a vibration to the wearer to decrease or stop tremor in persons with Parkinson’s disease (PD).
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Studies
Study First Submitted Date | 2018-12-19 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-12-17 |
Start Month Year | February 26, 2019 |
Primary Completion Month Year | November 27, 2019 |
Verification Month Year | November 2020 |
Verification Date | 2020-11-30 |
Last Update Posted Date | 2020-12-17 |
Results First Posted Date | 2020-12-17 |
Detailed Descriptions
Sequence: | 20573952 |
Description | Participation will be completed in one visit at VCU Parkinson's and Movement Disorders Center. A baseline Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) will be taken prior to vibration therapy. The RMBand (experimental device) will be placed on the arm of the participant to provide the vibration therapy. The MDS-UPDRS Part III will be repeated both during and after the therapy. Participants will be asked to provide feedback about the device, the therapy session and how they are feeling. |
Facilities
Sequence: | 198630695 |
Name | Virginia Commonwealth University |
City | Richmond |
State | Virginia |
Zip | 23298 |
Country | United States |
Conditions
Sequence: | 51790013 |
Name | Parkinson Disease |
Downcase Name | parkinson disease |
Id Information
Sequence: | 39855187 |
Id Source | org_study_id |
Id Value | HM20012404 |
Countries
Sequence: | 42254026 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55210666 | Sequence: | 55210667 |
Group Type | Experimental | Group Type | Experimental |
Title | Lower dose vibration | Title | Higher dose vibration |
Description | RMBand lower dose vibration | Description | RMBand higher dose vibration |
Interventions
Sequence: | 52112621 | Sequence: | 52112622 |
Intervention Type | Device | Intervention Type | Device |
Name | RMBand lower dose | Name | RMBand higher dose |
Description | Light-weight portable device that delivers low dose vibration to the arm | Description | Light-weight portable device that delivers higher dose vibration to the arm |
Design Outcomes
Sequence: | 176153634 | Sequence: | 176153635 | Sequence: | 176153636 | Sequence: | 176153637 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Measure | Clinical Rating for Tremor | Measure | Objective Measurement of Tremor Frequency (Hz) | Measure | Objective Measurement of Tremor Amplitude (mm). |
Time Frame | This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off. | Time Frame | Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. . | Time Frame | Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment. | Time Frame | Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment. |
Description | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Description | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. |
Description | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. |
Browse Conditions
Sequence: | 191950703 | Sequence: | 191950704 | Sequence: | 191950705 | Sequence: | 191950706 | Sequence: | 191950707 | Sequence: | 191950708 | Sequence: | 191950709 | Sequence: | 191950710 | Sequence: | 191950711 |
Mesh Term | Parkinson Disease | Mesh Term | Parkinsonian Disorders | Mesh Term | Basal Ganglia Diseases | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Movement Disorders | Mesh Term | Synucleinopathies | Mesh Term | Neurodegenerative Diseases |
Downcase Mesh Term | parkinson disease | Downcase Mesh Term | parkinsonian disorders | Downcase Mesh Term | basal ganglia diseases | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | movement disorders | Downcase Mesh Term | synucleinopathies | Downcase Mesh Term | neurodegenerative diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47964007 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Virginia Commonwealth University |
Overall Officials
Sequence: | 29060523 |
Role | Principal Investigator |
Name | Ingrid Pretzer-Aboff, PhD, RN |
Affiliation | Virginia Commonwealth University |
Design Group Interventions
Sequence: | 67689829 | Sequence: | 67689830 |
Design Group Id | 55210666 | Design Group Id | 55210667 |
Intervention Id | 52112621 | Intervention Id | 52112622 |
Eligibilities
Sequence: | 30541670 |
Gender | All |
Minimum Age | 21 Years |
Maximum Age | 95 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Parkinson's disease (PD) as diagnosed by a movement disorder specialist Exclusion Criteria: Known diagnosis of Parkinson Plus Syndrome |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254206584 |
Number Of Facilities | 1 |
Number Of Nsae Subjects | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 9 |
Were Results Reported | True |
Months To Report Results | 11 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 21 |
Maximum Age Num | 95 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Designs
Sequence: | 30290204 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Subject Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Milestones
Sequence: | 40799723 | Sequence: | 40799724 | Sequence: | 40799725 | Sequence: | 40799726 | Sequence: | 40799727 | Sequence: | 40799728 |
Result Group Id | 55879876 | Result Group Id | 55879877 | Result Group Id | 55879876 | Result Group Id | 55879877 | Result Group Id | 55879876 | Result Group Id | 55879877 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 15 | Count | 15 | Count | 15 | Count | 15 | Count | 0 | Count | 0 |
Participant Flows
Sequence: | 3902853 |
Outcome Counts
Sequence: | 73593018 | Sequence: | 73593019 | Sequence: | 73593020 | Sequence: | 73593021 | Sequence: | 73593022 | Sequence: | 73593023 | Sequence: | 73593024 | Sequence: | 73593025 |
Outcome Id | 30636650 | Outcome Id | 30636650 | Outcome Id | 30636651 | Outcome Id | 30636651 | Outcome Id | 30636652 | Outcome Id | 30636652 | Outcome Id | 30636653 | Outcome Id | 30636653 |
Result Group Id | 55879878 | Result Group Id | 55879879 | Result Group Id | 55879880 | Result Group Id | 55879881 | Result Group Id | 55879878 | Result Group Id | 55879879 | Result Group Id | 55879882 | Result Group Id | 55879879 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 15 | Count | 15 | Count | 15 | Count | 15 | Count | 15 | Count | 15 | Count | 15 | Count | 15 |
Provided Documents
Sequence: | 2568501 | Sequence: | 2568502 |
Document Type | Informed Consent Form | Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | False | Has Protocol | True |
Has Icf | True | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2018-10-01 | Document Date | 2018-10-01 |
Url | https://ClinicalTrials.gov/ProvidedDocs/14/NCT03799614/ICF_001.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/14/NCT03799614/Prot_SAP_002.pdf |
Reported Event Totals
Sequence: | 27805369 | Sequence: | 27805370 | Sequence: | 27805371 | Sequence: | 27805372 | Sequence: | 27805373 | Sequence: | 27805374 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 |
Subjects At Risk | 15 | Subjects At Risk | 15 | Subjects At Risk | 15 | Subjects At Risk | 15 | Subjects At Risk | 15 | Subjects At Risk | 15 |
Created At | 2023-08-06 18:18:13.636944 | Created At | 2023-08-06 18:18:13.636944 | Created At | 2023-08-06 18:18:13.636944 | Created At | 2023-08-06 18:18:13.636944 | Created At | 2023-08-06 18:18:13.636944 | Created At | 2023-08-06 18:18:13.636944 |
Updated At | 2023-08-06 18:18:13.636944 | Updated At | 2023-08-06 18:18:13.636944 | Updated At | 2023-08-06 18:18:13.636944 | Updated At | 2023-08-06 18:18:13.636944 | Updated At | 2023-08-06 18:18:13.636944 | Updated At | 2023-08-06 18:18:13.636944 |
Reported Events
Sequence: | 524777665 | Sequence: | 524777666 |
Result Group Id | 55879883 | Result Group Id | 55879884 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Time Frame | two hours, during time of study activities | Time Frame | two hours, during time of study activities |
Event Type | other | Event Type | other |
Subjects Affected | 0 | Subjects Affected | 1 |
Subjects At Risk | 15 | Subjects At Risk | 15 |
Event Count | 0 | Event Count | 1 |
Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders |
Adverse Event Term | muscle tightness | Adverse Event Term | muscle tightness |
Frequency Threshold | 0 | Frequency Threshold | 0 |
Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment |
Responsible Parties
Sequence: | 28669164 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3833597 |
Pi Employee | No |
Restriction Type | GT60 |
Result Contacts
Sequence: | 3833562 |
Organization | Virginia Commonwealth University |
Name | Dr. Ingrid Pretzer-Aboff |
Phone | 804-828-3340 |
iaboff@vcu.edu | |
Outcomes
Sequence: | 30636650 | Sequence: | 30636651 | Sequence: | 30636652 | Sequence: | 30636653 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary |
Title | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Title | Clinical Rating for Tremor | Title | Objective Measurement of Tremor Frequency (Hz) | Title | Objective Measurement of Tremor Amplitude (mm). |
Description | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Description | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. |
Description | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. |
Time Frame | This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off. | Time Frame | Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. . | Time Frame | Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment. | Time Frame | Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment. |
Units | score on a scale | Units | score on a scale | Units | hertz | Units | millimeters |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 234242622 | Sequence: | 234242623 | Sequence: | 234242624 | Sequence: | 234242625 | Sequence: | 234242626 | Sequence: | 234242627 | Sequence: | 234242628 | Sequence: | 234242629 | Sequence: | 234242633 | Sequence: | 234242630 | Sequence: | 234242631 | Sequence: | 234242632 | Sequence: | 234242634 | Sequence: | 234242635 | Sequence: | 234242636 | Sequence: | 234242637 | Sequence: | 234242638 | Sequence: | 234242639 | Sequence: | 234242640 | Sequence: | 234242641 | Sequence: | 234242642 | Sequence: | 234242643 | Sequence: | 234242644 | Sequence: | 234242645 |
Outcome Id | 30636650 | Outcome Id | 30636650 | Outcome Id | 30636650 | Outcome Id | 30636650 | Outcome Id | 30636650 | Outcome Id | 30636650 | Outcome Id | 30636651 | Outcome Id | 30636651 | Outcome Id | 30636651 | Outcome Id | 30636651 | Outcome Id | 30636651 | Outcome Id | 30636651 | Outcome Id | 30636652 | Outcome Id | 30636652 | Outcome Id | 30636652 | Outcome Id | 30636652 | Outcome Id | 30636652 | Outcome Id | 30636652 | Outcome Id | 30636653 | Outcome Id | 30636653 | Outcome Id | 30636653 | Outcome Id | 30636653 | Outcome Id | 30636653 | Outcome Id | 30636653 |
Result Group Id | 55879878 | Result Group Id | 55879879 | Result Group Id | 55879878 | Result Group Id | 55879879 | Result Group Id | 55879878 | Result Group Id | 55879879 | Result Group Id | 55879880 | Result Group Id | 55879881 | Result Group Id | 55879881 | Result Group Id | 55879880 | Result Group Id | 55879881 | Result Group Id | 55879880 | Result Group Id | 55879878 | Result Group Id | 55879879 | Result Group Id | 55879878 | Result Group Id | 55879879 | Result Group Id | 55879878 | Result Group Id | 55879879 | Result Group Id | 55879882 | Result Group Id | 55879879 | Result Group Id | 55879882 | Result Group Id | 55879879 | Result Group Id | 55879882 | Result Group Id | 55879879 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Classification | Baseline | Classification | Baseline | Classification | During vibration treatment | Classification | During vibration treatment | Classification | Post vibration treatment | Classification | Post vibration treatment | Classification | Baseline | Classification | Baseline | Classification | Post vibration | Classification | During vibration | Classification | During vibration | Classification | Post vibration | Classification | Baseline | Classification | Baseline | Classification | During Vibration | Classification | During Vibration | Classification | Post Vibration | Classification | Post Vibration | Classification | Baseline | Classification | Baseline | Classification | During vibration | Classification | During vibration | Classification | Post vibration | Classification | Post vibration |
Title | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Title | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Title | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Title | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Title | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Title | Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) | Title | Clinical Rating for Tremor | Title | Clinical Rating for Tremor | Title | Clinical Rating for Tremor | Title | Clinical Rating for Tremor | Title | Clinical Rating for Tremor | Title | Clinical Rating for Tremor | Title | Objective Measurement of Tremor Frequency (Hz) | Title | Objective Measurement of Tremor Frequency (Hz) | Title | Objective Measurement of Tremor Frequency (Hz) | Title | Objective Measurement of Tremor Frequency (Hz) | Title | Objective Measurement of Tremor Frequency (Hz) | Title | Objective Measurement of Tremor Frequency (Hz) | Title | Objective Measurement of Tremor Amplitude (mm). | Title | Objective Measurement of Tremor Amplitude (mm). | Title | Objective Measurement of Tremor Amplitude (mm). | Title | Objective Measurement of Tremor Amplitude (mm). | Title | Objective Measurement of Tremor Amplitude (mm). | Title | Objective Measurement of Tremor Amplitude (mm). |
Description | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Description | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Description | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Description | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Description | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Description | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 – 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time. | Description | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. |
Description | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. |
Description | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. |
Description | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. |
Description | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. |
Description | Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 – 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 – 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes. |
Description | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. | Description | This is a device that will objectively measure tremor amplitude pre, during, and post treatment. |
Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | hertz | Units | hertz | Units | hertz | Units | hertz | Units | hertz | Units | hertz | Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 32.67 | Param Value | 27.4 | Param Value | 33.67 | Param Value | 27.33 | Param Value | 32.67 | Param Value | 28.6 | Param Value | 15.47 | Param Value | 13.87 | Param Value | 14.13 | Param Value | 15.87 | Param Value | 13.20 | Param Value | 14.53 | Param Value | 4.77 | Param Value | 4.51 | Param Value | 4.79 | Param Value | 3.99 | Param Value | 3.36 | Param Value | 4.64 | Param Value | 0.71 | Param Value | 0.43 | Param Value | 0.76 | Param Value | 0.44 | Param Value | 0.70 | Param Value | 0.52 |
Param Value Num | 32.67 | Param Value Num | 27.4 | Param Value Num | 33.67 | Param Value Num | 27.33 | Param Value Num | 32.67 | Param Value Num | 28.6 | Param Value Num | 15.47 | Param Value Num | 13.87 | Param Value Num | 14.13 | Param Value Num | 15.87 | Param Value Num | 13.2 | Param Value Num | 14.53 | Param Value Num | 4.77 | Param Value Num | 4.51 | Param Value Num | 4.79 | Param Value Num | 3.99 | Param Value Num | 3.36 | Param Value Num | 4.64 | Param Value Num | 0.71 | Param Value Num | 0.43 | Param Value Num | 0.76 | Param Value Num | 0.44 | Param Value Num | 0.7 | Param Value Num | 0.52 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Dispersion Value | 12.88 | Dispersion Value | 11.25 | Dispersion Value | 14.31 | Dispersion Value | 11.14 | Dispersion Value | 13.67 | Dispersion Value | 10.39 | Dispersion Value | 7.94 | Dispersion Value | 4.03 | Dispersion Value | 5.63 | Dispersion Value | 8.55 | Dispersion Value | 4.03 | Dispersion Value | 7.98 | Dispersion Value | 1.57 | Dispersion Value | 1.31 | Dispersion Value | 1.13 | Dispersion Value | 1.12 | Dispersion Value | 0.87 | Dispersion Value | 1.48 | Dispersion Value | 0.82 | Dispersion Value | 0.41 | Dispersion Value | 0.72 | Dispersion Value | 0.31 | Dispersion Value | 0.75 | Dispersion Value | 0.47 |
Dispersion Value Num | 12.88 | Dispersion Value Num | 11.25 | Dispersion Value Num | 14.31 | Dispersion Value Num | 11.14 | Dispersion Value Num | 13.67 | Dispersion Value Num | 10.39 | Dispersion Value Num | 7.94 | Dispersion Value Num | 4.03 | Dispersion Value Num | 5.63 | Dispersion Value Num | 8.55 | Dispersion Value Num | 4.03 | Dispersion Value Num | 7.98 | Dispersion Value Num | 1.57 | Dispersion Value Num | 1.31 | Dispersion Value Num | 1.13 | Dispersion Value Num | 1.12 | Dispersion Value Num | 0.87 | Dispersion Value Num | 1.48 | Dispersion Value Num | 0.82 | Dispersion Value Num | 0.41 | Dispersion Value Num | 0.72 | Dispersion Value Num | 0.31 | Dispersion Value Num | 0.75 | Dispersion Value Num | 0.47 |
Baseline Counts
Sequence: | 11328791 | Sequence: | 11328792 | Sequence: | 11328793 |
Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 15 | Count | 15 | Count | 30 |
Result Groups
Sequence: | 55879875 | Sequence: | 55879876 | Sequence: | 55879873 | Sequence: | 55879874 | Sequence: | 55879877 | Sequence: | 55879878 | Sequence: | 55879879 | Sequence: | 55879880 | Sequence: | 55879881 | Sequence: | 55879882 | Sequence: | 55879883 | Sequence: | 55879884 |
Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Participant Flow | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Total | Title | Low Dose Vibration | Title | Lower Dose Vibration | Title | Higher Dose Vibration | Title | High Dose Vibration | Title | Low Dose Vibration | Title | Higher Dose Vibration | Title | Lower Dose Vibration | Title | Higher Dose Vibration | Title | Low Dose Vibration Amplitude | Title | Lower Dose Vibration | Title | Higher Dose Vibration |
Description | Total of all reporting groups | Description | RMBand lower dose vibration
RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm |
Description | RMBand lower dose vibration
RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm |
Description | RMBand higher dose vibration
RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm |
Description | RMBand higher dose vibration
RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm |
Description | RMBand low dose vibration
RMBand: Light-weight portable device that delivers low dose vibration to the arm |
Description | RMBand high dose vibration
RMBand: Light-weight portable device that delivers higher dose vibration to the arm |
Description | RMBand lower dose vibration
RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm |
Description | RMBand higher dose vibration
RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm |
Description | RMBand low dose vibration
RMBand: Light-weight portable device that delivers low dose vibration to the arm,reported in mm. |
Description | RMBand lower dose vibration
RMBand lower dose: Light-weight portable device that delivers low dose vibration (frequency of 80 Hz) to the arm |
Description | RMBand higher dose vibration
RMBand higher dose: Light-weight portable device that delivers higher dose (frequency of 160 Hz) vibration to the arm |
Baseline Measurements
Sequence: | 124996019 | Sequence: | 124996020 | Sequence: | 124996021 | Sequence: | 124996022 | Sequence: | 124996023 | Sequence: | 124996024 | Sequence: | 124996025 | Sequence: | 124996026 | Sequence: | 124996027 | Sequence: | 124996028 | Sequence: | 124996029 | Sequence: | 124996030 | Sequence: | 124996031 | Sequence: | 124996032 | Sequence: | 124996033 | Sequence: | 124996034 | Sequence: | 124996035 | Sequence: | 124996036 | Sequence: | 124996037 | Sequence: | 124996038 | Sequence: | 124996039 | Sequence: | 124996040 | Sequence: | 124996041 | Sequence: | 124996042 | Sequence: | 124996043 | Sequence: | 124996044 | Sequence: | 124996045 | Sequence: | 124996046 | Sequence: | 124996047 | Sequence: | 124996048 | Sequence: | 124996049 | Sequence: | 124996050 | Sequence: | 124996051 | Sequence: | 124996052 | Sequence: | 124996053 | Sequence: | 124996054 | Sequence: | 124996055 | Sequence: | 124996056 | Sequence: | 124996057 |
Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 | Result Group Id | 55879873 | Result Group Id | 55879874 | Result Group Id | 55879875 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Classification | United States | Classification | United States | Classification | United States | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Asian | Category | Asian | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | White | Category | White | Category | White | Category | More than one race | Category | More than one race | Category | More than one race | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | ||||||||||||||||||||||||
Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Region of Enrollment | Title | Region of Enrollment | Title | Region of Enrollment | Title | Clinical Rating Scale for Tremor, total score | Title | Clinical Rating Scale for Tremor, total score | Title | Clinical Rating Scale for Tremor, total score | Title | MDS UPDRS II – IV total | Title | MDS UPDRS II – IV total | Title | MDS UPDRS II – IV total |
Description | Movement Disorder Society Unified Parkinson Rating Scale, (MDS UPDRS, score for parts II – !V. | Description | Movement Disorder Society Unified Parkinson Rating Scale, (MDS UPDRS, score for parts II – !V. | Description | Movement Disorder Society Unified Parkinson Rating Scale, (MDS UPDRS, score for parts II – !V. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | participants | Units | participants | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 67.3 | Param Value | 67.6 | Param Value | 67.4 | Param Value | 4 | Param Value | 8 | Param Value | 12 | Param Value | 11 | Param Value | 7 | Param Value | 18 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 15 | Param Value | 14 | Param Value | 29 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 15 | Param Value | 15 | Param Value | 30 | Param Value | 21.13 | Param Value | 18.07 | Param Value | 19.6 | Param Value | 44.26 | Param Value | 38.47 | Param Value | 41.37 |
Param Value Num | 67.3 | Param Value Num | 67.6 | Param Value Num | 67.4 | Param Value Num | 4.0 | Param Value Num | 8.0 | Param Value Num | 12.0 | Param Value Num | 11.0 | Param Value Num | 7.0 | Param Value Num | 18.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 15.0 | Param Value Num | 14.0 | Param Value Num | 29.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 15.0 | Param Value Num | 15.0 | Param Value Num | 30.0 | Param Value Num | 21.13 | Param Value Num | 18.07 | Param Value Num | 19.6 | Param Value Num | 44.26 | Param Value Num | 38.47 | Param Value Num | 41.37 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 6.7 | Dispersion Value | 8.4 | Dispersion Value | 7.63 | Dispersion Value | 10.69 | Dispersion Value | 5.22 | Dispersion Value | 8.55 | Dispersion Value | 16.41 | Dispersion Value | 14.08 | Dispersion Value | 15.56 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 6.7 | Dispersion Value Num | 8.4 | Dispersion Value Num | 7.63 | Dispersion Value Num | 10.69 | Dispersion Value Num | 5.22 | Dispersion Value Num | 8.55 | Dispersion Value Num | 16.41 | Dispersion Value Num | 14.08 | Dispersion Value Num | 15.56 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 30 |
]]>
https://zephyrnet.com/NCT03799601
2019-03-01
https://zephyrnet.com/?p=NCT03799601
NCT03799601https://www.clinicaltrials.gov/study/NCT03799601?tab=tableXianglin Yuan, MD.xlyuan@tjh.tjmu.cn0086-13667241722Anlotinib which has shown an affirmatory efficacy in ALTER0303 controlled trial as a 3rd-line treatment on advanced NSCLC is a tyrosine kinase inhibitor with a favorable safety profile in phase I trial which mainly targets VEGFR1/2/3, FGFR, PDGFR and c-kit. The purpose of this trail is to establish whether advanced non-squamous NSCLC patients could benefit from the combination treatment of docetaxel, carboplatin and anlotinib as the first-line and maintenance treatment.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | March 1, 2019 |
Primary Completion Month Year | December 1, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20741248 |
Description | First-line patients (or postoperative recurrence) with locally advanced or metastatic NSCLC were enrolled in this trail. The patients (clinical stage ⅢB/Ⅳ, with no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene) were confirmed by histological or cytological diagnosis. The primary endpoint is PFS; secondary endpoint includes OS, DCR and ORR. The study was single-arm, conducted at 8 centers in China mainland. The primary end point was PFS (time from enrollment to first RECIST1.1-defined PD or death). 45 patients were planned for enrollment. This estimate was based on 80% power, with a two-sided 5% significance level. We analyzed PFS and OS using Kaplan-Meier methodology. The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial. |
Facilities
Sequence: | 200280799 |
Name | Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, |
City | Wuhan |
State | Hubei |
Zip | 430000 |
Country | China |
Facility Contacts
Sequence: | 28132917 |
Facility Id | 200280799 |
Contact Type | primary |
Name | Xianglin Yuan, MD. |
xlyuan@tjh.tjmu.cn | |
Phone | 0086-13667241722 |
Browse Interventions
Sequence: | 96133426 | Sequence: | 96133427 | Sequence: | 96133428 | Sequence: | 96133429 | Sequence: | 96133430 | Sequence: | 96133431 | Sequence: | 96133432 |
Mesh Term | Carboplatin | Mesh Term | Docetaxel | Mesh Term | Antineoplastic Agents | Mesh Term | Tubulin Modulators | Mesh Term | Antimitotic Agents | Mesh Term | Mitosis Modulators | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | carboplatin | Downcase Mesh Term | docetaxel | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | tubulin modulators | Downcase Mesh Term | antimitotic agents | Downcase Mesh Term | mitosis modulators | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52221717 |
Name | NSCLC |
Downcase Name | nsclc |
Id Information
Sequence: | 40195766 |
Id Source | org_study_id |
Id Value | TJCC-LC-20190108 |
Countries
Sequence: | 42609750 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55650014 |
Group Type | Experimental |
Title | combination of docetaxel, carboplatin and anlotinib |
Interventions
Sequence: | 52535521 | Sequence: | 52535522 | Sequence: | 52535523 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Anlotinib | Name | Docetaxel | Name | Carboplatin |
Description | Anlotinib which has shown an affirmatory efficacy in ALTER0303 controlled trial as a 3rd-line treatment on advanced NSCLC is a tyrosine kinase inhibitor with a favorable safety profile in phase I trial which mainly targets VEGFR1/2/3, FGFR, PDGFR and c-kit. | Description | a chemotherapy medication used to treat a number of types of cancer.This includes breast cancer, head and neck cancer, stomach cancer, prostate cancer and non-small-cell lung cancer.It may be used by itself or along with other chemotherapy medication.It is given by slow injection into a vein. | Description | Carboplatin is used to treat a number of forms of cancer. This includes ovarian cancer, lung cancer, head and neck cancer, brain cancer, and neuroblastoma. It may be used for some types of testicular cancer but cisplatin is generally more effective. |
Keywords
Sequence: | 79942038 | Sequence: | 79942039 | Sequence: | 79942040 | Sequence: | 79942041 |
Name | Anlotinib | Name | Docetaxel | Name | Carboplatin | Name | NSCLC |
Downcase Name | anlotinib | Downcase Name | docetaxel | Downcase Name | carboplatin | Downcase Name | nsclc |
Design Outcomes
Sequence: | 177562120 | Sequence: | 177562121 | Sequence: | 177562122 | Sequence: | 177562123 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | progression-free survival | Measure | Overall Survival | Measure | Disease Control Rate | Measure | Overall Response Rate |
Time Frame | Estimated about 24 months. | Time Frame | Estimated about 24 months. | Time Frame | Estimated about 24 months. | Time Frame | Estimated about 24 months. |
Description | Clinical response of treatment according to RESIST v1.1 criteria (PFS, progression-free survival) | Description | Clinical response of treatment according to RESIST v1.1 criteria (OS, overall survival) | Description | Clinical response of treatment according to RESIST v1.1 criteria (DCR, disease control rate) | Description | Clinical response of treatment according to RESIST v1.1 criteria (ORR, Overall Response Rate) |
Browse Conditions
Sequence: | 193679203 | Sequence: | 193679204 | Sequence: | 193679205 | Sequence: | 193679206 | Sequence: | 193679207 | Sequence: | 193679208 | Sequence: | 193679209 | Sequence: | 193679210 | Sequence: | 193679211 | Sequence: | 193679212 |
Mesh Term | Carcinoma, Non-Small-Cell Lung | Mesh Term | Carcinoma, Bronchogenic | Mesh Term | Bronchial Neoplasms | Mesh Term | Lung Neoplasms | Mesh Term | Respiratory Tract Neoplasms | Mesh Term | Thoracic Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases |
Downcase Mesh Term | carcinoma, non-small-cell lung | Downcase Mesh Term | carcinoma, bronchogenic | Downcase Mesh Term | bronchial neoplasms | Downcase Mesh Term | lung neoplasms | Downcase Mesh Term | respiratory tract neoplasms | Downcase Mesh Term | thoracic neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366604 | Sequence: | 48366605 |
Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Tongji Hospital | Name | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
Overall Officials
Sequence: | 29313003 |
Role | Study Chair |
Name | Xianglin Yuan, MD. |
Affiliation | Tongji Hospital |
Central Contacts
Sequence: | 12020631 |
Contact Type | primary |
Name | Xianglin Yuan, MD. |
Phone | 0086-13667241722 |
xlyuan@tjh.tjmu.cn | |
Role | Contact |
Design Group Interventions
Sequence: | 68217635 | Sequence: | 68217636 | Sequence: | 68217637 |
Design Group Id | 55650014 | Design Group Id | 55650014 | Design Group Id | 55650014 |
Intervention Id | 52535521 | Intervention Id | 52535522 | Intervention Id | 52535523 |
Eligibilities
Sequence: | 30794819 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 75 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
≥18 years of age on the day of signing informed consent and with good compliance and agree to accept follow-up of disease progression and adverse events. Women of child-bearing age should take appropriate contraceptive measures and should not breastfeed from screening to 3 months after stopping the study and treatment.Before starting administration, the pregnancy test was negative, or one of the following criteria was met to prove that there was no risk of pregnancy: Postmenopause is defined as amenorrhea at least 12 months after age 50 and cessation of all exogenous hormone replacement therapy; Exclusion Criteria: Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer), Lung sarcomatoid carcinoma; Physical examination and laboratory findings: A known history of HIV testing positive or acquired immunodeficiency syndrome (AIDS); |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004493 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 75 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30540859 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26697011 |
Intervention Id | 52535521 |
Name | Anlotinib Hydrochloride |
Responsible Parties
Sequence: | 28907179 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799588
2019-01-08
https://zephyrnet.com/?p=NCT03799588
NCT03799588https://www.clinicaltrials.gov/study/NCT03799588?tab=tableNANANAThis study will examine the correlation between the transpulmonary pressure and the actual setting on the biphasic chest cuirass device is the primary study end point.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-03-08 |
Start Month Year | January 8, 2019 |
Primary Completion Month Year | January 31, 2022 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-03-08 |
Detailed Descriptions
Sequence: | 20576911 |
Description | Conventional mechanical ventilation is known as positive pressure ventilation (PPV) because the machine delivers positive pressure directly into the airways to ventilate and expand the lungs. In a healthy lung, inflation occurs when the pressure inside the lung is greater than the pressure outside the lung. This transpulmonary pressure is the difference between the pressure inside the lung (in the alveolus) and the pressure just outside the lung (the pleural cavity). Since positive pressure ventilation delivers pressure directly into the airways, the transpulmonary pressure is increased by making the lung pressure more positive. This is markedly different than physiologic breathing and carries an increased risk of ventilator-associated lung injury1. In the setting of sick lungs, where the pressure required to open collapsed areas of lung may be more than areas of healthy lung, this higher pressure can in turn cause damage to the areas of healthy lung. The known effects of this ventilator-associated lung injury from positive pressure ventilation can be avoided with the use of negative pressure ventilation. In negative pressure ventilation (NPV), the transpulmonary pressure is increased by making the pleural pressure more negative. This is achieved by using a plastic shell that covers the chest and generates negative pressure between the plastic shell and the chest. This pressure is distributed more evenly across a large surface of the chest wall and results in more uniform lung expansion. As a result, NPV results in better oxygen delivery and less lung injury than positive pressure ventilation2.
However, despite the extensive use of NPV in other countries, there is little data available regarding the transpulmonary pressure that these machines can generate; i.e. how well does negative pressure in the plastic shell transmit to the pleural cavity to expand the lung. There is a large amount of data supporting the use of biphasic cuirass ventilation to minimize lung damage3 and improve hemodynamics4-9, but no studies have been done to date that look at the transpulmonary pressure and how it differs depending on age and size. It is still unclear what optimal pressure is required via the chest cuirass to expand and ventilate the lungs via. It is also unknown what maximum pressures can be used before the lung becomes overinflated and complications arise. This study will examine the correlation between the transpulmonary pressure and the actual setting on the biphasic chest cuirass device is the primary study end point. |
Facilities
Sequence: | 198653046 |
Name | Oishei Children's Hospital |
City | Buffalo |
State | New York |
Zip | 14203 |
Country | United States |
Conditions
Sequence: | 51797600 |
Name | Lung Diseases |
Downcase Name | lung diseases |
Id Information
Sequence: | 39861467 |
Id Source | org_study_id |
Id Value | STUDY00002374 |
Countries
Sequence: | 42259143 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55217086 |
Group Type | Experimental |
Title | Biphasic Chest Cuirass Arm |
Description | This is the only arm in the study and all patients will receive negative pressure ventilation via the biphasic chest cuirass. |
Interventions
Sequence: | 52119692 |
Intervention Type | Device |
Name | Biphasic Chest Cuirass |
Description | Patients will have a esophageal manometer placed after intubation and before initiation of negative pressure ventilation. |
Keywords
Sequence: | 79254888 | Sequence: | 79254889 | Sequence: | 79254890 |
Name | Pediatrics | Name | biphasic chest cuirass | Name | transpulmonary pressure |
Downcase Name | pediatrics | Downcase Name | biphasic chest cuirass | Downcase Name | transpulmonary pressure |
Design Outcomes
Sequence: | 176174171 |
Outcome Type | primary |
Measure | Transpulmonary Pressure Deliverance |
Time Frame | 1 year |
Description | Examining the correlation between the transpulmonary pressure and the actual setting on the biphasic chest cuirass device is the primary study end point. |
Browse Conditions
Sequence: | 191981778 | Sequence: | 191981777 |
Mesh Term | Respiratory Tract Diseases | Mesh Term | Lung Diseases |
Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | lung diseases |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list |
Sponsors
Sequence: | 47970753 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | State University of New York at Buffalo |
Overall Officials
Sequence: | 29064571 |
Role | Principal Investigator |
Name | Bree C Kramer, DO |
Affiliation | University at Buffalo |
Design Group Interventions
Sequence: | 67697337 |
Design Group Id | 55217086 |
Intervention Id | 52119692 |
Eligibilities
Sequence: | 30545892 |
Gender | Male |
Minimum Age | 6 Months |
Maximum Age | 5 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Are between the age of 6 months and 5 years Exclusion Criteria: Previous history of chronic lung disease or cyanotic heart disease or |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254224131 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 6 |
Maximum Age Num | 5 |
Minimum Age Unit | Months |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30294295 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | After routine intubation for elective urologic procedures in the OR, the patient will be placed on a biphasic chest cuirass after anesthesia induction. A esophageal manometer will then be placed to measure transpulmonary pressures. The patient will be switched off the anesthesia ventilator and the biphasic chest cuirass will begin negative pressure ventilation. During this time, the patient will continue to receive inhalation anesthetic gas. After 30 minutes, the biphasic chest cuirass will terminate and the patient will again receive positive pressure ventilation via the anesthesia ventilator. |
Responsible Parties
Sequence: | 28672847 |
Responsible Party Type | Principal Investigator |
Name | Bree Cyrene Kramer |
Title | Assistant Clinical Professor of Pediatrics |
Affiliation | State University of New York at Buffalo |
Study References
Sequence: | 51693049 | Sequence: | 51693050 |
Pmid | 9142069 | Pmid | 7653758 |
Reference Type | background | Reference Type | background |
Citation | Scholz SE, Knothe C, Thiel A, Hempelmann G. Improved oxygen delivery by positive pressure ventilation with continuous negative external chest pressure. Lancet. 1997 May 3;349(9061):1295-6. doi: 10.1016/S0140-6736(05)62507-X. No abstract available. | Citation | Petros AJ, Fernando SS, Shenoy VS, al-Saady NM. The Hayek oscillator. Nomograms for tidal volume and minute ventilation using external high frequency oscillation. Anaesthesia. 1995 Jul;50(7):601-6. doi: 10.1111/j.1365-2044.1995.tb15112.x. |
]]>
https://zephyrnet.com/NCT03799575
2019-01-02
https://zephyrnet.com/?p=NCT03799575
NCT03799575https://www.clinicaltrials.gov/study/NCT03799575?tab=tableAndreia L Pinto, MSCandreia.lucia.pinto@gmail.com+351969721099Observational study of Internal Limiting Membrane peeled in macular Hole surgery and studied by Transmission electronic Microscopy (TEM) and Optical Coherence Tomography (OCT) findings in closed holes.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | January 2, 2019 |
Primary Completion Month Year | July 2, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20727133 |
Description | A non-randomized prospective study of eyes with MH willing to have surgery at the Department of Ophthalmology of Santa Maria Hospital, Lisbon.
Surgeries are performed under local or general anesthesia, pars plana vitrectomy with internal limiting membrane peeling, fluid gas exchange and face down position. Two samples of discarded ILM peeled in Macular hole surgery is studied in Laboratory. Laboratory Analysis Two samples of ILM per patient are harvested, one will be immediately fixed and submitted to Optic Microscopy (OM) and Transmission Electron Microscopy (TEM) analysis, and another sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis. Both samples from same patient will follow the protocol available at dx.doi.org/10.17504/protocols.io.qjiduke. Image acquisition Six electron-micrographs will be acquired for each fragment, using a Hitachi H-7000 electron microscope equipped with a megaview III digital camera. Fields of interest will be randomly selected, and acquisition of 15,000x magnification images. Histology and immunohistochemistry ILM samples will be stained with anti-GFAP antibody (anti-glial fibrillary acidic protein), to detect this protein in glial cells. Results: Only successful macular hole closure will be considered, BCVA will be compared before and after surgery and related to OCT findings. ILM findings in TEM analysis will be compared with and without enriched medium. |
Facilities
Sequence: | 200159071 |
Status | Recruiting |
Name | Hospital Santa Maria |
City | Lisbon |
State | Lisboa |
Zip | 1649-035 |
Country | Portugal |
Facility Contacts
Sequence: | 28113707 |
Facility Id | 200159071 |
Contact Type | primary |
Name | Mun Y Faria, MD |
munfaria1@gmail.com | |
Phone | +351966026791 |
Conditions
Sequence: | 52185355 |
Name | C11.768.740 |
Downcase Name | c11.768.740 |
Id Information
Sequence: | 40168986 |
Id Source | org_study_id |
Id Value | MD26339 |
Countries
Sequence: | 42580596 |
Name | Portugal |
Removed | False |
Design Groups
Sequence: | 55609000 | Sequence: | 55609001 |
Title | A | Title | B |
Description | Two samples of ILM per patient are harvested, group A will be immediately fixed and submitted to Optic Microscopy (OM) and Transmission Electron Microscopy (TEM) analysis, and another sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis. | Description | Group B sample will be incubated in enriched medium 199 (Gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to OM and TEM analysis. |
Interventions
Sequence: | 52499322 |
Intervention Type | Behavioral |
Name | Transmission Electron Microscopy analysis |
Description | Morphology of two vitreal side of Internal Limiting Membrane in contact |
Design Outcomes
Sequence: | 177431667 |
Outcome Type | primary |
Measure | Fibrosis in vitreal sides of Internal Limiting Membranes |
Time Frame | 12 months |
Description | Fibrilliary process between two vitreal sides of Internal Limiting Membranes in contact, after incubation in enriched medium |
Browse Conditions
Sequence: | 193539667 | Sequence: | 193539668 | Sequence: | 193539669 |
Mesh Term | Retinal Perforations | Mesh Term | Retinal Diseases | Mesh Term | Eye Diseases |
Downcase Mesh Term | retinal perforations | Downcase Mesh Term | retinal diseases | Downcase Mesh Term | eye diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332219 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Hospital de Santa Maria, Portugal |
Overall Officials
Sequence: | 29292920 |
Role | Principal Investigator |
Name | Mun Y Faria, MD |
Affiliation | Hospital Santa Maria, Centro Hospitalar Universitário Lisboa Norte, 1649-035 Lisboa, PT |
Central Contacts
Sequence: | 12012279 | Sequence: | 12012280 |
Contact Type | primary | Contact Type | backup |
Name | Nuno P Ferreira, MD | Name | Andreia L Pinto, MSC |
Phone | +351918503467 | Phone | +351969721099 |
ngcpferreira@gmail.com | andreia.lucia.pinto@gmail.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68168041 | Sequence: | 68168042 |
Design Group Id | 55609000 | Design Group Id | 55609001 |
Intervention Id | 52499322 | Intervention Id | 52499322 |
Eligibilities
Sequence: | 30773513 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 90 Years |
Healthy Volunteers | No |
Population | A non-randomized prospective study of eyes with MH willing to have surgery at the Department of Ophthalmology of Santa Maria Hospital, Lisbon.
Inclusion criteria Full Thickness Macular Hole |
Criteria | Inclusion Criteria:
All macular holes were staged based on recent OCT based classification and only full thickness macular hole, grade 2 to 4 IMH are considered for study. Exclusion Criteria: Excluding criteria are maculopathy other than IMH, surgeries of recurrence of IMH, other retinal diseases, or an axial length greater than 26.0 mm. Mean follow-up will be at least 12 months after surgery. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952460 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 90 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30519644 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28885945 |
Responsible Party Type | Principal Investigator |
Name | Mun Yueh de Faria |
Title | MD |
Affiliation | Hospital de Santa Maria, Portugal |
Study References
Sequence: | 52078780 |
Pmid | 31191990 |
Reference Type | derived |
Citation | Faria MY, Sousa DC, Almeida BC, Pinto AL, Ferreira NP. Morphology of Peeled Internal Limiting Membrane in Macular Hole Surgery. J Ophthalmol. 2019 May 2;2019:1345683. doi: 10.1155/2019/1345683. eCollection 2019. |
]]>
https://zephyrnet.com/NCT03799562
2019-05-01
https://zephyrnet.com/?p=NCT03799562
NCT03799562https://www.clinicaltrials.gov/study/NCT03799562?tab=tableChristine E Marx, MD MAchristine.marx@va.gov(919) 286-0411This study seeks to determine if pregnenolone can improve symptoms of PTSD and other symptoms that commonly occur with PTSD in Iraq/Afghanistan-era Veterans. The total study duration is 10 weeks. Eligible Veterans with PTSD will receive either pregnenolone or placebo throughout the study duration and will complete mental and physical health assessments at each study visit. Eligible participants will attend 6 in-person study visits and receive several short “check-in” phone calls.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-12-13 |
Start Month Year | May 1, 2019 |
Primary Completion Month Year | December 1, 2024 |
Verification Month Year | December 2022 |
Verification Date | 2022-12-31 |
Last Update Posted Date | 2022-12-13 |
Detailed Descriptions
Sequence: | 20818827 |
Description | BACKGROUND: There is an acute and urgent need to develop new and effective posttraumatic stress disorder (PTSD) pharmacotherapies, as there are currently only two FDA-approved medications for the treatment of PTSD (both of which are from the same drug class and have shown only moderate effect sizes in FDA registration trials). Many Veterans with PTSD thus remain symptomatic despite the availability of these treatments, increasing the likelihood of receiving pharmacological treatment interventions for which there is little or no empirical evidence. Multiple national and VA working groups focusing on PTSD have identified the critical need to address the paucity of PTSD pharmacotherapies, and have strongly recommended more randomized clinical trials to evaluate possible effective pharmacological treatments. Both preclinical and clinical data suggest that reductions in neurosteroids are involved in the pathophysiology of PTSD, and that ameliorating these deficits could potentially be clinically therapeutic – the proposed investigation targeting a neurosteroid intervention for the treatment of PTSD could thus be a promising research avenue. The investigators therefore propose to conduct a randomized clinical trial (RCT) to determine the efficacy of a neurosteroid intervention (pregnenolone) for PTSD and commonly co-occurring disorders in Iraq/Afghanistan-era Veterans, an understudied cohort that may be less treatment-refractory.
METHODS: This study will be a 10-week randomized, placebo-controlled, double-blind clinical trial of pregnenolone or matching placebo in Veterans with PTSD. The trial will include a 2-week single-blind placebo lead-in phase followed by 8 weeks of study medication (placebo or pregnenolone). Forty-five subjects meeting DSM-5 criteria for PTSD (as measured by a CAPS-5 score of 30) will be randomized to receive pregnenolone, and 45 subjects meeting DSM-5 criteria for PTSD will be randomized to receive placebo. The primary outcome for this RCT will be changes in total CAPS-5 score at Visit 6 for this modified intent-to-treat sample. Secondary clinical outcomes for this RCT include changes in pain intensity and functional interference, as measured by the Brief Pain Inventory, Short Form (BPI-SF) and depression symptoms by the Hamilton-Depression Rating Scale (HAM-D). Blood samples will be collected for serum analysis at all study visits and frozen in a -80 degree freezer. Upon completion of the study, samples will be thawed and analyzed using Gas Chromatography/Mass Spectrometry for neurosteroid analyses and inflammatory markers will be quantified. Genetic analyses will be conducted to determine therapeutic response. PREDICTED RESULTS: The investigators hypothesize that treatment with pregnenolone will be efficacious in Iraq/Afghanistan-era Veterans with PTSD, and will significantly reduce PTSD symptoms as assessed by the CAPS-5 (primary endpoint) compared to placebo. Secondary endpoints will include the assessment of conditions that frequently co-occur with PTSD; specifically, the investigators hypothesize that pregnenolone will also demonstrate efficacy for co-occurring chronic pain symptoms and depression symptoms. The investigators hypothesize that increases in pregnenolone and other neurosteroids (and decreases in inflammatory markers) will predict improvements in PTSD, depression, and chronic pain symptoms. The investigators also hypothesize that neurosteroids are dysregulated in PTSD, and that specific SNPs of genes coding for neurosteroidogenic enzymes will be associated with therapeutic response. |
Facilities
Sequence: | 200953723 |
Status | Recruiting |
Name | Durham VA Medical Center, Durham, NC |
City | Durham |
State | North Carolina |
Zip | 27705 |
Country | United States |
Facility Contacts
Sequence: | 28246269 | Sequence: | 28246270 |
Facility Id | 200953723 | Facility Id | 200953723 |
Contact Type | primary | Contact Type | backup |
Name | Virginia J Rhodes | Name | John D Whited, MD MHS |
Virginia.Rhodes@va.gov | john.whited@va.gov | ||
Phone | 919-286-0411 | Phone | (919) 286-0411 |
Phone Extension | 177632 | Phone Extension | 176926 |
Facility Investigators
Sequence: | 18419314 |
Facility Id | 200953723 |
Role | Principal Investigator |
Name | Jennifer C Naylor, PhD |
Conditions
Sequence: | 52419868 |
Name | Posttraumatic Stress Disorder |
Downcase Name | posttraumatic stress disorder |
Id Information
Sequence: | 40334795 | Sequence: | 40334796 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | MHBB-004-18S | Id Value | I01CX001784-01 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/I01CX001784-01 |
Countries
Sequence: | 42761961 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55868892 | Sequence: | 55868891 |
Group Type | Placebo Comparator | Group Type | Experimental |
Title | Placebo | Title | Pregnenolone |
Description | Same as pregnenolone (active study medication), except placebo dispensed. | Description | Placebo lead in 14 DAYS, followed by Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial |
Interventions
Sequence: | 52728479 | Sequence: | 52728480 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Pregnenolone | Name | Placebo |
Description | Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial. Placebo will be identical to the pregnenolone arm, except placebo will be dispensed. | Description | Same as pregnenolone (active study medication), except placebo dispensed. |
Keywords
Sequence: | 80204244 | Sequence: | 80204245 | Sequence: | 80204246 | Sequence: | 80204247 | Sequence: | 80204248 |
Name | Depression | Name | Pain | Name | Clinical Trial | Name | Veteran | Name | Supplement |
Downcase Name | depression | Downcase Name | pain | Downcase Name | clinical trial | Downcase Name | veteran | Downcase Name | supplement |
Design Outcomes
Sequence: | 178306993 | Sequence: | 178306994 | Sequence: | 178306995 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in Clinician Administered PTSD Scale for DSM-5 (Visit 6-Baseline) | Measure | Change in Brief Pain Inventory, Short Form (Visit 6-Baseline) | Measure | Change in Hamilton-Depression Inventory (Visit 6-Baseline) |
Time Frame | Through study completion, an average of 5 years | Time Frame | Through study completion, an average of 5 years | Time Frame | Through study completion, an average of 5 years |
Description | The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to make a diagnosis of PTSD and assess PTSD symptoms. It assesses the intensity and frequency of PTSD symptoms. Scores range from 0-80; higher score indicates greater severity. | Description | The Brief Pain Inventory, Short Form (BPI-SF) is a self-reported scale that measures the severity of pain and the interference of pain on function. The scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, average pain in the past 24 hours, and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. | Description | The HAM-D measures the severity of depressive symptoms. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. |
Browse Conditions
Sequence: | 194431101 | Sequence: | 194431102 | Sequence: | 194431103 | Sequence: | 194431104 |
Mesh Term | Stress Disorders, Post-Traumatic | Mesh Term | Stress Disorders, Traumatic | Mesh Term | Trauma and Stressor Related Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | stress disorders, post-traumatic | Downcase Mesh Term | stress disorders, traumatic | Downcase Mesh Term | trauma and stressor related disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48549974 |
Agency Class | FED |
Lead Or Collaborator | lead |
Name | VA Office of Research and Development |
Overall Officials
Sequence: | 29414361 |
Role | Principal Investigator |
Name | Jennifer C Naylor, PhD |
Affiliation | Durham VA Medical Center, Durham, NC |
Central Contacts
Sequence: | 12074310 | Sequence: | 12074311 |
Contact Type | primary | Contact Type | backup |
Name | Jennifer C Naylor, PhD | Name | Christine E Marx, MD MA |
Phone | (919) 286-0411 | Phone | (919) 286-0411 |
jennifer.naylor2@va.gov | christine.marx@va.gov | ||
Phone Extension | 7722 | Phone Extension | 5112 |
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68487288 | Sequence: | 68487289 |
Design Group Id | 55868891 | Design Group Id | 55868892 |
Intervention Id | 52728479 | Intervention Id | 52728480 |
Eligibilities
Sequence: | 30908192 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
DSM-5 diagnosis of PTSD with CAPS-5 Total Score 3 Females will be required to use a medically and study approved contraceptive or otherwise not be of child-bearing potential Birth control methods must be non-hormonal Exclusion Criteria: History of allergy to pregnenolone Current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern Prior suicide attempt history or suicidal ideation that does not require clinical intervention or represent an imminent concern is permitted Serious unstable medical illness, such as: history of cerebrovascular accident Standard pharmacological interventions for PTSD will not be exclusionary, including, but not limited to: antidepressant medications such as SSRIs, SNRIs, tricyclics, bupropion, mirtazapine, venlafaxine, and nefazodone Initiation or change in psychotherapy within 3 months of randomization i.e., psychotherapy must be stable for 3 months prior to study start As indicated by the DSM-5, moderate or severe Substance Use Disorders (excluding caffeine and tobacco) within 1 month of study entry Mild Alcohol Use Disorder is not exclusionary, at the judgment of the PI and her medical team |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254167606 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30653904 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Masking Description | This is a randomized, double-blind, placebo-controlled trial. All roles will be masked with the exception of the research pharmacist. |
Intervention Model Description | Participants will be randomized to receive the active study medication (pregnenolone) or placebo. |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 29020559 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799549
None
https://zephyrnet.com/?p=NCT03799549
NCT03799549https://www.clinicaltrials.gov/study/NCT03799549?tab=tableNANANA[Trial of device that is not approved or cleared by the U.S. FDA]
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-04-12 |
Last Update Posted Date | 2019-04-12 |
Id Information
Sequence: | 40266151 |
Id Source | org_study_id |
Id Value | SK-0118 |
Sponsors
Sequence: | 48460040 |
Lead Or Collaborator | lead |
Name | [Redacted] |
Calculated Values
Sequence: | 254272071 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Single Facility | False |
Responsible Parties
Sequence: | 28964691 |
Organization | [Redacted] |
Old Name Title | [Redacted] |
]]>
https://zephyrnet.com/NCT03799536
2019-01-09
https://zephyrnet.com/?p=NCT03799536
NCT03799536https://www.clinicaltrials.gov/study/NCT03799536?tab=tableNANANAThis is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject was randomly assigned to the reference or the test formulation in each period of the study (sequences RT or TR), in order to evaluate if both formulations are bioequivalent.The study was conducted in multiple groups.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-06-07 |
Start Month Year | January 9, 2019 |
Primary Completion Month Year | February 4, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-06-07 |
Detailed Descriptions
Sequence: | 20721593 |
Description | The objective of this study is to establish if two formulations of sotalol are bioequivalent. The test formulation is Sotalol Tablets, 160 mg (Pharmtechnology LLC, Belarus). The reference formulation is Sotalex®, Tablets, 160 mg (Bristol-Myers Squibb GmbH & Co. KGaA, Germany). 36 healthy adult volunteers of both genders with age ranging from 18 to 55 years old will receive a single tablet (160 mg of sotalol) of the test and the reference products with 200 ml of water after an overnight fast of at least 10 hours, according to the pre-defined randomization list. In the first period, 18 subjects will receive the test product and 18 subjects the reference product.In the second period subjects will receive the products in the opposite order. Subjects will fast 4 hours after administration of the study drugs during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour prior to administration of the study drugs and 2 hours after administration of the study drugs in each period. In each period blood samples were collected before dosing and 0,5 ; 1; 1,5; 2 ; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing (total number: 19). The washout period will be 14 days. A validated HPLC/MS/MS method will be used to determine plasma concentrations of analyte (sotalol). ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-t and 90% confidence interval will be constructed for the ratio of geometric least square means of the test and the reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval for the analyte, both falls within the acceptable range of 80.00% to 125.00% for Cmax and AUC0-t. |
Facilities
Sequence: | 200107909 |
Name | National Anti-Doping Laboratory |
City | Settl.Lesnoy |
State | Minsk Region |
Zip | 223040 |
Country | Belarus |
Browse Interventions
Sequence: | 96050076 | Sequence: | 96050077 | Sequence: | 96050078 | Sequence: | 96050079 | Sequence: | 96050080 | Sequence: | 96050081 | Sequence: | 96050082 | Sequence: | 96050083 | Sequence: | 96050084 | Sequence: | 96050085 | Sequence: | 96050086 |
Mesh Term | Sotalol | Mesh Term | Adrenergic beta-Antagonists | Mesh Term | Adrenergic Antagonists | Mesh Term | Adrenergic Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Physiological Effects of Drugs | Mesh Term | Anti-Arrhythmia Agents | Mesh Term | Sympatholytics | Mesh Term | Autonomic Agents | Mesh Term | Peripheral Nervous System Agents |
Downcase Mesh Term | sotalol | Downcase Mesh Term | adrenergic beta-antagonists | Downcase Mesh Term | adrenergic antagonists | Downcase Mesh Term | adrenergic agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | anti-arrhythmia agents | Downcase Mesh Term | sympatholytics | Downcase Mesh Term | autonomic agents | Downcase Mesh Term | peripheral nervous system agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52171123 |
Name | Bioequivalence |
Downcase Name | bioequivalence |
Id Information
Sequence: | 40158566 |
Id Source | org_study_id |
Id Value | BE-SOTL-160- 2018 |
Countries
Sequence: | 42568869 |
Name | Belarus |
Removed | False |
Design Groups
Sequence: | 55593071 | Sequence: | 55593072 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Sequence AB | Title | Sequence BA |
Description | Subjects assigned to sequence AB will receive a single 160 mg dose of the test product Sotalol (1 x 160 mg tablet) marked as A in the sequence in the period 1 and a single 160 mg dose of the reference product Sotalex (1 x 160 mg tablet) marked as B in the sequence in the period 2 . These treatments will be administered orally with approximately 200 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. | Description | Subjects assigned to sequence BA will receive a single 160 mg dose of the reference product Sotalex (1 x 160 mg tablet) marked as B in the sequence in the period 1 and a single 160 mg dose of the test product Sotalol (1 x 160 mg tablet) marked as A in the sequence in the period 2 . These treatments will be administered orally with approximately 200 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
Interventions
Sequence: | 52485371 | Sequence: | 52485372 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Sotalol | Name | Sotalex |
Description | Sotalol, Tablets,160 mg, manufactured by Pharmtechnology LLC, Belarus | Description | Sotalex, Tablets,160 mg, manufactured by Bristol-Myers Squibb GmbH & Co. KGaA, Germany |
Keywords
Sequence: | 79868375 | Sequence: | 79868376 | Sequence: | 79868377 |
Name | Bioequivalence | Name | Sotalol | Name | Sotalex |
Downcase Name | bioequivalence | Downcase Name | sotalol | Downcase Name | sotalex |
Design Outcomes
Sequence: | 177378503 | Sequence: | 177378496 | Sequence: | 177378497 | Sequence: | 177378498 | Sequence: | 177378499 | Sequence: | 177378500 | Sequence: | 177378501 | Sequence: | 177378502 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol | Measure | Cmax of sotalol for the test and the reference products | Measure | AUC0-t of sotalol for the test and the reference products | Measure | AUC0-∞ of sotalol for the test and the reference products | Measure | Tmax of sotalol for the test and the reference products | Measure | T1/2 of sotalol for the test and the reference products | Measure | Kel of sotalol for the test and the reference products | Measure | AUCresid of sotalol for the test and the reference products |
Time Frame | 28 days | Time Frame | Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing | Time Frame | Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing | Time Frame | Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing | Time Frame | Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing | Time Frame | Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing | Time Frame | Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing | Time Frame | Time points: 0,00 (within 30 minutes before dosing) and 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 4,5; 5; 6; 8; 10; 12; 16; 24; 36; 48; 72 hours after dosing |
Description | An AE is defined as any untoward medical occurrence in a subject administered an investigational product and which does not necessarily have a causal relationship with the treatment. The data from participants who had taken at least one investigational product was analyzed. | Description | Maximum concentration in plasma among observed concentrations at pre-specified time points | Description | Area under the plasma concentration versus time curve from time 0 to the last measured concentration | Description | Area under the plasma concentration versus time curve from time 0 to to infinite time | Description | Time to maximum measured plasma concentration | Description | Elimination or terminal half-life | Description | Elimination rate constant | Description | Residual area |
Sponsors
Sequence: | 48319201 | Sequence: | 48319202 |
Agency Class | INDUSTRY | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Pharmtechnology LLC | Name | National Anti-Doping Labaratory |
Overall Officials
Sequence: | 29285302 |
Role | Principal Investigator |
Name | Anastasia Teteryukova, MD |
Affiliation | National Anti-Doping Labaratory |
Design Group Interventions
Sequence: | 68149001 | Sequence: | 68149002 |
Design Group Id | 55593071 | Design Group Id | 55593072 |
Intervention Id | 52485371 | Intervention Id | 52485372 |
Eligibilities
Sequence: | 30765292 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 55 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Caucasian men or women aged between 18 to 55 years Exclusion Criteria: Known history of allergy |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253878332 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 0 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 55 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30511459 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Single |
Masking Description | The subjects and the investigator will not be blinded towards the identity of the study products. However, analysts will be blinded towards identity of the study products administered. |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26673677 | Sequence: | 26673678 |
Intervention Id | 52485371 | Intervention Id | 52485372 |
Name | the test product | Name | the reference product |
Responsible Parties
Sequence: | 28877753 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799523
2019-01-16
https://zephyrnet.com/?p=NCT03799523
NCT03799523https://www.clinicaltrials.gov/study/NCT03799523?tab=tableNANANAThe first goal of this project is to validate the superiority of semi-permanent marks used in conjunction with specialized light-based surface imaging (SIGRT) in an effort to phase out the use of permanent tattoos for the investigator’s patients. The secondary goal of this project is to validate the superiority of specialized light-based surface imaging for daily radiation set-up compared to standard-of-care imaging methods using ionizing radiation, such as weekly port films or cone-beam CT (CBCT) scans during a radiation therapy course for breast cancer.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-19 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-01-25 |
Start Month Year | January 16, 2019 |
Primary Completion Month Year | December 2023 |
Verification Month Year | January 2023 |
Verification Date | 2023-01-31 |
Last Update Posted Date | 2023-01-25 |
Detailed Descriptions
Sequence: | 20815550 |
Description | This study uses surface imaging for breast patients to standardize or normalize planning position & minimize variability of port films thus reducing systematic error. The primary objective of this study is to demonstrate the superiority of using surface imaging to combine an ideally gated treatment planning CT and verification images timed to the breathing cycle, quantified as the total within-subject variation of the measured location relative to current methods of radiation delivery not using this approach. The secondary objective is to demonstrate the superiority of specialized light-based surface imaging for daily radiation set-up without tattoos compared to standard-of-care methods with regard to the total within-subject variation of the measured location determined by weekly port films during a course of radiation for breast cancer. |
Facilities
Sequence: | 200889880 |
Name | UT Health San Antonio Mays Cancer Center |
City | San Antonio |
State | Texas |
Zip | 78229 |
Country | United States |
Conditions
Sequence: | 52410820 |
Name | Breast Cancer |
Downcase Name | breast cancer |
Id Information
Sequence: | 40327860 | Sequence: | 40327861 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | CTMS# 18-0135 | Id Value | 18-769H |
Id Type | Other Identifier | ||
Id Type Description | UT Health Science Center Institutional Review Board | ||
Countries
Sequence: | 42751098 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55858392 |
Group Type | Experimental |
Title | Subjects undergoing breast radiotherapy |
Description | At the time of CT simulation study participants will receive temporary skin markings to be covered in clear medical grade tape. Light-based surface imaging will be used to determine alignment between the patient and the radiation machine. Radiation treatment will proceed as standard of care. |
Interventions
Sequence: | 52718720 | Sequence: | 52718721 |
Intervention Type | Other | Intervention Type | Other |
Name | Temporary skin markings | Name | Surface imaging |
Description | To use temporary markings in lieu of localization tattoos. | Description | To use light-based surface imaging for patient positioning during radiation treatment. |
Design Outcomes
Sequence: | 178265296 |
Outcome Type | primary |
Measure | Position measurement from Port films. |
Time Frame | Once weekly for 3 weeks up to 5 weeks |
Description | Distance measured (centimeters) from the planned position of radiotherapy to the actual position of radiotherapy on weekly port films. Port films are x-rays of the treatment field which are done to ensure that the patient and the radiation machine are properly aligned to each other. Weekly port films will be obtained for the duration of radiation treatment, which will be from three to five weeks in length. |
Sponsors
Sequence: | 48542077 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | The University of Texas Health Science Center at San Antonio |
Overall Officials
Sequence: | 29409518 |
Role | Principal Investigator |
Name | Eva Galvan, MD |
Affiliation | Principal Investigator |
Design Group Interventions
Sequence: | 68472889 | Sequence: | 68472890 |
Design Group Id | 55858392 | Design Group Id | 55858392 |
Intervention Id | 52718720 | Intervention Id | 52718721 |
Eligibilities
Sequence: | 30903191 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age ≥ 18 years Exclusion Criteria: Age < 18 years |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254158531 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30648908 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29015552 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799510
2018-12-13
https://zephyrnet.com/?p=NCT03799510
NCT03799510https://www.clinicaltrials.gov/study/NCT03799510?tab=tableNANANAThe clinical trial phase 2b is designed to assess the safety and the specific immune response of the active ingredient (protein + adjuvant) in healthy and then in infected school children from 8 to 11 years of age with intestinal and/or urinary schistosomiasis, living in the Valley of the Senegal River, a highly endemic area for schistosomiasis.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-12-09 |
Start Month Year | December 13, 2018 |
Primary Completion Month Year | July 1, 2019 |
Verification Month Year | December 2019 |
Verification Date | 2019-12-31 |
Last Update Posted Date | 2019-12-09 |
Detailed Descriptions
Sequence: | 20709967 |
Description | A phase 2b trial, self-contained, open-label, controlled, randomized study in three parallel arms, two of them formed by groups of healthy or infected school children, both receiving three (3) injections at D0, W4 (Week 4), W8; both groups receiving 50 μg Sm14 vaccine candidate solution, combined with 2.5μg GLA-SE. The third group is composed by non-vaccinated infected school children.
Sm14: recombinant protein produced in yeast following Good Manufacturing Practices (GMP) conditions, presented in vials containing 0.55 ml solution Sm14, 0.4 ml solution is diluted with 0.4 ml of GLA (Synthetic Glucopyranosyl lipid A) for intramuscular administration. Medical examinations are performed at D0 (before injection, 1 hr and 4 hr after), and a safety evaluation at 24 hrs and 48 hrs, after each injection. Blood analysis: Liver function tests – renal function tests – blood counts, at W-1 before inclusion, and at W9 and W21 during the follow-up. Blood samples for immune response analysis at D0, W12 and W21. |
Facilities
Sequence: | 199964475 |
Name | Biomedical Research Center EPLS |
City | Saint Louis |
Zip | BP226 |
Country | Senegal |
Conditions
Sequence: | 52138950 |
Name | Schistosomiasis |
Downcase Name | schistosomiasis |
Id Information
Sequence: | 40135018 |
Id Source | org_study_id |
Id Value | Sm14 Phase 2b – Sn |
Countries
Sequence: | 42542639 |
Name | Senegal |
Removed | False |
Design Groups
Sequence: | 55559287 | Sequence: | 55559288 | Sequence: | 55559289 |
Group Type | Experimental | Group Type | Experimental | Group Type | No Intervention |
Title | Group 1 | Title | Group 2 | Title | Group 3 |
Description | Healthy school children with no infectious history of Schistosomiasis receiving three (3) intramuscular injections of 50 μg Sm14 with 2.5 μg GLA-SE solution at D0, W4, W8 (D=day; W=week). Three-month follow-up (W12, W20). | Description | School children with an infectious history of S. haematobium and-or S. mansoni and pretreated with 1 dose of Praziquantel (2-4 weeks prior to the first vaccine injection) receiving three (3) intramuscular injections of 50 μg Sm14 with 2.5 μg GLA-SE solution at D0, W4, W8 (D=day; W=week). Three-month follow-up (W12, W20). | Description | School children with an infectious history of S. haematobium and S. mansoni and pretreated with 1 dose of Praziquantel (2-4 weeks prior to the first vaccine injection) not receiving vaccine. Control group. |
Interventions
Sequence: | 52454850 | Sequence: | 52454851 |
Intervention Type | Biological | Intervention Type | Drug |
Name | Sm14 | Name | GLA-SE solution |
Description | Three 0.5 mL intra-muscular injections of the vaccine solution (50μg Sm14) will be administered on D0, W4, W8 (D = day, W = week). | Description | The lot concentration 10μg/mL for injection of 2.5μg GLA-SE/injection. |
Keywords
Sequence: | 79822738 | Sequence: | 79822739 | Sequence: | 79822740 | Sequence: | 79822741 | Sequence: | 79822742 | Sequence: | 79822743 | Sequence: | 79822744 |
Name | Schistosomiasis | Name | Recombinant vaccine | Name | rSm14 | Name | GLA-SE | Name | Fatty acid-binding protein (FABP) | Name | Phase II Clinical Trial | Name | Senegal |
Downcase Name | schistosomiasis | Downcase Name | recombinant vaccine | Downcase Name | rsm14 | Downcase Name | gla-se | Downcase Name | fatty acid-binding protein (fabp) | Downcase Name | phase ii clinical trial | Downcase Name | senegal |
Design Outcomes
Sequence: | 177263392 | Sequence: | 177263393 | Sequence: | 177263394 | Sequence: | 177263395 | Sequence: | 177263396 | Sequence: | 177263397 | Sequence: | 177263398 | Sequence: | 177263399 | Sequence: | 177263400 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Measure | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Measure | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Measure | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Measure | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Measure | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Measure | Qualitative and quantitative assessment of the Immunogenicity | Measure | Qualitative and quantitative assessment of the Immunogenicity | Measure | Qualitative and quantitative assessment of the Immunogenicity |
Time Frame | within 2 days of the administration of the first dose (Day 0) | Time Frame | Day 30-Day 32: within 2 days of the administration of the second dose (Week 4) | Time Frame | Days 60-67 : within 7 days of the administration of the third dose (Week 8) | Time Frame | Day 90: three months after the first injection (Week 12) | Time Frame | Day 120: four months after the first injection (Week 16) | Time Frame | Day 150: five months after the first injection (Week 21) | Time Frame | The Day of first Sm14 vaccine administration (Day 0) | Time Frame | At the 30th day after the third Sm14 vaccine administration (Week 12) | Time Frame | At the 90th day after the third Sm14 vaccine administration (Week 21) |
Description | Local signs and symptoms included Pain, Swelling and Inflammation at the injection site, heaviness or pain upon passive or active movement of the injected limb, Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates.
General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances. |
Description | Local signs and symptoms included Pain, Swelling and Inflammation at the injection site, Heaviness or pain upon passive or active movement of the injected limb, Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates.
General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances. |
Description | Local signs and symptoms included Pain, Swelling and Inflammation at the injection site. Heaviness or pain upon passive or active movement of the injected limb, Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates.
General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances. Laboratory tests (blood count, liver and kidney biological functions). |
Description | Injection local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection. Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances. | Description | Local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection.
Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances. |
Description | Local signs and symptoms included pain or tenderness, swelling, induration and erythema at the site of injection.
Complete physical examination including an examination of general appearance, body weight and forehead temperature, head, eyes, ears, nose and throat, neck, skin, cardiovascular and respiratory system, abdominal system, nervous system, lymphatic area, blood pressure, pulse and respiratory rates. General signs and symptoms including fever, headache, nausea, vomiting, myalgia, arthralgia, irritability/fussiness and drowsiness, loss of appetite and sleep disturbances. |
Description | Immunogenicity was evaluated by Isotype analysis of the antibodies produced specifically against the rSm14 and vaccine-induced (ELISA) and Specific rSm14 cellular response (on PBMC), production of intracellular cytokines (PBMCs stimulation and cytokine dosing). Cellular immune responses measured by PBMC luminex assay for T-cell cytokines (Milliplex ® MAP kit).
Correlation between the development and magnitude of humoral responses measured by antibody IgG production to the Sm14 Schisto protein using enzyme-linked immunosorbent assay (ELISA). |
Description | Immunogenicity was evaluated by Isotype analysis of the antibodies produced specifically against the rSm14 and vaccine-induced (ELISA) and Specific rSm14 cellular response (on PBMC), production of intracellular cytokines (PBMCs stimulation and cytokine dosing). Cellular immune responses measured by PBMC luminex assay for T-cell cytokines (Milliplex ® MAP kit).
Correlation between the development and magnitude of humoral responses measured by antibody IgG production to the Sm14 Schisto protein using enzyme-linked immunosorbent assay (ELISA). |
Description | Immunogenicity was evaluated by Isotype analysis of the antibodies produced specifically against the rSm14 andvaccine-induced (ELISA) and Specific rSm14 cellular response (on PBMC), production of intracellular cytokines (PBMCs stimulation and cytokine dosing). Cellular immune responses measured by PBMC luminex assay for T-cell cytokines (Milliplex ® MAP kit).
Correlation between the development and magnitude of humoral responses measured by antibody IgG production to the Sm14 Schisto protein using enzyme-linked immunosorbent assay (ELISA). |
Browse Conditions
Sequence: | 193366325 | Sequence: | 193366326 | Sequence: | 193366327 | Sequence: | 193366328 | Sequence: | 193366329 | Sequence: | 193366330 |
Mesh Term | Schistosomiasis | Mesh Term | Trematode Infections | Mesh Term | Helminthiasis | Mesh Term | Parasitic Diseases | Mesh Term | Infections | Mesh Term | Vector Borne Diseases |
Downcase Mesh Term | schistosomiasis | Downcase Mesh Term | trematode infections | Downcase Mesh Term | helminthiasis | Downcase Mesh Term | parasitic diseases | Downcase Mesh Term | infections | Downcase Mesh Term | vector borne diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290665 | Sequence: | 48290666 | Sequence: | 48290667 | Sequence: | 48290668 |
Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Oswaldo Cruz Foundation | Name | Orygen Biotecnologia SA | Name | Biomedical Research Center EPLS | Name | Access to Advanced Health Institute (AAHI) |
Overall Officials
Sequence: | 29268506 | Sequence: | 29268507 | Sequence: | 29268508 | Sequence: | 29268509 |
Role | Study Chair | Role | Principal Investigator | Role | Study Director | Role | Study Director |
Name | Miriam Tendler, MD, PhD | Name | Modou DIOP, MD | Name | Gilles RIVEAU, PharmD, PhD | Name | Anne-Marie SCHACHT, CRA |
Affiliation | Oswaldo Cruz Foundation | Affiliation | Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS) | Affiliation | Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS). | Affiliation | Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS). |
Design Group Interventions
Sequence: | 68107378 | Sequence: | 68107379 | Sequence: | 68107380 | Sequence: | 68107381 |
Design Group Id | 55559287 | Design Group Id | 55559288 | Design Group Id | 55559287 | Design Group Id | 55559288 |
Intervention Id | 52454850 | Intervention Id | 52454850 | Intervention Id | 52454851 | Intervention Id | 52454851 |
Eligibilities
Sequence: | 30747692 |
Gender | All |
Minimum Age | 8 Years |
Maximum Age | 11 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
School children, of public schools in villages of Saint Louis region (Senegal), female or male, 8 to 11 years old (inclusive) at the time of inclusion. Exclusion Criteria: School child who does not respond to one of the inclusion criteria |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254121779 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 6 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 8 |
Maximum Age Num | 11 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 6 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30493975 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | None (Open Label) |
Masking Description | No masking |
Intervention Other Names
Sequence: | 26655388 | Sequence: | 26655389 | Sequence: | 26655390 | Sequence: | 26655391 |
Intervention Id | 52454850 | Intervention Id | 52454851 | Intervention Id | 52454851 | Intervention Id | 52454851 |
Name | rSm14 | Name | • Glucopyranosyl Lipid A in Stable Emulsion | Name | • Glucopyranosyl Lipid Adjuvant-Stable Emulsion | Name | • Toll-like Receptor 4 Agonist GLA-SE |
Responsible Parties
Sequence: | 28860255 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52032531 | Sequence: | 52032532 | Sequence: | 52032533 | Sequence: | 52032534 | Sequence: | 52032535 | Sequence: | 52032536 |
Pmid | 2022660 | Pmid | 19150418 | Pmid | 21298114 | Pmid | 26571311 | Pmid | 23284726 | Pmid | 30469320 |
Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result |
Citation | Moser D, Tendler M, Griffiths G, Klinkert MQ. A 14-kDa Schistosoma mansoni polypeptide is homologous to a gene family of fatty acid binding proteins. J Biol Chem. 1991 May 5;266(13):8447-54. | Citation | Ramos CR, Spisni A, Oyama S Jr, Sforca ML, Ramos HR, Vilar MM, Alves AC, Figueredo RC, Tendler M, Zanchin NI, Pertinhez TA, Ho PL. Stability improvement of the fatty acid binding protein Sm14 from S. mansoni by Cys replacement: structural and functional characterization of a vaccine candidate. Biochim Biophys Acta. 2009 Apr;1794(4):655-62. doi: 10.1016/j.bbapap.2008.12.010. Epub 2008 Dec 25. | Citation | Coler RN, Bertholet S, Moutaftsi M, Guderian JA, Windish HP, Baldwin SL, Laughlin EM, Duthie MS, Fox CB, Carter D, Friede M, Vedvick TS, Reed SG. Development and characterization of synthetic glucopyranosyl lipid adjuvant system as a vaccine adjuvant. PLoS One. 2011 Jan 26;6(1):e16333. doi: 10.1371/journal.pone.0016333. | Citation | Santini-Oliveira M, Coler RN, Parra J, Veloso V, Jayashankar L, Pinto PM, Ciol MA, Bergquist R, Reed SG, Tendler M. Schistosomiasis vaccine candidate Sm14/GLA-SE: Phase 1 safety and immunogenicity clinical trial in healthy, male adults. Vaccine. 2016 Jan 20;34(4):586-594. doi: 10.1016/j.vaccine.2015.10.027. Epub 2015 Nov 10. | Citation | Lambert SL, Yang CF, Liu Z, Sweetwood R, Zhao J, Cheng L, Jin H, Woo J. Molecular and cellular response profiles induced by the TLR4 agonist-based adjuvant Glucopyranosyl Lipid A. PLoS One. 2012;7(12):e51618. doi: 10.1371/journal.pone.0051618. Epub 2012 Dec 28. | Citation | Tendler M, Almeida MS, Vilar MM, Pinto PM, Limaverde-Sousa G. Current Status of the Sm14/GLA-SE Schistosomiasis Vaccine: Overcoming Barriers and Paradigms towards the First Anti-Parasitic Human(itarian) Vaccine. Trop Med Infect Dis. 2018 Nov 21;3(4):121. doi: 10.3390/tropicalmed3040121. Erratum In: Trop Med Infect Dis. 2019 Jan 19;4(1): |
]]>
https://zephyrnet.com/NCT03799497
2013-06-07
https://zephyrnet.com/?p=NCT03799497
NCT03799497https://www.clinicaltrials.gov/study/NCT03799497?tab=tableNANANABody Image distortion is a key diagnostic feature for Anorexia Nervosa. Patients suffering from Anorexia Nervosa tend to perceive themselves as fatter than they are. This bias might be at the origin of a reinforcement of anorectic behavior which might alter medical care. The objective of this study is to identify neural correlates of self-recognition in Anorexia Nervosa. Patients are hypothesized to activate the self-recognition network when seeing images of a fatter body shape than their own.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-09-16 |
Start Month Year | June 7, 2013 |
Primary Completion Month Year | June 7, 2020 |
Verification Month Year | September 2020 |
Verification Date | 2020-09-30 |
Last Update Posted Date | 2020-09-16 |
Detailed Descriptions
Sequence: | 20762935 |
Description | Patients suffering from Anorexia Nervosa and control subjects (matched by age and study level) are recruited in medical care facilities in Lille's Metropolis. They are asked to identify their body shape when being presented with 3 different stimuli, i.e.real (RBS), estimated (EBS) and neutral body shape (NBS), in a functional magnetic resonance imaging or functional MRI (fMRI) machine. While answering to this identification paradigm, we hoped to identify modifications in the self body-recognition network. |
Facilities
Sequence: | 200458210 |
Name | CHRU,Hôpital Fontan 2 |
City | Lille |
Country | France |
Conditions
Sequence: | 52277473 |
Name | Anorexia Nervosa |
Downcase Name | anorexia nervosa |
Id Information
Sequence: | 40235475 | Sequence: | 40235476 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 2009_48 | Id Value | 2010-A00545-34 |
Id Type | Other Identifier | ||
Id Type Description | ID-RCB number, ANSM | ||
Countries
Sequence: | 42653071 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55711604 | Sequence: | 55711605 |
Title | Patients suffering from Anorexia Nervosa | Title | Control group |
Description | Subjects with a diagnostic of anorexia nervosa disorder | Description | Healthy subjects with no psychiatric disorder |
Keywords
Sequence: | 80018988 | Sequence: | 80018989 | Sequence: | 80018990 |
Name | Anorexia nervosa | Name | functional MRI (fMRI) | Name | self body-shape recognition |
Downcase Name | anorexia nervosa | Downcase Name | functional mri (fmri) | Downcase Name | self body-shape recognition |
Design Outcomes
Sequence: | 177770721 |
Outcome Type | primary |
Measure | Measure of the activation brain areas in self body-recognition network |
Time Frame | 15 days |
Description | Level of activation areas in the self body-recognition network measured during fMRI |
Browse Conditions
Sequence: | 193892826 | Sequence: | 193892827 | Sequence: | 193892828 | Sequence: | 193892829 | Sequence: | 193892830 |
Mesh Term | Anorexia | Mesh Term | Anorexia Nervosa | Mesh Term | Signs and Symptoms, Digestive | Mesh Term | Feeding and Eating Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | anorexia | Downcase Mesh Term | anorexia nervosa | Downcase Mesh Term | signs and symptoms, digestive | Downcase Mesh Term | feeding and eating disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48418656 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University Hospital, Lille |
Overall Officials
Sequence: | 29342626 |
Role | Principal Investigator |
Name | Olivier Cottencin, MD, PhD |
Affiliation | University Hospital, Lille |
Eligibilities
Sequence: | 30827042 |
Sampling Method | Non-Probability Sample |
Gender | Female |
Minimum Age | 15 Years |
Maximum Age | 45 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | Volontary subjects : patients suffering from Anorexia Nervosa and control subjects, matched by age and study level |
Criteria | Inclusion Criteria:
Providing informed, dated and signed consent (for minors, consent must be signed by both parents) Exclusion Criteria: Pregnant or breast-feeding women |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254123737 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 85 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 15 |
Maximum Age Num | 45 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30572972 |
Observational Model | Case-Control |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28939394 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799484
2019-01-04
https://zephyrnet.com/?p=NCT03799484
NCT03799484https://www.clinicaltrials.gov/study/NCT03799484?tab=tableNANANAThe purpose of this study is to determine whether there is a difference in clinical effect, duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia on one side of the forehead and petrolatum ointment on the other prior to Botulinum Toxin Type A administration for the treatment of forehead rhytides.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-06-18 |
Start Month Year | January 4, 2019 |
Primary Completion Month Year | June 14, 2019 |
Verification Month Year | June 2020 |
Verification Date | 2020-06-30 |
Last Update Posted Date | 2020-06-18 |
Results First Posted Date | 2020-06-18 |
Detailed Descriptions
Sequence: | 20562940 |
Description | This is a prospective, randomized, double-masked, comparative study in patients who present at the Robert Cizik Eye Clinic with horizontal forehead rhytides requiring treatment with botulinum toxin Type A (Botox ®; Allergan, Irvine, CA, USA).
The objective of this study is to determine whether there is a difference in clinical effect (weakness/paralysis of the frontalis muscle), duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia (2.5% lidocaine/2.5 % prilocaine cream, Impax Laboratories, LLC) on one side of the forehead and petrolatum ointment on the other prior to BTX-A administration for the treatment of forehead rhytides. Primary outcome variable is change of eyebrow excursion on each side of the forehead from baseline to each follow-up visit. Secondary outcome variables Duration of effect, defined as the elapsed time from injection to the end of botulinum, such that return of baseline frontalis function, i.e. within 2 mm of baseline value |
Facilities
Sequence: | 198527942 |
Name | Robert Cizik Eye Clinic |
City | Houston |
State | Texas |
Zip | 77030 |
Country | United States |
Browse Interventions
Sequence: | 95244644 | Sequence: | 95244645 | Sequence: | 95244646 | Sequence: | 95244647 | Sequence: | 95244648 | Sequence: | 95244649 | Sequence: | 95244650 | Sequence: | 95244651 | Sequence: | 95244652 | Sequence: | 95244653 | Sequence: | 95244654 | Sequence: | 95244655 | Sequence: | 95244656 | Sequence: | 95244657 | Sequence: | 95244658 | Sequence: | 95244659 | Sequence: | 95244660 | Sequence: | 95244661 | Sequence: | 95244662 | Sequence: | 95244663 | Sequence: | 95244664 | Sequence: | 95244665 | Sequence: | 95244666 |
Mesh Term | Lidocaine | Mesh Term | Prilocaine | Mesh Term | Petrolatum | Mesh Term | Botulinum Toxins | Mesh Term | Botulinum Toxins, Type A | Mesh Term | abobotulinumtoxinA | Mesh Term | Anesthetics, Local | Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Anti-Arrhythmia Agents | Mesh Term | Voltage-Gated Sodium Channel Blockers | Mesh Term | Sodium Channel Blockers | Mesh Term | Membrane Transport Modulators | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Acetylcholine Release Inhibitors | Mesh Term | Cholinergic Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Neuromuscular Agents | Mesh Term | Emollients | Mesh Term | Dermatologic Agents |
Downcase Mesh Term | lidocaine | Downcase Mesh Term | prilocaine | Downcase Mesh Term | petrolatum | Downcase Mesh Term | botulinum toxins | Downcase Mesh Term | botulinum toxins, type a | Downcase Mesh Term | abobotulinumtoxina | Downcase Mesh Term | anesthetics, local | Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | anti-arrhythmia agents | Downcase Mesh Term | voltage-gated sodium channel blockers | Downcase Mesh Term | sodium channel blockers | Downcase Mesh Term | membrane transport modulators | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | acetylcholine release inhibitors | Downcase Mesh Term | cholinergic agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | neuromuscular agents | Downcase Mesh Term | emollients | Downcase Mesh Term | dermatologic agents |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51763013 | Sequence: | 51763014 |
Name | Forehead Rhytides | Name | Forehead Wrinkles |
Downcase Name | forehead rhytides | Downcase Name | forehead wrinkles |
Id Information
Sequence: | 39832114 |
Id Source | org_study_id |
Id Value | HSC-MS-18-0908 |
Countries
Sequence: | 42231927 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55184009 | Sequence: | 55184010 |
Group Type | Other | Group Type | Other |
Title | Topical Anesthesia | Title | Petrolatum |
Description | 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection | Description | Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection |
Interventions
Sequence: | 52084252 | Sequence: | 52084253 | Sequence: | 52084254 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Device |
Name | Botulinum toxin type A | Name | 2.5% lidocaine/2.5% prilocaine | Name | petrolatum ointment |
Description | Botulinum toxin type A will be administered to both sides | Description | 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead | Description | petrolatum ointment will be applied to one side of the forehead |
Keywords
Sequence: | 79195454 | Sequence: | 79195455 |
Name | Rhytides | Name | Forehead Wrinkles |
Downcase Name | rhytides | Downcase Name | forehead wrinkles |
Design Outcomes
Sequence: | 176065007 | Sequence: | 176064999 | Sequence: | 176065000 | Sequence: | 176065001 | Sequence: | 176065002 | Sequence: | 176065003 | Sequence: | 176065004 | Sequence: | 176065005 | Sequence: | 176065006 | Sequence: | 176065008 | Sequence: | 176065009 | Sequence: | 176065010 | Sequence: | 176065011 | Sequence: | 176065012 | Sequence: | 176065013 | Sequence: | 176065014 | Sequence: | 176065015 | Sequence: | 176065016 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Eyebrow Excursion | Measure | Eyebrow Excursion | Measure | Eyebrow Excursion | Measure | Eyebrow Excursion | Measure | Duration of Botulinum Toxin Type A Effect | Measure | Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale | Measure | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Measure | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face | Measure | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face | Measure | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face |
Time Frame | Week 16 | Time Frame | Baseline | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | week 16 | Time Frame | week 16 | Time Frame | Immediately after botox injection | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | Week 16 | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | Week 16 | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | Week 16 |
Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value. | Description | A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. |
Sponsors
Sequence: | 47939525 | Sequence: | 47939526 |
Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | The University of Texas Health Science Center, Houston | Name | Robert Cizik Eye Clinic |
Overall Officials
Sequence: | 29045814 |
Role | Principal Investigator |
Name | Karina Richani-Reverol, MD |
Affiliation | The University of Texas Health Science Center, Houston |
Design Group Interventions
Sequence: | 67654565 | Sequence: | 67654566 | Sequence: | 67654567 | Sequence: | 67654568 |
Design Group Id | 55184010 | Design Group Id | 55184009 | Design Group Id | 55184009 | Design Group Id | 55184010 |
Intervention Id | 52084252 | Intervention Id | 52084252 | Intervention Id | 52084253 | Intervention Id | 52084254 |
Eligibilities
Sequence: | 30526478 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
18 to 65 years of age Exclusion Criteria: Previous injection of botulinum toxin in the intended treatment area for the study within the last 4 months |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254093111 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 5 |
Were Results Reported | True |
Months To Report Results | 11 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 14 |
Designs
Sequence: | 30275385 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Double |
Masking Description | Randomization will only be known by the principal investigator performing the injections and will not be disclosed to the participants or the brow excursion examiner. |
Subject Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26476003 | Sequence: | 26476004 | Sequence: | 26476005 |
Intervention Id | 52084252 | Intervention Id | 52084253 | Intervention Id | 52084254 |
Name | BTX-A | Name | EMLA | Name | Aquaphor |
Milestones
Sequence: | 40753554 | Sequence: | 40753555 | Sequence: | 40753556 |
Result Group Id | 55825946 | Result Group Id | 55825946 | Result Group Id | 55825946 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG000 |
Title | STARTED | Title | COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 14 | Count | 14 | Count | 0 |
Participant Flows
Sequence: | 3897729 |
Outcome Counts
Sequence: | 73515605 | Sequence: | 73515606 | Sequence: | 73515607 | Sequence: | 73515608 | Sequence: | 73515609 | Sequence: | 73515610 | Sequence: | 73515611 | Sequence: | 73515612 | Sequence: | 73515613 | Sequence: | 73515614 | Sequence: | 73515615 | Sequence: | 73515616 | Sequence: | 73515617 | Sequence: | 73515618 | Sequence: | 73515619 | Sequence: | 73515620 | Sequence: | 73515621 | Sequence: | 73515622 | Sequence: | 73515623 | Sequence: | 73515624 | Sequence: | 73515625 | Sequence: | 73515626 | Sequence: | 73515627 | Sequence: | 73515628 | Sequence: | 73515629 | Sequence: | 73515630 | Sequence: | 73515631 | Sequence: | 73515632 | Sequence: | 73515633 | Sequence: | 73515634 | Sequence: | 73515635 | Sequence: | 73515636 | Sequence: | 73515637 | Sequence: | 73515638 | Sequence: | 73515639 | Sequence: | 73515640 |
Outcome Id | 30603527 | Outcome Id | 30603527 | Outcome Id | 30603527 | Outcome Id | 30603527 | Outcome Id | 30603528 | Outcome Id | 30603528 | Outcome Id | 30603528 | Outcome Id | 30603528 | Outcome Id | 30603529 | Outcome Id | 30603529 | Outcome Id | 30603529 | Outcome Id | 30603529 | Outcome Id | 30603530 | Outcome Id | 30603530 | Outcome Id | 30603530 | Outcome Id | 30603530 | Outcome Id | 30603531 | Outcome Id | 30603531 | Outcome Id | 30603531 | Outcome Id | 30603531 | Outcome Id | 30603532 | Outcome Id | 30603532 | Outcome Id | 30603532 | Outcome Id | 30603532 | Outcome Id | 30603533 | Outcome Id | 30603534 | Outcome Id | 30603535 | Outcome Id | 30603536 | Outcome Id | 30603537 | Outcome Id | 30603538 | Outcome Id | 30603539 | Outcome Id | 30603540 | Outcome Id | 30603541 | Outcome Id | 30603542 | Outcome Id | 30603543 | Outcome Id | 30603544 |
Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | side of forehead (either left or right) | Units | side of forehead (either left or right) | Units | Participants | Units | Participants | Units | side of forehead (either left or right) | Units | side of forehead (either left or right) | Units | Participants | Units | Participants | Units | side of forehead (either left or right) | Units | side of forehead (either left or right) | Units | Participants | Units | Participants | Units | side of forehead (either left or right) | Units | side of forehead (either left or right) | Units | Participants | Units | Participants | Units | side of forehead (either left or right) | Units | side of forehead (either left or right) | Units | Participants | Units | Participants | Units | side of forehead (either left or right) | Units | side of forehead (either left or right) | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 | Count | 14 |
Provided Documents
Sequence: | 2565770 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2018-11-30 |
Url | https://ClinicalTrials.gov/ProvidedDocs/84/NCT03799484/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27770422 | Sequence: | 27770423 | Sequence: | 27770424 | Sequence: | 27770425 | Sequence: | 27770426 | Sequence: | 27770427 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 | Subjects At Risk | 14 |
Created At | 2023-08-06 14:23:58.045603 | Created At | 2023-08-06 14:23:58.045603 | Created At | 2023-08-06 14:23:58.045603 | Created At | 2023-08-06 14:23:58.045603 | Created At | 2023-08-06 14:23:58.045603 | Created At | 2023-08-06 14:23:58.045603 |
Updated At | 2023-08-06 14:23:58.045603 | Updated At | 2023-08-06 14:23:58.045603 | Updated At | 2023-08-06 14:23:58.045603 | Updated At | 2023-08-06 14:23:58.045603 | Updated At | 2023-08-06 14:23:58.045603 | Updated At | 2023-08-06 14:23:58.045603 |
Responsible Parties
Sequence: | 28655291 |
Responsible Party Type | Principal Investigator |
Name | Karina Richani-Reverol |
Title | Clinical Assistant Professor |
Affiliation | The University of Texas Health Science Center, Houston |
Result Agreements
Sequence: | 3828473 |
Pi Employee | Yes |
Result Contacts
Sequence: | 3828438 |
Organization | The University of Texas Health Science Center at Houston |
Name | Karina Richani-Reverol, MD |
Phone | (713) 559-5200 |
Karina.RichaniReverol@uth.tmc.edu | |
Outcomes
Sequence: | 30603528 | Sequence: | 30603527 | Sequence: | 30603529 | Sequence: | 30603530 | Sequence: | 30603531 | Sequence: | 30603532 | Sequence: | 30603533 | Sequence: | 30603534 | Sequence: | 30603535 | Sequence: | 30603536 | Sequence: | 30603537 | Sequence: | 30603538 | Sequence: | 30603539 | Sequence: | 30603540 | Sequence: | 30603541 | Sequence: | 30603542 | Sequence: | 30603543 | Sequence: | 30603544 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Duration of Botulinum Toxin Type A Effect | Title | Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face | Title | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face | Title | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face |
Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value. | Description | A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. | ||
Time Frame | Week 2 | Time Frame | Baseline | Time Frame | Week 6 | Time Frame | week 16 | Time Frame | week 16 | Time Frame | Immediately after botox injection | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | Week 16 | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | Week 16 | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | Week 16 | Time Frame | Week 2 | Time Frame | Week 6 | Time Frame | Week 16 |
Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters | Units | weeks | Units | units on a scale | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Units Analyzed | side of forehead (either left or right) | Units Analyzed | side of forehead (either left or right) | Units Analyzed | side of forehead (either left or right) | Units Analyzed | side of forehead (either left or right) | Units Analyzed | side of forehead (either left or right) | Units Analyzed | side of forehead (either left or right) | ||||||||||||||||||||||||
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Error | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Outcome Measurements
Sequence: | 234047580 | Sequence: | 234047581 | Sequence: | 234047582 | Sequence: | 234047583 | Sequence: | 234047584 | Sequence: | 234047585 | Sequence: | 234047586 | Sequence: | 234047587 | Sequence: | 234047588 | Sequence: | 234047589 | Sequence: | 234047590 | Sequence: | 234047591 | Sequence: | 234047592 | Sequence: | 234047593 | Sequence: | 234047594 | Sequence: | 234047595 | Sequence: | 234047596 | Sequence: | 234047597 | Sequence: | 234047598 | Sequence: | 234047599 | Sequence: | 234047600 | Sequence: | 234047601 | Sequence: | 234047602 | Sequence: | 234047603 | Sequence: | 234047604 | Sequence: | 234047605 | Sequence: | 234047606 | Sequence: | 234047607 | Sequence: | 234047608 | Sequence: | 234047609 | Sequence: | 234047610 | Sequence: | 234047611 | Sequence: | 234047612 | Sequence: | 234047613 | Sequence: | 234047614 | Sequence: | 234047615 | Sequence: | 234047616 | Sequence: | 234047617 | Sequence: | 234047618 | Sequence: | 234047619 | Sequence: | 234047620 | Sequence: | 234047621 | Sequence: | 234047622 | Sequence: | 234047623 | Sequence: | 234047624 | Sequence: | 234047625 | Sequence: | 234047626 | Sequence: | 234047627 | Sequence: | 234047628 | Sequence: | 234047629 | Sequence: | 234047630 | Sequence: | 234047631 | Sequence: | 234047632 | Sequence: | 234047633 | Sequence: | 234047634 | Sequence: | 234047635 | Sequence: | 234047636 | Sequence: | 234047637 | Sequence: | 234047638 | Sequence: | 234047639 |
Outcome Id | 30603527 | Outcome Id | 30603527 | Outcome Id | 30603528 | Outcome Id | 30603528 | Outcome Id | 30603529 | Outcome Id | 30603529 | Outcome Id | 30603530 | Outcome Id | 30603530 | Outcome Id | 30603531 | Outcome Id | 30603531 | Outcome Id | 30603532 | Outcome Id | 30603532 | Outcome Id | 30603533 | Outcome Id | 30603533 | Outcome Id | 30603533 | Outcome Id | 30603533 | Outcome Id | 30603533 | Outcome Id | 30603534 | Outcome Id | 30603534 | Outcome Id | 30603534 | Outcome Id | 30603534 | Outcome Id | 30603534 | Outcome Id | 30603535 | Outcome Id | 30603535 | Outcome Id | 30603535 | Outcome Id | 30603535 | Outcome Id | 30603535 | Outcome Id | 30603536 | Outcome Id | 30603536 | Outcome Id | 30603536 | Outcome Id | 30603536 | Outcome Id | 30603536 | Outcome Id | 30603537 | Outcome Id | 30603537 | Outcome Id | 30603537 | Outcome Id | 30603537 | Outcome Id | 30603537 | Outcome Id | 30603538 | Outcome Id | 30603538 | Outcome Id | 30603538 | Outcome Id | 30603538 | Outcome Id | 30603538 | Outcome Id | 30603539 | Outcome Id | 30603539 | Outcome Id | 30603539 | Outcome Id | 30603539 | Outcome Id | 30603539 | Outcome Id | 30603540 | Outcome Id | 30603540 | Outcome Id | 30603540 | Outcome Id | 30603540 | Outcome Id | 30603540 | Outcome Id | 30603541 | Outcome Id | 30603541 | Outcome Id | 30603541 | Outcome Id | 30603541 | Outcome Id | 30603541 | Outcome Id | 30603542 | Outcome Id | 30603543 | Outcome Id | 30603544 |
Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825947 | Result Group Id | 55825948 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 | Result Group Id | 55825949 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | Category | very satisfied | Category | satisfied | Category | neutral | Category | dissatisfied | Category | very dissatisfied | ||||||||||||||||||||||||||||||
Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Eyebrow Excursion | Title | Duration of Botulinum Toxin Type A Effect | Title | Duration of Botulinum Toxin Type A Effect | Title | Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale | Title | Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey | Title | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face | Title | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face | Title | Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face |
Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters. | Description | Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value. | Description | Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value. | Description | A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome. | Description | A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. | Description | Participants will be asked if there is a noticeable difference between the 2 sides of their face. | ||||
Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters | Units | millimeters | Units | weeks | Units | weeks | Units | units on a scale | Units | units on a scale | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 10.57 | Param Value | 10.57 | Param Value | 3.46 | Param Value | 3.43 | Param Value | 5.96 | Param Value | 5.68 | Param Value | 8.21 | Param Value | 8.07 | Param Value | 14.2857 | Param Value | 15.2857 | Param Value | 2.43 | Param Value | 3.96 | Param Value | 8 | Param Value | 6 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 7 | Param Value | 6 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 8 | Param Value | 2 | Param Value | 1 | Param Value | 3 | Param Value | 0 | Param Value | 8 | Param Value | 6 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 7 | Param Value | 5 | Param Value | 2 | Param Value | 0 | Param Value | 0 | Param Value | 8 | Param Value | 2 | Param Value | 1 | Param Value | 3 | Param Value | 0 | Param Value | 8 | Param Value | 6 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 6 | Param Value | 7 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 8 | Param Value | 2 | Param Value | 1 | Param Value | 3 | Param Value | 0 | Param Value | 3 | Param Value | 2 | Param Value | 0 |
Param Value Num | 10.57 | Param Value Num | 10.57 | Param Value Num | 3.46 | Param Value Num | 3.43 | Param Value Num | 5.96 | Param Value Num | 5.68 | Param Value Num | 8.21 | Param Value Num | 8.07 | Param Value Num | 14.2857 | Param Value Num | 15.2857 | Param Value Num | 2.43 | Param Value Num | 3.96 | Param Value Num | 8.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 7.0 | Param Value Num | 6.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 8.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 8.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 7.0 | Param Value Num | 5.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 8.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 8.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 6.0 | Param Value Num | 7.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 8.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 3.0 | Param Value Num | 2.0 | Param Value Num | 0.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 3.3 | Dispersion Value | 3.16 | Dispersion Value | 2.76 | Dispersion Value | 2.93 | Dispersion Value | 2.62 | Dispersion Value | 2.55 | Dispersion Value | 2.89 | Dispersion Value | 2.97 | Dispersion Value | 1.2317 | Dispersion Value | 0.7301 | Dispersion Value | 1.55 | Dispersion Value | 1.74 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 3.3 | Dispersion Value Num | 3.16 | Dispersion Value Num | 2.76 | Dispersion Value Num | 2.93 | Dispersion Value Num | 2.62 | Dispersion Value Num | 2.55 | Dispersion Value Num | 2.89 | Dispersion Value Num | 2.97 | Dispersion Value Num | 1.2317 | Dispersion Value Num | 0.7301 | Dispersion Value Num | 1.55 | Dispersion Value Num | 1.74 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Study References
Sequence: | 51655904 | Sequence: | 51655905 | Sequence: | 51655906 | Sequence: | 51655907 | Sequence: | 51655908 | Sequence: | 51655909 | Sequence: | 51655910 | Sequence: | 51655911 | Sequence: | 51655912 | Sequence: | 51655913 | Sequence: | 51655914 | Sequence: | 51655915 | Sequence: | 51655916 | Sequence: | 51655917 | Sequence: | 51655918 | Sequence: | 51655919 |
Pmid | 7365644 | Pmid | 9834738 | Pmid | 9279643 | Pmid | 15598005 | Pmid | 7824641 | Pmid | 2748749 | Pmid | 17117100 | Pmid | 24699554 | Pmid | 29016544 | Pmid | 27617615 | Pmid | 21120257 | Pmid | 19454924 | Pmid | 25705950 | Pmid | 15507786 | Pmid | 17376126 | Pmid | 15710113 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Scott AB. Botulinum toxin injection into extraocular muscles as an alternative to strabismus surgery. J Pediatr Ophthalmol Strabismus. 1980 Jan-Feb;17(1):21-5. doi: 10.3928/0191-3913-19800101-06. | Citation | Carruthers A, Carruthers J. Clinical indications and injection technique for the cosmetic use of botulinum A exotoxin. Dermatol Surg. 1998 Nov;24(11):1189-94. doi: 10.1111/j.1524-4725.1998.tb04097.x. | Citation | Carter SR, Seiff SR. Cosmetic botulinum toxin injections. Int Ophthalmol Clin. 1997 Summer;37(3):69-79. doi: 10.1097/00004397-199703730-00006. No abstract available. | Citation | Charles PD. Botulinum neurotoxin serotype A: a clinical update on non-cosmetic uses. Am J Health Syst Pharm. 2004 Nov 15;61(22 Suppl 6):S11-23. doi: 10.1093/ajhp/61.suppl_6.S11. | Citation | Carruthers A, Carruthers J. Aesthetic indications for botulinum toxin injections. Plast Reconstr Surg. 1995 Feb;95(2):427-8. doi: 10.1097/00006534-199502000-00049. No abstract available. | Citation | Clark RP, Berris CE. Botulinum toxin: a treatment for facial asymmetry caused by facial nerve paralysis. Plast Reconstr Surg. 1989 Aug;84(2):353-5. | Citation | Sami MS, Soparkar CN, Patrinely JR, Hollier LM, Hollier LH. Efficacy of botulinum toxin type a after topical anesthesia. Ophthalmic Plast Reconstr Surg. 2006 Nov-Dec;22(6):448-52. doi: 10.1097/01.iop.0000248989.33572.3c. | Citation | Gordin EA, Luginbuhl AL, Ortlip T, Heffelfinger RN, Krein H. Subcutaneous vs intramuscular botulinum toxin: split-face randomized study. JAMA Facial Plast Surg. 2014 May-Jun;16(3):193-8. doi: 10.1001/jamafacial.2013.2458. | Citation | Li Y, Dong W, Wang M, Xu N. Investigation of the Efficacy and Safety of Topical Vibration Anesthesia to Reduce Pain From Cosmetic Botulinum Toxin A Injections in Chinese Patients: A Multicenter, Randomized, Self-Controlled Study. Dermatol Surg. 2017 Dec;43 Suppl 3:S329-S335. doi: 10.1097/DSS.0000000000001349. | Citation | Shi LL, Sargen MR, Chen SC, Arbiser JL, Pollack BP. Effective local anesthesia for onabotulinumtoxin A injections to treat hyperhidrosis associated with traumatic amputation. Dermatol Online J. 2016 Jun 15;22(6):13030/qt38b203d0. | Citation | Baumann LS, Grunebaum L, Elsaie ML, Murdock J, Jablonka E, Figueras K, Bell M. Safety and efficacy of a rapid-acting topical 4% lidocaine gel in a unique drug delivery system. J Drugs Dermatol. 2010 Dec;9(12):1500-4. | Citation | Weiss RA, Lavin PT. Reduction of pain and anxiety prior to botulinum toxin injections with a new topical anesthetic method. Ophthalmic Plast Reconstr Surg. 2009 May-Jun;25(3):173-7. doi: 10.1097/IOP.0b013e3181a145ca. | Citation | Alam M, Bolotin D, Carruthers J, Hexsel D, Lawrence N, Minkis K, Ross EV. Consensus statement regarding storage and reuse of previously reconstituted neuromodulators. Dermatol Surg. 2015 Mar;41(3):321-6. doi: 10.1097/DSS.0000000000000303. | Citation | Carruthers J, Fagien S, Matarasso SL; Botox Consensus Group. Consensus recommendations on the use of botulinum toxin type a in facial aesthetics. Plast Reconstr Surg. 2004 Nov;114(6 Suppl):1S-22S. doi: 10.1097/01.PRS.0000144795.76040.D3. | Citation | Ito H, Ito H, Nakano S, Kusaka H. Low-dose subcutaneous injection of botulinum toxin type A for facial synkinesis and hyperlacrimation. Acta Neurol Scand. 2007 Apr;115(4):271-4. doi: 10.1111/j.1600-0404.2006.00746.x. | Citation | Tzou CH, Giovanoli P, Ploner M, Frey M. Are there ethnic differences of facial movements between Europeans and Asians? Br J Plast Surg. 2005 Mar;58(2):183-95. doi: 10.1016/j.bjps.2004.10.014. |
Baseline Counts
Sequence: | 11314641 |
Result Group Id | 55825945 |
Ctgov Group Code | BG000 |
Units | Participants |
Scope | overall |
Count | 14 |
Result Groups
Sequence: | 55825945 | Sequence: | 55825946 | Sequence: | 55825947 | Sequence: | 55825948 | Sequence: | 55825949 | Sequence: | 55825950 | Sequence: | 55825951 |
Ctgov Group Code | BG000 | Ctgov Group Code | FG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | All Participants | Title | All Participants | Title | Topical Anesthesia | Title | Petrolatum | Title | All Participants | Title | Topical Anesthesia | Title | Petrolatum |
Description | 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection. | Description | 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection. | Description | 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides 2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead |
Description | Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides petrolatum ointment: petrolatum ointment will be applied to one side of the forehead |
Description | 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection. | Description | 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides 2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead |
Description | Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection
Botulinum toxin type A: Botulinum toxin type A will be administered to both sides petrolatum ointment: petrolatum ointment will be applied to one side of the forehead |
Baseline Measurements
Sequence: | 124852627 | Sequence: | 124852628 | Sequence: | 124852629 | Sequence: | 124852630 | Sequence: | 124852631 | Sequence: | 124852632 | Sequence: | 124852633 | Sequence: | 124852634 |
Result Group Id | 55825945 | Result Group Id | 55825945 | Result Group Id | 55825945 | Result Group Id | 55825945 | Result Group Id | 55825945 | Result Group Id | 55825945 | Result Group Id | 55825945 | Result Group Id | 55825945 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 |
Classification | Asian | Classification | Hispanic | Classification | White | Classification | United States | ||||||||
Category | Female | Category | Male | ||||||||||||
Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Region of Enrollment | Title | Distance between both lateral canthi |
Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | millimeters |
Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean |
Param Value | 35.5 | Param Value | 9 | Param Value | 5 | Param Value | 1 | Param Value | 6 | Param Value | 7 | Param Value | 14 | Param Value | 98.29 |
Param Value Num | 35.5 | Param Value Num | 9.0 | Param Value Num | 5.0 | Param Value Num | 1.0 | Param Value Num | 6.0 | Param Value Num | 7.0 | Param Value Num | 14.0 | Param Value Num | 98.29 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||
Dispersion Value | 6.7 | Dispersion Value | 3.43 | ||||||||||||
Dispersion Value Num | 6.7 | Dispersion Value Num | 3.43 | ||||||||||||
Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 | Number Analyzed | 14 |
]]>
https://zephyrnet.com/NCT03799471
2019-02-26
https://zephyrnet.com/?p=NCT03799471
NCT03799471https://www.clinicaltrials.gov/study/NCT03799471?tab=tableNANANAThis study evaluates nervous system hypersensitivity in individuals with inflammatory bowel disease (IBD) and experiences of ongoing musculoskeletal (MSK) pain. Previous results and current literature suggest that MSK pain in IBD may be influenced by hypersensitivity of the central nervous system, termed central sensitization. However, specific mechanisms contributing to pain experiences are unknown. Therefore, primary aims are to explore aspects of central sensitization through sensory testing in this population, and to investigate association of psychological and IBD features to sensory profiles. This study hypothesizes that IBD patients with MSK pain will demonstrate altered sensory function, and IBD/psychosocial features will be associated with altered sensory functioning and worse pain experiences.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-08-28 |
Start Month Year | February 26, 2019 |
Primary Completion Month Year | July 19, 2019 |
Verification Month Year | August 2019 |
Verification Date | 2019-08-31 |
Last Update Posted Date | 2019-08-28 |
Facilities
Sequence: | 200594632 |
Name | Dartmouth-Hitchcock Medical Center |
City | Lebanon |
State | New Hampshire |
Zip | 03756-0001 |
Country | United States |
Conditions
Sequence: | 52321373 | Sequence: | 52321374 | Sequence: | 52321375 |
Name | Inflammatory Bowel Diseases | Name | Chronic Pain | Name | Central Sensitization |
Downcase Name | inflammatory bowel diseases | Downcase Name | chronic pain | Downcase Name | central sensitization |
Id Information
Sequence: | 40266105 |
Id Source | org_study_id |
Id Value | W19040 |
Countries
Sequence: | 42685623 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55760298 | Sequence: | 55760299 | Sequence: | 55760300 |
Title | IBD with MSK pain | Title | IBD without MSK pain | Title | Healthy Controls |
Description | IBD patients with self-reported MSK pain. No intervention. Participants will be assessed once regarding: somatosensory functioning, psychological features, MSK pain features, co-morbidity, and IBD features | Description | IBD patients without self-reported MSK pain. No intervention. Participants will be assessed once regarding: somatosensory functioning, psychological features, co-morbidity, and IBD features | Description | Healthy controls. No intervention. Participants will be assessed once regarding: somatosensory functioning, psychological features, and co-morbidity. |
Keywords
Sequence: | 80075943 | Sequence: | 80075944 |
Name | chronic musculoskeletal pain | Name | central hypersensitivity |
Downcase Name | chronic musculoskeletal pain | Downcase Name | central hypersensitivity |
Design Outcomes
Sequence: | 177934246 | Sequence: | 177934247 | Sequence: | 177934248 | Sequence: | 177934249 | Sequence: | 177934250 | Sequence: | 177934251 | Sequence: | 177934252 | Sequence: | 177934253 | Sequence: | 177934254 | Sequence: | 177934255 | Sequence: | 177934256 | Sequence: | 177934257 | Sequence: | 177934258 | Sequence: | 177934259 | Sequence: | 177934260 | Sequence: | 177934261 | Sequence: | 177934262 | Sequence: | 177934263 | Sequence: | 177934264 | Sequence: | 177934265 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other |
Measure | Pain pressure threshold (PPT) | Measure | Conditioned pain modulation (CPM) | Measure | Temporal summation (TS) | Measure | Central sensitization inventory (CSI) | Measure | Abdominal pain: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a short form | Measure | Abdominal pain intensity: numeric rating scale | Measure | Health-related quality of life (HRQOL) – EQ-5D | Measure | Situational Catastrophizing Questionnaire (SCQ) | Measure | Positive and Negative Affective Schedule (PANAS) | Measure | 10-item Perceived Stress Scale (PSS-10) | Measure | Hospital Anxiety and Depression Scale (HADS) | Measure | Total comorbidity score | Measure | MSK pain location | Measure | MSK pain – PROMIS Pain Interference 4a | Measure | MSK pain intensity – numeric rating scale | Measure | Health-related quality of life (EQ-5D) | Measure | IBD type | Measure | IBD duration | Measure | Vibration detection threshold (VDT) | Measure | Semmes-Weinstein monofilament examination (SWME) |
Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline | Time Frame | Baseline |
Description | PPT will be assessed using an electronic handheld algometer (Wagner Force One™ FDIX) in: 1) low back (local), and 2) contralateral tibialis anterior. Individuals in "IBD with MSK pain" group will undergo an additional PPT assessment related to the region identified as their "main" area of MSK pain.
PPT will be assessed by a series of 3 ascending stimulus intensities given as a slowly increasing ramp (50 kilopascal (kPa/s)) from 0 to a maximum pressure of 1000 kPa. Pressure corresponding to the moment when participants identify that the sensation of pressure alone changing to one of pressure and pain, will be recorded for each trial. PPT for each region will be described as the mean of three trials in kPa. Decreased values indicates hypersensitivity of the nervous system. |
Description | CPM in the present study includes: PPT of tibialis anterior (test stimulus) and cold pressor test (CPT) to the contralateral hand (conditioning stimulus).
PPT will be performed and recorded as descried above prior to and immediately following CPT. CPT: Hand will be submerged in an ice bath with the temperature maintained below 3°C for a maximum of 2 minutes. Participants will withdraw their hand when the pain perceived becomes intolerable or 2 minute maximum is reached. Participants will give a numeric pain rating (0-100) at the time of hand removal. Total immersion time (minutes:seconds) and pain rating will be recorded for CPT. CPM (primary outcome) will be defined as the absolute numerical difference of PPT after minus before the CPT, with positive values indicating successful pain modulation. |
Description | Mechanical TS in the present study will be assessed by a wind-up-ratio (WUR) of the volar aspect of the non-dominant arm using a Semmes-Weinstein monofilament (no. 6.45). The perceived intensity of a single stimulus will be compared with that of a series of 10 repetitive stimuli of the same physical intensity. Participants will be asked to give a pain rating for the single stimulus and a pain rating for the series of 10 stimuli as a whole, using a '0-100' numerical rating scale. This procedure will be repeated for three trials, with 1 minute between trials, and performed at different areas of the volar forearm for each trial. The mean pain rating of the 10 series divided by the mean pain rating of the single stimuli will be calculated as WUR. Higher scores indicate greater mechanical TS, indicating an increase in central sensitivity or facilitation. | Description | CSI is a self-report questionnaire indicating the presence of symptoms related to central sensitization syndromes. CSI consists of 25 statements where each statement is evaluated using a 5 point like scale with Never (0), Rarely (1), Sometimes (2), Often (3), and Always (4). This results in a cumulative score of 100. Scores equal to or greater than 40 indicate the likelihood of central sensitization. | Description | Positive findings for abdominal pain interference, include: mild (50-59), moderate (60-69), or severe (≥70). | Description | Numeric rating scales recorded for worst, average, and current pain levels, with positive findings as mild (1-4), moderate (5-6), or severe (7-10). | Description | The EQ-5D questionnaire descriptive system comprises five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each one with five possible levels: no problems (level 1), slight problems (level 2), moderate problems (level 3), severe problems (level 4), and extreme problems (level 5); as well as a visual analogue scale ranging from 0 to 100 with higher scores indicating 'best health'. | Description | SCQ asks participants to reflect on any pain experienced during CPM testing, and to indicate the degree to which they experienced each of 13 thoughts or feelings during this experience, on 5-point Likert scales ranging from (0) not at all to (4) all the time. Total scores range from 0 to 24, with higher score representing greater pain catastrophizing. | Description | This questionnaire includes words describing 10 positive and 10 negative emotions, and requires participants to indicate on a Likert scale (1-5) the extent for which they felt each emotion during the previous week, with higher sub-scores represent greater negative or positive affect styles, respectively. | Description | The PSS-10 evaluates the degree to which individuals believe their life has been unpredictable, uncontrollable, and overloaded during the previous month, using a Likert scale (0-4) for each item, with higher scores representing greater perceived stress. | Description | Scores for each subscale range from 0 to 21, with scores categorized as follows: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. Scores for the entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress. | Description | Total comorbidity scores will be calculated as numerical disease counts using health conditions identified on the Self-Administered Comorbidity Questionnaire, a 20-item extraintestinal manifestation (EIM) checklist developed from multiple EIM investigations, and conditions identified on the central sensitization inventory (CSI) (part B). Scores range from 0 to 39 with higher scores indicating greater comorbidity. | Description | Pain location will be recorded regionally (n=47) using a body diagram. Individuals with generalized pain will be categorically (yes/no) distinguished from those with regional pain using the modified widespread pain criterion which requires having pain in 4 out of 5 pain regions (4 quadrants plus axial pain). | Description | Positive findings for the PROMIS Pain Interference 4a, include: mild (50-59), moderate (60-69), or severe (≥70). | Description | Numeric rating scales for pain intensity will be recorded for worst, average, and current pain levels, with positive findings as mild (1-4), moderate (5-6), or severe (7-10) | Description | EQ-5D is a standardized instrument for measuring of health-related quality of life. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) each scored on a 5-point Likert scales ranging from (0) no problem to (4) severe. The EQ VAS records the patient's self-rated health on a 0 to 100 vertical visual analogue scale, with higher scores representing better health-related quality of life. | Description | IBD subtype recorded from medical charts as Crohn's disease, ulcerative colitis, or unspecified IBD. | Description | Time from initial IBD diagnosis – recorded from medical charts in years. | Description | VDT will be assessed using a Rydel-Seiffer graded tuning fork (64 Hz, 8/8 scale) placed over bony prominences (styloid process of the ulna and medial malleolus), bilaterally. Participants will verbally indicate the moment they can no longer feel the sensation of vibration, and the value (1-8) will be recorded. VDT of each site will be described as the mean of three trials. Lower scores indicate decreased thresholds and possible peripheral neuropathy. | Description | SWME of the upper limb will be performed using a 4.56 (4 g) monofilament at six locations divided over the palm and fingers, bilaterally. SWME of the lower limb will be performed using a 5.07 (10 g) monofilament at the pulp of the great toe, as well as the first, third, and fifth metatarsal heads, bilaterally. Participants will confirm (recorded as yes/no) application of the stimulus at each location. Incorrect response at any location indicates possible peripheral neuropathy. |
Browse Conditions
Sequence: | 194058662 | Sequence: | 194058663 | Sequence: | 194058664 | Sequence: | 194058665 | Sequence: | 194058666 | Sequence: | 194058670 | Sequence: | 194058671 | Sequence: | 194058672 | Sequence: | 194058667 | Sequence: | 194058668 | Sequence: | 194058669 |
Mesh Term | Musculoskeletal Pain | Mesh Term | Intestinal Diseases | Mesh Term | Inflammatory Bowel Diseases | Mesh Term | Chronic Pain | Mesh Term | Pain | Mesh Term | Gastroenteritis | Mesh Term | Muscular Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Neurologic Manifestations | Mesh Term | Gastrointestinal Diseases | Mesh Term | Digestive System Diseases |
Downcase Mesh Term | musculoskeletal pain | Downcase Mesh Term | intestinal diseases | Downcase Mesh Term | inflammatory bowel diseases | Downcase Mesh Term | chronic pain | Downcase Mesh Term | pain | Downcase Mesh Term | gastroenteritis | Downcase Mesh Term | muscular diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | digestive system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48459975 | Sequence: | 48459976 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Dartmouth-Hitchcock Medical Center | Name | University of Otago |
Overall Officials
Sequence: | 29365316 |
Role | Principal Investigator |
Name | Corey A Siegel, MD |
Affiliation | Dartmouth-Hitchcock Medical Center |
Eligibilities
Sequence: | 30852310 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | Dartmouth-Hitchcock Medical Center – IBD Center patient database. |
Criteria | Inclusion Criteria:
Adults (18 years of age or older) Exclusion Criteria: Participants with IBD (with and without MSK pain) will be excluded if they report any of the following: pregnancy |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254271951 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 4 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 15 |
Number Of Other Outcomes To Measure | 2 |
Designs
Sequence: | 30598162 |
Observational Model | Case-Control |
Time Perspective | Cross-Sectional |
Responsible Parties
Sequence: | 28964651 |
Responsible Party Type | Principal Investigator |
Name | Corey Siegel |
Title | Section Chief, Gastroenterology and Hepatology |
Affiliation | Dartmouth-Hitchcock Medical Center |
Study References
Sequence: | 52225797 | Sequence: | 52225780 | Sequence: | 52225810 | Sequence: | 52225781 | Sequence: | 52225782 | Sequence: | 52225783 | Sequence: | 52225784 | Sequence: | 52225785 | Sequence: | 52225786 | Sequence: | 52225787 | Sequence: | 52225811 | Sequence: | 52225788 | Sequence: | 52225789 | Sequence: | 52225790 | Sequence: | 52225791 | Sequence: | 52225792 | Sequence: | 52225793 | Sequence: | 52225794 | Sequence: | 52225795 | Sequence: | 52225796 | Sequence: | 52225798 | Sequence: | 52225799 | Sequence: | 52225800 | Sequence: | 52225801 | Sequence: | 52225802 | Sequence: | 52225803 | Sequence: | 52225804 | Sequence: | 52225805 | Sequence: | 52225806 | Sequence: | 52225807 | Sequence: | 52225808 | Sequence: | 52225809 | Sequence: | 52225812 | Sequence: | 52225813 | Sequence: | 52225814 | Sequence: | 52225815 | Sequence: | 52225816 | Sequence: | 52225817 | Sequence: | 52225818 | Sequence: | 52225819 | Sequence: | 52225820 | Sequence: | 52225821 | Sequence: | 52225822 | Sequence: | 52225823 | Sequence: | 52225824 | Sequence: | 52225825 | Sequence: | 52225826 | Sequence: | 52225827 | Sequence: | 52225828 | Sequence: | 52225829 | Sequence: | 52225830 | Sequence: | 52225831 | Sequence: | 52225832 | Sequence: | 52225833 | Sequence: | 52225834 | Sequence: | 52225835 | Sequence: | 52225836 | Sequence: | 52225837 | Sequence: | 52225838 | Sequence: | 52225839 | Sequence: | 52225840 | Sequence: | 52225841 |
Pmid | 19380256 | Pmid | 17602990 | Pmid | 6668417 | Pmid | 25687629 | Pmid | 24833941 | Pmid | 26170832 | Pmid | 27332879 | Pmid | 26512134 | Pmid | 16142874 | Pmid | 25547976 | Pmid | 20372115 | Pmid | 21551189 | Pmid | 21857821 | Pmid | 26614685 | Pmid | 20961685 | Pmid | 25952059 | Pmid | 27586831 | Pmid | 29105941 | Pmid | 19130619 | Pmid | 11289089 | Pmid | 11839418 | Pmid | 16159591 | Pmid | 17717610 | Pmid | 23697467 | Pmid | 18209518 | Pmid | 28052089 | Pmid | 26075963 | Pmid | 12687505 | Pmid | 23181971 | Pmid | 23265763 | Pmid | 11832252 | Pmid | 22884758 | Pmid | 25031113 | Pmid | 17101814 | Pmid | 3397865 | Pmid | 16988570 | Pmid | 29572719 | Pmid | 22398068 | Pmid | 27780886 | Pmid | 26071941 | Pmid | 27584819 | Pmid | 20847477 | Pmid | 16000093 | Pmid | 27916278 | Pmid | 23490634 | Pmid | 21951710 | Pmid | 15737809 | Pmid | 16697110 | Pmid | 19595541 | Pmid | 11640995 | Pmid | 18215749 | Pmid | 29350873 | Pmid | 20932788 | Pmid | 23759706 | Pmid | 26741741 | Pmid | 25330039 | Pmid | 24290446 | Pmid | 26222349 | Pmid | 20878051 | Pmid | 26379077 | Pmid | 28328574 | ||
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https://zephyrnet.com/NCT03799458
2018-07-11
https://zephyrnet.com/?p=NCT03799458
NCT03799458https://www.clinicaltrials.gov/study/NCT03799458?tab=tableNANANAAim 1: To use magnetoencephalography (MEG) and magnetic resonance imaging (MRI) in Veterans and civilians with mild traumatic brain injury (mTBI) and sensory postconcussive symptoms (PCS) to demonstrate the mechanism of therapeutic benefit of HD-tDCS for sensory symptoms, as shown by reliable changes in the activity of the cognitive control network (CCN) and sensory system network (SSN) following stimulation; Aim 2: this intervention will result in long-term improvements in measures of executive function, depression/anxiety, and quality of life.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-12 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-06-05 |
Start Month Year | July 11, 2018 |
Primary Completion Month Year | April 30, 2023 |
Verification Month Year | June 2023 |
Verification Date | 2023-06-30 |
Last Update Posted Date | 2023-06-05 |
Detailed Descriptions
Sequence: | 20701809 |
Description | Experimental Design and Methods Participants: 120 subjects will be recruited for this study from the NM VA Health Care System and community, 40 healthy controls subjects for an imaging-only group, and 80 mTBI subjects for the stimulation arm who have suffered injury at least 3 months prior to study enrollment, but not more than 15 years prior to enrollment. All participants will be 18-59 years of age.
Recruitment: Human participants (ages 18-59) will be invited to come to the University of New Mexico (UNM) to ask questions prior to providing consent. They will be provided with consent forms that describe the study procedures and potential risks. Once informed consent is obtained and the appropriate forms signed, the participant will be assigned a unique research subject identifier (URSI) number, and from that point forward all research data will only be labeled with the URSI number. The key linking identifiers of participants to the URSI will be maintained on a separate database that will be stored behind locked doors, in a locked filing cabinet in a secure area. All participants may then undergo demographic data collection, neuropsychological assessments sensory evaluation, at UNM. They may also undergo MEG and MRI at the Mind Research Network (MRN), located in the same building. Demographic Data: As part of the initial assessment, basic demographic data regarding the subject may be noted down, including age, gender, socioeconomic status, educational attainment, handedness, use of common stimulants such as caffeine, and brain injury severity. They may also be asked if they are willing to allow their medical record to be accessed, for the purposes of confirming details about any traumatic brain injury (TBI) as well as obtaining results of neuroimaging studies done at the time of injury or afterward. This will include medical, surgical, neurological and psychiatric history, results of lab tests, brain scans, electroencephalography tests, medication lists, information from doctor's visits and hospital visits. Neuropsychological testing procedures: All neuropsychological testing will be administered in the Center for Brain Recovery and Repair Core by trained study personnel under direct supervision of core directors. The following domains and tests will be administered: Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (Examiner); Digit Span; Delis-Kaplan Executive Function Systems (DKEFS) Trail-making Test Conditions 2 and 4; Hopkins Verbal Learning Test (HVLT); Frontal Systems Behavior Scale (FrSBe); Test of Memory Malingering (TOMM); Wechsler Test of Adult Reading (WTAR); Digit Symbol Coding; Handedness; Socioeconomic Status (SES); Patient's Global Impression of Change (PGIC); Glasgow Outcome Scale-Extended (GOSE). Sensory Assessment: Hearing, balance, and vision will be assessed using Common Data Element (CDE) instruments, including the Hearing Handicap Assessment, the Test for Visual Discomfort, the modified Balance Error Scoring System. Oculomotor control will be assessed using virtual reality goggles (Oculus) with implanted eye trackers (iScan). Magnetoencephalography: Magnetoencephalography (MEG) may be done after neuropsychological testing. The participant will sit in the MEG scanner to record brain magnetic fields. MEG setup takes between 10 and 30 minutes, and subsequent recording takes one hour. During MEG assessments participants will complete numerous tasks. Each task is designed to parse different cognitive mechanisms that contribute to sensory performance. In perceptual tasks, participants will discriminate tone pitches amongst novel distracting tones (Auditory Orienting Task; AOT). For eye movement tasks, participants are asked look either towards or away from a visual stimulus (Pro- and Anti-saccades). Magnetic resonance imaging (MRI): MRI scan(s) will be obtained for integration with MEG, as needed for analyses. Total scan time, including participant setup and removal, is expected to take 1 hour. Participants may lie down on a table and be placed into a long donut-shaped magnet. During the scan, participants will be asked to rest quietly or to fixate on a dot on a screen in front of them, or to perform a memory task. No contrast will be used. Any female over 18 who thinks she may be pregnant will complete a urine pregnancy screen before the MRI scan. Following initial testing, the participants in the stimulation arm of the study will receive 10 consecutive weekday sessions of high-definition transcranial direct current stimulation. 2 milliamperes active or sham anodal current will be delivered to the left dorsolateral prefrontal cortex for 30 minutes. During this time, participants will perform vision therapy tasks through a virtual reality headset, or a computer-based working memory task. Skin sensations will be assessed every 10 minutes. Post stimulation testing: the next available weekday following completion of the study protocol, subjects will return to UNM to repeat the demographic, neuropsychological, sensory, and imaging assessments. Long term followup: At 1 month, 3 months and 6 months after stimulation, subjects will be contacted via telephone or meet in person, and will be administered the Beck Depression Inventory (BDI-II), Posttraumatic Stress Disorder Checklist-Military (PCL-M), the Neurobehavioral Symptom Inventory (NSI), and Patient Global Impression of Change (PGIC) quality of life assessment tools utilized before and immediately after, after stimulation. Veterans will undergo these study followup visits at NMVAHCS, and civilians at UNM. |
Facilities
Sequence: | 199846146 |
Name | University of New Mexico Health Sciences Center |
City | Albuquerque |
State | New Mexico |
Zip | 87106 |
Country | United States |
Conditions
Sequence: | 52116838 |
Name | Mild Traumatic Brain Injury |
Downcase Name | mild traumatic brain injury |
Id Information
Sequence: | 40116755 |
Id Source | org_study_id |
Id Value | CDMRP-PT160096 |
Countries
Sequence: | 42520729 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55534787 | Sequence: | 55534788 | Sequence: | 55534789 |
Group Type | Active Comparator | Group Type | Sham Comparator | Group Type | No Intervention |
Title | Active Stimulation | Title | Sham Stimulation | Title | Imaging Only |
Description | Active HD-tDCS will be delivered while subjects perform sensory training tasks. | Description | Sham HD-tDCS will be delivered while subjects perform sensory training tasks. | Description | 40 subjects will undergo initial testing only as a healthy control group. |
Interventions
Sequence: | 52431833 | Sequence: | 52431834 |
Intervention Type | Device | Intervention Type | Device |
Name | Active High-definition transcranial direct current stimulation (HD-tDCS) | Name | Sham High-definition transcranial direct current stimulation (HD-tDCS) |
Description | Active HD-tDCS delivers active current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates. | Description | Sham HD-tDCS delivers sham current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates |
Design Outcomes
Sequence: | 177188508 | Sequence: | 177188509 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Postconcussive sensory symptoms | Measure | Magnetoencephalography peak activation |
Time Frame | 2 week visit | Time Frame | 2 week visit |
Description | Somatic sub scale score from the Neurobehavioral Symptom Inventory (NSI) (range 0-48; 0-12 mild; 13-24 moderate; 25-36 severe; 37-48 very severe) | Description | Peak activation during the Auditory Orienting Task (AOT) performed during magnetoencephalography |
Browse Conditions
Sequence: | 193275585 | Sequence: | 193275586 | Sequence: | 193275587 | Sequence: | 193275588 | Sequence: | 193275589 | Sequence: | 193275590 | Sequence: | 193275591 | Sequence: | 193275592 | Sequence: | 193275593 | Sequence: | 193275594 | Sequence: | 193275584 |
Mesh Term | Brain Injuries, Traumatic | Mesh Term | Brain Concussion | Mesh Term | Wounds and Injuries | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Craniocerebral Trauma | Mesh Term | Trauma, Nervous System | Mesh Term | Head Injuries, Closed | Mesh Term | Wounds, Nonpenetrating | Mesh Term | Brain Injuries |
Downcase Mesh Term | brain injuries, traumatic | Downcase Mesh Term | brain concussion | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | craniocerebral trauma | Downcase Mesh Term | trauma, nervous system | Downcase Mesh Term | head injuries, closed | Downcase Mesh Term | wounds, nonpenetrating | Downcase Mesh Term | brain injuries |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list |
Sponsors
Sequence: | 48269942 | Sequence: | 48269943 | Sequence: | 48269944 | Sequence: | 48269945 | Sequence: | 48269946 | Sequence: | 48269947 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | University of New Mexico | Name | Biomedical Research Institute of New Mexico | Name | New Jersey Institute of Technology | Name | University of Miami | Name | The Mind Research Network | Name | The City College of New York |
Design Group Interventions
Sequence: | 68077502 | Sequence: | 68077503 |
Design Group Id | 55534787 | Design Group Id | 55534788 |
Intervention Id | 52431833 | Intervention Id | 52431834 |
Eligibilities
Sequence: | 30734726 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 59 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
are US Veteran or Active Duty Military personnel aged 18-59, Exclusion Criteria: any history of moderate or severe TBI; 10) any significant blindness, to screen out peripheral sensory damage; 11) any significant deafness beyond mild hearing loss, to screen out peripheral sensory damage; 12) any ongoing litigation related to TBI, to prevent interference with legal proceedings; 13) any contraindication to MRI; 14) membership in an identified vulnerable population, including minors, pregnant women, and prisoners, so as to prevent coercion. |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254011363 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 58 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 59 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30481094 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Masking Description | Active and sham HD-tDCS will be delivered with the same device, and participants and research technician are blinded to the condition. |
Intervention Model Description | 120 subjects will be recruited for this study: 40 healthy controls subjects for the imaging-only group, and 80 mTBI subjects for the stimulation arm who have suffered mild TBI at least 3 months prior to study enrollment, but not more than 15 years prior to enrollment. The 80 mTBI subjects will be randomized to either active stimulation (40) or sham stimulation (40). |
Subject Masked | True |
Caregiver Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28847447 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799445
2019-07-25
https://zephyrnet.com/?p=NCT03799445
NCT03799445https://www.clinicaltrials.gov/study/NCT03799445?tab=tableMaura Gillisonmgillison@mdanderson.org713-792-6363This phase II trial studies the side effects and best dose of ipilimumab, nivolumab, and radiation therapy and how well they work in treating patients with advanced human papillomavirus (HPV) positive oropharyngeal squamous cell carcinoma. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving ipilimumab, nivolumab, and radiation therapy may work better in treating patients with HPV positive oropharyngeal squamous cell carcinoma.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-13 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-04-20 |
Start Month Year | July 25, 2019 |
Primary Completion Month Year | December 31, 2023 |
Verification Month Year | April 2023 |
Verification Date | 2023-04-30 |
Last Update Posted Date | 2023-04-20 |
Detailed Descriptions
Sequence: | 20839691 |
Description | PRIMARY OBJECTIVES:
I. To evaluate the safety, tolerability and feasibility of ipilimumab and nivolumab when administered concurrently with reduced-field radiotherapy (intensity-modulated radiation therapy [IMRT]). II. To evaluate the clinical complete response rate to ipilimumab, nivolumab and IMRT with reduced field at six months as indicated by fluorodeoxyglucose – positron emission tomography/computed tomography (FDG-PET/CT) post completion of radiation therapy (RT). III. To evaluate the 2-year progression-free survival (PFS) rate of subjects with low-intermediate volume, local-regionally advanced, human papilloma virus (HPV)-positive squamous cell carcinoma of the head and neck (SCCHN) treated with ipilimumab, nivolumab and reduced-field IMRT. SECONDARY OBJECTIVES: I. To evaluate overall response rate to six weeks of induction immunotherapy (IO). II. To evaluate the frequency of pharyngeal dysphasia as measured by Dynamic Imaging (Dynamic Imaging Grade of Swallowing Toxicity [DIGEST]) grade on modified barium swallow (MBS) and patient-reported symptoms (MD Anderson Dysphagia Inventory [MDADI]) at 6 month, 1 and 2 years after radiotherapy ([IMRT]. III. To measure acute and chronic toxicities per Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (CTCAE PRO). IV. To measure acute toxicity profiles at the end of radiation therapy and IO and at 6 months. V. To measure late toxicity profiles at 1 and 2 years. VI. To determine local and regional control at 6 and 12 months. VII. To determine patterns of failure (local-regional relapse vs. distant) at 1 and 2 years. VIII. To determine overall survival (OS) at 1 and 2 years. CORRELATIVE OBJECTIVES: I. To evaluate associations between total mutational load, interferon (INF) gamma score, T cell clonality at diagnosis with clinical response to induction, combination CTLA-4 PD-1 checkpoint blockade. II. To evaluate changes in the tumor immune microenvironment (CD8 + INF gamma score, T cell clonality, in tumor biopsy specimens pre and post induction immunotherapy (IO). III. To evaluate dynamic changes in and clearance of oral HPV and cell-free deoxyribonucleic acid (cfDNA) viral load during therapy and to investigate associations with PFS and OS. EXPLORATORY OBJECTIVES: I. To evaluate changes in peripheral blood lymphocyte phenotypes and serum cytokine profiles before and after induction IO. II. To evaluate changes in the T cell receptor repertoire in tumor-infiltrating lymphocyte (TIL) and the peripheral blood in tumor biopsy specimens pre and post induction IO. III. To determine the negative and positive predictive values (NPV and PPV) of FDG-PET/CT 12-14 weeks after end of RT for 1 year and 2 year PFS and OS. OUTLINE: Patients receive nivolumab intravenously (IV) over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 30 minutes on day 1. Treatment repeats every for 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of cycle 2, patients also undergo IMRT 5 days a week (Monday-Friday) for 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 2 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. |
Facilities
Sequence: | 201189730 |
Status | Recruiting |
Name | M D Anderson Cancer Center |
City | Houston |
State | Texas |
Zip | 77030 |
Country | United States |
Facility Contacts
Sequence: | 28265827 |
Facility Id | 201189730 |
Contact Type | primary |
Name | Maura L. Gillison |
Phone | 713-792-6363 |
Facility Investigators
Sequence: | 18429847 |
Facility Id | 201189730 |
Role | Principal Investigator |
Name | Maura L. Gillison |
Browse Interventions
Sequence: | 96542851 | Sequence: | 96542852 | Sequence: | 96542853 | Sequence: | 96542854 | Sequence: | 96542855 | Sequence: | 96542856 |
Mesh Term | Nivolumab | Mesh Term | Ipilimumab | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Antineoplastic Agents | Mesh Term | Immune Checkpoint Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | nivolumab | Downcase Mesh Term | ipilimumab | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | immune checkpoint inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52473688 | Sequence: | 52473689 | Sequence: | 52473690 | Sequence: | 52473691 | Sequence: | 52473692 | Sequence: | 52473693 | Sequence: | 52473694 | Sequence: | 52473695 | Sequence: | 52473696 | Sequence: | 52473697 | Sequence: | 52473698 |
Name | Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Name | Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Name | Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma | Name | Oropharyngeal Basaloid Carcinoma | Name | Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Name | Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Name | Posterior Tongue Squamous Cell Carcinoma | Name | Soft Palate Squamous Cell Carcinoma | Name | Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 | Name | Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 | Name | Tonsillar Squamous Cell Carcinoma |
Downcase Name | clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 | Downcase Name | clinical stage ii hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 | Downcase Name | human papillomavirus positive oropharyngeal squamous cell carcinoma | Downcase Name | oropharyngeal basaloid carcinoma | Downcase Name | pathologic stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 | Downcase Name | pathologic stage ii hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 | Downcase Name | posterior tongue squamous cell carcinoma | Downcase Name | soft palate squamous cell carcinoma | Downcase Name | stage iii oropharyngeal squamous cell carcinoma ajcc v7 | Downcase Name | stage iva oropharyngeal squamous cell carcinoma ajcc v7 | Downcase Name | tonsillar squamous cell carcinoma |
Id Information
Sequence: | 40375496 | Sequence: | 40375497 | Sequence: | 40375498 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | 2018-0381 | Id Value | NCI-2018-03260 | Id Value | 2018-0381 |
Id Type | Registry Identifier | Id Type | Other Identifier | ||
Id Type Description | CTRP (Clinical Trial Reporting Program) | Id Type Description | M D Anderson Cancer Center | ||
Countries
Sequence: | 42811279 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55929314 |
Group Type | Experimental |
Title | Treatment (nivolumab, ipilimumab, IMRT) |
Description | Patients receive nivolumab IV over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 30 minutes on day 1. Treatment repeats every for 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of cycle 2, patients also undergo IMRT 5 days a week (Monday-Friday) for 6 weeks in the absence of disease progression or unacceptable toxicity. |
Interventions
Sequence: | 52783865 | Sequence: | 52783866 | Sequence: | 52783867 | Sequence: | 52783868 | Sequence: | 52783869 |
Intervention Type | Radiation | Intervention Type | Biological | Intervention Type | Biological | Intervention Type | Other | Intervention Type | Other |
Name | Intensity-Modulated Radiation Therapy | Name | Ipilimumab | Name | Nivolumab | Name | Quality-of-Life Assessment | Name | Questionnaire Administration |
Description | Undergo IMRT | Description | Given IV | Description | Given IV | Description | Ancillary studies | Description | Ancillary studies |
Design Outcomes
Sequence: | 178513931 | Sequence: | 178513932 | Sequence: | 178513933 | Sequence: | 178513934 | Sequence: | 178513935 | Sequence: | 178513936 | Sequence: | 178513937 | Sequence: | 178513938 | Sequence: | 178513939 | Sequence: | 178513940 | Sequence: | 178513941 | Sequence: | 178513942 | Sequence: | 178513943 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Dose limiting toxicity (DLT) (safety lead-in) | Measure | Complete response rate (Phase II) | Measure | Progression-free survival (PFS) (Phase II) | Measure | Number of patients who experience a >= grade 3 treatment-related adverse event (safety lead-in) | Measure | Number of patients who tolerated protocol therapy (safety lead-in) | Measure | Number of patients who achieve a clinical complete response (safety lead-in) | Measure | Incidence of acute and chronic adverse events (Phase II) | Measure | Acute toxicity profiles (Phase II) | Measure | Number of patients who experience >= grade 3 treatment-related adverse event (Phase II) | Measure | Late toxicity profiles (Phase II) | Measure | Patient-reported swallowing outcomes (Phase II) | Measure | Patterns of failure (local-regional relapse versus [vs] distant) (Phase II) | Measure | Overall survival (Phase II) |
Time Frame | Up to 28 days post-completion of radiation therapy | Time Frame | At 6 months | Time Frame | From start of therapy to progression or disease or death from any cause, assessed up to 2 years | Time Frame | Up to 28 days post-completion of radiation therapy | Time Frame | Up to 12 weeks (end of cycle 2) | Time Frame | Up to 28 weeks after radiation therapy | Time Frame | Up to 3 months from the end of intensity-modulated radiation therapy (IMRT) | Time Frame | At the end of radiation therapy, end of IO, and 6 months | Time Frame | At the end of radiation therapy, end of IO, and 6 months | Time Frame | At 1 and 2 years | Time Frame | At 1 and 2 years | Time Frame | At 1 and 2 years | Time Frame | At 1 and 2 years |
Description | Defined as any >= grade 3 adverse event (Common Terminology Criteria for Adverse Events [CTCAE], version [v.] 4) that is related to immunotherapy (IO) that does not resolve to grade 1 or less within 28 days. | Description | The number of patients who tolerated protocol therapy, including completion of radiotherapy without a treatment break and who were administered immunotherapy (IO) will be assessed. | Description | Incidence of adverse events (acute and chronic toxicities) will be assessed per CTCAE Patient Reported Outcome (PRO). | Description | Will be assessed by CTCAE v 4. | Description | Will be assessed per CTCAE v 4. |
Browse Conditions
Sequence: | 194642944 | Sequence: | 194642945 | Sequence: | 194642946 | Sequence: | 194642947 | Sequence: | 194642948 | Sequence: | 194642949 | Sequence: | 194642950 | Sequence: | 194642951 | Sequence: | 194642952 | Sequence: | 194642953 | Sequence: | 194642954 | Sequence: | 194642955 | Sequence: | 194642956 | Sequence: | 194642957 | Sequence: | 194642958 |
Mesh Term | Carcinoma | Mesh Term | Carcinoma, Squamous Cell | Mesh Term | Squamous Cell Carcinoma of Head and Neck | Mesh Term | Oropharyngeal Neoplasms | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Neoplasms, Squamous Cell | Mesh Term | Head and Neck Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Pharyngeal Neoplasms | Mesh Term | Otorhinolaryngologic Neoplasms | Mesh Term | Pharyngeal Diseases | Mesh Term | Stomatognathic Diseases | Mesh Term | Otorhinolaryngologic Diseases |
Downcase Mesh Term | carcinoma | Downcase Mesh Term | carcinoma, squamous cell | Downcase Mesh Term | squamous cell carcinoma of head and neck | Downcase Mesh Term | oropharyngeal neoplasms | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | neoplasms, squamous cell | Downcase Mesh Term | head and neck neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | pharyngeal neoplasms | Downcase Mesh Term | otorhinolaryngologic neoplasms | Downcase Mesh Term | pharyngeal diseases | Downcase Mesh Term | stomatognathic diseases | Downcase Mesh Term | otorhinolaryngologic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48600519 | Sequence: | 48600520 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | M.D. Anderson Cancer Center | Name | National Cancer Institute (NCI) |
Overall Officials
Sequence: | 29444061 |
Role | Principal Investigator |
Name | Maura L Gillison |
Affiliation | M.D. Anderson Cancer Center |
Central Contacts
Sequence: | 12086171 |
Contact Type | primary |
Name | Maura Gillison |
Phone | 713-792-6363 |
mgillison@mdanderson.org | |
Role | Contact |
Design Group Interventions
Sequence: | 68564033 | Sequence: | 68564034 | Sequence: | 68564035 | Sequence: | 68564036 | Sequence: | 68564037 |
Design Group Id | 55929314 | Design Group Id | 55929314 | Design Group Id | 55929314 | Design Group Id | 55929314 | Design Group Id | 55929314 |
Intervention Id | 52783865 | Intervention Id | 52783866 | Intervention Id | 52783867 | Intervention Id | 52783868 | Intervention Id | 52783869 |
Eligibilities
Sequence: | 30938913 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Histologically or cytologically newly confirmed diagnosis of squamous cell carcinoma (including the histological variants of papillary or basaloid) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls) Exclusion Criteria: Cancers of the oral cavity (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254254490 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 10 |
Designs
Sequence: | 30684531 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26823847 | Sequence: | 26823848 | Sequence: | 26823849 | Sequence: | 26823850 | Sequence: | 26823851 | Sequence: | 26823852 | Sequence: | 26823853 | Sequence: | 26823854 | Sequence: | 26823855 | Sequence: | 26823856 | Sequence: | 26823857 | Sequence: | 26823858 | Sequence: | 26823859 | Sequence: | 26823860 |
Intervention Id | 52783865 | Intervention Id | 52783865 | Intervention Id | 52783865 | Intervention Id | 52783866 | Intervention Id | 52783866 | Intervention Id | 52783866 | Intervention Id | 52783866 | Intervention Id | 52783866 | Intervention Id | 52783867 | Intervention Id | 52783867 | Intervention Id | 52783867 | Intervention Id | 52783867 | Intervention Id | 52783867 | Intervention Id | 52783868 |
Name | IMRT | Name | Intensity Modulated RT | Name | Intensity-Modulated Radiotherapy | Name | Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody | Name | BMS-734016 | Name | MDX-010 | Name | MDX-CTLA4 | Name | Yervoy | Name | BMS-936558 | Name | MDX-1106 | Name | NIVO | Name | ONO-4538 | Name | Opdivo | Name | Quality of Life Assessment |
Links
Sequence: | 4411106 |
Url | http://www.mdanderson.org |
Description | MD Anderson Cancer Center Website |
Responsible Parties
Sequence: | 29051261 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799432
2019-07-08
https://zephyrnet.com/?p=NCT03799432
NCT03799432https://www.clinicaltrials.gov/study/NCT03799432?tab=tableNANANAThe purpose of this study is to partner with the North Carolina Child Treatment Program (NC CTP) and the SAMHSA-funded National Child Traumatic Stress Network (NCTSN) to develop and pilot the Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS). The COAST-IS intervention will involve coaching organizational leaders and therapists to use Intervention Mapping to select and tailor strategies. Intervention Mapping is a multistep process that is inherently ecological and incorporates theory, evidence, and stakeholder perspectives to ensure that intervention components effectively address key determinants of change. After collaboratively developing COAST-IS in Year 1, the investigators will conduct a randomized pilot trial of the intervention within an NC CTP learning collaborative, randomly assigning eight organizations to the learning collaborative-only condition or the learning collaborative plus COAST-IS condition. Participants will include organizational leaders (e.g., CEOs/Directors, Clinical Directors, Supervisors) and therapists (e.g., Licensed Clinical Social Workers, Licensed Psychologists, Licensed Professional Counselors). The investigators will evaluate COAST-IS in the following aims: 1) to assess the acceptability, appropriateness, feasibility, and utility of COAST-IS; 2) to evaluate organizational stakeholders’ fidelity to the core elements of Intervention Mapping; and 3) to demonstrate the feasibility of testing COAST-IS in a larger effectiveness trial. This work is significant because it will yield a systematic method that integrates theory, evidence, and stakeholder perspectives to improve the effectiveness and precision of implementation strategies. Ultimately, COAST-IS may have the potential to improve implementation and sustainment of a wide-range of EBPs in mental health and other health sectors.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-09 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-04-27 |
Start Month Year | July 8, 2019 |
Primary Completion Month Year | December 31, 2020 |
Verification Month Year | April 2022 |
Verification Date | 2022-04-30 |
Last Update Posted Date | 2022-04-27 |
Facilities
Sequence: | 201296264 |
Name | North Carolina Child Treatment Program |
City | Durham |
State | North Carolina |
Zip | 27701 |
Country | United States |
Conditions
Sequence: | 52511142 | Sequence: | 52511143 |
Name | Psychological Trauma | Name | Mental Health |
Downcase Name | psychological trauma | Downcase Name | mental health |
Id Information
Sequence: | 40401616 | Sequence: | 40401617 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 17-0978 | Id Value | 1K01MH113806-01 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/1K01MH113806-01 |
Countries
Sequence: | 42837787 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55967529 | Sequence: | 55967530 |
Group Type | Experimental | Group Type | Active Comparator |
Title | TF-CBT Learning collaborative + COAST-IS | Title | TF-CBT Learning collaborative |
Description | In addition to participating in a learning collaborative for implementing trauma-focused cognitive behavioral therapy (TF-CBT) with periodic coaching calls, organizations will receive additional training and tailored implementation support. | Description | Organizations will participate in a learning collaborative for implementing trauma-focused cognitive behavioral therapy (TF-CBT) with periodic coaching calls. |
Interventions
Sequence: | 52818778 | Sequence: | 52818779 |
Intervention Type | Other | Intervention Type | Other |
Name | COAST-IS | Name | TF-CBT Learning Collaborative |
Description | COAST-IS has been designed to equip organizations with the knowledge, motivation, and skill needed to thoughtfully match implementation strategies to identified determinants by applying intervention mapping. The COAST-IS intervention will include four different modes of delivery: 1) dissemination of educational materials; 2) five web-based interactive education sessions on the need for tailoring implementation strategies and the application of intervention mapping; 3) site visits to discuss change objectives necessary to successfully implement trauma-focused cognitive behavioral therapy; and 4) organizational coaching related to using an intervention mapping approach. | Description | The learning collaborative model was adapted from the Breakthrough Series Collaborative model. Leadership of the collaboratives includes experts in evidence-based practices, implementation, and quality improvement. Main components include: 1) three face-to-face learning sessions (2-days each) that provide clinical training; 2) post-learning session action periods structured to facilitate therapists' application of learned skills; 3) a secure website to facilitate faculty-to-participant and peer-to-peer learning and document use of quality improvement methods; 4) fidelity monitoring and coaching; 5) a senior leader track supporting organizational change; 6) monthly outcomes monitoring; and 7) sustainability planning. |
Keywords
Sequence: | 80329878 | Sequence: | 80329879 | Sequence: | 80329880 | Sequence: | 80329881 |
Name | Implementation Science | Name | Cognitive Behavioral Therapy | Name | Children | Name | Youth |
Downcase Name | implementation science | Downcase Name | cognitive behavioral therapy | Downcase Name | children | Downcase Name | youth |
Design Outcomes
Sequence: | 178643283 | Sequence: | 178643284 | Sequence: | 178643285 | Sequence: | 178643286 | Sequence: | 178643287 | Sequence: | 178643288 | Sequence: | 178643289 | Sequence: | 178643290 | Sequence: | 178643291 | Sequence: | 178643292 | Sequence: | 178643293 | Sequence: | 178643294 | Sequence: | 178643295 | Sequence: | 178643296 | Sequence: | 178643297 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Evaluate the acceptability of COAST-IS | Measure | Evaluate the appropriateness of COAST-IS | Measure | Evaluate the feasibility of COAST-IS | Measure | Evaluate the perceived utility of COAST-IS | Measure | Fidelity to COAST-IS | Measure | Fidelity to TF-CBT | Measure | Fidelity to TF-CBT | Measure | Organizational Readiness for Implementing Change (ORIC) | Measure | Evidence-based Practice Attitudes Scales (EBPAS) | Measure | Inner Setting of the Consolidated Framework for Implementation Research | Measure | Scale for Implementation Climate | Measure | Psychological Safety Scale (PSS) | Measure | Implementation Leadership Scale (ILS) | Measure | Implementation Citizenship Behavior Scale (ICBS) | Measure | Prior Experiences with Implementation |
Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 6 months | Time Frame | 1 year | Time Frame | Baseline, 1 year | Time Frame | Baseline, 1 year | Time Frame | Baseline, 1 year | Time Frame | Baseline, 1 year | Time Frame | Baseline, 1 year | Time Frame | Baseline, 1 year | Time Frame | Baseline, 1 year | Time Frame | Baseline, 1 year |
Description | This will be assessed with the 4-item measure: Acceptability of Intervention. This measure is rated on a 5 point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree), with completely disagree having a score of 1 and completely agree having a score of 5. Higher scores indicate greater acceptability. | Description | This will be assessed with the 4-item measure: Intervention Appropriateness.This measure is rated on a 5 point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree), with completely disagree having a score of 1 and completely agree having a score of 5. Higher scores indicate greater appropriateness. | Description | This will be assessed with the 4-item measure: Feasibility of Intervention.This measure is rated on a 5 point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree), with completely disagree having a score of 1 and completely agree having a score of 5. Higher scores indicate greater feasibility. | Description | Semi-structured interview will focus on the perceived utility of COAST-IS. | Description | Fidelity to COAST-IS will be measured with a fidelity assessment tool adapted from the Stages of Implementation Completion measure, which assesses organizations' progression through eight stages of implementation (engagement through competency [conceptualized as the start of sustainment]). | Description | Therapist fidelity and adherence to TF-CBT will be assessed with the TF-CBT Fidelity Metric. This instrument consists of 12 scales (e.g., gradual exposure, cognitive processing) that allow a trainer to rate (on a 4-point scale) each TF-CBT component applied by a therapist within a session. | Description | Therapist fidelity and adherence to TF-CBT will be assessed with the TF-CBT Fidelity Metric. This instrument consists of 12 scales (e.g., gradual exposure, cognitive processing) that allow a trainer to rate (on a 4-point scale) each TF-CBT component applied by a therapist within a session. | Description | The 12 items comprising the ORIC measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether members of an organization, collectively, are (1) committed to implementing a new practice or process and (2) believe that they have the capacity to do so. For these two subscales and the overall ORIC scale, organizations receive scores between 1 and 5 (higher scores are considered more positive). | Description | The 15 items comprising the EBPAS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure articulates practitioner willingness to adopt new interventions as a function of four factors: (1) appeal of the new intervention, (2) organizational requirements, (3) practitioner openness, and (4) divergence (perceived incompatibility with practice or limited usefulness of research-based interventions). For these four subscales and the overall EBPAS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive). | Description | This questionnaire assesses factors related to the inner setting of organizations that are believed to be important in influencing the implementation of interventions. Thirty items from this questionnaire will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. These items measure three factors: (1) culture, (2) learning climate, and (3) available resources. Organizations receive scores between 1 and 5 for each of these factors (higher scores are considered more positive). | Description | The six items comprising this measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether organizations are primed for implementation via three factors: the extent to which employees believe implementation is (1) expected, (2) supported, and (3) rewarded. For these three subscales and the overall ICS scale, organizations receive scores between 1 and 5 (higher scores are considered more positive). | Description | The seven items comprising the PSS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses how much the environment of a work team makes members feel they can safely engage in learning behavior (e.g., seeking feedback, discussing errors, asking questions, experimenting) without great risk of losing face. Organizations receive a score between 1 and 7 for this scale (higher scores are considered more positive). | Description | The 12 items comprising the ILS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses whether leadership is proactive, knowledgeable, supportive, and perseverant based on specific actions leaders take in promoting implementation. For these four subscales and the overall ILS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive). | Description | The six items comprising the ICBS measure will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. This measure assesses two critical employee behaviors that go beyond what is required to support the implementation of evidence-based practices: (1) helping their peers with implementation-related activities and (2) keeping informed about issues related to evidence-based practice and implementation efforts. For these two subscales and the overall ICBS scale, organizations receive scores between 0 and 4 (higher scores are considered more positive). | Description | This questionnaire assesses employees' experiences and judgments toward previous innovation implementation, which may affect their implementation behavior regarding future innovations. Sixteen items from this questionnaire will be included in an organizational barrier assessment that will be administered to all enrolled participants and will guide implementation support provided through COAST-IS. These items measure four subscales: (1) perceived intensity of previous innovations, (2) perceived failure of previous innovations, (3) innovation-targeted helplessness, and (4) innovation fatigue. Organizations receive scores between 1 and 5 for each of these subscales (higher scores are considered more negative). |
Browse Conditions
Sequence: | 194782684 | Sequence: | 194782685 | Sequence: | 194782686 | Sequence: | 194782687 |
Mesh Term | Psychological Trauma | Mesh Term | Stress Disorders, Traumatic | Mesh Term | Trauma and Stressor Related Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | psychological trauma | Downcase Mesh Term | stress disorders, traumatic | Downcase Mesh Term | trauma and stressor related disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48633725 | Sequence: | 48633726 | Sequence: | 48633727 | Sequence: | 48633728 | Sequence: | 48633729 |
Agency Class | OTHER | Agency Class | NIH | Agency Class | UNKNOWN | Agency Class | NETWORK | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Washington University School of Medicine | Name | National Institute of Mental Health (NIMH) | Name | North Carolina Child Treatment Program | Name | National Child Traumatic Stress Network | Name | UCLA-Duke National Center for Child Traumatic Stress |
Overall Officials
Sequence: | 29462751 |
Role | Principal Investigator |
Name | Byron J Powell, PhD |
Affiliation | Washington University School of Medicine |
Design Group Interventions
Sequence: | 68611695 | Sequence: | 68611696 | Sequence: | 68611697 |
Design Group Id | 55967529 | Design Group Id | 55967530 | Design Group Id | 55967529 |
Intervention Id | 52818778 | Intervention Id | 52818779 | Intervention Id | 52818779 |
Eligibilities
Sequence: | 30958980 |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Employed at an organization participating in a North Carolina Child Treatment Program TF-CBT learning collaborative Working as an organizational leader (e.g., senior leaders and clinical supervisors) or therapist Direct involvement in the organization's implementation of TF-CBT |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 253975780 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 18 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 5 |
Number Of Secondary Outcomes To Measure | 2 |
Number Of Other Outcomes To Measure | 8 |
Designs
Sequence: | 30704547 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Health Services Research |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29071273 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52416722 |
Pmid | 32391524 |
Reference Type | derived |
Citation | Powell BJ, Haley AD, Patel SV, Amaya-Jackson L, Glienke B, Blythe M, Lengnick-Hall R, McCrary S, Beidas RS, Lewis CC, Aarons GA, Wells KB, Saldana L, McKay MM, Weinberger M. Improving the implementation and sustainment of evidence-based practices in community mental health organizations: a study protocol for a matched-pair cluster randomized pilot study of the Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS). Implement Sci Commun. 2020;1:9. doi: 10.1186/s43058-020-00009-5. Epub 2020 Feb 25. |
]]>
https://zephyrnet.com/NCT03799419
2019-04-01
https://zephyrnet.com/?p=NCT03799419
NCT03799419https://www.clinicaltrials.gov/study/NCT03799419?tab=tableMartha Falkensteinmfalkenstein@mclean.harvard.edu617-855-4424This study will conduct the development and preliminary evaluation of Cognitive Bias Modification for Interpretation (CBM-I) and Approach Avoidance Training (AAT) as augmentations to treatment as usual for OCD and related disorders. CBM-I refers to computerized interventions designed to directly manipulate interpretation bias through repeated practice on a training task, thereby inducing cognitive changes in a relatively automatic or implicit manner. In AAT, automatic approach tendencies toward feared stimuli are re-trained. Specifically, this study will examine the feasibility, acceptability, and clinical outcomes associated with CBM-I and AAT.
Adults with obsessive compulsive disorder (OCD) and related disorders will be recruited from a treatment program for these disorders and participants will be randomly assigned to either receive: 1) eight sessions of CBM-I or eight sessions of psychoeducation as a control condition, or 2) AAT or eight sessions of an inactive (sham) version of the AAT training.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-03-15 |
Start Month Year | April 1, 2019 |
Primary Completion Month Year | September 2024 |
Verification Month Year | March 2023 |
Verification Date | 2023-03-31 |
Last Update Posted Date | 2023-03-15 |
Facilities
Sequence: | 198942328 |
Status | Recruiting |
Name | McLean Hospital |
City | Belmont |
State | Massachusetts |
Zip | 02478 |
Country | United States |
Facility Contacts
Sequence: | 27982637 |
Facility Id | 198942328 |
Contact Type | primary |
Name | Martha Falkenstein |
mfalkenstein@mclean.harvard.edu | |
Phone | 617-855-4424 |
Conditions
Sequence: | 51881526 | Sequence: | 51881527 |
Name | Obsessive-Compulsive Disorder | Name | Obsessive-compulsive Disorders and Symptoms |
Downcase Name | obsessive-compulsive disorder | Downcase Name | obsessive-compulsive disorders and symptoms |
Id Information
Sequence: | 39929117 |
Id Source | org_study_id |
Id Value | 2017P002864 |
Countries
Sequence: | 42322966 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55301063 | Sequence: | 55301064 | Sequence: | 55301065 | Sequence: | 55301066 |
Group Type | Experimental | Group Type | Sham Comparator | Group Type | Experimental | Group Type | Sham Comparator |
Title | Cognitive bias modification with treatment as usual | Title | Psychoeducation with treatment as usual | Title | Approach avoidance training with treatment as usual | Title | Inactive sham approach avoidance training |
Description | Participants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting interpretation bias | Description | Participants in this group will receive usual treatment in the program and 8 sessions of psychoeducation | Description | Participants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting automatic approach tendencies | Description | Participants in this group will receive usual treatment in the program and 8 sessions of a sham approach avoidance training |
Interventions
Sequence: | 52199460 | Sequence: | 52199461 | Sequence: | 52199462 | Sequence: | 52199463 |
Intervention Type | Behavioral | Intervention Type | Behavioral | Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Cognitive bias modification for interpretation bias | Name | Psychoeducation | Name | Approach avoidance training | Name | Inactive sham approach avoidance training |
Description | Eight sessions of scenario-based CBM-I training for OCD will be administered, based on the widely-used paradigm of ambiguous scenario training developed by Mathews and Mackintosh (2000), in which participants are presented with scenarios that are ambiguous in whether or not they are threatening. Participants will complete a computer task consisting of a series of written scenarios designed to improve interpretation and attributional biases; these scenarios conclude with word fragments, which participants must fill in to resolve the ambiguity. | Description | Eight sessions of psychoeducation will be administered, which will describe symptoms of anxiety, the nature of biased thinking in anxiety, and summarize common psychosocial as well as pharmacological treatments for anxiety. The sessions will provide relevant information but will not provide training in changing thinking styles. | Description | Eight sessions of this computerized training program will be used to train approach tendencies, following previously validated procedures (Najmi, Kuckertz, & Amir, 2010). During the training program, participants will view a series of these images and be prompted to push or pull a joystick according to prompts on the screen, instead of the content of the picture. Avoidance will be stimulated through both pushing away (images on the screen will decrease in size upon the joystick being pushed), and approach will be stimulated through pulling towards pictures (images will increase in size to simulate approach). | Description | Eight sessions of the approach avoidance training will be administered, however the percentage of push vs pull trials will be altered in this sham version of the training. |
Keywords
Sequence: | 79401306 | Sequence: | 79401307 | Sequence: | 79401308 |
Name | cognitive bias modification | Name | interpretation bias | Name | approach avoidance |
Downcase Name | cognitive bias modification | Downcase Name | interpretation bias | Downcase Name | approach avoidance |
Design Outcomes
Sequence: | 176414902 | Sequence: | 176414899 | Sequence: | 176414900 | Sequence: | 176414901 | Sequence: | 176414903 | Sequence: | 176414904 | Sequence: | 176414905 | Sequence: | 176414906 | Sequence: | 176414907 | Sequence: | 176414908 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in Suicide Implicit Association Test | Measure | Change in Average Score on Obsessive Beliefs Questionnaire | Measure | Change in Average Score on Yale-Brown Obsessive Compulsive Scale | Measure | Change in Columbia-Suicide Severity Rating Scale | Measure | Change in Average Score on Depressive Symptom Index Suicidality Subscale. There are 4 items scored from 0-3 with greater numbers indicating greater severity. | Measure | Credibility/Expectancy Questionnaire | Measure | Exit Interview | Measure | Change in Behavioral Approach Test | Measure | Change in Average Score on Behavioral Inhibition/Behavioral Activation Scales | Measure | Dimensional Obsessive-Compulsive Scale |
Time Frame | Weeks 0, 2, and 4 | Time Frame | Weeks 0, 2, 4, and 8 | Time Frame | Weeks 0, 4, and 8 | Time Frame | Weeks 0, 4, and 8 | Time Frame | Weeks 0, 1, 2, 3, and 4 | Time Frame | Week 0 | Time Frame | Week 4 | Time Frame | Weeks 0, 2, and 4 | Time Frame | Weeks 0, 2, 4, and 8 | Time Frame | Weeks 0, 2, 4, and 8 |
Description | Computerized task which assesses implicit thoughts about self-injury, death, and suicide. | Description | Measure of interpretation biases, specifically: Inflated Responsibility/Overestimation of Threat, Perfectionism/Intolerance of Uncertainty, and Importance/Control of Thoughts. 44-item self-report measure, items scored 1-7 and summed; greater scores indicate greater severity. | Description | Interviewer-rated measure of OCD symptoms. It is 19 items, with only items 1-10 scored (from 0-4). Total scores range from 0-40, with higher scores reflecting greater severity. | Description | An interviewer-rated assessment of retrospective suicidality as well as recent suicidal ideation and behavior. Minimum total score 0, maximum total score 5, higher total scores indicate more suicidal ideation and/or behavior. | Description | Self-report measure of suicidality | Description | Measure of treatment expectancy and rationale credibility in our study. The items are rated on 9-point scales, with a total score range of 3 to 27. Greater scores indicate greater expectations and perceptions of treatment credibility. | Description | This interview will be conducted by a member of the study staff to obtain participant feedback on satisfaction and how the intervention might be improved. | Description | Behavioral Approach Test (BAT) will be administered as a measure of OCD-related avoidance, based on previously validated procedures (Cougle et al., 2007; Amir, Kuckertz, & Najmi, 2013). Participants rate peak anxiety 0-100 for each step of approaching feared stimuli.
Three different types of BAT will be implemented in order to measure avoidance with multiple types of contaminants, each with six steps on a hierarchy to be completed sequentially, providing a rating of anxiety 0-100 for each step. |
Description | 24-item measure of behavioral approach and behavioral avoidance, rated 1-4 and summed. | Description | (DOCS; Abramowitz et al., 2010) participants with contamination fears will be identified by their DOCS contamination subscale score; the DOCS is part of the admission measures in the OCD Institute's main study protocol. Additionally, we will examine these scores as an outcome measure for contamination-related obsessions and compulsions. It includes 20 items and is rated 0-4. |
Browse Conditions
Sequence: | 192315455 | Sequence: | 192315456 | Sequence: | 192315457 | Sequence: | 192315458 | Sequence: | 192315459 |
Mesh Term | Compulsive Personality Disorder | Mesh Term | Obsessive-Compulsive Disorder | Mesh Term | Personality Disorders | Mesh Term | Mental Disorders | Mesh Term | Anxiety Disorders |
Downcase Mesh Term | compulsive personality disorder | Downcase Mesh Term | obsessive-compulsive disorder | Downcase Mesh Term | personality disorders | Downcase Mesh Term | mental disorders | Downcase Mesh Term | anxiety disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48048244 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mclean Hospital |
Central Contacts
Sequence: | 11947809 |
Contact Type | primary |
Name | Martha Falkenstein |
Phone | 617-855-4424 |
mfalkenstein@mclean.harvard.edu | |
Role | Contact |
Design Group Interventions
Sequence: | 67795305 | Sequence: | 67795306 | Sequence: | 67795307 | Sequence: | 67795308 |
Design Group Id | 55301063 | Design Group Id | 55301064 | Design Group Id | 55301065 | Design Group Id | 55301066 |
Intervention Id | 52199460 | Intervention Id | 52199461 | Intervention Id | 52199462 | Intervention Id | 52199463 |
Eligibilities
Sequence: | 30594239 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Currently receiving treatment at the McLean Hospital OCD Institute Exclusion Criteria: Currently undergoing electroconvulsive therapy (ECT) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253885480 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 9 |
Designs
Sequence: | 30341874 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | Triple |
Subject Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28718372 |
Responsible Party Type | Principal Investigator |
Name | Martha J Falkenstein |
Title | Staff Psychologist |
Affiliation | Mclean Hospital |
]]>
https://zephyrnet.com/NCT03799406
2016-10-01
https://zephyrnet.com/?p=NCT03799406
NCT03799406https://www.clinicaltrials.gov/study/NCT03799406?tab=tableNANANAThis study was conducted to evaluate the effect of oral vitamin D supplementation on the clinical course of acute bronchiolitis, and to investigate whether vitamin D deficiency among infants who required hospital-based care for bronchiolitis is associated with the severity of the acute episode.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-29 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-11 |
Start Month Year | October 1, 2016 |
Primary Completion Month Year | March 1, 2017 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-11 |
Detailed Descriptions
Sequence: | 20716264 |
Description | This is a double blind randomized controlled trial which was conducted on 60 infants who required hospital-based care for acute bronchiolitis. The patients were recruited in the period from October 2018 to January 2019. Informed consents were obtained from all caregivers, and approved by Institutional Research Board of our University.
The diagnosis of acute bronchiolitis was based on a first episode of respiratory distress with wheezing and/ or crackles, preceded by an infection of the upper airways (rhinorrhea, coryza, cough, fever). Disease severity was evaluated using Modified-Tal scoring systems for bronchiolitis, since it is repeatable and can reliably be used in research and clinical practice Sample size: Our hospital data have shown that the mean LOS for cases admitted with acute bronchiolitis was 3 ± 2 days. Assuming a reduction in length of hospital stay by 50% and study power of 80% to detect a clinical significance (α error) of 0.05 between interventional groups, we calculated a sample size of 30 patients in each treatment group. Randomization and Enrollment: Patients were randomized to receive vitamin D3 treatment [100 IU/Kg/day in acute bronchiolitis] (vitamin D group) or placebo (placebo group) all through the period of admission as a previous cohort observational study has postulated that vitamin D daily dose close to 100 IU/kg body weight is favorable for infants up to age 12 months. Both groups were equal in number. Both vitamin D3 and placebo were in drop form and were identical in shape and nearly the same taste and color. The assignments were kept in sealed envelopes till data analysis. The randomization and allocation process were done by a higher nursing staff blinded to the study. Throughout the study, the medical staff, and parents were blind to assignments. All patients were hospitalized and received treatment. The treatment consisted of intravenous fluids, oxygenation, and antipyretics if needed, and nebulized hypertonic saline. Nebulized adrenaline or salbutamol was added in severe cases according to the decision of a senior pediatrician. The validated clinical score for acute bronchiolitis were taken after a period of adjustment of at least 5 min and with the child quiet, not crying, without fever, and breathing room air. Respiratory rate were determined by observation of the thoracic movement over a full minute. The degree of accessory muscle use was based on the degree of intercostal or subcostal retraction. Physical examination as well as clinical severity score was recorded for each case at admission and every 12 hours, and at discharge. On discharge, all caregivers of breastfed, partially breastfed and bottle fed infants were advised to continue vitamin D supplementation at dose 400 IU per day All patients were submitted to careful history taking, complete clinical examination and the following laboratory investigations. Complete blood count Venous blood samples were collected from every subject by sterile venipuncture using disposable syringes. Each sample was then distributed as follows: One ml of blood was disposed into a plastic tube containing EDTA solution for performing complete blood count using electronic cell counter (sysmex kx-21,Japon). |
Facilities
Sequence: | 200053145 |
Name | Mansoura University Children's Hospital |
City | Mansourah |
Country | Egypt |
Browse Interventions
Sequence: | 96027720 | Sequence: | 96027721 | Sequence: | 96027722 | Sequence: | 96027723 | Sequence: | 96027724 | Sequence: | 96027725 | Sequence: | 96027726 |
Mesh Term | Vitamin D | Mesh Term | Cholecalciferol | Mesh Term | Vitamins | Mesh Term | Micronutrients | Mesh Term | Physiological Effects of Drugs | Mesh Term | Bone Density Conservation Agents | Mesh Term | Calcium-Regulating Hormones and Agents |
Downcase Mesh Term | vitamin d | Downcase Mesh Term | cholecalciferol | Downcase Mesh Term | vitamins | Downcase Mesh Term | micronutrients | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | bone density conservation agents | Downcase Mesh Term | calcium-regulating hormones and agents |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52156391 |
Name | Bronchiolitis |
Downcase Name | bronchiolitis |
Id Information
Sequence: | 40148157 |
Id Source | org_study_id |
Id Value | MS/16.01.38 |
Countries
Sequence: | 42557682 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55577820 | Sequence: | 55577821 |
Group Type | Active Comparator | Group Type | Placebo Comparator |
Title | Intervention group | Title | Placebo group |
Description | cholecalciferol at dose of 100 IU/Kg/day | Description | placebo |
Interventions
Sequence: | 52471929 | Sequence: | 52471930 |
Intervention Type | Drug | Intervention Type | Other |
Name | Cholecalciferol | Name | Placebo |
Description | Therapeutic trial of vitamin D supplementation during acute episode of bronchiolitis | Description | Placebo supplementation during acute episode of bronchiolitis |
Keywords
Sequence: | 79847977 | Sequence: | 79847978 | Sequence: | 79847979 | Sequence: | 79847980 | Sequence: | 79847981 |
Name | Acute bronchiolitis | Name | Vitamin D | Name | Modified Tal score | Name | Randomized | Name | Controlled trial |
Downcase Name | acute bronchiolitis | Downcase Name | vitamin d | Downcase Name | modified tal score | Downcase Name | randomized | Downcase Name | controlled trial |
Design Outcomes
Sequence: | 177327651 |
Outcome Type | primary |
Measure | length of hospital stay |
Time Frame | 3 to 5 days |
Description | Length of hospital stay in days |
Browse Conditions
Sequence: | 193431809 | Sequence: | 193431802 | Sequence: | 193431803 | Sequence: | 193431804 | Sequence: | 193431805 | Sequence: | 193431806 | Sequence: | 193431807 | Sequence: | 193431808 |
Mesh Term | Lung Diseases | Mesh Term | Bronchiolitis | Mesh Term | Bronchitis | Mesh Term | Respiratory Tract Infections | Mesh Term | Infections | Mesh Term | Bronchial Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Lung Diseases, Obstructive |
Downcase Mesh Term | lung diseases | Downcase Mesh Term | bronchiolitis | Downcase Mesh Term | bronchitis | Downcase Mesh Term | respiratory tract infections | Downcase Mesh Term | infections | Downcase Mesh Term | bronchial diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | lung diseases, obstructive |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48305984 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mansoura University |
Overall Officials
Sequence: | 29277890 |
Role | Principal Investigator |
Name | amal osman, M.D. |
Affiliation | Mansoura University |
Design Group Interventions
Sequence: | 68130769 | Sequence: | 68130770 |
Design Group Id | 55577820 | Design Group Id | 55577821 |
Intervention Id | 52471929 | Intervention Id | 52471930 |
Eligibilities
Sequence: | 30757308 |
Gender | All |
Minimum Age | 1 Month |
Maximum Age | 24 Months |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Infants aged 1-24 months of age, diagnosed clinically as acute bronchiolitis and presented with any of the following: Persistent resting oxygen saturation below 92% in room air. Exclusion Criteria: Infants with history of prematurity (< 37 weeks), chronic cardiopulmonary disease, immunodeficiency, neuromuscular disease, and any other chronic medical condition. |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254226290 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 5 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 1 |
Maximum Age Num | 24 |
Minimum Age Unit | Month |
Maximum Age Unit | Months |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30503533 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26665860 |
Intervention Id | 52471929 |
Name | Vitamin D |
Responsible Parties
Sequence: | 28869811 |
Responsible Party Type | Principal Investigator |
Name | Amal Osman |
Title | Lecturer of Pediatrics, Mansoura University |
Affiliation | Mansoura University |
Study References
Sequence: | 52049362 |
Pmid | 33305842 |
Reference Type | derived |
Citation | Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2. |
]]>
https://zephyrnet.com/NCT03799393
2017-08-01
https://zephyrnet.com/?p=NCT03799393
NCT03799393https://www.clinicaltrials.gov/study/NCT03799393?tab=tableNANANAThis study explores the utility of a tablet computer-based, individually-tailored application called Computer Intervention Authoring Software (CIAS) in the Emergency Department for discharge education on proper child car restraint safety. The investigators hypothesize that tablet-based, individually-tailored discharge instructions are more effective than current standard, one-size-fits-all, printed discharge instructions. This is a randomized, controlled, non-blinded trial of of children age 0-21 years old in the Emergency Department. Patients will be randomized to receive either (a) a brief tablet-based questionnaire followed by standard, paper discharge instructions or (b) a brief tablet-based questionnaire followed by the intervention – CIAS, a tablet-based computer program. One week after discharge, participants in both groups will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint. These variables will be compared between the control and intervention groups.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-24 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-12-09 |
Start Month Year | August 1, 2017 |
Primary Completion Month Year | February 28, 2019 |
Verification Month Year | December 2021 |
Verification Date | 2021-12-31 |
Last Update Posted Date | 2021-12-09 |
Detailed Descriptions
Sequence: | 20792333 |
Description | This study explores the utility of a tablet computer-based, individually-tailored technology called Computer Intervention Authoring Software (CIAS) in the Emergency Department for discharge education on proper child car restraint safety. The investigators hypothesize that tablet-based, individually-tailored discharge instructions are more effective than current standard, one-size-fits-all, printed discharge instructions. This is a randomized, controlled, non-blinded trial of a convenience sample of 200 children age 0-21 years old who present to the Hasbro Children's Hospital Emergency Department by car and have access to a smartphone and/or email. Patients will be randomized to receive either (a) a brief tablet-based questionnaire followed by standard, paper discharge instructions or (b) a brief tablet-based questionnaire followed by the intervention – CIAS, a computer program that allows families to interact with a tablet computer to receive educational information customized to the patient. Children 13 years old and above will answer questions themselves instead of having their parent/guardian answer for them. Both group will be offered information for the Lifespan Injury Prevention Center's Kohl's Car Seat Program. Both groups will complete a questionnaire on the usefulness of their discharge education. One week after discharge, participants in both groups will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint. These variables will be compared between the control and intervention groups. |
Facilities
Sequence: | 200729942 |
Name | Hasbro Children's Hospital Emergency Department |
City | Providence |
State | Rhode Island |
Zip | 02903 |
Country | United States |
Conditions
Sequence: | 52352795 | Sequence: | 52352796 | Sequence: | 52352797 |
Name | Safety Issues | Name | Injuries | Name | Car Accident |
Downcase Name | safety issues | Downcase Name | injuries | Downcase Name | car accident |
Id Information
Sequence: | 40288731 |
Id Source | org_study_id |
Id Value | 2012-17 |
Countries
Sequence: | 42710615 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55795171 | Sequence: | 55795172 |
Group Type | Active Comparator | Group Type | Experimental |
Title | Control Group | Title | Experimental/CIAS Group |
Description | The control group will receive a brief tablet-based questionnaire followed by standard, paper discharge instructions on car safety. Children ≥13 years old and above will answer questions themselves. They will complete a questionnaire on the usefulness of their discharge education.
One week after discharge, participants will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint. |
Description | The Experimental/CIAS Group will receive a brief tablet-based questionnaire followed by the intervention – CIAS, an interactive tablet computer program that gives educational information customized to the patient's age and size. Children ≥13 years old will answer questions and interact with the program themselves. They will complete a questionnaire on the usefulness of their discharge education.
One week after discharge, participants will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint. |
Interventions
Sequence: | 52663852 | Sequence: | 52663851 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Standard Printed Discharge Instructions | Name | CIAS (Computer Intervention Authoring Software) |
Description | Patients/families will receive standard, printed discharge instructions. This is a 5 page general document from our Injury Prevention Center that describes appropriate car restraint safety for all age groups, not specific to the child enrolled. | Description | This is a digital application that allows families to interact with a tablet computer to receive educational information customized to the patient's age and size. allows authors to develop screening, assessment, and intervention tools for patients without requiring new programming. The CIAS intervention is programmed using tailored branching logic to allow a custom path through the intervention based on the respondent's answers. Delivery of the intervention uses a two-dimensional avatar narrator character that mimics the conversational structure of person-delivered brief interventions. |
Keywords
Sequence: | 80118423 | Sequence: | 80118424 | Sequence: | 80118425 | Sequence: | 80118426 | Sequence: | 80118427 |
Name | injury prevention | Name | car safety | Name | car seats | Name | booster seats | Name | car restraints |
Downcase Name | injury prevention | Downcase Name | car safety | Downcase Name | car seats | Downcase Name | booster seats | Downcase Name | car restraints |
Design Outcomes
Sequence: | 178048746 | Sequence: | 178048747 | Sequence: | 178048748 | Sequence: | 178048749 | Sequence: | 178048750 | Sequence: | 178048751 | Sequence: | 178048752 | Sequence: | 178048753 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Demonstration of age-appropriate car restraint knowledge | Measure | Change in car restraint knowledge | Measure | Actions taken related to car restraints | Measure | Rate of difference types of actions taken related to car restraints | Measure | Satisfaction with discharge education – CIAS | Measure | Parental confidence in type of car restraint | Measure | Parental confidence in car restraint installation | Measure | Parental confidence in buckling the car restraint |
Time Frame | one week after enrollment | Time Frame | one week after enrollment | Time Frame | one week after enrollment | Time Frame | one week after enrollment | Time Frame | during intervention/enrollment | Time Frame | one week after enrollment | Time Frame | one week after enrollment | Time Frame | one week after enrollment |
Description | Rate of correct response to a post-intervention follow-up survey question regarding age appropriate car restraint for child in control group vs. intervention group. | Description | Change in rate of correct response pre-intervention vs. post-intervention compared between control group vs. intervention | Description | Rate of parental self-report of actions taken related to changing use of car restraints on post-intervention follow-up survey. This will be a binary variable (NO action taken vs. YES action taken). | Description | Rates of each specific type of actions taken will also be compared between control and intervention groups (e.g. percentage of subjects who purchased a new car restraint device in each group, percentage of patients that had car seat installation checked at a fire department in each group, etc). | Description | For intervention group only – parent/patient satisfaction with education given on discharge based on score on Technology Posttrial Impressions Questionnaire. We will examine 13 individual components scored on an ordinal scale 1 to 5 (poor, fair, good, very good, excellent). Mean total score will be calculated. | Description | Change in parental confidence that child is in the correct type of car restraint, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:
How confident are you that your child is in the right type of car restraint? 1- not at all confident 2- 3- 4- 5- very confident |
Description | Change in parental confidence that car restraint is correctly installed, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:
How confident are you that your car restraint is installed correctly? 1- not at all confident 2- 3- 4- 5- very confident |
Description | Change in parental confidence that the child is correctly buckled in the car restraint, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:
How confident are you that your child is correctly buckled into the car restraint? 1- not at all confident 2- 3- 4- 5- very confident |
Browse Conditions
Sequence: | 194177447 | Sequence: | 194177448 | Sequence: | 194177449 |
Mesh Term | Emergencies | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | emergencies | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48488244 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Lifespan |
Overall Officials
Sequence: | 29381423 |
Role | Study Director |
Name | Susan Duffy, MD, MPH |
Affiliation | Associate Professor |
Design Group Interventions
Sequence: | 68396841 | Sequence: | 68396842 |
Design Group Id | 55795172 | Design Group Id | 55795171 |
Intervention Id | 52663851 | Intervention Id | 52663852 |
Eligibilities
Sequence: | 30870131 |
Gender | All |
Minimum Age | N/A |
Maximum Age | 21 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
– Children age 0-21 years presenting to the children's emergency department for any chief complaint whose parent/guardian owns or has access to a car that the child rides in (or for adolescents 16 years or older, have access to a car themselves). Exclusion Criteria: No access to email or a smart phone |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254027863 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 19 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Maximum Age Num | 21 |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30615929 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28982467 |
Responsible Party Type | Principal Investigator |
Name | Almaz Dessie |
Title | Principal Investigator |
Affiliation | Lifespan |
]]>
https://zephyrnet.com/NCT03799380
2019-11-05
https://zephyrnet.com/?p=NCT03799380
NCT03799380https://www.clinicaltrials.gov/study/NCT03799380?tab=tableNANANAThe purpose of this study is to decrease the rate of visits to the Emergency Department (ED) and Acute Care Clinics (ACC) for dehydration for head & neck (H&N) and esophageal cancer patients that are given Gatorade while receiving radiation therapy with or without chemotherapy.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-11-03 |
Start Month Year | November 5, 2019 |
Primary Completion Month Year | May 5, 2021 |
Verification Month Year | November 2021 |
Verification Date | 2021-11-30 |
Last Update Posted Date | 2021-11-03 |
Detailed Descriptions
Sequence: | 20837991 |
Description | Among patients with cancer of the H&N or esophagus, complications related to dehydration are fairly common, and can result in requiring IV fluid support in an ACC setting, ED or even inpatient admission. By instructing participants to drink a reasonable amount of a common electrolyte-rich energy drink from the initiation of treatment through its completion, the hypothesis will be tested that this inexpensive and easily administered preventative strategy can significantly decrease the rate of ACC and ED visits.
The objectives of this study are to decrease the frequency of ACC visits during the course of radiation therapy and decrease the frequency of ED visits during the course of radiation therapy. The study team also seeks to decrease the incidence of orthostatic vital signs during the course of radiation therapy and decrease the number of days of missed treatments due to radiation toxicity during the course of radiation therapy. In the pilot cohort, participants will be given Gatorade G2 to drink daily during the course of radiation, along with standard of care nutritional support from dietitians. The randomized Phase 2 cohort has two study groups. Group 1 will receive standard of care nutritional support. Group 2 will receive standard of care nutritional support plus the study agent, Gatorade G2. |
Facilities
Sequence: | 201176072 |
Name | Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
City | Cleveland |
State | Ohio |
Zip | 44106 |
Country | United States |
Conditions
Sequence: | 52469404 | Sequence: | 52469405 | Sequence: | 52469406 |
Name | Dehydration | Name | Head & Neck Cancer | Name | Esophageal Cancer |
Downcase Name | dehydration | Downcase Name | head & neck cancer | Downcase Name | esophageal cancer |
Id Information
Sequence: | 40372466 |
Id Source | org_study_id |
Id Value | CASE8318 |
Countries
Sequence: | 42807918 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55924638 | Sequence: | 55924639 |
Group Type | Active Comparator | Group Type | Experimental |
Title | Control – Standard of Care | Title | Experimental – Gatorade |
Description | Standard of care nutritional support | Description | Standard of care nutritional support with the addition of daily Gatorade G2 |
Interventions
Sequence: | 52779740 | Sequence: | 52779741 |
Intervention Type | Dietary Supplement | Intervention Type | Dietary Supplement |
Name | Gatorade G2 | Name | Standard of care nutritional support |
Description | Gatorade (G2), 20 oz. bottle, daily through the entire course of radiation therapy (approximately 5-7 weeks) | Description | Standard of care nutritional support |
Design Outcomes
Sequence: | 178498165 | Sequence: | 178498166 | Sequence: | 178498163 | Sequence: | 178498164 |
Outcome Type | secondary | Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary |
Measure | Incidence of orthostatic vital signs | Measure | Missed days of radiation +/- chemotherapy/immunotherapy treatment | Measure | ACC visits | Measure | ED visits |
Time Frame | Up to 11 weeks after start of treatment | Time Frame | Up to 7 weeks after start of treatment | Time Frame | Up to 11 weeks after start of treatment | Time Frame | Up to 11 weeks after start of treatment |
Description | Number of orthostatic vital signs during the course of radiation therapy assessed at weekly visits. | Description | Number of missed days of radiation treatment among H&N and esophageal cancer patients undergoing radiation +/- chemotherapy/immunotherapy during the course of treatment. | Description | ACC visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation. | Description | Number of ED visits during the course of radiation (7 weeks). Participants are followed for 4 weeks after completion of radiation. |
Browse Conditions
Sequence: | 194626385 | Sequence: | 194626386 | Sequence: | 194626387 | Sequence: | 194626388 | Sequence: | 194626389 | Sequence: | 194626390 | Sequence: | 194626391 | Sequence: | 194626392 | Sequence: | 194626393 | Sequence: | 194626394 | Sequence: | 194626395 | Sequence: | 194626396 | Sequence: | 194626397 |
Mesh Term | Head and Neck Neoplasms | Mesh Term | Esophageal Neoplasms | Mesh Term | Dehydration | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Gastrointestinal Neoplasms | Mesh Term | Digestive System Neoplasms | Mesh Term | Digestive System Diseases | Mesh Term | Esophageal Diseases | Mesh Term | Gastrointestinal Diseases | Mesh Term | Water-Electrolyte Imbalance | Mesh Term | Metabolic Diseases | Mesh Term | Pathologic Processes |
Downcase Mesh Term | head and neck neoplasms | Downcase Mesh Term | esophageal neoplasms | Downcase Mesh Term | dehydration | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | gastrointestinal neoplasms | Downcase Mesh Term | digestive system neoplasms | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | esophageal diseases | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | water-electrolyte imbalance | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48596466 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Case Comprehensive Cancer Center |
Overall Officials
Sequence: | 29441657 |
Role | Principal Investigator |
Name | Elisha Fredman, MD |
Affiliation | University Hospitals Cleveland Medical Center |
Design Group Interventions
Sequence: | 68558422 | Sequence: | 68558423 |
Design Group Id | 55924639 | Design Group Id | 55924638 |
Intervention Id | 52779740 | Intervention Id | 52779741 |
Eligibilities
Sequence: | 30936492 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
– Subjects must have histologically confirmed primary invasive cancer of the H&N (Nasopharynx/Nasal Cavity, Oral cavity, Oropharynx, Larynx, Hypopharynx) or Esophagus. Histologies: squamous cell carcinoma, adenocarcinoma, adenoid cystic carcinoma, sinonasal undifferentiated carcinoma Stages: Any stage that necessitates radiation therapy (either definitive, neoadjuvant or adjuvant) as per standard practice guidelines (NCCN, ASTRO) Subjects must have received no prior radiation therapy to the head, neck, thorax or abdomen in the last 1 year (with the exception of scalp squamous cell or basal cell carcinoma. Exclusion Criteria: The presence of any of the following will exclude a subject from study enrollment. Prior radiation therapy to the head, neck, thorax or abdomen in the last year, with the exception of scalp squamous cell or basal cell carcinoma. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254222790 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 18 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30682117 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29048843 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799367
2018-07-09
https://zephyrnet.com/?p=NCT03799367
NCT03799367https://www.clinicaltrials.gov/study/NCT03799367?tab=tableNANANAParents commonly find giving medicines to babies, using oral syringes or spoons, difficult and emotionally stressful. In developing countries, additional stress arises due to hygiene difficulties and the lack of clean water. To overcome these challenges and encourage breastfeeding, we have developed the concept of a Therapeutic Nipple Shield, a delivery system that makes it possible to give medicine and nutrients to babies during breastfeeding. It consists of a silicone nipple shield that allows the release of medicine/nutrients into human milk during the feed. Presentations of a prototype to parents and staff at the Rosie Hospital was very positive, and encouraged this clinical study. This study aims to give a vitamin B12 supplement to babies during breastfeeding. The supplement will be placed into a nipple shield, both of which are commercially available, and the mother will breastfeed her baby as usual. Before and after the feed, we will 1) collect a small blood sample from the baby to see whether the vitamin levels in the infant have increased, 2) ask the mother to participate in two short interviews about her expectations and experiences using the Therapeutic Nipple Shield.
<![CDATA[
Studies
Study First Submitted Date | 2018-07-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | July 9, 2018 |
Primary Completion Month Year | December 31, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Facilities
Sequence: | 200617878 |
Name | addenbrookes Hospital |
City | Cambridge |
Country | United Kingdom |
Conditions
Sequence: | 52328196 | Sequence: | 52328197 | Sequence: | 52328198 | Sequence: | 52328199 |
Name | Medication Systems | Name | Breast Feeding | Name | Milk, Human | Name | Infant, Newborn |
Downcase Name | medication systems | Downcase Name | breast feeding | Downcase Name | milk, human | Downcase Name | infant, newborn |
Id Information
Sequence: | 40271016 |
Id Source | org_study_id |
Id Value | 18/LO/0551 |
Countries
Sequence: | 42691058 |
Name | United Kingdom |
Removed | False |
Interventions
Sequence: | 52639205 |
Intervention Type | Device |
Name | Drug delivery during breastfeeding |
Description | This study aims to give a vitamin B12 supplement to babies during breastfeeding. 30 mother-infant pairs will be recruited. The supplement will be placed into a nipple shield, both of which are commercially available, and the mother will breastfeed her baby as usual. Before and after the feed, we will 1) collect a small blood sample from the baby to see whether the vitamin levels in the infant have increased, 2) ask the mother to participate in two short interviews about her expectations and experiences using the Therapeutic Nipple Shield. |
Design Outcomes
Sequence: | 177959668 | Sequence: | 177959669 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Detection of the change in vitamin B12 concentration in the infants' blood 6-8 hours following vitamin B12 delivery from a nipple shield device during breastfeeding | Measure | Qualitative assessment of impact on maternal expectation, experience and acceptability |
Time Frame | Blood sampling base line and 6-8 hours post feed | Time Frame | Interviews will be conducted prior to and post interventional feed and will last about 30-50 min. |
Description | Two infant blood samples will be taken – one base line and one post intervention | Description | Semi-structured interviews will be conducted before and after vitamin B12 delivery during breastfeeding |
Sponsors
Sequence: | 48466339 | Sequence: | 48466340 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Cambridge University Hospitals NHS Foundation Trust | Name | University of Cambridge |
Eligibilities
Sequence: | 30856276 |
Gender | All |
Minimum Age | 7 Days |
Maximum Age | 12 Months |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
No known allergy or hypersensitivity against any ingredient used in the study Infant aged up to 12 months Confident breastfeeder (exclusively or non-exclusively) Exclusion Criteria: The participant may not enter the study if ANY of the following apply: Not confident at breastfeeding |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254312995 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 5 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 7 |
Maximum Age Num | 12 |
Minimum Age Unit | Days |
Maximum Age Unit | Months |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30602115 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Device Feasibility |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28968630 |
Responsible Party Type | Principal Investigator |
Name | Kathryn Beardsall |
Title | University Lecturer, University of Cambridge |
Affiliation | Cambridge University Hospitals NHS Foundation Trust |
Study References
Sequence: | 52232544 |
Pmid | 35245341 |
Reference Type | derived |
Citation | Maier T, Peirce P, Baird L, Whitehouse SL, Slater NKH, Beardsall K. Drug delivery from a solid formulation during breastfeeding-A feasibility study with mothers and infants. PLoS One. 2022 Mar 4;17(3):e0264747. doi: 10.1371/journal.pone.0264747. eCollection 2022. |
]]>
https://zephyrnet.com/NCT03799354
2019-09-18
https://zephyrnet.com/?p=NCT03799354
NCT03799354https://www.clinicaltrials.gov/study/NCT03799354?tab=tablePaola Baiardi, Mathpaola.baiardi@icsmaugeri.it0039+0382+592In the context of pulmonary rehabilitation of COPD patients, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of adverse events.
Maximal Strength Training (MST) is a kind of RT typically performed at ~85-90% of 1RM with maximal velocity to be developed in the concentric phase. Recent literature indicates a significant amelioration on the Rate of Force Development (RFD) after MST in healthy subjects, post-menopausal woman and older populations.
When comparing to the conventional ET, MST generates a little change in muscle mass (no hypertrophy), but a much greater improvement in the RFD. It has been described that neural adjustments play a major role in the MST-induced adaptations. MST is also well documented to improve aerobic endurance by improving walking work efficiency.
Only a small cohort study of COPD patients was conducted, describing that MST can meaningfully improve strength and RFD, with an increase of around 32% for mechanical efficiency and a decrease of the perceived effort during submaximal job. This improvement could determine best performances in daily activities and a best quality of life. The main aims of this physiological pilot randomized controlled trail will be to evaluate feasibility and efficacy of the MST compared to standard ET on strength, effort tolerance, fatigue, economy of walking, dyspnea and risk of falls in a populations of COPD patients, in a short and middle term (6 months).
<![CDATA[
Studies
Study First Submitted Date | 2018-12-04 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-08-11 |
Start Month Year | September 18, 2019 |
Primary Completion Month Year | June 15, 2023 |
Verification Month Year | December 2021 |
Verification Date | 2021-12-31 |
Last Update Posted Date | 2022-08-11 |
Detailed Descriptions
Sequence: | 20822172 |
Description | Exercise intolerance is a cardinal problem existing in patients with Chronic Obstructive Pulmonary Disease (COPD). Moreover, skeletal muscle dysfunction is a common extra-pulmonary manifestation, leading to fatigue, decrease in activity of daily living (ADL) performance and quality of life and increase of risk of falls, mainly in older patients. In the context of pulmonary rehabilitation, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of adverse events.
As concern the RT programs, metanalysis in COPD describe that training have been mainly performed with the lower limbs and the training intensities are heterogeneous, generally ranging from 40% to 70% of 1-Repetition Maximum (1-RM). Maximal Strength Training (MST) is a RT typically performed at ~85-90% of 1RM with maximal velocity to be developed in the concentric phase. Recent literature indicates a significant amelioration on the Rate of Force Development (RFD) after MST in healthy subjects, post-menopausal woman and older populations. When comparing to the conventional ET, MST generates a little change in muscle mass (no hypertrophy), but a much greater improvement in the RFD. It has been described that neural adjustments play a major role in the MST-induced adaptations. MST is also well documented to improve aerobic endurance by improving walking work efficiency. Although the mechanisms at the base of MST effect on the mechanical efficiency have not been completely clarified, there is evidence that changes in the relationships between power and speed bring to a longer relaxation phase inside the cycle of job, improving the recovery between contractions. In this field, only a small cohort study of COPD patients was conducted describing that MST can meaningfully improve the strength and the RFD, with an increase of around 32% for mechanical efficiency and a decrease of the perceived effort during submaximal job. This improvement could determine best performances in daily activities and a best quality of life. Nevertheless, this study has been conducted only in a small cohort (twelve patients) of patients with COPD and further studies are necessary to define the impact on the different components that determine the effort intolerance. The main aim of this physiological pilot randomized controlled trail will be to test the feasibility and the efficacy of the MST compared to standard ET on strength, effort tolerance, fatigue, economy of walking, dyspnea and risk of falls in a populations of COPD patients, in a short and middle term (6 months). |
Facilities
Sequence: | 201025529 |
Status | Recruiting |
Name | ICS Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Lumezzane |
City | Lumezzane |
State | Brescia |
Zip | 25065 |
Country | Italy |
Facility Contacts
Sequence: | 28249728 | Sequence: | 28249729 |
Facility Id | 201025529 | Facility Id | 201025529 |
Contact Type | primary | Contact Type | backup |
Name | Mara Paneroni, MSc, PT | Name | Michele Vitacca, MD |
mara.paneroni@icsmaugeri.it | michele.vitacca@icsmaugeri.it | ||
Phone | 0039+030+8253 | Phone | 0039+030+8253 |
Phone Extension | 122 | Phone Extension | 182 |
Conditions
Sequence: | 52429186 |
Name | Chronic Obstructive Pulmonary Disease |
Downcase Name | chronic obstructive pulmonary disease |
Id Information
Sequence: | 40342075 |
Id Source | org_study_id |
Id Value | ICS Maugeri CE 2241 |
Countries
Sequence: | 42773619 |
Name | Italy |
Removed | False |
Design Groups
Sequence: | 55879528 | Sequence: | 55879529 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Treatment Group | Title | Control group |
Description | Maximal strenght training (MST) plus endurance training (ET) | Description | Endurance training (ET) |
Interventions
Sequence: | 52738550 | Sequence: | 52738551 |
Intervention Type | Other | Intervention Type | Other |
Name | Maximal strenght training (MST) plus endurance training (ET) | Name | Endurance training (ET) |
Description | Patients will perform an addictive out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions) consisting of:
MST- It will consist of four sets of five repetitions on a leg-press with a focus on the rate of force development during the concentric contraction of the quadriceps from a 90° to legs complete extension. The load will be 85-90% of 1RM. When a patient will be able to perform more than five repetitions in a set, the load will be increased. All strength training will be performed on a seated horizontal leg press. |
Description | Patients will perform a usual out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions). They will perform ET by cycling sessions that will last 40 minutes/each at constant-load, starting from a load intensity corresponding to patient specific AT, assessed during the baseline incremental test. The intensity will be gradually increased during the sessions with a symptom-based progression, according to the protocol by Maltais and coworkers. A 3-min warm-up and cool-down will be provided. Heart rate (HR), blood pressure, oxygen pulsoxymetry, and symptoms by Borg CR10 scale will be monitored at the beginning and end of each session.
Out of the training-days, both groups will continue their normal daily living with modest regular activity, as recommended by their physician. |
Keywords
Sequence: | 80217494 | Sequence: | 80217495 | Sequence: | 80217496 |
Name | rehabilitation | Name | resistive training | Name | exercise |
Downcase Name | rehabilitation | Downcase Name | resistive training | Downcase Name | exercise |
Design Outcomes
Sequence: | 178349218 | Sequence: | 178349219 | Sequence: | 178349220 | Sequence: | 178349221 | Sequence: | 178349222 | Sequence: | 178349223 | Sequence: | 178349224 | Sequence: | 178349225 | Sequence: | 178349226 | Sequence: | 178349227 | Sequence: | 178349228 | Sequence: | 178349229 | Sequence: | 178349230 | Sequence: | 178349231 | Sequence: | 178349232 | Sequence: | 178349233 | Sequence: | 178349234 | Sequence: | 178349235 | Sequence: | 178349236 | Sequence: | 178349237 | Sequence: | 178349238 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in walking efficiency | Measure | Change in Leg Strength by 1-Repetition Maximum on leg press | Measure | Change in maximal Rate of Force Development (RFD) | Measure | Change in maximal effort tolerance | Measure | Change in Constant Load Effort tolerance | Measure | Change in Fatigue (physiological evaluation) | Measure | Change in Fatigue (qualitative evaluation) | Measure | Change in Muscle volume | Measure | Change in Dyspnea | Measure | Concentration of CRP | Measure | Change in Low grade Inflammation | Measure | Concentration of Tumor necrosis factor alpha | Measure | Concentration of Interleukin-6 | Measure | Muscular proteolyses by 3-MeH concentration | Measure | Change in Balance (qualitative measure) | Measure | Change in quality of life | Measure | Patient Satisfaction: Likert Scale | Measure | Change in Falls | Measure | Hospitalizations | Measure | Mortality | Measure | Change in Balance (quantitative measure) |
Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | baseline and 8 weeks | Time Frame | at 8 weeks | Time Frame | baseline and 8 months | Time Frame | baseline and 8 months | Time Frame | baseline and 8 months | Time Frame | baseline and 8 weeks |
Description | The text will be executed using a portable metabolimeter detecting oxygen consumption (VO2).
After a 10 min of warm up on a treadmill, the patient will walk 5 min at submaximal steady state walking at 4.5 km/h at 5% incline. Using the average of VO2 of the last minute of walking, the walking efficiency will be defined as percentage of change as follows: external work accomplished/ energy expenditure x 100. |
Description | 1-Repetition Maximum (1RM) will be evaluated. 1RM will be measured on a horizontal leg press at a knee angle of 90°. 1RM will be recorded as the heaviest lifted load achieved, applying rest periods of ~4 min between test lifts and increments of 5 kg between each trial until failure. | Description | Immediately after the maximal test 1-RM (see above), using the same apparatus, maximal rate of Force Development (RFD) will be assessed using a force platform and applying a load corresponding to 75% of the participant's pre-test 1RM. The subjects will be instructed to execute the lift as rapidly as possible in the concentric phase. RFD will be analyzed as the time difference between 10% and 90% of Peak force. | Description | It will be evaluated by VO2 consumption on maximal cardiopulmonary exercise test (CPET) on cycloergometer | Description | It will be evaluated by evaluated by time of execution of Cardiopulmonary Constant-Load Endurance Test | Description | To define peripheral and central component of fatigue, before and after CLET, the investigators will test the difference on force produced during a single twitch superimposed on the Maximal Voluntary Contraction (MVC) and the force produced by the electrically evoked Resting Twitch (RT) produced, at rest, 5 seconds after the MVC. | Description | Fatigue Severity Scale (scale measuring fatigue, 9-item scale ranging from 7 = absence of fatigue to 63= maximal presence of fatigue) | Description | Sagittal ultrasound images of the Vastus Lateralis (VL) muscle will be recorded with an 8-12 MHz linear transducer. Images will be obtained with a 90° flexion of hip and knee, at 50% of femur length. The pennation angle (hp) of the VL fascicles will be measured as the angle between the VL muscle fascicles and the deep aponeurosis of the insertion. | Description | Barthel Index Dyspnea (scale measuring dyspnea during basal ADL, 10-item scale ranging from 0 = absence of dyspnea to 100 = maximal dyspnea) | Description | C reactive protein [CRP] (mg/dl) | Description | Evaluation of neutrophils/ lymphocytes ratio | Description | TNF-alpha (pg/ml) | Description | IL6 (pg/ml) | Description | Evaluation of urinary 3 Methyl-Histine (3-MeH) (micromol/ml) | Description | BERG scale ( scale measuring balance, composed by 14 balance related tasks, ranging from 0 = worse balance to 56= best balance) | Description | EuroQol 5-D (scale measuring quality of life, composed by 2 sessions: one of 5 questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with multiple choice ranging from 0 = no problem to 25= very low quality of life and one using Visual Analogic Scale (VAS) to quantify the health status ranging from 0 = worst health condition to 100 = best health condition. The two scale sessions are considered separately. | Description | Likert Scale 0-4 ( 0=completely unsatisfied, 4= very satisfied). | Description | Evaluation of the rate of falls | Description | Evaluation of the rate of hospitalizations | Description | Evaluation of deaths (number) | Description | The fall risk (FR) assessment will be evaluated by Balance Board. |
Browse Conditions
Sequence: | 194467913 | Sequence: | 194467914 | Sequence: | 194467915 | Sequence: | 194467916 | Sequence: | 194467917 | Sequence: | 194467918 | Sequence: | 194467919 |
Mesh Term | Lung Diseases, Obstructive | Mesh Term | Pulmonary Disease, Chronic Obstructive | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | lung diseases, obstructive | Downcase Mesh Term | pulmonary disease, chronic obstructive | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48558168 | Sequence: | 48558169 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Istituti Clinici Scientifici Maugeri SpA | Name | Universita di Verona |
Overall Officials
Sequence: | 29419480 |
Role | Principal Investigator |
Name | Mara Paneroni, MSc, PT |
Affiliation | Istituti Clinici Scientifici Maugeri |
Central Contacts
Sequence: | 12076270 | Sequence: | 12076271 |
Contact Type | primary | Contact Type | backup |
Name | Mara Paneroni, MSc, PT | Name | Paola Baiardi, Math |
Phone | 0039+030+8253 | Phone | 0039+0382+592 |
mara.paneroni@icsmaugeri.it | paola.baiardi@icsmaugeri.it | ||
Phone Extension | 122 | Phone Extension | 599 |
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68501762 | Sequence: | 68501763 |
Design Group Id | 55879528 | Design Group Id | 55879529 |
Intervention Id | 52738550 | Intervention Id | 52738551 |
Eligibilities
Sequence: | 30913340 |
Gender | All |
Minimum Age | 50 Years |
Maximum Age | 80 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
COPD clinical definition according to GOLD guidelines with forced expiratory volume (FEV1)/ forced vital capacity (FVC) < 70%, and FEV1 < 50% of predicted Exclusion Criteria: pulmonary diseases other than COPD |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254176376 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 50 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 20 |
Designs
Sequence: | 30659035 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Pilot randomized controlled trial |
Responsible Parties
Sequence: | 29025709 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52339669 | Sequence: | 52339670 | Sequence: | 52339671 | Sequence: | 52339672 |
Pmid | 24787074 | Pmid | 10378915 | Pmid | 17277584 | Pmid | 19804581 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigare R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Respiratory Society statement: update on limb muscle dysfunction in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 May 1;189(9):e15-62. doi: 10.1164/rccm.201402-0373ST. | Citation | Hoff J, Helgerud J, Wisloff U. Maximal strength training improves work economy in trained female cross-country skiers. Med Sci Sports Exerc. 1999 Jun;31(6):870-7. doi: 10.1097/00005768-199906000-00016. | Citation | Hoff J, Tjonna AE, Steinshamn S, Hoydal M, Richardson RS, Helgerud J. Maximal strength training of the legs in COPD: a therapy for mechanical inefficiency. Med Sci Sports Exerc. 2007 Feb;39(2):220-6. doi: 10.1249/01.mss.0000246989.48729.39. | Citation | Wang E, Helgerud J, Loe H, Indseth K, Kaehler N, Hoff J. Maximal strength training improves walking performance in peripheral arterial disease patients. Scand J Med Sci Sports. 2010 Oct;20(5):764-70. doi: 10.1111/j.1600-0838.2009.01014.x. |
]]>
https://zephyrnet.com/NCT03799341
2019-11-13
https://zephyrnet.com/?p=NCT03799341
NCT03799341https://www.clinicaltrials.gov/study/NCT03799341?tab=tableStuart R Steinhauer, PhDStuart.Steinhauer@va.gov(412) 360-2397The proposed work will investigate changes in brain signaling and cognitive functioning that support recovery from addiction, as well as use of pretreatment neurocognitive functioning to inform substance use treatment planning. Substance use disorders are prevalent amongst Veterans. Cocaine addiction, in particular, has been shown to complicate treatment of other high priority behavioral health problems in the Veteran population (e.g., PTSD, opioid addiction). While there are currently no approved medications to support recovery from cocaine addiction, research indicates that Contingency Management (CM) – a behavioral intervention for cocaine users – can be effective. However, individual responses are variable and long-term benefits are limited. This CDA will test a new model of how CM works by examining brain-based predictors and indicators of treatment response. Results will have immediate implications for measurement-based implementation of existing CM variants within the VA, supporting access to the version of CM that is best aligned with each Veteran’s needs.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-03-06 |
Start Month Year | November 13, 2019 |
Primary Completion Month Year | December 31, 2023 |
Verification Month Year | March 2023 |
Verification Date | 2023-03-31 |
Last Update Posted Date | 2023-03-06 |
Detailed Descriptions
Sequence: | 20685817 |
Description | Electrophysiological methods, including event-related potential and functional connectivity approaches, have potential to clarify mechanisms of substance use treatment response and characterize individual differences therein. Veterans are disproportionately affected by disorders of addiction, of which cocaine use disorder (CUD) is particularly problematic due to high relapse rates and the absence of approved pharmacotherapy options. Behavioral interventions for CUD have therefore become an important focus and Contingency Management (CM) has emerged as the best-supported approach. CM involves reinforcing cocaine abstinence (established through objective testing) with reliable, short-term reward, such as chances to win prizes (i.e., Prize-Based CM or PBCM). Given robust empirical support, nationwide dissemination of PBCM has been supported by a VHA initiative since 2011. However, PBCM response rates are variable and long-term benefits are limited – problems magnified by the cost of implementation with respect to staffing and prizes. Measurement-based approaches to PBCM implementation have promise to improve the effectiveness and efficiency of CM programming but have not yet been investigated within the VA or considered in relation to promising neuromarkers. Importantly, two versions of PBCM are already utilized at VA sites and may differentially benefit individuals with distinct neurocognitive profiles. Specifically, VA PBCM programs employ either abstract (voucher prize) or concrete (tangible prize) incentives, the latter of which may more effectively incentivize abstinence in Veterans with poor future-oriented thinking and planning ability. While selection between existing PBCM variants currently reflects practical considerations only, pretreatment neurocognitive functioning could meaningfully and realistically inform clinical decision-making in this regard.
This project aims to advance measurement-based implementation of CM by testing a novel neurocognitive model with immediate implications for the use of abstract versus concrete PBCM incentives within the VA. Specifically, the future-minded decision-making (FMDM) model posits that CM scaffolds future-oriented goal representation and self-control to support abstinence during in the moment use-related decision-making. For individuals with greater FMDM impairment, concrete, readily-accessible incentives may be more effective than abstract voucher-based rewards (which require future-oriented thinking and planning to acquire value). To test this model, neurocognitive substrates of FMDM will be examined as predictors of differential treatment response in voucher (VoucherPBCM) versus tangible prize (TangiblePBCM) versions of PBCM. Treatment-related change in neural and cognitive-behavioral correlates of FMDM will also be evaluated in PBCM-adherent versus non-adherent subgroups. Veterans with CUD will be allocated to VoucherPBCM or TangiblePBCM conditions and followed for a 12-week treatment interval. Pre- and post-treatment electroencephalography (EEG) and cognitive-behavioral assessments will be used to measure FMDM-related constructs (working memory, self-control, future-oriented decision-making, future reward representation) and related neuromarkers. These measures will be investigated as predictors of differential treatment response in VoucherPBCM versus TangiblePBCM, as well as maintenance of gains during a post-treatment follow-up period. Change in FMDM-related neural and cognitive measures over the course of treatment will also be evaluated for evidence of neuroadaptation (e.g., changes in functional connectivity) and enhancement of FMDM function through PBCM. Taken together, results of the current research project will represent a first step toward precision implementation of CM within the VA. |
Facilities
Sequence: | 199669286 |
Status | Recruiting |
Name | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA |
City | Pittsburgh |
State | Pennsylvania |
Zip | 15240 |
Country | United States |
Facility Contacts
Sequence: | 28064311 | Sequence: | 28064312 |
Facility Id | 199669286 | Facility Id | 199669286 |
Contact Type | primary | Contact Type | backup |
Name | Sarah E Forster, PhD | Name | Stuart R Steinhauer, PhD |
Sarah.Forster2@va.gov | Stuart.Steinhauer@va.gov | ||
Phone | 412-360-2365 | Phone | (412) 360-2397 |
Facility Investigators
Sequence: | 18305269 |
Facility Id | 199669286 |
Role | Principal Investigator |
Name | Sarah E. Forster, PhD |
Conditions
Sequence: | 52075941 |
Name | Cocaine Use Disorder |
Downcase Name | cocaine use disorder |
Id Information
Sequence: | 40082978 | Sequence: | 40082979 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | NURA-002-18S | Id Value | CX001807-01A1 |
Id Type | Other Grant/Funding Number | ||
Id Type Description | VA CSR&D | ||
Countries
Sequence: | 42482393 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55489107 | Sequence: | 55489108 |
Group Type | Experimental | Group Type | Experimental |
Title | Tangible Prize-Based Contingency Management (TangiblePBCM) | Title | Voucher Prize-Based Contingency Management (VoucherPBCM) |
Description | For participants assigned to TangiblePBCM, prize draws resulting in one or more small, large, or jumbo wins will result in access to a prize cabinet stocked with small, medium, large, and jumbo financial incentive items. Medium incentive items are included for selection in the event that a patient draws several small prize slips on the same day and are considered equivalent to 4 small prizes. Selection of specific prize items will be informed by patient preference and items will be restocked at least every 2 weeks. The prize cabinet will be open during TangiblePBCM sessions such that prize items are readily visible. Selection of prizes, maintenance of the prize cabinet, and policies regarding prize redemption will follow published guidance on administration of TangiblePBCM within the context of research protocols. | Description | For participants assigned to VoucherPBCM, prize draws resulting in one or more small, large, or jumbo wins will be reinforced with VA Canteen vouchers in the specified incentive range (i.e., small, large, or jumbo). |
Interventions
Sequence: | 52388954 | Sequence: | 52388955 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Prize-Based Contingency Management | Name | Treatment As Usual Outpatient Substance Use Treatment |
Description | Participants assigned to Prize-based Contingency
Management (PBCM) conditions will receive PBCM as an adjunct to TAU. PBCM will involve twice weekly one-on-one sessions with a provider for 12-weeks. During each session, a urine specimen provided by the patient will be tested for cocaine using a point-of-care dip-test. Results of point-of-care testing will be shared with the patient and negative results will be reinforced with draws from a fish bowl containing 500 paper slips, 250 of which award small, large, or jumbo prizes (remaining slips deliver words of encouragement). Patients will be reinforced with a single prize draw for their first negative specimen; an additional prize draw will be added for each consecutive negative result (up to 8 prize draws per session). Abstinence-contingent prize draws will be reset to one upon either a positive test result or unexcused, missed appointment. |
Description | All participants will receive treatment as usual outpatient substance use services during the 12-week treatment interval. TAU will specifically entail recommended participation in at least two outpatient group and/or individual psychotherapy encounters per week within the Center for Treatment of Addictive Disorders (CTAD) at VA Pittsburgh Healthcare System. Participants will additionally continue any previously prescribed pharmacotherapy for substance use and/or other mental health conditions, if applicable. |
Keywords
Sequence: | 79711704 | Sequence: | 79711705 | Sequence: | 79711706 | Sequence: | 79711707 | Sequence: | 79711708 | Sequence: | 79711709 | Sequence: | 79711710 | Sequence: | 79711711 | Sequence: | 79711712 | Sequence: | 79711713 | Sequence: | 79711714 |
Name | Cocaine-Related Disorders | Name | Contingency Management | Name | Reward | Name | Choice Behavior | Name | Executive Function | Name | Precision Medicine | Name | Evidence-Based Practice | Name | Prospective Thinking | Name | Electroencephalography | Name | Event-Related Potentials | Name | Functional Connectivity |
Downcase Name | cocaine-related disorders | Downcase Name | contingency management | Downcase Name | reward | Downcase Name | choice behavior | Downcase Name | executive function | Downcase Name | precision medicine | Downcase Name | evidence-based practice | Downcase Name | prospective thinking | Downcase Name | electroencephalography | Downcase Name | event-related potentials | Downcase Name | functional connectivity |
Design Outcomes
Sequence: | 177054177 | Sequence: | 177054178 | Sequence: | 177054179 | Sequence: | 177054180 | Sequence: | 177054181 | Sequence: | 177054182 | Sequence: | 177054183 | Sequence: | 177054184 | Sequence: | 177054185 | Sequence: | 177054186 | Sequence: | 177054187 | Sequence: | 177054188 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | % Cocaine-Negative Urine Specimens | Measure | Longest Duration of Cocaine Abstinence | Measure | % Contingency Management (CM) Sessions Attended (CM Groups Only) | Measure | Total Non-CM Treatment Encounters | Measure | % Self-Reported Cocaine-Abstinent Days During Treatment | Measure | % Self-Reported Drug- and Alcohol-Abstinent Days During Treatment | Measure | % Self-Reported Stimulant-Abstinent Days at Post-Treatment (CM Groups Only) | Measure | % Self-Reported Drug- and Alcohol-Abstinent Days at Post-Treatment (CM Groups Only) | Measure | Pre- to Post-Treatment Change in Theta Synchronization | Measure | Pre- to Post-Treatment Change in Executive Working Memory | Measure | Pre- to Post-Treatment Change in Episodic Future Thinking Effect (Delay Discounting) | Measure | Pre- to Post-Treatment Change Spontaneous Eyeblink Rate |
Time Frame | 12-Week Treatment Interval | Time Frame | 12-Week Treatment Interval | Time Frame | 12-Week Treatment Interval | Time Frame | 12-Week Treatment Interval | Time Frame | 12-Week Treatment Interval | Time Frame | 12-Week Treatment Interval | Time Frame | 6 Month Post-Treatment Interval | Time Frame | 6 Month Post-Treatment Interval | Time Frame | 12-Week Treatment Interval | Time Frame | 12-Week Treatment Interval | Time Frame | 12-Week Treatment Interval | Time Frame | 12-Week Treatment Interval |
Description | Proportion of urine specimens provided during the 12-week treatment interval that test negative for cocaine. | Description | Longest period of objectively verified abstinence from cocaine during treatment. | Description | Proportion of CM treatment sessions attended. | Description | Number of non-CM treatment encounters during treatment (documented in chart and/or self-reported) | Description | Proportion of self-reported cocaine-abstinent days during the 12-week treatment interval. | Description | Proportion of self-reported drug- and alcohol-abstinent days during the 12-week treatment interval. | Description | Proportion of self-reported stimulant-abstinent days during the 6 month post-treatment interval. | Description | Proportion of self-reported drug- and alcohol-abstinent days during the 6 month post-treatment interval. | Description | Treatment-related change in theta synchronization between anterior cingulate cortex and lateral prefrontal cortex during high conflict events in the Parametric Conflict Flankers task. | Description | Treatment-related change in Brown-Peterson working memory scores. We will specifically use a modified Brown-Peterson test (Auditory Consonant Trigrams) for which both age- and Veteran-specific norms exist. Summary scores for this measure (including 9-, 18-, and 36-second delay conditions) can range from 0-45, with higher scores indicating improved executive working memory performance. | Description | Treatment-related change in the difference in delay discounting slopes (ln(k)) estimated for discounting conditions with and without personally meaningful event tags. | Description | Treatment-related change in spontaneous eyeblink rate at rest. |
Sponsors
Sequence: | 48231043 |
Agency Class | FED |
Lead Or Collaborator | lead |
Name | VA Office of Research and Development |
Overall Officials
Sequence: | 29229791 |
Role | Principal Investigator |
Name | Sarah E. Forster, PhD |
Affiliation | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA |
Central Contacts
Sequence: | 11988926 | Sequence: | 11988927 |
Contact Type | primary | Contact Type | backup |
Name | Sarah E Forster, PhD | Name | Stuart R Steinhauer, PhD |
Phone | (412) 360-2365 | Phone | (412) 360-2397 |
Sarah.Forster2@va.gov | Stuart.Steinhauer@va.gov | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68022635 | Sequence: | 68022636 | Sequence: | 68022637 | Sequence: | 68022638 |
Design Group Id | 55489107 | Design Group Id | 55489108 | Design Group Id | 55489107 | Design Group Id | 55489108 |
Intervention Id | 52388954 | Intervention Id | 52388954 | Intervention Id | 52388955 | Intervention Id | 52388955 |
Eligibilities
Sequence: | 30709974 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 75 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Military Veterans Exclusion Criteria: History of Severe Traumatic Brain Injury, Seizure Disorder, or other Neurological Illness |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253935080 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 75 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 6 |
Number Of Other Outcomes To Measure | 4 |
Designs
Sequence: | 30456565 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Participants will be randomly assigned to receive: (1) 12 weeks of TangiblePBCM (n = 70) or (2) 12 weeks of VoucherPBCM (n = 70). CM recipients will also be followed for 6 months post treatment. The proposed design enables evaluation of CM outcome predictors within 140 CM recipients – both with respect to initial treatment response and longer term (6 month) outcomes. All participants will receive a Baseline Assessment prior to the 12 Week Treatment interval, as well as a Follow-up Assessment at the conclusion of this period. Data from Baseline and Follow-up Assessments will enable longitudinal analysis of treatment-related change in EEG and cognitive-behavioral measures in TangiblePBCM and VoucherPBCM in treatment adherent versus treatment non-adherent subgroups. |
Responsible Parties
Sequence: | 28823039 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799328
2019-05-23
https://zephyrnet.com/?p=NCT03799328
NCT03799328https://www.clinicaltrials.gov/study/NCT03799328?tab=tableNANANAOral immunotherapy (OIT) is a food allergy treatment where small amounts of the food a child is allergic to is eaten and gradually increased over time with the aim to be able to eat a certain amount of the allergen without experiencing an allergic reaction. While this process works in many children there are concerns about safety, feasibility and drop-outs and how to adapt protocols for multiple allergies.
Many OIT trials have targeted approximately 4000mg of single food/day. In these trials up to 40% drop-out. There is evidence much lower doses can have beneficial effects.
The investigators will evaluate if low doses of foods can allow for OIT to multiple foods. This approach may have efficacy against accidental exposure and be able to demonstrate immune changes. This approach may have a low burden of treatment and a low rate of allergic reactions and
<![CDATA[
Studies
Study First Submitted Date | 2018-11-20 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-05-06 |
Start Month Year | May 23, 2019 |
Primary Completion Month Year | January 2025 |
Verification Month Year | May 2022 |
Verification Date | 2022-05-31 |
Last Update Posted Date | 2022-05-06 |
Detailed Descriptions
Sequence: | 20562430 |
Description | This is a single-arm, open label, study of the intervention of low dose multiple-nut OIT in nut allergic children.
After meeting eligibility criteria, participants will have a food challenge to 2-5 nuts. If the oral food challenge is positive, participants will be enrolled in the study to multiple nut OIT. A blood draw and quality of life (QOL) survey will occur at baseline. Participants will have dose escalation visits of the multiple nut OIT every 2 months to a target dose of 30mg of each nut protein. A blood draw and QOL survey will occur at 6 months. Participants will then continue with daily ingestion of the 30mg of each nut protein for 1 year with visits every 3 months. After 18 months from the start of the study, another oral food challenge will be given to participants to assess the change in the maximum tolerated dose of nuts. A blood draw will assess changes in the immune parameters. A QOL survey will occur at 18 months to assess changes in QOL. |
Facilities
Sequence: | 198524681 |
Name | Hospital for Sick Children |
City | Toronto |
State | Ontario |
Zip | M5G1X8 |
Country | Canada |
Conditions
Sequence: | 51761827 |
Name | Food Allergy |
Downcase Name | food allergy |
Id Information
Sequence: | 39831227 |
Id Source | org_study_id |
Id Value | 1000060633 |
Countries
Sequence: | 42230995 |
Name | Canada |
Removed | False |
Design Groups
Sequence: | 55182572 |
Group Type | Experimental |
Title | multi-OIT |
Description | Low dose OIT with multiple allergens |
Interventions
Sequence: | 52082940 |
Intervention Type | Other |
Name | multi-OIT |
Description | low dose OIT to multiple foods |
Design Outcomes
Sequence: | 176059986 | Sequence: | 176059987 | Sequence: | 176059988 | Sequence: | 176059989 | Sequence: | 176059990 | Sequence: | 176059991 | Sequence: | 176059992 | Sequence: | 176059993 | Sequence: | 176059994 | Sequence: | 176059995 | Sequence: | 176059996 | Sequence: | 176059997 | Sequence: | 176059998 | Sequence: | 176059999 | Sequence: | 176060000 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Desensitization to allergic food as assessed by change in maximum tolerated dose in a dichotomous manner | Measure | Immunological change in IgG4 | Measure | Desensitization to allergic food as assessed by change in maximum tolerated dose on a linear scale | Measure | Immunological change in IgG4 | Measure | Desensitization to allergic food as assessed by maximum tolerated dose | Measure | Desensitization to allergic food as assessed by maximum tolerated dose | Measure | Feasibility analysis as assessed by can the patients achieve the maintenance dosing of the allergen mix for OIT | Measure | Feasibility analysis as assessed by drop-out rate | Measure | Incidence of Treatment-Emergent Adverse Events: Safety analysis as assessed by use of epinephrine | Measure | Quality of life scale | Measure | Change in allergen specific IgE, and components | Measure | Basophil activation test | Measure | Skin prick test (SPT) reactivity to the individual nut extracts | Measure | High content functional immune profiling via mass cytometry and single cell sorting | Measure | Number of participants with treatment related adverse effects |
Time Frame | month 0, month 18 | Time Frame | month 0, month 18 | Time Frame | month 0, month 18 | Time Frame | pre-study, month 18 | Time Frame | month 18 | Time Frame | month 0, month 18 | Time Frame | month 18 | Time Frame | month 18 | Time Frame | month 18 | Time Frame | month 0, month 18 | Time Frame | month 0, month 18 | Time Frame | month 0, month 18 | Time Frame | month 0, month 18 | Time Frame | pre-study, month 18 | Time Frame | month 0, month 18 |
Description | Change in how much nuts the participant can eat without an allergic reaction after the low dose OIT assessed as dichotomous did the participant reach 5 times the baseline eliciting dose | Description | Change in allergen specific immunoglobulin G4 (IgG4) from baseline to end | Description | A continuous variable amount tolerated at baseline vs at end | Description | Change in IgG4 from measures from historical data to 18 month of study. Some patients will have historical IgG4 values to compare | Description | Did they reach 300mg (cumulative) on the 18 month exit oral food challenge | Description | Did they reach 140mg (cumulative) on the 18 month exit oral food challenge | Description | Proportion who achieve maintenance doses of their allergen mix (descriptive) | Description | Proportion who drop-out of the study (descriptive) | Description | Administration of epinephrine; (descriptive); | Description | Change in quality of life at 18m of children compared to baseline assessment (using validated questionnaire: Food allergy quality of life questionnaires (FAQLQ) FAQLQ Parental form (PF) for ages 0-12 OR the FAQLQ-teenager form (TF) using total score. The FAQLQ total and domain scores range from 1-7 with higher scores indicative of worse health related quality of life with the total score being the average of the domain scores. The domains include Emotional Impact, Social and Dietary Restrictions, Food Anxiety, Allergen Avoidance, and Risk of Accidental Exposure. | Description | Change in allergen specific IgE, and components via microarray | Description | Basophil activation test | Description | The size of the skin prick test will be compared | Description | Compare the change in the immune pattern | Description | Diaries will be analyzed for allergic symptoms and tabulated |
Browse Conditions
Sequence: | 191834671 | Sequence: | 191834672 | Sequence: | 191834673 | Sequence: | 191834674 |
Mesh Term | Hypersensitivity | Mesh Term | Food Hypersensitivity | Mesh Term | Immune System Diseases | Mesh Term | Hypersensitivity, Immediate |
Downcase Mesh Term | hypersensitivity | Downcase Mesh Term | food hypersensitivity | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | hypersensitivity, immediate |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47938447 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | The Hospital for Sick Children |
Overall Officials
Sequence: | 29045136 |
Role | Principal Investigator |
Name | Julia Upton |
Affiliation | The Hospital for Sick Children |
Design Group Interventions
Sequence: | 67652690 |
Design Group Id | 55182572 |
Intervention Id | 52082940 |
Eligibilities
Sequence: | 30525763 |
Gender | All |
Minimum Age | 6 Months |
Maximum Age | 15 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Relevant allergy to 2-5 nuts Exclusion Criteria: History of frequent or repeated, severe or life-threatening episodes of anaphylactic shock |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254091700 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 6 |
Maximum Age Num | 15 |
Minimum Age Unit | Months |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 4 |
Number Of Other Outcomes To Measure | 9 |
Designs
Sequence: | 30274672 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Provided Documents
Sequence: | 2565148 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2018-11-13 |
Url | https://ClinicalTrials.gov/ProvidedDocs/28/NCT03799328/Prot_SAP_000.pdf |
Responsible Parties
Sequence: | 28654595 |
Responsible Party Type | Principal Investigator |
Name | Julia Upton |
Title | Principal Investigator |
Affiliation | The Hospital for Sick Children |
]]>
https://zephyrnet.com/NCT03799315
2019-01-14
https://zephyrnet.com/?p=NCT03799315
NCT03799315https://www.clinicaltrials.gov/study/NCT03799315?tab=tableNANANASmoking rates remain above 60% for individuals involved in the criminal justice system and contribute to elevated mortality rates in this population. Addressing smoking disparities among justice-involved individuals is a critical public health issue in Minnesota, one of a few states with rising incarceration rates. People who are incarcerated represent the intersection of multiple high-priority populations (disproportionately African-American, Native American, low-income, homeless, on Medicaid, and suffering from mental illness and substance use disorders). This study examines the impact of a smoking cessation intervention for individuals discharged from jail to the community on smoking abstinence. Participants will be randomized to either 1) guideline-based, in-person smoking cessation counseling during incarceration, telephone counseling after incarceration, and nicotine replacement, or 2) enhanced treatment as usual. This study’s findings will be used to develop a larger, multi-site study that is fully powered to measure longer-term health and smoking cessation outcomes.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-09-14 |
Start Month Year | January 14, 2019 |
Primary Completion Month Year | March 16, 2020 |
Verification Month Year | September 2020 |
Verification Date | 2020-09-30 |
Last Update Posted Date | 2020-09-14 |
Detailed Descriptions
Sequence: | 20735760 |
Description | Outcome assessments will be conducted for both arms at 1 week, 3 weeks, and 12 weeks post discharge from jail. During these assessments, seven-day point prevalence abstinence will be bio-verified with exhaled carbon monoxide, and self-reported general health, physical health, mental health, and substance use measures will also be obtained. The analysis is fully powered (i.e., power > .8) to detect significant between group effects on the primary outcome (i.e., the longitudinal, between group effect on bio-verified seven-day point prevalence abstinence over the 3 weeks post discharge). All analyses will be conducted on the intent to treat sample and will utilize pre-specified logistic and linear regression models. |
Facilities
Sequence: | 200244169 |
Name | Hennepin Healthcare Research Institute |
City | Minneapolis |
State | Minnesota |
Zip | 55415 |
Country | United States |
Browse Interventions
Sequence: | 96113049 | Sequence: | 96113050 | Sequence: | 96113051 | Sequence: | 96113052 | Sequence: | 96113053 | Sequence: | 96113054 | Sequence: | 96113055 | Sequence: | 96113056 | Sequence: | 96113057 | Sequence: | 96113058 |
Mesh Term | Nicotine | Mesh Term | Ganglionic Stimulants | Mesh Term | Autonomic Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Nicotinic Agonists | Mesh Term | Cholinergic Agonists | Mesh Term | Cholinergic Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | nicotine | Downcase Mesh Term | ganglionic stimulants | Downcase Mesh Term | autonomic agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | nicotinic agonists | Downcase Mesh Term | cholinergic agonists | Downcase Mesh Term | cholinergic agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52208079 |
Name | Tobacco Use |
Downcase Name | tobacco use |
Id Information
Sequence: | 40186125 |
Id Source | org_study_id |
Id Value | RC-2018-0013 |
Countries
Sequence: | 42599618 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55634631 | Sequence: | 55634632 |
Group Type | Experimental | Group Type | No Intervention |
Title | Jail-Based Use of Smoking Cessation Treatment (JUST) | Title | Enhanced Treatment As Usual (TAU) |
Description | Participants will receive guidline-based smoking cessation counseling while in jail and phone-based smoking cessation counseling sessions and nicotine lozenges after release from jail. | Description | Participants will receive the usual, limited smoking cessation treatment while in jail, plus an additional health and wellness education session in jail. Nicotine lozenges will be offered at the end of the study to those who did not quit smoking. |
Interventions
Sequence: | 52522046 | Sequence: | 52522047 |
Intervention Type | Drug | Intervention Type | Behavioral |
Name | Nicotine Replacement Therapy | Name | Counseling |
Description | All participants randomized to the JUST group will receive training on proper use of nicotine lozenges to aid in smoking cessation. Upon release from jail, participants will receive 2mg nicotine lozenges. | Description | All participants randomized to the JUST group will receive one hour of in-person, individual, guideline-based smoking cessation counseling during their jail stay. Upon release from jail, they will receive four 30-minute counseling phone calls over 3 weeks. These phone calls will take place at 24 hours, day 7, day 14, and day 20. |
Keywords
Sequence: | 79922895 | Sequence: | 79922896 | Sequence: | 79922897 | Sequence: | 79922898 | Sequence: | 79922899 |
Name | Incarceration | Name | Smoking | Name | Counseling | Name | Nicotine Replacement | Name | Disparities |
Downcase Name | incarceration | Downcase Name | smoking | Downcase Name | counseling | Downcase Name | nicotine replacement | Downcase Name | disparities |
Design Outcomes
Sequence: | 177511092 | Sequence: | 177511093 | Sequence: | 177511094 | Sequence: | 177511095 | Sequence: | 177511096 | Sequence: | 177511097 | Sequence: | 177511098 | Sequence: | 177511099 | Sequence: | 177511100 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Bioverified 7-day point prevalence abstinence from smoking | Measure | Time to Lapse | Measure | Time to Relapse | Measure | Bio-verified 7-day point prevalence abstinence from smoking | Measure | Health-related quality of life | Measure | Depressive symptoms | Measure | Self-Reported Affect | Measure | Health care utilization | Measure | Substance abuse |
Time Frame | Over 3 weeks | Time Frame | 1 week, 3 weeks, 12 weeks | Time Frame | 3 weeks, 12 weeks | Time Frame | Over 12 weeks | Time Frame | 1 week, 3 weeks, 12 weeks | Time Frame | 1 week, 3 weeks, 12 weeks | Time Frame | 1 week, 3 weeks, 12 weeks | Time Frame | 1 week, 3 weeks, 12 weeks | Time Frame | 1 week, 3 weeks, 12 weeks |
Description | Bioverified 7-day point prevalence abstinence from smoking | Description | Days to first lapse (i.e., any cigarette use, even a puff) | Description | Days to first relapse | Description | Bioverified 7-day point prevalence abstinence from smoking | Description | Self-Reported health using the SF-12 total score and physical and mental health composite scores. Lower scores indicate worse health. | Description | The 10 item Center for Epidemiologic Studies Depression Scale (CESD-10) ranges from 0-30 with higher scores indicating higher depression symptoms. | Description | 10-item Positive and Negative Affect Scales (PANAS). The 5-item positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect. The 5-item negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect. | Description | Self-reported hospitalizations and use of the emergency department | Description | Self-reported substance abuse using the Drug Abuse Screening Test-10. Higher scores indicate more severe drug abuse. |
Sponsors
Sequence: | 48353668 | Sequence: | 48353669 | Sequence: | 48353670 |
Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Hennepin Healthcare Research Institute | Name | Hennepin County Adult Detention Center | Name | Brown University |
Design Group Interventions
Sequence: | 68199155 | Sequence: | 68199156 |
Design Group Id | 55634631 | Design Group Id | 55634631 |
Intervention Id | 52522046 | Intervention Id | 52522047 |
Eligibilities
Sequence: | 30786852 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 64 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Use of ≥ 1 cigarette per day prior to incarceration Exclusion Criteria: Active tuberculosis |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253989600 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 14 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 64 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30532922 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28899216 |
Responsible Party Type | Principal Investigator |
Name | Tyler Winkelman |
Title | Clinician-Investigator |
Affiliation | Hennepin Healthcare Research Institute |
Study References
Sequence: | 52103034 | Sequence: | 52103035 | Sequence: | 52103036 | Sequence: | 52103037 | Sequence: | 52103038 | Sequence: | 52103039 | Sequence: | 52103040 | Sequence: | 52103041 | Sequence: | 52103042 | Sequence: | 52103043 | Sequence: | 52103044 | Sequence: | 52103045 | Sequence: | 52103046 | Sequence: | 52103047 | Sequence: | 52103048 | Sequence: | 52103049 | Sequence: | 52103050 | Sequence: | 52103051 | Sequence: | 52103052 | Sequence: | 52103053 | Sequence: | 52103054 | Sequence: | 52103055 | Sequence: | 52103056 | Sequence: | 52103057 |
Pmid | 27832052 | Pmid | 30635028 | Pmid | 28116579 | Pmid | 25097186 | Pmid | 27638837 | Pmid | 28323472 | Pmid | 29309230 | Pmid | 24817280 | Pmid | 21974746 | Pmid | 23567902 | Pmid | 11716663 | Pmid | 22160762 | Pmid | 12915172 | Pmid | 26069036 | Pmid | 28415979 | Pmid | 27798322 | Pmid | 21802731 | Pmid | 18381994 | Pmid | 20509891 | Pmid | 34228127 | ||||||||
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | derived |
Citation | Jamal A, King BA, Neff LJ, Whitmill J, Babb SD, Graffunder CM. Current Cigarette Smoking Among Adults – United States, 2005-2015. MMWR Morb Mortal Wkly Rep. 2016 Nov 11;65(44):1205-1211. doi: 10.15585/mmwr.mm6544a2. | Citation | Winkelman TNA, Vickery KD, Busch AM. Tobacco use among non-elderly adults with and without criminal justice involvement in the past year: United States, 2008-2016. Addict Sci Clin Pract. 2019 Jan 11;14(1):2. doi: 10.1186/s13722-019-0131-y. | Citation | Puljevic C, Kinner SA, de Andrade D. Extending smoking abstinence after release from smoke-free prisons: protocol for a randomised controlled trial. Health Justice. 2017 Dec;5(1):1. doi: 10.1186/s40352-016-0046-6. Epub 2017 Jan 23. | Citation | Binswanger IA, Carson EA, Krueger PM, Mueller SR, Steiner JF, Sabol WJ. Prison tobacco control policies and deaths from smoking in United States prisons: population based retrospective analysis. BMJ. 2014 Aug 5;349:g4542. doi: 10.1136/bmj.g4542. | Citation | Travis J, Western B, Redburn S, eds. The Growth of Incarceration in the United States: Exploring Causes and Consequences. Washington, D.C.: The National Academies Press; 2014. doi:10.17226/18613. | Citation | Winkelman TN, Kieffer EC, Goold SD, Morenoff JD, Cross K, Ayanian JZ. Health Insurance Trends and Access to Behavioral Healthcare Among Justice-Involved Individuals-United States, 2008-2014. J Gen Intern Med. 2016 Dec;31(12):1523-1529. doi: 10.1007/s11606-016-3845-5. | Citation | Winkelman TN, Choi H, Davis MM. The Affordable Care Act, Insurance Coverage, and Health Care Utilization of Previously Incarcerated Young Men: 2008-2015. Am J Public Health. 2017 May;107(5):807-811. doi: 10.2105/AJPH.2017.303703. Epub 2017 Mar 21. | Citation | Vickery KD, Bodurtha P, Winkelman TNA, Hougham C, Owen R, Legler MS, Erickson E, Davis MM. Cross-Sector Service Use Among High Health Care Utilizers In Minnesota After Medicaid Expansion. Health Aff (Millwood). 2018 Jan;37(1):62-69. doi: 10.1377/hlthaff.2017.0991. | Citation | Frank JW, Linder JA, Becker WC, Fiellin DA, Wang EA. Increased hospital and emergency department utilization by individuals with recent criminal justice involvement: results of a national survey. J Gen Intern Med. 2014 Sep;29(9):1226-33. doi: 10.1007/s11606-014-2877-y. Epub 2014 May 10. | Citation | Clarke JG, Martin RA, Stein L, Lopes CE, Mello J, Friedmann P, Bock B. Working Inside for Smoking Elimination (Project W.I.S.E.) study design and rationale to prevent return to smoking after release from a smoke free prison. BMC Public Health. 2011 Oct 5;11:767. doi: 10.1186/1471-2458-11-767. | Citation | Clarke JG, Stein LA, Martin RA, Martin SA, Parker D, Lopes CE, McGovern AR, Simon R, Roberts M, Friedman P, Bock B. Forced smoking abstinence: not enough for smoking cessation. JAMA Intern Med. 2013 May 13;173(9):789-94. doi: 10.1001/jamainternmed.2013.197. | Citation | Mulder I, Tijhuis M, Smit HA, Kromhout D. Smoking cessation and quality of life: the effect of amount of smoking and time since quitting. Prev Med. 2001 Dec;33(6):653-60. doi: 10.1006/pmed.2001.0941. | Citation | Piper ME, Kenford S, Fiore MC, Baker TB. Smoking cessation and quality of life: changes in life satisfaction over 3 years following a quit attempt. Ann Behav Med. 2012 Apr;43(2):262-70. doi: 10.1007/s12160-011-9329-2. | Citation | Lemon SC, Friedmann PD, Stein MD. The impact of smoking cessation on drug abuse treatment outcome. Addict Behav. 2003 Sep;28(7):1323-31. doi: 10.1016/s0306-4603(02)00259-9. | Citation | Thurgood SL, McNeill A, Clark-Carter D, Brose LS. A Systematic Review of Smoking Cessation Interventions for Adults in Substance Abuse Treatment or Recovery. Nicotine Tob Res. 2016 May;18(5):993-1001. doi: 10.1093/ntr/ntv127. Epub 2015 Jun 11. | Citation | Busch AM, Tooley EM, Dunsiger S, Chattillion EA, Srour JF, Pagoto SL, Kahler CW, Borrelli B. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial. BMC Public Health. 2017 Apr 17;17(1):323. doi: 10.1186/s12889-017-4250-7. | Citation | A randomised controlled study of the Health Intervention "SNAP" in Northern Territory prisons- where smoking is banned- to prevent relapse to smoking. Trial Review. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371923. Published October 10, 2017. Accessed December 29, 2017. | Citation | de Andrade D, Kinner SA. Systematic review of health and behavioural outcomes of smoking cessation interventions in prisons. Tob Control. 2016 Sep;26(5):495-501. doi: 10.1136/tobaccocontrol-2016-053297. Epub 2016 Oct 18. | Citation | Fiore MC, Jaen CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service; 2008. https://bphc.hrsa.gov/buckets/treatingtobacco.pdf. Accessed October 17, 2017. | Citation | Prisoner Research FAQs. HHS.gov. https://www.hhs.gov/ohrp/regulations-andpolicy/ guidance/faq/prisoner-research/index.html. Accessed December 18, 2017. | Citation | Binswanger IA, Nowels C, Corsi KF, Long J, Booth RE, Kutner J, Steiner JF. "From the prison door right to the sidewalk, everything went downhill," a qualitative study of the health experiences of recently released inmates. Int J Law Psychiatry. 2011 Jul-Aug;34(4):249-55. doi: 10.1016/j.ijlp.2011.07.002. Epub 2011 Jul 29. | Citation | Wang EA, White MC, Jamison R, Goldenson J, Estes M, Tulsky JP. Discharge planning and continuity of health care: findings from the San Francisco County Jail. Am J Public Health. 2008 Dec;98(12):2182-4. doi: 10.2105/AJPH.2007.119669. Epub 2008 Apr 1. | Citation | Wang EA, Green J. Incarceration as a key variable in racial disparities of asthma prevalence. BMC Public Health. 2010 May 28;10:290. doi: 10.1186/1471-2458-10-290. | Citation | Winkelman TNA, Ford BR, Dunsiger S, Chrastek M, Cameron S, Strother E, Bock BC, Busch AM. Feasibility and Acceptability of a Smoking Cessation Program for Individuals Released From an Urban, Pretrial Jail: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2115687. doi: 10.1001/jamanetworkopen.2021.15687. |
]]>
https://zephyrnet.com/NCT03799302
2018-08-01
https://zephyrnet.com/?p=NCT03799302
NCT03799302https://www.clinicaltrials.gov/study/NCT03799302?tab=tableTed Donahuetedd@oslc.org541-285-2711This study aims to test the impact of an empirically derived implementation strategy-under real-world conditions and across multiple child service systems-on successful adoption and sustainment of two evidence-based programs that address adolescent substance abuse: Treatment Foster Care Oregon (TFCO; formerly Multidimensional Treatment Foster Care) and Multidimensional Family Therapy (MDFT), both developed with funding from NIDA. Methods for this study utilize “technology-based approaches” for “implementing large-scale change.” Leveraging previous data focused on developing and testing the 8-staged Stages of Implementation Completion (SIC) tool, a randomized evaluation of a SIC Coaching Strategy (SIC-CS) is proposed. Study activities include extending the SIC into the Sustainment Phase and testing the SIC-CS to support the adoption of new evidence-based programs.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-13 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-07-22 |
Start Month Year | August 1, 2018 |
Primary Completion Month Year | January 2023 |
Verification Month Year | July 2022 |
Verification Date | 2022-07-31 |
Last Update Posted Date | 2022-07-22 |
Facilities
Sequence: | 199189122 |
Status | Recruiting |
Name | Oregon Social Learning Center |
City | Eugene |
State | Oregon |
Zip | 97401 |
Country | United States |
Facility Contacts
Sequence: | 28003923 | Sequence: | 28003924 |
Facility Id | 199189122 | Facility Id | 199189122 |
Contact Type | primary | Contact Type | backup |
Name | Courtenay Padgett | Name | Lisa Saldana, PhD |
courtp@oslc.org | lisas@oslc.org | ||
Phone | 541-485-2711 | Phone | 541-485-2711 |
Facility Investigators
Sequence: | 18267812 |
Facility Id | 199189122 |
Role | Principal Investigator |
Name | Lisa Saldana, PhD |
Conditions
Sequence: | 51953393 |
Name | Evidence Based Practice |
Downcase Name | evidence based practice |
Id Information
Sequence: | 39989609 |
Id Source | org_study_id |
Id Value | R01DA044745 |
Id Type | U.S. NIH Grant/Contract |
Id Link | https://reporter.nih.gov/quickSearch/R01DA044745 |
Countries
Sequence: | 42380514 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55353391 | Sequence: | 55353392 |
Group Type | No Intervention | Group Type | Experimental |
Title | Standard Consultation | Title | SIC Coaching Consultation |
Description | Sites in this arm will receive the standard consultation from the TFCO or MDFT purveyors | Description | In addition to the standard consultation from the TFCO or MDFT purveyors, sites in this arm will also receive feedback on how they are doing in terms of completing expected activities in their efforts to implement the designated EBP. |
Interventions
Sequence: | 52265626 |
Intervention Type | Behavioral |
Name | SIC Coaching |
Description | Sites receiving consultation to implement either TFCO or MDFT will also receive consultation on their implementation fidelity as measured and tracked by the SIC. |
Design Outcomes
Sequence: | 176606146 |
Outcome Type | primary |
Measure | Stages of Implementation Completion (SIC) |
Time Frame | Baseline through month 60 |
Description | The SIC is an 8-stage observational assessment tool recording organizational site completion of implementation activities that map onto the three phases of implementation (Pre-Implementation, Implementation, Sustainability). |
Sponsors
Sequence: | 48115544 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Oregon Social Learning Center |
Overall Officials
Sequence: | 29160890 |
Role | Principal Investigator |
Name | Lisa Saldana, PHD |
Affiliation | Oregon Social Learning Center |
Central Contacts
Sequence: | 11959552 | Sequence: | 11959553 |
Contact Type | primary | Contact Type | backup |
Name | Lisa Saldana | Name | Ted Donahue |
Phone | 541-485-2711 | Phone | 541-285-2711 |
lisas@oslc.org | tedd@oslc.org | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 67857640 |
Design Group Id | 55353392 |
Intervention Id | 52265626 |
Eligibilities
Sequence: | 30637058 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Senior leadership staff from teams that either currently are sustaining or who achieve 1-year sustainment post certification during the first year of the project Exclusion Criteria: none |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254132236 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30383992 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28750727 |
Responsible Party Type | Principal Investigator |
Name | Lisa Saldana |
Title | Principal Investigator |
Affiliation | Oregon Social Learning Center |
]]>
https://zephyrnet.com/NCT03799289
2019-01-03
https://zephyrnet.com/?p=NCT03799289
NCT03799289https://www.clinicaltrials.gov/study/NCT03799289?tab=tableNANANAThe purpose of this study is to examine two approaches for improving long-term weight loss success. All participants will receive a 12-week, in-person standard behavioral weight loss program followed by either 12 weeks of yoga instruction or 12 weeks of cooking/dietary education instruction (determined via randomization procedures). Assessments of weight, physical activity, dietary behaviors, and psychosocial factors will occur at baseline, 3, and 6 months.
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Studies
Study First Submitted Date | 2018-12-05 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-10-28 |
Start Month Year | January 3, 2019 |
Primary Completion Month Year | June 18, 2020 |
Verification Month Year | June 2021 |
Verification Date | 2021-06-30 |
Last Update Posted Date | 2021-10-28 |
Results First Posted Date | 2021-10-28 |
Detailed Descriptions
Sequence: | 20559316 |
Description | Behavioral weight loss (WL) programs result in clinically significant weight losses; however rates of long-term WL maintenance are poor. Previous studies suggest that long-term WL success may require an enhanced ability to overcome physiological and hedonic urges to eat and an improved capacity for dealing with life stressors, negative mood states, and food cravings. Thus interventions which target stress reduction and reduce the tendency to use food as a coping strategy for aversive experiences may offer a protective effect against dietary lapses; thereby improving long-term WL outcomes. Yoga is a mind-body intervention which reduces stress and improves overall physical and psychological well-being and offers promise for strengthening the psychological skill set needed for maintaining important weight-related behaviors long-term. The physical and cognitive skills practiced within yoga target multiple underlying psychological processes (e.g., mindfulness, distress tolerance) which could reduce emotional eating, improve dietary choices, and enhance one's ability to tolerate food cravings or hedonic urges to eat. While yoga is an effective treatment approach for other chronic health conditions, it has not been examined as a potential intervention for improving long-term WL outcomes. Within the context of the obesity field, yoga has been viewed as a mode of exercise and not necessarily as a mind-body intervention approach (as is the case in other fields). Thus, given the lower caloric expenditure of yoga in comparison to many forms of aerobic exercise, the effect of yoga on important weight- related processes and behaviors has not been examined.
The primary aims of this study are to examine the feasibility and acceptability of implementing yoga within a weight management program. Secondary aims focus on examining the impact of yoga, relative to a cooking/dietary education intervention (matched for contact time) on important psychological constructs (perceived stress, mindfulness, and distress tolerance) and weight. Sixty women with overweight or obesity will be randomly assigned to a 12-week standard behavioral WL program, followed by either 12 weeks of group-based yoga or 12 weeks of cooking/dietary information classes. Both groups will be instructed to self-monitor and achieve the dietary and aerobic exercise goals throughout the 24-week program. Primary assessments will occur at baseline and weeks 12 and 24. |
Facilities
Sequence: | 198498215 |
Name | Weight Control and Diabetes Research Center |
City | Providence |
State | Rhode Island |
Zip | 02903 |
Country | United States |
Conditions
Sequence: | 51754237 |
Name | Obesity |
Downcase Name | obesity |
Id Information
Sequence: | 39825469 | Sequence: | 39825470 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 2096-18 | Id Value | R03DK115978-01A1 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/R03DK115978-01A1 |
Countries
Sequence: | 42225517 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55175384 | Sequence: | 55175385 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Iyengar Yoga | Title | Cooking/dietary education |
Description | Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed. | Description | Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations. |
Interventions
Sequence: | 52075617 | Sequence: | 52075618 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Behavioral weight loss followed by yoga instruction | Name | Behavioral weight loss followed by cooking/dietary education instruction |
Description | 12-week standard behavioral weight loss program followed by a 12-week yoga intervention | Description | 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention |
Keywords
Sequence: | 79182957 | Sequence: | 79182958 | Sequence: | 79182959 | Sequence: | 79182960 | Sequence: | 79182961 |
Name | Obesity | Name | Weight loss | Name | physical activity | Name | yoga | Name | exercise |
Downcase Name | obesity | Downcase Name | weight loss | Downcase Name | physical activity | Downcase Name | yoga | Downcase Name | exercise |
Design Outcomes
Sequence: | 176033855 | Sequence: | 176033856 | Sequence: | 176033857 | Sequence: | 176033858 | Sequence: | 176033859 | Sequence: | 176033860 | Sequence: | 176033861 | Sequence: | 176033862 | Sequence: | 176033863 | Sequence: | 176033864 | Sequence: | 176033865 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Program Satisfaction Ratings | Measure | Intervention Session Attendance | Measure | Feasibility of the Intervention (Retention) | Measure | Changes in Perceived Stress (Measured Via the Perceived Stress Scale) | Measure | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Observing Subscale | Measure | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Describing Subscale | Measure | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Acting With Awareness Subscale | Measure | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-judgmental Inner Critic Subscale | Measure | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-reactivity Subscale | Measure | Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale) | Measure | Change in Weight |
Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks |
Description | Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied) | Description | Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100). | Description | Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment | Description | Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased. | Description | The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased. | Description | Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss. |
Browse Conditions
Sequence: | 191805387 | Sequence: | 191805388 | Sequence: | 191805389 |
Mesh Term | Weight Loss | Mesh Term | Body Weight | Mesh Term | Body Weight Changes |
Downcase Mesh Term | weight loss | Downcase Mesh Term | body weight | Downcase Mesh Term | body weight changes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47931499 | Sequence: | 47931500 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | The Miriam Hospital | Name | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Overall Officials
Sequence: | 29041257 |
Role | Principal Investigator |
Name | Jessica Unick, PhD |
Affiliation | The Miriam Hospital's Weight Control & Diabetes Research Center |
Design Group Interventions
Sequence: | 67643575 | Sequence: | 67643576 |
Design Group Id | 55175384 | Design Group Id | 55175385 |
Intervention Id | 52075617 | Intervention Id | 52075618 |
Eligibilities
Sequence: | 30521601 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
BMI 25-40 kg/m2 Exclusion Criteria: Presence of any condition that would limit one's ability to exercise or lose weight safely |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254081799 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 17 |
Were Results Reported | True |
Months To Report Results | 14 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30270614 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Milestones
Sequence: | 40739741 | Sequence: | 40739742 | Sequence: | 40739743 | Sequence: | 40739744 | Sequence: | 40739745 | Sequence: | 40739746 | Sequence: | 40739747 | Sequence: | 40739748 | Sequence: | 40739749 | Sequence: | 40739750 | Sequence: | 40739751 | Sequence: | 40739752 |
Result Group Id | 55809366 | Result Group Id | 55809367 | Result Group Id | 55809366 | Result Group Id | 55809367 | Result Group Id | 55809366 | Result Group Id | 55809367 | Result Group Id | 55809366 | Result Group Id | 55809367 | Result Group Id | 55809366 | Result Group Id | 55809367 | Result Group Id | 55809366 | Result Group Id | 55809367 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Initial Weight Loss Program (Weeks 1-12) | Period | Initial Weight Loss Program (Weeks 1-12) | Period | Initial Weight Loss Program (Weeks 1-12) | Period | Initial Weight Loss Program (Weeks 1-12) | Period | Initial Weight Loss Program (Weeks 1-12) | Period | Initial Weight Loss Program (Weeks 1-12) | Period | Maintenance Intervention (Weeks 13-24) | Period | Maintenance Intervention (Weeks 13-24) | Period | Maintenance Intervention (Weeks 13-24) | Period | Maintenance Intervention (Weeks 13-24) | Period | Maintenance Intervention (Weeks 13-24) | Period | Maintenance Intervention (Weeks 13-24) |
Count | 30 | Count | 30 | Count | 24 | Count | 27 | Count | 6 | Count | 3 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 0 | Count | 0 |
Participant Flows
Sequence: | 3896129 |
Outcome Counts
Sequence: | 73491903 | Sequence: | 73491904 | Sequence: | 73491905 | Sequence: | 73491906 | Sequence: | 73491907 | Sequence: | 73491908 | Sequence: | 73491909 | Sequence: | 73491910 | Sequence: | 73491911 | Sequence: | 73491912 | Sequence: | 73491913 | Sequence: | 73491914 | Sequence: | 73491915 | Sequence: | 73491916 | Sequence: | 73491917 | Sequence: | 73491918 | Sequence: | 73491919 | Sequence: | 73491920 | Sequence: | 73491921 | Sequence: | 73491922 | Sequence: | 73491923 | Sequence: | 73491924 |
Outcome Id | 30592640 | Outcome Id | 30592640 | Outcome Id | 30592641 | Outcome Id | 30592641 | Outcome Id | 30592642 | Outcome Id | 30592642 | Outcome Id | 30592643 | Outcome Id | 30592643 | Outcome Id | 30592644 | Outcome Id | 30592644 | Outcome Id | 30592645 | Outcome Id | 30592645 | Outcome Id | 30592646 | Outcome Id | 30592646 | Outcome Id | 30592647 | Outcome Id | 30592647 | Outcome Id | 30592648 | Outcome Id | 30592648 | Outcome Id | 30592649 | Outcome Id | 30592649 | Outcome Id | 30592650 | Outcome Id | 30592650 |
Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 | Count | 24 | Count | 27 |
Provided Documents
Sequence: | 2564033 | Sequence: | 2564034 |
Document Type | Study Protocol and Statistical Analysis Plan | Document Type | Informed Consent Form |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | True |
Has Sap | True | Has Sap | False |
Document Date | 2020-05-16 | Document Date | 2019-05-03 |
Url | https://ClinicalTrials.gov/ProvidedDocs/89/NCT03799289/Prot_SAP_002.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/89/NCT03799289/ICF_000.pdf |
Reported Event Totals
Sequence: | 27759742 | Sequence: | 27759743 | Sequence: | 27759744 | Sequence: | 27759745 | Sequence: | 27759746 | Sequence: | 27759747 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 24 | Subjects At Risk | 24 | Subjects At Risk | 24 | Subjects At Risk | 27 | Subjects At Risk | 27 | Subjects At Risk | 27 |
Created At | 2023-08-06 13:09:20.552364 | Created At | 2023-08-06 13:09:20.552364 | Created At | 2023-08-06 13:09:20.552364 | Created At | 2023-08-06 13:09:20.552364 | Created At | 2023-08-06 13:09:20.552364 | Created At | 2023-08-06 13:09:20.552364 |
Updated At | 2023-08-06 13:09:20.552364 | Updated At | 2023-08-06 13:09:20.552364 | Updated At | 2023-08-06 13:09:20.552364 | Updated At | 2023-08-06 13:09:20.552364 | Updated At | 2023-08-06 13:09:20.552364 | Updated At | 2023-08-06 13:09:20.552364 |
Responsible Parties
Sequence: | 28650760 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3826873 |
Pi Employee | No |
Result Contacts
Sequence: | 3826838 |
Organization | The Miriam Hospital |
Name | Jessica Unick, PD (Principal Investigator) |
Phone | 401-793-8966 |
junick@lifespan.org | |
Outcomes
Sequence: | 30592640 | Sequence: | 30592641 | Sequence: | 30592642 | Sequence: | 30592643 | Sequence: | 30592644 | Sequence: | 30592645 | Sequence: | 30592646 | Sequence: | 30592647 | Sequence: | 30592648 | Sequence: | 30592649 | Sequence: | 30592650 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Program Satisfaction Ratings | Title | Intervention Session Attendance | Title | Feasibility of the Intervention (Retention) | Title | Changes in Perceived Stress (Measured Via the Perceived Stress Scale) | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Observing Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Describing Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Acting With Awareness Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-judgmental Inner Critic Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-reactivity Subscale | Title | Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale) | Title | Change in Weight |
Description | Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied) | Description | Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100). | Description | Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment | Description | Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased. | Description | The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased. | Description | Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss. |
Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks | Time Frame | Change from 12 to 24 weeks |
Units | units on a scale | Units | percentage of sessions attended | Units | Participants | Units | units on a scale | Units | units on a scale | Units | Change on a scale | Units | units on a scale | Units | Change on a scale | Units | units on a scale | Units | units on a scale | Units | Percent weight change |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||
Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 233985906 | Sequence: | 233985907 | Sequence: | 233985908 | Sequence: | 233985909 | Sequence: | 233985910 | Sequence: | 233985911 | Sequence: | 233985912 | Sequence: | 233985913 | Sequence: | 233985924 | Sequence: | 233985914 | Sequence: | 233985915 | Sequence: | 233985916 | Sequence: | 233985917 | Sequence: | 233985918 | Sequence: | 233985919 | Sequence: | 233985920 | Sequence: | 233985921 | Sequence: | 233985922 | Sequence: | 233985923 | Sequence: | 233985925 | Sequence: | 233985926 | Sequence: | 233985927 |
Outcome Id | 30592640 | Outcome Id | 30592640 | Outcome Id | 30592641 | Outcome Id | 30592641 | Outcome Id | 30592642 | Outcome Id | 30592642 | Outcome Id | 30592643 | Outcome Id | 30592643 | Outcome Id | 30592649 | Outcome Id | 30592644 | Outcome Id | 30592644 | Outcome Id | 30592645 | Outcome Id | 30592645 | Outcome Id | 30592646 | Outcome Id | 30592646 | Outcome Id | 30592647 | Outcome Id | 30592647 | Outcome Id | 30592648 | Outcome Id | 30592648 | Outcome Id | 30592649 | Outcome Id | 30592650 | Outcome Id | 30592650 |
Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 | Result Group Id | 55809369 | Result Group Id | 55809368 | Result Group Id | 55809369 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Title | Program Satisfaction Ratings | Title | Program Satisfaction Ratings | Title | Intervention Session Attendance | Title | Intervention Session Attendance | Title | Feasibility of the Intervention (Retention) | Title | Feasibility of the Intervention (Retention) | Title | Changes in Perceived Stress (Measured Via the Perceived Stress Scale) | Title | Changes in Perceived Stress (Measured Via the Perceived Stress Scale) | Title | Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale) | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Observing Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Observing Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Describing Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Describing Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Acting With Awareness Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Acting With Awareness Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-judgmental Inner Critic Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-judgmental Inner Critic Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-reactivity Subscale | Title | Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) – Non-reactivity Subscale | Title | Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale) | Title | Change in Weight | Title | Change in Weight |
Description | Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied) | Description | Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied) | Description | Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100). | Description | Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100). | Description | Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment | Description | Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment | Description | Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased. | Description | Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased. | Description | The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased. | Description | The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased. | Description | The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased. | Description | Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss. | Description | Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss. |
Units | units on a scale | Units | units on a scale | Units | percentage of sessions attended | Units | percentage of sessions attended | Units | Participants | Units | Participants | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | Change on a scale | Units | Change on a scale | Units | units on a scale | Units | units on a scale | Units | Change on a scale | Units | Change on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | Percent weight change | Units | Percent weight change |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 7.6 | Param Value | 8.3 | Param Value | 75.4 | Param Value | 75.9 | Param Value | 24 | Param Value | 27 | Param Value | 0.01 | Param Value | -0.06 | Param Value | 0.02 | Param Value | 1.7 | Param Value | 0.9 | Param Value | -0.17 | Param Value | -0.9 | Param Value | -0.29 | Param Value | 0.04 | Param Value | 0.46 | Param Value | 0.74 | Param Value | 0.33 | Param Value | -1.67 | Param Value | -0.06 | Param Value | -0.33 | Param Value | -0.38 |
Param Value Num | 7.6 | Param Value Num | 8.3 | Param Value Num | 75.4 | Param Value Num | 75.9 | Param Value Num | 24.0 | Param Value Num | 27.0 | Param Value Num | 0.01 | Param Value Num | -0.06 | Param Value Num | 0.02 | Param Value Num | 1.7 | Param Value Num | 0.9 | Param Value Num | -0.17 | Param Value Num | -0.9 | Param Value Num | -0.29 | Param Value Num | 0.04 | Param Value Num | 0.46 | Param Value Num | 0.74 | Param Value Num | 0.33 | Param Value Num | -1.67 | Param Value Num | -0.06 | Param Value Num | -0.33 | Param Value Num | -0.38 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||
Dispersion Value | 2.9 | Dispersion Value | 2.4 | Dispersion Value | 24.6 | Dispersion Value | 27.1 | Dispersion Value | 0.51 | Dispersion Value | 0.60 | Dispersion Value | 0.51 | Dispersion Value | 5.9 | Dispersion Value | 3.7 | Dispersion Value | 5.1 | Dispersion Value | 3.9 | Dispersion Value | 3.06 | Dispersion Value | 5.03 | Dispersion Value | 4.34 | Dispersion Value | 4.59 | Dispersion Value | 3.17 | Dispersion Value | 3.82 | Dispersion Value | 0.60 | Dispersion Value | 2.91 | Dispersion Value | 4.03 | ||||
Dispersion Value Num | 2.9 | Dispersion Value Num | 2.4 | Dispersion Value Num | 24.6 | Dispersion Value Num | 27.1 | Dispersion Value Num | 0.51 | Dispersion Value Num | 0.6 | Dispersion Value Num | 0.51 | Dispersion Value Num | 5.9 | Dispersion Value Num | 3.7 | Dispersion Value Num | 5.1 | Dispersion Value Num | 3.9 | Dispersion Value Num | 3.06 | Dispersion Value Num | 5.03 | Dispersion Value Num | 4.34 | Dispersion Value Num | 4.59 | Dispersion Value Num | 3.17 | Dispersion Value Num | 3.82 | Dispersion Value Num | 0.6 | Dispersion Value Num | 2.91 | Dispersion Value Num | 4.03 | ||||
Baseline Counts
Sequence: | 11310350 | Sequence: | 11310351 | Sequence: | 11310352 |
Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 24 | Count | 27 | Count | 51 |
Result Groups
Sequence: | 55809363 | Sequence: | 55809364 | Sequence: | 55809365 | Sequence: | 55809366 | Sequence: | 55809367 | Sequence: | 55809368 | Sequence: | 55809369 | Sequence: | 55809370 | Sequence: | 55809371 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Iyengar Yoga | Title | Cooking/Dietary Education | Title | Total | Title | Iyengar Yoga | Title | Cooking/Dietary Education | Title | Iyengar Yoga | Title | Cooking/Dietary Education | Title | Iyengar Yoga | Title | Cooking/Dietary Education |
Description | Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention |
Description | Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention |
Description | Total of all reporting groups | Description | Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention |
Description | Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention |
Description | Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention |
Description | Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention |
Description | Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention |
Description | Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention |
Baseline Measurements
Sequence: | 124801200 | Sequence: | 124801201 | Sequence: | 124801202 | Sequence: | 124801173 | Sequence: | 124801174 | Sequence: | 124801175 | Sequence: | 124801176 | Sequence: | 124801177 | Sequence: | 124801178 | Sequence: | 124801179 | Sequence: | 124801180 | Sequence: | 124801181 | Sequence: | 124801182 | Sequence: | 124801183 | Sequence: | 124801184 | Sequence: | 124801185 | Sequence: | 124801186 | Sequence: | 124801187 | Sequence: | 124801188 | Sequence: | 124801189 | Sequence: | 124801190 | Sequence: | 124801191 | Sequence: | 124801192 | Sequence: | 124801193 | Sequence: | 124801194 | Sequence: | 124801195 | Sequence: | 124801196 | Sequence: | 124801197 | Sequence: | 124801198 | Sequence: | 124801199 | Sequence: | 124801203 | Sequence: | 124801204 | Sequence: | 124801205 | Sequence: | 124801206 | Sequence: | 124801207 | Sequence: | 124801208 | Sequence: | 124801209 | Sequence: | 124801210 | Sequence: | 124801211 | Sequence: | 124801212 | Sequence: | 124801213 | Sequence: | 124801214 | Sequence: | 124801215 | Sequence: | 124801216 | Sequence: | 124801217 | Sequence: | 124801218 | Sequence: | 124801219 | Sequence: | 124801220 |
Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 | Result Group Id | 55809363 | Result Group Id | 55809364 | Result Group Id | 55809365 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Classification | United States | Classification | United States | Classification | United States | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Asian | Category | Asian | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | White | Category | White | Category | White | Category | More than one race | Category | More than one race | Category | More than one race | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | ||||||||||||||||||||||||
Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Region of Enrollment | Title | Region of Enrollment | Title | Region of Enrollment | Title | Body mass index (BMI) at baseline (pre weight loss) | Title | Body mass index (BMI) at baseline (pre weight loss) | Title | Body mass index (BMI) at baseline (pre weight loss) | Title | Body mass index (BMI) at 12 weeks (post weight loss intervention) | Title | Body mass index (BMI) at 12 weeks (post weight loss intervention) | Title | Body mass index (BMI) at 12 weeks (post weight loss intervention) |
Description | Post-12 week weight loss was considered the 'new baseline' for those receiving the the yoga and cooking interventions, as we were examining these as intervention approaches for improving long-term weight loss | Description | Post-12 week weight loss was considered the 'new baseline' for those receiving the the yoga and cooking interventions, as we were examining these as intervention approaches for improving long-term weight loss | Description | Post-12 week weight loss was considered the 'new baseline' for those receiving the the yoga and cooking interventions, as we were examining these as intervention approaches for improving long-term weight loss | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Units | Participants | Units | Participants | Units | Participants | Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | participants | Units | participants | Units | kg /m^2 | Units | kg /m^2 | Units | kg /m^2 | Units | kg/m^2 | Units | kg/m^2 | Units | kg/m^2 |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 1 | Param Value | 1 | Param Value | 2 | Param Value | 48.7 | Param Value | 49.1 | Param Value | 48.7 | Param Value | 24 | Param Value | 27 | Param Value | 51 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 4 | Param Value | 2 | Param Value | 6 | Param Value | 20 | Param Value | 25 | Param Value | 45 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 19 | Param Value | 23 | Param Value | 42 | Param Value | 3 | Param Value | 3 | Param Value | 6 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 24 | Param Value | 27 | Param Value | 51 | Param Value | 34.6 | Param Value | 34.5 | Param Value | 34.6 | Param Value | 33.1 | Param Value | 31.8 | Param Value | 32.4 |
Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 48.7 | Param Value Num | 49.1 | Param Value Num | 48.7 | Param Value Num | 24.0 | Param Value Num | 27.0 | Param Value Num | 51.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 4.0 | Param Value Num | 2.0 | Param Value Num | 6.0 | Param Value Num | 20.0 | Param Value Num | 25.0 | Param Value Num | 45.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 19.0 | Param Value Num | 23.0 | Param Value Num | 42.0 | Param Value Num | 3.0 | Param Value Num | 3.0 | Param Value Num | 6.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 24.0 | Param Value Num | 27.0 | Param Value Num | 51.0 | Param Value Num | 34.6 | Param Value Num | 34.5 | Param Value Num | 34.6 | Param Value Num | 33.1 | Param Value Num | 31.8 | Param Value Num | 32.4 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 9.9 | Dispersion Value | 9.5 | Dispersion Value | 9.6 | Dispersion Value | 4.1 | Dispersion Value | 3.5 | Dispersion Value | 3.8 | Dispersion Value | 4.5 | Dispersion Value | 3.7 | Dispersion Value | 4.1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 9.9 | Dispersion Value Num | 9.5 | Dispersion Value Num | 9.6 | Dispersion Value Num | 4.1 | Dispersion Value Num | 3.5 | Dispersion Value Num | 3.8 | Dispersion Value Num | 4.5 | Dispersion Value Num | 3.7 | Dispersion Value Num | 4.1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 | Number Analyzed | 24 | Number Analyzed | 27 | Number Analyzed | 51 |
]]>
https://zephyrnet.com/NCT03799276
2019-01-15
https://zephyrnet.com/?p=NCT03799276
NCT03799276https://www.clinicaltrials.gov/study/NCT03799276?tab=tableSophie Seang, MDsophie.seang@aphp.fr33142164183Antiretroviral therapy is currently the only way to control HIV disease progression in HIV infected subjects and to prevent transmission. However a sustained virological control through antiretroviral therapy is requested for these objectives. There is currently 8-10% of patients who failed therapy for many reasons other than virological resistance including social unstability, psychiatric disorders, migrant status, drug or alcohol addictions. Because many of these vulnerabilities can be managed and patients helped for following adequately cares and treatments, study team designed the OPTICARE Program to help reduce impact of the patients’ vulnerabilities.
The OPTICARE study is designed as a prospective implementation interventional study which aims to improve retention in care among vulnerable HIV infected patients over 48 weeks.
The OPTICARE program is a support program dedicated to patients either lost to follow up or in highly fraility situation that will offer an individualized care management to fill their gaps towards optimized care and control of viral replication. Our aim is, in patients virally failing in relation with poor adherence to care and treatment to test first part whether tracking proactively lost to follow up patients or detecting frail individuals at risk of lost to care is effective and secondly to evaluate the efficacy, the feasibility and the acceptability of an intervention tailored to each individual to get them to treatment success with viral suppression. In our context, a randomized approach would not be seen as ethical or possible in an environment where investigators need to evaluate such intervention as a pilot approach. Investigators therefore enrolled patients in a cohort population study OPTICARE program aim to actively identify vulnerable HIV+ population and promote optimal access to health care to this population using retention in care program in order to enable long term HIV infection control.
The primary objective is to assess the feasability and the effectiveness of the OPTICARE program. The OPTICARE program aims to propose an individualized care to vulnerable HIV infected patients (UNAIDS/Second 90% goal) and to drive them to treatment success (UNAIDS/Third 90% goal) within a one-year period.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-05-12 |
Start Month Year | January 15, 2019 |
Primary Completion Month Year | June 15, 2022 |
Verification Month Year | May 2023 |
Verification Date | 2023-05-31 |
Last Update Posted Date | 2023-05-12 |
Detailed Descriptions
Sequence: | 20665983 |
Description | The OPTICARE program is an individualized program proposed to vulnerable HIV infected patients according to a baseline evaluation of the clinical, social, psychological and cultural aspects.
Once enrolled in the OPTICARE program, each patient will benefit of: A comprehensive and complete check up personal interview, through a daily visit, with a physician, an educational nurse, a social worker and a cultural mediator (if needed), in order to identify mains issues Regarding the specific needs, each patient may benefit of: a personal assistance to complete administrative procedures (update health insurance, assistance to fill administrative papers, provide a budget for photo ID, transport tickets) A multidisciplinary team (physician, educational nurse, psychotherapist, social worker and cultural mediator) will proactively assist the patient (home visits, recall) during a one year follow up. The program is initially proposed to the patient. In case of non-acceptance, the patient can further join the program after 3 months. Patients who do not accept the OPTICARE program will be followed up in standard of care according to French HIV management guidelines. (https://cns.sante.fr/actualites/prise-en-charge-du-vih-recommandations-du-groupe-dexperts/). All administratives and social procedures will be given to the social district. |
Facilities
Sequence: | 199484753 |
Status | Recruiting |
Name | Yasmine Dudoit |
City | Paris |
Zip | 75013 |
Country | France |
Facility Contacts
Sequence: | 28039724 | Sequence: | 28039725 |
Facility Id | 199484753 | Facility Id | 199484753 |
Contact Type | primary | Contact Type | backup |
Name | Yasmine Dudoit | Name | Sophie Seang, MD |
yasmine.dudoit@aphp.fr | sophie.seang@aphp.fr | ||
Phone | 330142164181 | Phone | 33142164183 |
Conditions
Sequence: | 52026073 |
Name | HIV Infections |
Downcase Name | hiv infections |
Id Information
Sequence: | 40044816 |
Id Source | org_study_id |
Id Value | CREPATS 08 |
Countries
Sequence: | 42442144 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55433550 |
Group Type | Experimental |
Title | Opticare study |
Description | Phase I: Identification and Selection of study population The first step will include an active search by OPTICARE team for vulnerable and lost to follow up patients
Phase II: Implementation of the individualized follow-up program The patients who agree to participate to the program will be defined as the OPTICARE population. |
Interventions
Sequence: | 52338401 |
Intervention Type | Other |
Name | Opticare study |
Description | Each patient will be evaluated by
An HIV physician Following these interviews and visits, a multisciplinary team will define for each patient an individualized OPTICARE program based on the following items: clinical, psychological/psychiatric, social status and follow up visits will be planned with the patient. Regular (Day 15 and monthly) phone calls will be set up during the first six months of the OPTICARE program, to assess the clinical status and ART adherence. Patients will have their medical, biological and social status assessed through visits at W4, W12, W24, W36 (medical and social status only) and W 48 with all members of the OPTICARE team. |
Design Outcomes
Sequence: | 176876087 |
Outcome Type | primary |
Measure | Measure of plasma viral load to assess the effectiveness of the OPTICARE Program to attend HIV plasma viral load < 50 cp/ml at week 48 |
Time Frame | 12 months |
Description | Measure of plasma viral load assessed by RNA quantification using COBAS 6800 system (Roche) |
Browse Conditions
Sequence: | 192910405 | Sequence: | 192910406 | Sequence: | 192910407 | Sequence: | 192910408 | Sequence: | 192910409 | Sequence: | 192910410 | Sequence: | 192910411 | Sequence: | 192910412 | Sequence: | 192910413 | Sequence: | 192910414 | Sequence: | 192910415 | Sequence: | 192910416 | Sequence: | 192910417 | Sequence: | 192910418 |
Mesh Term | HIV Infections | Mesh Term | Blood-Borne Infections | Mesh Term | Communicable Diseases | Mesh Term | Infections | Mesh Term | Sexually Transmitted Diseases, Viral | Mesh Term | Sexually Transmitted Diseases | Mesh Term | Lentivirus Infections | Mesh Term | Retroviridae Infections | Mesh Term | RNA Virus Infections | Mesh Term | Virus Diseases | Mesh Term | Genital Diseases | Mesh Term | Urogenital Diseases | Mesh Term | Immunologic Deficiency Syndromes | Mesh Term | Immune System Diseases |
Downcase Mesh Term | hiv infections | Downcase Mesh Term | blood-borne infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | infections | Downcase Mesh Term | sexually transmitted diseases, viral | Downcase Mesh Term | sexually transmitted diseases | Downcase Mesh Term | lentivirus infections | Downcase Mesh Term | retroviridae infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | genital diseases | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | immunologic deficiency syndromes | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48183685 | Sequence: | 48183686 | Sequence: | 48183687 |
Agency Class | OTHER | Agency Class | INDUSTRY | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | Name | ViiV Healthcare | Name | Institut de Sante Publique, d'Epidemiologie et de Developpement |
Overall Officials
Sequence: | 29201525 |
Role | Principal Investigator |
Name | Sophie Seang, MD |
Affiliation | Pitie Salpetriere Hospital |
Central Contacts
Sequence: | 11977103 | Sequence: | 11977104 |
Contact Type | primary | Contact Type | backup |
Name | Yasmine Dudoit | Name | Sophie Seang, MD |
Phone | 33142164181 | Phone | 33142164183 |
yasmine.dudoit@aphp.fr | sophie.seang@aphp.fr | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 67955894 |
Design Group Id | 55433550 |
Intervention Id | 52338401 |
Eligibilities
Sequence: | 30680162 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients Lost to follow-up defined as a patient with no clinical visit: In the 12 months period for patients > 250/mm3 CD4 cells or AND with HIV plasma viral load > 400 cp/ml (following French HIV guidelines) HIV+ patients with virological failure defined as HIV plasma viral load (pVL) > 400 cp/ml (2 determinations with at least two weeks apart) HIV+ patients newly diagnosed with virological failure 6 months after ART initiation (virological failure defined by two HIV plasma viral load > 50cp/ml following French HIV guidelines *) and with one of the following vulnerable risk factors : Social frailty (lack of health insurance, homeless, accommodation by family/friends, post incarceration) A standard glass is defined by a quantity of pure alcohol of 10 grams, corresponding to approximately 10 cl of wine, 25 cl of beer at 5% vol, or 3 cl of alcohol at 40% vol. (https://www.sfalcoologie.asso.fr/download/RBP2014-SFA-Mesusage-AA.pdf) Exclusion Criteria: Patients unwilling to participate. https://cns.sante.fr/actualites/prise-en-charge-du-vih-recommandations-du-groupe-dexperts |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253878348 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 41 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30426905 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28793431 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799263
2019-02-01
https://zephyrnet.com/?p=NCT03799263
NCT03799263https://www.clinicaltrials.gov/study/NCT03799263?tab=tableNANANAThe six minute walking test (6MWT) is a recognized clinical test to evaluate exercise capacity in different diseases and different conditions. The modalities of performance are described in International Guidelines. The usually reported measure is the distance in meters walked in 6 minutes. Despite the report of a single variable during the test is considered as a limit, changes in monitored variables are seldom analyzed together with the distance walked. In the past there have been some attempts of multifactorial evaluation of 6MWT, however up to date, there is no system considering together the changes of different variables. The investigators wonder whether a multidimensional index based on variables monitored during the 6MWT would better predict 24 month exacerbations and mortality in COPD patients.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-03-03 |
Start Month Year | February 1, 2019 |
Primary Completion Month Year | January 31, 2021 |
Verification Month Year | March 2023 |
Verification Date | 2023-03-31 |
Last Update Posted Date | 2023-03-03 |
Detailed Descriptions
Sequence: | 20685819 |
Description | Rationale: the six minute walking test (6MWT) is a recognized clinical test to evaluate exercise capacity in different diseases and different conditions. In COPD patients the 6MWT is a marker of severity, influenced by the severity of airway obstruction as well as of comorbidities. This test has been shown as a predictor of survival and need of hospitalization. The modalities of performance are described in International Guidelines. The usually reported measure is the distance in meters walked in 6 minutes. However, besides the pathological conditions, this result is influenced by the individual demographic and anthropometrics characteristics. The Minimal Clinically Important Difference in COPD subjects is reported to be 30 meters (m.). A decrease greater than 30 m., as compared to the previous year, is a predictor of death risk. During the test some physiological variables should be monitored such as heart rate (HR), and pulse oxymetry (SpO2). An oxyhemoglobin desaturation >4% or a SpO2 <90% during the test, are also predictors of increased risk of death or hospitalization. In addition, also the difference between the HR at baseline and that after one minute after the end of the test (recovery heart rate: HRR) seems to be a predictor of survival and COPD exacerbation rates. Despite the report of a single variable during the test is considered as a limit, changes in monitored variables are seldom analyzed together with the distance walked. In the past there have been some attempts of multifactorial evaluation of 6MWT, however up to date, there is no system considering together the changes of different variables. We wonder whether a multidimensional index based on variables monitored during the 6MWT would better predict 24 month exacerbations and mortality in COPD patients.
Objectives: Primary Objective: To develop and validate a multidimensional index in COPD subjects with different grades of severity as assessed by the Global Initiative for Chronic Obstructive Lung disease as a predictor of 24 month exacerbation rate. Secondary Objectives: To evaluate the predictive value of 24 month mortality. To evaluate the relationship of this index and other accepted clinical predictors. |
Facilities
Sequence: | 199669288 |
Name | Maugeri Foundation |
City | Tradate |
State | VA |
Zip | 21049 |
Country | Italy |
Conditions
Sequence: | 52075944 | Sequence: | 52075945 | Sequence: | 52075946 | Sequence: | 52075947 |
Name | COPD | Name | Mortality | Name | Disease Exacerbation | Name | Exercise Capacity |
Downcase Name | copd | Downcase Name | mortality | Downcase Name | disease exacerbation | Downcase Name | exercise capacity |
Id Information
Sequence: | 40082981 |
Id Source | org_study_id |
Id Value | 2019001 |
Countries
Sequence: | 42482395 |
Name | Italy |
Removed | False |
Interventions
Sequence: | 52388957 |
Intervention Type | Procedure |
Name | evaluation group |
Description | Recordings Pneumologic assessment Severity grades (I-IV: old GOLD and A-D: new GOLD) Smoke History Drug therapy Comorbidities 6MWT performed within previous 10-14 months, if available. Measurements Standard exams usually performed at Rehab Center Lung Function tests and diffusing capacity of the lung for carbon monoxide Arterial Blood Gases Dyspnoea Health Status and Health Related Quality of Life Daily activity Lower limb muscle strength Exercise capacity |
Design Outcomes
Sequence: | 177054200 | Sequence: | 177054201 | Sequence: | 177054202 | Sequence: | 177054203 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | COPD Exacerbation | Measure | Mortality | Measure | hospitalizations | Measure | symptoms and anthropometrics characteristics correlation |
Time Frame | 24 month | Time Frame | 24 month | Time Frame | 24 month | Time Frame | 24 month |
Description | number of patients with acute exacerbations (treated with antibiotics or steroids) | Description | number of patients died | Description | number of patients hospitalized for COPD | Description | Index correlation capacity with dyspnoea (Medical Research Council questionnaire, Barthel Dyspnoea), body weight (kilogram), heart frequency (HR), distance walked (6MWT) |
Browse Conditions
Sequence: | 193107893 | Sequence: | 193107894 | Sequence: | 193107895 |
Mesh Term | Disease Progression | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | disease progression | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48231045 | Sequence: | 48231046 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Maugeri Foundation | Name | Università degli Studi di Sassari |
Overall Officials
Sequence: | 29229793 |
Role | Study Director |
Name | Antonio Spanevello, Prof |
Affiliation | Maugeri Foundation |
Eligibilities
Sequence: | 30709976 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 45 Years |
Maximum Age | 85 Years |
Population | Stable COPD patients assessed for Pulmonary Rehabilitation |
Criteria | Inclusion Criteria:
COPD diagnosis and grades of severity as assessed by the "old" (I to IV) and "new" (A to D) GOLD guidelines (23) Exclusion Criteria: Associated Comorbidities with short term severe prognosis |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253935084 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 24 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 45 |
Maximum Age Num | 85 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30456567 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28823041 |
Responsible Party Type | Principal Investigator |
Name | elisabetta zampogna |
Title | Dr |
Affiliation | Maugeri Foundation |
Study References
Sequence: | 51971733 | Sequence: | 51971734 | Sequence: | 51971735 | Sequence: | 51971736 | Sequence: | 51971737 | Sequence: | 51971738 |
Pmid | 6805625 | Pmid | 20471236 | Pmid | 12091180 | Pmid | 12917227 | Pmid | 28624883 | Pmid | 18550610 |
Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result |
Citation | Butland RJ, Pang J, Gross ER, Woodcock AA, Geddes DM. Two-, six-, and 12-minute walking tests in respiratory disease. Br Med J (Clin Res Ed). 1982 May 29;284(6329):1607-8. doi: 10.1136/bmj.284.6329.1607. No abstract available. | Citation | Spruit MA, Watkins ML, Edwards LD, Vestbo J, Calverley PM, Pinto-Plata V, Celli BR, Tal-Singer R, Wouters EF; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study investigators. Determinants of poor 6-min walking distance in patients with COPD: the ECLIPSE cohort. Respir Med. 2010 Jun;104(6):849-57. doi: 10.1016/j.rmed.2009.12.007. Epub 2010 May 14. | Citation | ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185. | Citation | Lama VN, Flaherty KR, Toews GB, Colby TV, Travis WD, Long Q, Murray S, Kazerooni EA, Gross BH, Lynch JP 3rd, Martinez FJ. Prognostic value of desaturation during a 6-minute walk test in idiopathic interstitial pneumonia. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1084-90. doi: 10.1164/rccm.200302-219OC. Epub 2003 Aug 13. | Citation | Rodriguez DA, Kortianou EA, Alison JA, Casas A, Giavedoni S, Barberan-Garcia A, Arbillaga A, Vilaro J, Gimeno-Santos E, Vogiatzis I, Rabinovich R, Roca J. Heart Rate Recovery After 6-min Walking Test Predicts Acute Exacerbation in COPD. Lung. 2017 Aug;195(4):463-467. doi: 10.1007/s00408-017-0027-0. Epub 2017 Jun 17. | Citation | Puhan MA, Mador MJ, Held U, Goldstein R, Guyatt GH, Schunemann HJ. Interpretation of treatment changes in 6-minute walk distance in patients with COPD. Eur Respir J. 2008 Sep;32(3):637-43. doi: 10.1183/09031936.00140507. Epub 2008 Jun 11. |
]]>
https://zephyrnet.com/NCT03799250
2019-06-30
https://zephyrnet.com/?p=NCT03799250
NCT03799250https://www.clinicaltrials.gov/study/NCT03799250?tab=tableBinyamin Zeribibenjzr@gmail.comNAFluid therapy is a cornerstone in patient therapy perioperatively. Many studies have addressed the amount of fluid administered (restrictive vs liberal strategies). Other studies focused on the type of fluids (colloid vs crystalloids), and in the last twenty years a more common subject of research was- the correct evaluation of the dynamic fluid status of patients.Bolus driven fluid therapy has been investigated in many goal-directed hemodynamic therapy (GDHT) trials and has become a widely used approach in intraoperative fluid management.
While there are numerous studies on the intraoperative outcome of GDHT, research on the immediate postoperative outcome of GDHT therapy use is scarce.
In this study the investigators aim to evaluate the efficacy of bolus-based fluid management guided by common clinical parameters in postoperative period in post-anesthesia care unit.
In this randomized clinical trial all patients will be randomized to one of the following groups:
The control group will receive standard care which includes fluid maintenance program as dictated by the operating room anesthesiologist and as needed boluses through the PACU stay.
The GDT group will not receive any maintenance fluid. Fluid boluses will be given according to the flowchart attached.
Measurements of hemodynamic variables including heart rate and automatic non-invasive blood pressure measurements as well pulse oximetry as routine procedures will be recorded and stored by Metavision system (iMDsoft company) at regular intervals, all according to standard clinical practice.
Blood gases measurement will be performed upon admission and at discharge. Urine output will be measured and recorded every hour.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-09-25 |
Start Month Year | June 30, 2019 |
Primary Completion Month Year | December 2020 |
Verification Month Year | December 2018 |
Verification Date | 2018-12-31 |
Last Update Posted Date | 2019-09-25 |
Detailed Descriptions
Sequence: | 20716267 |
Description | Methods Prior to surgery the patient will be assessed in the pre-anesthesia clinic, study protocol will be explained, questions answered and informed consent form will be signed by one of the investigating physicians. In case of an urgent case with no pre-anesthetic clinic visit, the process will take place in the entrance to the surgery room. Following surgery, patients will be assessed for eligibility and randomized to one of the study arms.
The control group will receive standard care which includes fluid maintenance program as dictated by the operating room anesthesiologist and as needed boluses through the PACU stay. Study Arm: The GDT group will not receive any maintenance fluid. Fluid boluses will be given according to the flowchart attached. Baseline MAP and HR will be measured in the pre-anesthetic clinic or if not available will be recorded according to community medical record. Blood products will be administered according to departmental guidelines and clinician decision unrelated to participation in the study. Patients will be extubated, either in the operating room or postoperatively, when they fulfilled standard clinical criteria (adequate protective reflexes, adequate oxygenation, and stable hemodynamics), according to clinical indication unrelated to the participation in the study. Measurements of hemodynamic variables including heart rate and automatic non-invasive blood pressure measurements as well pulse oximetry as routine procedures will be recorded and stored by Metavision system (iMDsoft company) at regular intervals, all according to standard clinical practice. Blood gases measurement will be performed upon admission and at discharge. Urine output will be measured and recorded every hour. Other laboratory exams will be taken based on the physician discretion unrelated to the participation in the study. Data Collection: For each participating patient the following data will be collected and recorded: Demographic data |
Facilities
Sequence: | 200053165 |
Status | Recruiting |
Name | Rabin Medical Center |
City | Petah tikva |
Country | Israel |
Facility Contacts
Sequence: | 28097472 |
Facility Id | 200053165 |
Contact Type | primary |
Name | nadav sheffy, md |
nadavs1@gmail.com | |
Phone | 972522246447 |
Facility Investigators
Sequence: | 18326398 |
Facility Id | 200053165 |
Role | Principal Investigator |
Name | nadav sheffy, md |
Conditions
Sequence: | 52156396 |
Name | Ringer's Lactate |
Downcase Name | ringer's lactate |
Id Information
Sequence: | 40148163 |
Id Source | org_study_id |
Id Value | 824-18 |
Countries
Sequence: | 42557689 |
Name | Israel |
Removed | False |
Design Groups
Sequence: | 55577830 | Sequence: | 55577831 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Goal Directed Hemodynamic Therapy | Title | Control Group |
Description | The GDT (Goal Directed Therapy) group will not receive any maintenance fluid. Fluid boluses will be given according to the flowchart attached.
Baseline MAP and HR will be measured in the pre-anesthetic clinic or if not available will be recorded according to community medical record. Measurements of hemodynamic variables including heart rate and automatic non-invasive blood pressure measurements as well pulse oximetry as routine procedures will be recorded and stored by Metavision system (iMDsoft company) at regular intervals, all according to standard clinical practice. Blood gases measurement will be performed upon admission and at discharge. Urine output will be measured and recorded every hour. Other laboratory exams will be taken based on the physician discretion unrelated to the participation in the study. |
Description | The control group will receive standard care which includes fluid maintenance program as dictated by the operating room anesthesiologist and as needed boluses through the PACU (Post Anesthesia Care Unit) stay. |
Interventions
Sequence: | 52471939 | Sequence: | 52471940 |
Intervention Type | Drug | Intervention Type | Other |
Name | Ringer lactate | Name | standard care |
Description | Comparison between fluid maintenance in PACU compared to a bolus based goal directed hemodynamic therapy in the PACU | Description | standard care |
Design Outcomes
Sequence: | 177327660 | Sequence: | 177327661 | Sequence: | 177327662 | Sequence: | 177327663 | Sequence: | 177327664 | Sequence: | 177327665 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The rate of postoperative complications measured according to the European Perioperative Clinical Outcome definitions and Clavien-Dindo Classification in the week following the intervention | Measure | The total amount of fluid infused. | Measure | Length of stay in PACU | Measure | Length of stay in hospital | Measure | Post-operative pulmonary complications | Measure | Acute kidney injury |
Time Frame | 1 week post surgery | Time Frame | 1 week post operative | Time Frame | 8 hours after surgery | Time Frame | 1 month after surgery | Time Frame | 1 week after surgery | Time Frame | 1 week after surgery |
Description | Postoperative complication rates according to the EPCO classification |
Sponsors
Sequence: | 48305990 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Rabin Medical Center |
Overall Officials
Sequence: | 29277893 | Sequence: | 29277894 |
Role | Principal Investigator | Role | Study Chair |
Name | Nadav O Sheffy, MD | Name | Leonid O Eidelman, MD |
Affiliation | Rabin Medical Center | Affiliation | Rabin Medical Center |
Central Contacts
Sequence: | 12004724 | Sequence: | 12004725 |
Contact Type | primary | Contact Type | backup |
Name | Nadav Sheffy, MD | Name | Binyamin Zeribi |
Phone | 972522246447 | ||
nadavs1@gmail.com | benjzr@gmail.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68130780 | Sequence: | 68130781 |
Design Group Id | 55577830 | Design Group Id | 55577831 |
Intervention Id | 52471939 | Intervention Id | 52471940 |
Eligibilities
Sequence: | 30757313 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patient undergoing general surgery, vascular surgery or urological surgery and who are expected to stay in the PACU for more than 8 hours. Exclusion Criteria: – Pregnancy |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254226389 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30503538 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28869816 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52049364 | Sequence: | 52049365 | Sequence: | 52049366 | Sequence: | 52049367 | Sequence: | 52049368 | Sequence: | 52049369 | Sequence: | 52049370 | Sequence: | 52049371 | Sequence: | 52049372 | Sequence: | 52049373 | Sequence: | 52049374 | Sequence: | 52049375 | Sequence: | 52049376 | Sequence: | 52049377 | Sequence: | 52049378 |
Pmid | 23672779 | Pmid | 16356219 | Pmid | 25104915 | Pmid | 28558654 | Pmid | 12357146 | Pmid | 26829494 | Pmid | 29576114 | Pmid | 29742967 | Pmid | 17115398 | Pmid | 28880931 | Pmid | 21873370 | Pmid | 20613538 | Pmid | 9510275 | Pmid | 25058504 | Pmid | 15273542 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Cecconi M, Corredor C, Arulkumaran N, Abuella G, Ball J, Grounds RM, Hamilton M, Rhodes A. Clinical review: Goal-directed therapy-what is the evidence in surgical patients? The effect on different risk groups. Crit Care. 2013 Mar 5;17(2):209. doi: 10.1186/cc11823. | Citation | Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8. | Citation | Della Rocca G, Vetrugno L, Tripi G, Deana C, Barbariol F, Pompei L. Liberal or restricted fluid administration: are we ready for a proposal of a restricted intraoperative approach? BMC Anesthesiol. 2014 Aug 1;14:62. doi: 10.1186/1471-2253-14-62. eCollection 2014. | Citation | Malbouisson LMS, Silva JM Jr, Carmona MJC, Lopes MR, Assuncao MS, Valiatti JLDS, Simoes CM, Auler JOC Jr. A pragmatic multi-center trial of goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery. BMC Anesthesiol. 2017 May 30;17(1):70. doi: 10.1186/s12871-017-0356-9. | Citation | Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012. | Citation | Hand WR, Stoll WD, McEvoy MD, McSwain JR, Sealy CD, Skoner JM, Hornig JD, Tennant PA, Wolf B, Day TA. Intraoperative goal-directed hemodynamic management in free tissue transfer for head and neck cancer. Head Neck. 2016 Apr;38 Suppl 1(Suppl 1):E1974-80. doi: 10.1002/hed.24362. Epub 2016 Feb 1. | Citation | Calvo-Vecino JM, Ripolles-Melchor J, Mythen MG, Casans-Frances R, Balik A, Artacho JP, Martinez-Hurtado E, Serrano Romero A, Fernandez Perez C, Asuero de Lis S; FEDORA Trial Investigators Group. Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial). Br J Anaesth. 2018 Apr;120(4):734-744. doi: 10.1016/j.bja.2017.12.018. Epub 2018 Feb 3. | Citation | Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, Christophi C, Leslie K, McGuinness S, Parke R, Serpell J, Chan MTV, Painter T, McCluskey S, Minto G, Wallace S; Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9. | Citation | Sanders GM. Randomized clinical trial assessing the effect of Doppler-optimized fluid management on outcome after elective colorectal resection (Br J Surg) 2006; 93; 1069-1076. Br J Surg. 2006 Dec;93(12):1563. doi: 10.1002/bjs.5683. No abstract available. | Citation | Weinberg L, Ianno D, Churilov L, Chao I, Scurrah N, Rachbuch C, Banting J, Muralidharan V, Story D, Bellomo R, Christophi C, Nikfarjam M. Restrictive intraoperative fluid optimisation algorithm improves outcomes in patients undergoing pancreaticoduodenectomy: A prospective multicentre randomized controlled trial. PLoS One. 2017 Sep 7;12(9):e0183313. doi: 10.1371/journal.pone.0183313. eCollection 2017. | Citation | Challand C, Struthers R, Sneyd JR, Erasmus PD, Mellor N, Hosie KB, Minto G. Randomized controlled trial of intraoperative goal-directed fluid therapy in aerobically fit and unfit patients having major colorectal surgery. Br J Anaesth. 2012 Jan;108(1):53-62. doi: 10.1093/bja/aer273. Epub 2011 Aug 26. | Citation | Van der Linden PJ, Dierick A, Wilmin S, Bellens B, De Hert SG. A randomized controlled trial comparing an intraoperative goal-directed strategy with routine clinical practice in patients undergoing peripheral arterial surgery. Eur J Anaesthesiol. 2010 Sep;27(9):788-93. doi: 10.1097/EJA.0b013e32833cb2dd. | Citation | Valentine RJ, Duke ML, Inman MH, Grayburn PA, Hagino RT, Kakish HB, Clagett GP. Effectiveness of pulmonary artery catheters in aortic surgery: a randomized trial. J Vasc Surg. 1998 Feb;27(2):203-11; discussion 211-2. doi: 10.1016/s0741-5214(98)70351-9. | Citation | Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118. | Citation | Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. |
]]>
https://zephyrnet.com/NCT03799237
2018-10-01
https://zephyrnet.com/?p=NCT03799237
NCT03799237https://www.clinicaltrials.gov/study/NCT03799237?tab=tableSivaneswari Selvarajoo, BScsivaneswariselvarajoo@gmail.com+60108968645During dengue outbreaks, the Ministry of Health Malaysia employs various methods to control the spread of disease, including killing the larvae of Aedes mosquitoes, fogging, together with educating and disseminating information about the dengue outbreak, to the community. However, this is too late. Research has shown that when an outbreak has occurred, the viral infection has already spread among the community. Therefore, this current trial aims to educate the public (via questionnaire survey and interactions with the residential managements, mainly), detect dengue-infected mosquitoes, inform the communities of the presence of dengue-infected mosquitoes, followed by approaching and educating them to take precautionary measures before the outbreak happens. Trapping (using gravid oviposition sticky (GOS) traps) and detecting dengue virus non-structural 1 (NS1) antigen (using dengue NS1 kit) in the Aedes mosquitoes will be a more reliable way to alert the community before a potential dengue outbreak in their housing area. The community will receive information of presence of infected mosquitoes and probable dengue infections before dengue cases are reported. This will be an ideal time for clean-ups and for search and destroy activities. With this shift in approach and the use of newer techniques, it is hoped that deaths and epidemics due to dengue will be reduced.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | October 1, 2018 |
Primary Completion Month Year | March 31, 2020 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20735757 |
Description | This cluster randomised controlled trial will be conducted to provide evidence on the efficacy of an integrated active vector surveillance and preventive strategy in the community. It aims to demonstrate effectiveness of a new proactive paradigm in reducing dengue epidemics. The main hypotheses are 1) This new paradigm (GOS trap and dengue NS1 kit for detection of dengue in Aedes) will reduce dengue epidemics compared to the usual current vector surveillance/control carried out by the Ministry of Health. 2) Community will be more receptive to this new surveillance activity as they will receive information of dengue transmissions before dengue cases are reported.
The study sites at PJU10, Damansara Damai, Petaling Jaya, Selangor, Malaysia are Intervention arm: Harmoni Apartment, Impian Apartment, Park Avenue Condominium, and Suria Shop Apartment Activities to be carried out include: A. Questionnaire survey and blood taking for dengue seroprevalence among residents from both arms When people in the community are gathered at an identified, suitable area, the Knowledge, Attitude and Practice (KAP) questionnaires will be distributed for them to answer. After the questionnaire survey, about 3 ml of venous blood would be taken by trained personnel for dengue IgG and IgM serology. B. Placement of the GOS mosquito trap in the intervention arm The GOS mosquito traps will be placed in the intervention arm and serviced weekly. The trapped Aedes mosquitoes would be checked for dengue virus via dengue NS1 rapid diagnostic test kit. The GOS mosquito traps will also be placed randomly in the control arm once per month for entomological survey. C. If a dengue-positive mosquito is found, flyers and banners will be distributed and hung to inform the residents of the presence of dengue transmission in the apartment block/apartment. Alternatively, the residents may also be approached house-to-house or an educational booth set up at strategic locations in the apartment to warn and educate the residents. D. The KAP questionnaire survey will be carried out again 3 months before the completion of the trial in the intervention arm to gauge the communities' perception of this intervention. |
Facilities
Sequence: | 200244156 |
Status | Recruiting |
Name | Petaling Jaya City Council |
City | Petaling Jaya |
State | Selangor |
Country | Malaysia |
Facility Contacts
Sequence: | 28127966 |
Facility Id | 200244156 |
Contact Type | primary |
Name | Poo Soon Ong, Master |
Conditions
Sequence: | 52208074 |
Name | Dengue |
Downcase Name | dengue |
Id Information
Sequence: | 40186121 | Sequence: | 40186122 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | GOSNS1-1 | Id Value | MO013-2017 |
Id Type | Other Grant/Funding Number | ||
Id Type Description | Malaysia Ministry of Education | ||
Countries
Sequence: | 42599613 |
Name | Malaysia |
Removed | False |
Design Groups
Sequence: | 55634627 | Sequence: | 55634628 |
Group Type | Experimental | Group Type | No Intervention |
Title | GOS trap and dengue NS1 antigen kit | Title | Control |
Description | Gravid Oviposition Sticky (GOS) traps will be placed to trap adult Aedes mosquitoes and changed weekly. NS1 will be used to detect dengue in trapped Aedes mosquitoes. When dengue NS1 positive mosquitoes are found, community will be alerted via flyers, banners and other means. Routine Aedes/dengue control and surveillance will be carried out as usual as per the current Ministry of Health guidelines. | Description | The GOS traps will be placed randomly in the control arm once per month for entomological survey. Routine Aedes control and surveillance will be carried out as per the current Ministry of Health guidelines. Dengue control measure will be initiated by the health authorities when human cases are reported from this arm. |
Interventions
Sequence: | 52522043 |
Intervention Type | Other |
Name | GOS trap and dengue NS1 antigen kit |
Description | The GOS trap lure and sticky surfaces to trap gravid Aedes mosquitoes. Three GOS traps will be placed on every 3 floors of the residential blocks. The traps will be changed weekly. Trapped Aedes mosquitoes will be identified to species. The mosquitoes will then be dissected, to remove the abdomen from the thorax. Five to seven abdomens of the same mosquito species will be pooled and tested for dengue NS1 antigen using the SD Biosensor Standard Q dengue NS1 antigen test kit. If the pool is tested positive for dengue NS1, the head and thorax of the respective abdomens will be subjected to the same procedure for dengue NS1 antigen test, individually. This may allow us to identify a focus where there could be dengue-infected individuals. Flyers/Posters will be disseminated besides, house-to-house approach to inform the residents of the findings and apartment blocks where these mosquitoes were found. The apartment management will also make use of social media disseminate this information. |
Keywords
Sequence: | 79922882 | Sequence: | 79922883 | Sequence: | 79922884 | Sequence: | 79922885 | Sequence: | 79922886 |
Name | Dengue | Name | Adult Aedes | Name | GOS trap | Name | Dengue NS1 antigen test | Name | Early dengue detection and surveillance |
Downcase Name | dengue | Downcase Name | adult aedes | Downcase Name | gos trap | Downcase Name | dengue ns1 antigen test | Downcase Name | early dengue detection and surveillance |
Design Outcomes
Sequence: | 177511066 | Sequence: | 177511067 | Sequence: | 177511068 | Sequence: | 177511069 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in number of weekly notified dengue cases in intervention arm | Measure | Change in the duration of dengue outbreaks in intervention arm | Measure | Change in adult Aedes density in the intervention arm | Measure | Change in level of dengue Knowledge, Attitude and Practice in the intervention arm |
Time Frame | Assess weekly, through study completion, 1 and a half years | Time Frame | Through study completion, an average of 1 and a half years | Time Frame | Assess weekly, through study completion, within 1 and half years. | Time Frame | 6 months after recruitment for pre-trial questionnaire survey. 3 months after recruitment for post-trial questionnaire survey, through study completion, 1 and a half years |
Description | The number of notified dengue cases in the study sites will be obtained from the District Health Office | Description | The duration of dengue outbreaks in the study sites will be obtained from the District Health Office. | Description | Based on the weekly trap index | Description | The mean of the percentage score of the population for each domain (knowledge & attitude/practises) will be determined for the pre- and post-test. Then, paired t-test will be performed to determine the presence of significant changes in both means (An increase in score percentage indicate a better outcome). Additionally, an individual percentage score of 80% and above indicates indicates good knowledge/attitude/practice. |
Browse Conditions
Sequence: | 193626881 | Sequence: | 193626882 | Sequence: | 193626883 | Sequence: | 193626884 | Sequence: | 193626885 | Sequence: | 193626886 | Sequence: | 193626887 | Sequence: | 193626888 | Sequence: | 193626889 |
Mesh Term | Dengue | Mesh Term | Arbovirus Infections | Mesh Term | Vector Borne Diseases | Mesh Term | Infections | Mesh Term | Virus Diseases | Mesh Term | Flavivirus Infections | Mesh Term | Flaviviridae Infections | Mesh Term | RNA Virus Infections | Mesh Term | Hemorrhagic Fevers, Viral |
Downcase Mesh Term | dengue | Downcase Mesh Term | arbovirus infections | Downcase Mesh Term | vector borne diseases | Downcase Mesh Term | infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | flavivirus infections | Downcase Mesh Term | flaviviridae infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | hemorrhagic fevers, viral |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48353659 | Sequence: | 48353660 | Sequence: | 48353661 |
Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Jonathan Liew Wee Kent | Name | Petaling Jaya City Council, Malaysia | Name | Selangor State Health Department, Malaysia |
Overall Officials
Sequence: | 29305961 | Sequence: | 29305962 |
Role | Principal Investigator | Role | Study Director |
Name | Jonathan WK Liew, PhD | Name | Indra Vythilingam, PhD |
Affiliation | University of Malaya | Affiliation | University of Malaya |
Central Contacts
Sequence: | 12017205 | Sequence: | 12017206 |
Contact Type | primary | Contact Type | backup |
Name | Jonathan WK Liew, PhD | Name | Sivaneswari Selvarajoo, BSc |
Phone | +60178858375 | Phone | +60108968645 |
jonathanliew@um.edu.my | sivaneswariselvarajoo@gmail.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68199152 |
Design Group Id | 55634627 |
Intervention Id | 52522043 |
Eligibilities
Sequence: | 30786849 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Age 18 years and above, including pregnant women and healthy individuals Exclusion Criteria: Age below 18 years |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989595 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30532919 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Cluster Randomized Controlled Trial |
Provided Documents
Sequence: | 2582458 | Sequence: | 2582459 |
Document Type | Informed Consent Form | Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | False | Has Protocol | True |
Has Icf | True | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2019-01-02 | Document Date | 2019-01-04 |
Url | https://ClinicalTrials.gov/ProvidedDocs/37/NCT03799237/ICF_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/37/NCT03799237/Prot_SAP_001.pdf |
Responsible Parties
Sequence: | 28899213 |
Responsible Party Type | Sponsor-Investigator |
Name | Jonathan Liew Wee Kent |
Title | Postdoctoral Research Fellow |
Affiliation | University of Malaya |
Study References
Sequence: | 52103019 | Sequence: | 52103020 | Sequence: | 52103021 | Sequence: | 52103022 | Sequence: | 52103023 | Sequence: | 52103024 | Sequence: | 52103025 | Sequence: | 52103026 |
Pmid | 28327173 | Pmid | 25600599 | Pmid | 29125255 | Pmid | 21175947 | Pmid | 17607465 | Pmid | 23478581 | Pmid | 26094839 | Pmid | 31477185 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | derived |
Citation | Lau SM, Chua TH, Sulaiman WY, Joanne S, Lim YA, Sekaran SD, Chinna K, Venugopalan B, Vythilingam I. A new paradigm for Aedes spp. surveillance using gravid ovipositing sticky trap and NS1 antigen test kit. Parasit Vectors. 2017 Mar 21;10(1):151. doi: 10.1186/s13071-017-2091-y. | Citation | Klungthong C, Manasatienkij W, Phonpakobsin T, Chinnawirotpisan P, Rodpradit P, Hussem K, Thaisomboonsuk B, Ong-ajchaowlerd P, Nisalak A, Kalayanarooj S, Buddhari D, Gibbons RV, Jarman RG, Yoon IK, Fernandez S. Monitoring and improving the sensitivity of dengue nested RT-PCR used in longitudinal surveillance in Thailand. J Clin Virol. 2015 Feb;63:25-31. doi: 10.1016/j.jcv.2014.12.009. Epub 2014 Dec 12. | Citation | Roslan MA, Ngui R, Vythilingam I, Sulaiman WYW. Evaluation of sticky traps for adult Aedes mosquitoes in Malaysia: a potential monitoring and surveillance tool for the efficacy of control strategies. J Vector Ecol. 2017 Dec;42(2):298-307. doi: 10.1111/jvec.12270. | Citation | Chadee DD, Ritchie SA. Efficacy of sticky and standard ovitraps for Aedes aegypti in Trinidad, West Indies. J Vector Ecol. 2010 Dec;35(2):395-400. doi: 10.1111/j.1948-7134.2010.00098.x. | Citation | Gama RA, Silva EM, Silva IM, Resende MC, Eiras AE. Evaluation of the sticky MosquiTRAP for detecting Aedes (Stegomyia) aegypti (L.) (Diptera: Culicidae) during the dry season in Belo Horizonte, Minas Gerais, Brazil. Neotrop Entomol. 2007 Mar-Apr;36(2):294-302. doi: 10.1590/s1519-566×2007000200018. | Citation | Lee C, Vythilingam I, Chong CS, Abdul Razak MA, Tan CH, Liew C, Pok KY, Ng LC. Gravitraps for management of dengue clusters in Singapore. Am J Trop Med Hyg. 2013 May;88(5):888-892. doi: 10.4269/ajtmh.12-0329. Epub 2013 Mar 11. | Citation | Lau SM, Vythilingam I, Doss JI, Sekaran SD, Chua TH, Wan Sulaiman WY, Chinna K, Lim YA, Venugopalan B. Surveillance of adult Aedes mosquitoes in Selangor, Malaysia. Trop Med Int Health. 2015 Oct;20(10):1271-80. doi: 10.1111/tmi.12555. Epub 2015 Jul 14. | Citation | Liew JWK, Selvarajoo S, Tan W, Ahmad Zaki R, Vythilingam I. Gravid oviposition sticky trap and dengue non-structural 1 antigen test for early surveillance of dengue in multi-storey dwellings: study protocol of a cluster randomized controlled trial. Infect Dis Poverty. 2019 Sep 3;8(1):71. doi: 10.1186/s40249-019-0584-y. |
]]>
https://zephyrnet.com/NCT03799224
2018-12-01
https://zephyrnet.com/?p=NCT03799224
NCT03799224https://www.clinicaltrials.gov/study/NCT03799224?tab=tableChen-Hua Yanyanchenhua@vip.sina.com+86 010 88326666Allogeneic haematopoietic stem cell transplantation (allo-HSCT) remains one of the currently available curative therapies for acute leukemia (AL). Leukemia relapse is one of the mainly causes of transplant failure. We reported previously that patients with relapse or refractory AL were at very high risk of relapse post allo-HSCT, with cumulative relapse rate of 50-80%. Decitabine has been demonstrated efficacy in the treatment of patients with recurrent or refractory leukemia and myelodysplastic syndrome. It was reported that the combination of decitabine, with busulfan and cyclophosphamide as a preparative regimen for allo-HSCT using HLA-matching donors was safe and effective. In this prospective, single-arm clinical trial, we aimed to examine the efficacy of combining decitabine with modified busulfan and cyclophosphamide (mBU/CY) as a preparative regimen for allo-HSCT in recurrent and refractory AL patients.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-05-29 |
Start Month Year | December 1, 2018 |
Primary Completion Month Year | December 31, 2021 |
Verification Month Year | May 2019 |
Verification Date | 2019-05-31 |
Last Update Posted Date | 2019-05-29 |
Detailed Descriptions
Sequence: | 20721625 |
Description | Patients enrolled in this study would receive decitabine 200mg·m-2·d-1 on day -12 and -11 pre-HSCT. The conditioning therapy for human leukocyte antigen (HLA)-mismatched HSCT patients was modified BU/CY plus ATG (thymoglobulin; Sang Stat, France) consisting of cytarabine (Ara-C 4 g·m-2·d-1) intravenously on days -10 to -9, busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, cyclophosphamide (CY 1.8 g·m-2·d-1), intravenously on days -5 to -4, semustine (Me-CCNU, 250 mg·m-2), orally once on day -3, and ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2. In matched sibling transplantations, patients received hydroxycarbamide (80 mg·kg-1) orally on day -10 and a lower dose of Ara-C (2 g·m-2·d-1) on day -9, but otherwise an identical regimen to the HLA-mismatched patients without ATG.
BM(bone marrow) samples from patients were obtained to assess leukemia status after HSCT. The time points that we monitored BM samples included at time of allo-HSCT; 1 month, 2 months, 3 months, 4.5 months, 6 months, 9 months, and 12 months after allo-HSCT; and every 6 months thereafter to the defined endpoints or for at least until 5 years after transplantation. |
Facilities
Sequence: | 200108113 |
Status | Recruiting |
Name | Peking University Institute of Hematology,Beijing |
City | Beijing |
State | Beijing |
Zip | 100044 |
Country | China |
Facility Contacts
Sequence: | 28106410 | Sequence: | 28106411 |
Facility Id | 200108113 | Facility Id | 200108113 |
Contact Type | primary | Contact Type | backup |
Name | Chen-hua Yan, MD | Name | Jing Liu, MD |
yanchenhua@vip.sina.com | liujing0245@bjmu.edu.cn | ||
Phone | 86 010 88326666 | Phone | 86 010 88326666 |
Facility Investigators
Sequence: | 18332492 |
Facility Id | 200108113 |
Role | Principal Investigator |
Name | Xiao-Jun Huang, MD |
Browse Interventions
Sequence: | 96050229 | Sequence: | 96050230 | Sequence: | 96050231 | Sequence: | 96050232 | Sequence: | 96050233 | Sequence: | 96050234 |
Mesh Term | Decitabine | Mesh Term | Antimetabolites, Antineoplastic | Mesh Term | Antimetabolites | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antineoplastic Agents | Mesh Term | Enzyme Inhibitors |
Downcase Mesh Term | decitabine | Downcase Mesh Term | antimetabolites, antineoplastic | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | enzyme inhibitors |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52171218 | Sequence: | 52171219 | Sequence: | 52171220 |
Name | Stem Cell Transplant Complications | Name | Relapse Leukemia | Name | Refractory Leukemia |
Downcase Name | stem cell transplant complications | Downcase Name | relapse leukemia | Downcase Name | refractory leukemia |
Id Information
Sequence: | 40158622 |
Id Source | org_study_id |
Id Value | decitabine pre-HSCT for R/R AL |
Countries
Sequence: | 42568933 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55593155 | Sequence: | 55593156 |
Group Type | Experimental | Group Type | Experimental |
Title | Decitabine plus mBU/CY for HLA-mismatched HSCT | Title | Decitabine plus mBU/CY for matched sibling transplant |
Description | Decitabine plus mBU/CY as precondition regimen for recurrent and refractory acute leukemia at the time of HLA-mismatched HSCT
Details: The conditioning therapy for human leukocyte antigen (HLA)-mismatched HSCT patients was decitabine plus modified BU/CY and ATG,consisting of decitabine 100mg·m-2·d-1 q12h on days-12 and -11,cytarabine (Ara-C 4 g·m-2·d-1) intravenously on days -10 to -9, busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, cyclophosphamide (CY 1.8 g·m-2·d-1), intravenously on days -5 to -4, semustine (Me-CCNU, 250 mg/m2), orally once on day -3, and ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2 |
Description | Decitabine plus mBU/CY as precondition regimen for High Risk Acute Leukemia With MRD (minimal residual disease) at the time of matched sibling transplant.
Details: In matched sibling transplantations, patients received decitabine 100mg·m-2·d-1 q12h on days-12 and -11,hydroxycarbamide (80 mg/kg) orally on day -10 and a lower dose of Ara-C (2 g·m-2·d-1) on day -9, busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, cyclophosphamide (CY 1.8 g·m-2·d-1), intravenously on days -5 to -4, semustine (Me-CCNU, 250 mg/m2), orally once on day -3. |
Interventions
Sequence: | 52485463 | Sequence: | 52485464 | Sequence: | 52485465 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Decitabine | Name | mBU/CY and ATG | Name | mBU/CY |
Description | Decitabine 200mg.m-2.d-1 intravenously on days -12 and -11 | Description | Ara-C 4 g·m-2·d-1 intravenously on days -10 to -9 Busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, Cyclophosphamide (CY 1.8 g·m-2·d-1) intravenously on days -5 to -4 Semustine (Me-CCNU, 250 mg·m-2) orally once on day -3 ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2 | Description | hydroxycarbamide (80 mg·kg-1) orally on day -10 Ara-C (2 g·m-2·d-1) on day -9 Busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, Cyclophosphamide (CY 1.8 g·m-2·d-1) intravenously on days -5 to -4 Semustine (Me-CCNU, 250 mg·m-2) orally once on day -3 |
Keywords
Sequence: | 79868505 | Sequence: | 79868506 | Sequence: | 79868507 | Sequence: | 79868508 |
Name | recurrent acute leukemia | Name | refractory acute leukemia | Name | preconditioning regimen | Name | allogeneic stem cell transplantation |
Downcase Name | recurrent acute leukemia | Downcase Name | refractory acute leukemia | Downcase Name | preconditioning regimen | Downcase Name | allogeneic stem cell transplantation |
Design Outcomes
Sequence: | 177378813 | Sequence: | 177378814 | Sequence: | 177378815 | Sequence: | 177378816 | Sequence: | 177378817 | Sequence: | 177378818 | Sequence: | 177378819 | Sequence: | 177378820 | Sequence: | 177378821 | Sequence: | 177378822 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | 1 year cumulative incidence of relapse | Measure | 2 year cumulative incidence of relapse | Measure | Non-relapse mortality | Measure | 1 year overall survival | Measure | 5 years overall survival | Measure | 1 year leukemia free survival | Measure | 5 years leukemia free survival | Measure | engraftment | Measure | Acute graft versus host disease | Measure | Chronic graft versus host disease |
Time Frame | 1 year post allo-HSCT | Time Frame | 2 years post allo-HSCT | Time Frame | 1 year post allo-HSCT | Time Frame | 1 year post allo-HSCT | Time Frame | 5 years post allo-HSCT] 1 year leukemia free survival | Time Frame | 1 year post allo-HSCT | Time Frame | 5 years post allo-HSCT | Time Frame | 100 days post allo-HSCT | Time Frame | 100 days post allo-HSCT | Time Frame | 1 years post allo-HSCT |
Description | The cumulative incidence of relapse at 1 year post allo-HSCT | Description | The cumulative incidence of relapse at 2 years post allo-HSCT | Description | The cumulative incidence of non-relapse mortality at 1 year post allo-HSCT | Description | The overall survival at 1 year post allo-HSCT | Description | The overall survival at 5 years post allo-HSCT | Description | The leukemia free survival at 1 years post allo-HSCT | Description | The leukemia free survival at 5 years post allo-HSCT | Description | The total neutrophil and platelet engraftment rate | Description | The cumulative incidence of grade II-IV acute graft versus host disease | Description | The cumulative incidence of intermediate to severe chronic graft versus host disease |
Browse Conditions
Sequence: | 193486661 | Sequence: | 193486662 | Sequence: | 193486663 | Sequence: | 193486664 | Sequence: | 193486665 | Sequence: | 193486666 |
Mesh Term | Leukemia | Mesh Term | Recurrence | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | leukemia | Downcase Mesh Term | recurrence | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319267 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Peking University People's Hospital |
Overall Officials
Sequence: | 29285342 |
Role | Study Chair |
Name | Xiao-Jun Huang |
Affiliation | Peking University People's Hospital |
Central Contacts
Sequence: | 12008870 | Sequence: | 12008871 |
Contact Type | primary | Contact Type | backup |
Name | Xiao-Jun Huang | Name | Chen-Hua Yan |
Phone | +86 010 88326666 | Phone | +86 010 88326666 |
yanchenhua@vip.sina.com | yanchenhua@vip.sina.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68149111 | Sequence: | 68149112 | Sequence: | 68149113 | Sequence: | 68149114 |
Design Group Id | 55593155 | Design Group Id | 55593156 | Design Group Id | 55593155 | Design Group Id | 55593156 |
Intervention Id | 52485463 | Intervention Id | 52485463 | Intervention Id | 52485464 | Intervention Id | 52485465 |
Eligibilities
Sequence: | 30765341 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 55 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
patients with relapsed acute leukemia Exclusion Criteria: pregnancy women |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253883255 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 55 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30511508 |
Allocation | Non-Randomized |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Patients enrolled in this study would receive decitabine 200mg·m-2·d-1 on day -12 and -11 pre-HSCT. The conditioning therapy for human leukocyte antigen (HLA)-mismatched HSCT patients was modified BU/CY plus ATG. In matched sibling transplantations, patients received hydroxycarbamide (80 mg·kg-1) orally on day -10 and a lower dose of Ara-C (2 g·m-2·d-1) on day -9, but otherwise an identical regimen to the HLA-mismatched patients without ATG.BM samples from patients would be obtained to assess leukemia status after HSCT. The time points that we monitored BM samples included at time of allo-HSCT; 1 month, 2 months, 3 months, 4.5 months, 6 months, 9 months, and 12 months after allo-HSCT; and every 6 months thereafter to the defined endpoints or for at least until 5 year after transplantation. |
Responsible Parties
Sequence: | 28877802 |
Responsible Party Type | Principal Investigator |
Name | Xiaojun Huang,MD |
Title | Director of the Hematology Department |
Affiliation | Peking University People's Hospital |
]]>
https://zephyrnet.com/NCT03799211
2018-06-04
https://zephyrnet.com/?p=NCT03799211
NCT03799211https://www.clinicaltrials.gov/study/NCT03799211?tab=tableNANANAMigraine patients are oftentimes referred for evidence based behavioral therapies to prevent migraine. Yet, at follow-up visits, they report not seeing the behavioral therapist. This is a pilot feasibility acceptability study to assess whether motivational interviewing (MI) can be implemented in the headache center setting to help improve initiation and adherence to behavioral therapy for migraine. We will also assess patients’ reasons for making/not making the appointment.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-31 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-07-23 |
Start Month Year | June 4, 2018 |
Primary Completion Month Year | January 1, 2019 |
Verification Month Year | July 2020 |
Verification Date | 2020-07-31 |
Last Update Posted Date | 2020-07-23 |
Results First Posted Date | 2020-07-23 |
Facilities
Sequence: | 200233720 |
Name | NYU Langone |
City | New York |
State | New York |
Zip | 10016 |
Country | United States |
Conditions
Sequence: | 52204174 |
Name | Migraine |
Downcase Name | migraine |
Id Information
Sequence: | 40183286 |
Id Source | org_study_id |
Id Value | 16-00937 |
Countries
Sequence: | 42596886 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55630429 | Sequence: | 55630430 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Motivational Interviewing | Title | Usual Care |
Interventions
Sequence: | 52518367 | Sequence: | 52518368 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Motivational Interviewing | Name | Treatment as Usual |
Description | Phone call using motivational interviewing technique | Description | will receive a regular study phone call after three months |
Design Outcomes
Sequence: | 177498710 | Sequence: | 177498711 | Sequence: | 177498712 | Sequence: | 177498713 | Sequence: | 177498714 | Sequence: | 177498715 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Percentage of Patients Who Made an Appointment for Behavioral Therapy | Measure | Percentage of Participants Who Attended Appointments | Measure | Percentage of Participants Who Initiated Appointments | Measure | Mean Reported Importance of Managing Migraine | Measure | Mean Reported Confidence in Managing Migraines | Measure | Mean Reported Confidence in Behavioral Therapy |
Time Frame | 3-6 Months | Time Frame | 3-6 Months | Time Frame | Month 3-4 post-recruitment | Time Frame | First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline) | Time Frame | First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline) | Time Frame | First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline) |
Description | Of those who initiated behavioral therapy, percentage who attended appointments | Description | Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. | Description | Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. | Description | Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence. |
Browse Conditions
Sequence: | 193612179 | Sequence: | 193612180 | Sequence: | 193612181 | Sequence: | 193612182 | Sequence: | 193612183 | Sequence: | 193612184 |
Mesh Term | Migraine Disorders | Mesh Term | Headache Disorders, Primary | Mesh Term | Headache Disorders | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases |
Downcase Mesh Term | migraine disorders | Downcase Mesh Term | headache disorders, primary | Downcase Mesh Term | headache disorders | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48350097 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | NYU Langone Health |
Overall Officials
Sequence: | 29303713 |
Role | Principal Investigator |
Name | Mia Minen, MD |
Affiliation | NYU Langone |
Design Group Interventions
Sequence: | 68194259 | Sequence: | 68194260 |
Design Group Id | 55630429 | Design Group Id | 55630430 |
Intervention Id | 52518367 | Intervention Id | 52518368 |
Eligibilities
Sequence: | 30784602 |
Gender | All |
Minimum Age | 16 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Migraine diagnosis age 16+ Exclusion Criteria: Unable to read the questionnaire, no phone number |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 253985177 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 7 |
Were Results Reported | True |
Months To Report Results | 18 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 16 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30530683 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Drop Withdrawals
Sequence: | 29007649 | Sequence: | 29007650 | Sequence: | 29007651 | Sequence: | 29007652 |
Result Group Id | 56116378 | Result Group Id | 56116379 | Result Group Id | 56116378 | Result Group Id | 56116379 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject |
Count | 2 | Count | 13 | Count | 2 | Count | 0 |
Milestones
Sequence: | 41031649 | Sequence: | 41031650 | Sequence: | 41031651 | Sequence: | 41031652 | Sequence: | 41031653 | Sequence: | 41031654 |
Result Group Id | 56116378 | Result Group Id | 56116379 | Result Group Id | 56116378 | Result Group Id | 56116379 | Result Group Id | 56116378 | Result Group Id | 56116379 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 36 | Count | 40 | Count | 32 | Count | 27 | Count | 4 | Count | 13 |
Participant Flows
Sequence: | 3923169 |
Outcome Counts
Sequence: | 74046062 | Sequence: | 74046063 | Sequence: | 74046064 | Sequence: | 74046065 | Sequence: | 74046066 | Sequence: | 74046067 | Sequence: | 74046068 | Sequence: | 74046069 | Sequence: | 74046070 | Sequence: | 74046071 | Sequence: | 74046072 | Sequence: | 74046073 |
Outcome Id | 30823261 | Outcome Id | 30823261 | Outcome Id | 30823262 | Outcome Id | 30823262 | Outcome Id | 30823263 | Outcome Id | 30823263 | Outcome Id | 30823264 | Outcome Id | 30823264 | Outcome Id | 30823265 | Outcome Id | 30823265 | Outcome Id | 30823266 | Outcome Id | 30823266 |
Result Group Id | 56116380 | Result Group Id | 56116381 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 32 | Count | 27 | Count | 27 | Count | 32 | Count | 27 | Count | 32 | Count | 27 | Count | 32 | Count | 27 | Count | 32 | Count | 27 | Count | 32 |
Provided Documents
Sequence: | 2582162 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2019-12-23 |
Url | https://ClinicalTrials.gov/ProvidedDocs/11/NCT03799211/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27958312 | Sequence: | 27958313 | Sequence: | 27958314 | Sequence: | 27958315 | Sequence: | 27958316 | Sequence: | 27958317 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 0 | Subjects At Risk | 0 | Subjects At Risk | 0 | Subjects At Risk | 0 | Subjects At Risk | 0 | Subjects At Risk | 0 |
Created At | 2023-08-09 06:44:03.854711 | Created At | 2023-08-09 06:44:03.854711 | Created At | 2023-08-09 06:44:03.854711 | Created At | 2023-08-09 06:44:03.854711 | Created At | 2023-08-09 06:44:03.854711 | Created At | 2023-08-09 06:44:03.854711 |
Updated At | 2023-08-09 06:44:03.854711 | Updated At | 2023-08-09 06:44:03.854711 | Updated At | 2023-08-09 06:44:03.854711 | Updated At | 2023-08-09 06:44:03.854711 | Updated At | 2023-08-09 06:44:03.854711 | Updated At | 2023-08-09 06:44:03.854711 |
Responsible Parties
Sequence: | 28896984 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3853913 |
Pi Employee | Yes |
Result Contacts
Sequence: | 3853878 |
Organization | NYU Langone Health |
Name | Mia Minen, MD, MPH |
Phone | 212-263-7744 |
Mia.Minen@nyulangone.org | |
Outcomes
Sequence: | 30823261 | Sequence: | 30823262 | Sequence: | 30823263 | Sequence: | 30823264 | Sequence: | 30823265 | Sequence: | 30823266 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Percentage of Patients Who Made an Appointment for Behavioral Therapy | Title | Percentage of Participants Who Attended Appointments | Title | Percentage of Participants Who Initiated Appointments | Title | Mean Reported Importance of Managing Migraine | Title | Mean Reported Confidence in Managing Migraines | Title | Mean Reported Confidence in Behavioral Therapy |
Description | Of those who initiated behavioral therapy, percentage who attended appointments | Description | Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. | Description | Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. | Description | Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence. | ||||
Time Frame | 3-6 Months | Time Frame | 3-6 Months | Time Frame | Month 3-4 post-recruitment | Time Frame | First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline) | Time Frame | First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline) | Time Frame | First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline) |
Units | percentage of participants | Units | percentage of participants | Units | percentage of participants | Units | units on a scale | Units | score on a scale | Units | score on a scale |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||
Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 235818943 | Sequence: | 235818944 | Sequence: | 235818945 | Sequence: | 235818946 | Sequence: | 235818947 | Sequence: | 235818948 | Sequence: | 235818933 | Sequence: | 235818934 | Sequence: | 235818935 | Sequence: | 235818936 | Sequence: | 235818937 | Sequence: | 235818938 | Sequence: | 235818939 | Sequence: | 235818940 | Sequence: | 235818941 | Sequence: | 235818942 | Sequence: | 235818949 | Sequence: | 235818950 |
Outcome Id | 30823265 | Outcome Id | 30823265 | Outcome Id | 30823265 | Outcome Id | 30823265 | Outcome Id | 30823266 | Outcome Id | 30823266 | Outcome Id | 30823261 | Outcome Id | 30823261 | Outcome Id | 30823262 | Outcome Id | 30823262 | Outcome Id | 30823263 | Outcome Id | 30823263 | Outcome Id | 30823264 | Outcome Id | 30823264 | Outcome Id | 30823264 | Outcome Id | 30823264 | Outcome Id | 30823266 | Outcome Id | 30823266 |
Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116380 | Result Group Id | 56116381 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 | Result Group Id | 56116382 | Result Group Id | 56116383 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Classification | First Follow-Up Call | Classification | First Follow-Up Call | Classification | Last Follow-Up Call | Classification | Last Follow-Up Call | Classification | First Follow-Up Call | Classification | First Follow-Up Call | Classification | First Follow-Up Call | Classification | First Follow-Up Call | Classification | Last Follow-Up Call | Classification | Last Follow-Up Call | Classification | Last Follow-Up Call | Classification | Last Follow-Up Call | ||||||||||||
Title | Mean Reported Confidence in Managing Migraines | Title | Mean Reported Confidence in Managing Migraines | Title | Mean Reported Confidence in Managing Migraines | Title | Mean Reported Confidence in Managing Migraines | Title | Mean Reported Confidence in Behavioral Therapy | Title | Mean Reported Confidence in Behavioral Therapy | Title | Percentage of Patients Who Made an Appointment for Behavioral Therapy | Title | Percentage of Patients Who Made an Appointment for Behavioral Therapy | Title | Percentage of Participants Who Attended Appointments | Title | Percentage of Participants Who Attended Appointments | Title | Percentage of Participants Who Initiated Appointments | Title | Percentage of Participants Who Initiated Appointments | Title | Mean Reported Importance of Managing Migraine | Title | Mean Reported Importance of Managing Migraine | Title | Mean Reported Importance of Managing Migraine | Title | Mean Reported Importance of Managing Migraine | Title | Mean Reported Confidence in Behavioral Therapy | Title | Mean Reported Confidence in Behavioral Therapy |
Description | Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. | Description | Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. | Description | Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. | Description | Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence. | Description | Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence. | Description | Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence. | Description | Of those who initiated behavioral therapy, percentage who attended appointments | Description | Of those who initiated behavioral therapy, percentage who attended appointments | Description | Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. | Description | Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. | Description | Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. | Description | Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance. | Description | Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence. | Description | Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence. | ||||||||
Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | percentage of participants | Units | percentage of participants | Units | percentage of participants | Units | percentage of participants | Units | percentage of participants | Units | percentage of participants | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | score on a scale | Units | score on a scale |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | NA | Param Value | 6.26 | Param Value | 6.59 | Param Value | 6.62 | Param Value | NA | Param Value | 4.83 | Param Value | 37.5 | Param Value | 22.2 | Param Value | 22.2 | Param Value | 21.9 | Param Value | 40.7 | Param Value | 68.8 | Param Value | NA | Param Value | 9.16 | Param Value | 9.19 | Param Value | 9.22 | Param Value | 5.35 | Param Value | 5.04 |
Param Value Num | 6.26 | Param Value Num | 6.59 | Param Value Num | 6.62 | Param Value Num | 4.83 | Param Value Num | 37.5 | Param Value Num | 22.2 | Param Value Num | 22.2 | Param Value Num | 21.9 | Param Value Num | 40.7 | Param Value Num | 68.8 | Param Value Num | 9.16 | Param Value Num | 9.19 | Param Value Num | 9.22 | Param Value Num | 5.35 | Param Value Num | 5.04 | ||||||
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||
Dispersion Value | NA | Dispersion Value | 2.27 | Dispersion Value | 2.26 | Dispersion Value | 2.50 | Dispersion Value | NA | Dispersion Value | 2.47 | Dispersion Value | NA | Dispersion Value | 1.27 | Dispersion Value | 1.3 | Dispersion Value | 1.18 | Dispersion Value | 2.59 | Dispersion Value | 1.95 | ||||||||||||
Dispersion Value Num | 2.27 | Dispersion Value Num | 2.26 | Dispersion Value Num | 2.5 | Dispersion Value Num | 2.47 | Dispersion Value Num | 1.27 | Dispersion Value Num | 1.3 | Dispersion Value Num | 1.18 | Dispersion Value Num | 2.59 | Dispersion Value Num | 1.95 | ||||||||||||||||||
Explanation Of Na | Only one follow-up call was conducted for this arm | Explanation Of Na | Only one follow-up call was conducted for this arm | Explanation Of Na | Only one follow-up call was conducted for this arm |
Baseline Counts
Sequence: | 11389330 | Sequence: | 11389331 | Sequence: | 11389332 |
Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 36 | Count | 40 | Count | 76 |
Result Groups
Sequence: | 56116375 | Sequence: | 56116376 | Sequence: | 56116377 | Sequence: | 56116378 | Sequence: | 56116379 | Sequence: | 56116380 | Sequence: | 56116381 | Sequence: | 56116382 | Sequence: | 56116383 | Sequence: | 56116384 | Sequence: | 56116385 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Motivational Interviewing | Title | Usual Care | Title | Total | Title | Motivational Interviewing | Title | Usual Care | Title | Motivational Interviewing | Title | Usual Care | Title | Usual Care | Title | Motivational Interviewing | Title | Motivational Interviewing | Title | Usual Care |
Description | Motivational Interviewing: Phone call using motivational interviewing technique | Description | Treatment as Usual: will receive a regular study phone call after three months | Description | Total of all reporting groups | Description | Motivational Interviewing: Phone call using motivational interviewing technique | Description | Treatment as Usual: will receive a regular study phone call after three months | Description | Motivational Interviewing: Phone call using motivational interviewing technique | Description | Treatment as Usual: will receive a regular study phone call after three months | Description | Treatment as Usual: will receive a regular study phone call after three months | Description | Motivational Interviewing: Phone call using motivational interviewing technique | Description | Motivational Interviewing: Phone call using motivational interviewing technique | Description | Treatment as Usual: will receive a regular study phone call after three months |
Baseline Measurements
Sequence: | 125670055 | Sequence: | 125670033 | Sequence: | 125670034 | Sequence: | 125670035 | Sequence: | 125670036 | Sequence: | 125670037 | Sequence: | 125670038 | Sequence: | 125670039 | Sequence: | 125670040 | Sequence: | 125670041 | Sequence: | 125670042 | Sequence: | 125670043 | Sequence: | 125670044 | Sequence: | 125670045 | Sequence: | 125670046 | Sequence: | 125670047 | Sequence: | 125670048 | Sequence: | 125670049 | Sequence: | 125670050 | Sequence: | 125670051 | Sequence: | 125670052 | Sequence: | 125670053 | Sequence: | 125670054 | Sequence: | 125670056 | Sequence: | 125670057 | Sequence: | 125670058 | Sequence: | 125670059 | Sequence: | 125670060 | Sequence: | 125670061 | Sequence: | 125670062 | Sequence: | 125670063 | Sequence: | 125670064 | Sequence: | 125670065 | Sequence: | 125670066 | Sequence: | 125670067 | Sequence: | 125670068 | Sequence: | 125670069 | Sequence: | 125670070 | Sequence: | 125670071 | Sequence: | 125670072 | Sequence: | 125670073 | Sequence: | 125670074 |
Result Group Id | 56116376 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 | Result Group Id | 56116375 | Result Group Id | 56116376 | Result Group Id | 56116377 |
Ctgov Group Code | BG001 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Classification | United States | Classification | United States | Classification | United States | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Category | Asian | Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Asian | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | White | Category | White | Category | White | Category | More than one race | Category | More than one race | Category | More than one race | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | ||||||||||||
Title | Race (NIH/OMB) | Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Region of Enrollment | Title | Region of Enrollment | Title | Region of Enrollment |
Units | Participants | Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | participants | Units | participants |
Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number |
Param Value | 0 | Param Value | 40.4 | Param Value | 38.1 | Param Value | 39.3 | Param Value | 32 | Param Value | 39 | Param Value | 71 | Param Value | 4 | Param Value | 1 | Param Value | 5 | Param Value | 6 | Param Value | 4 | Param Value | 10 | Param Value | 30 | Param Value | 36 | Param Value | 66 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 3 | Param Value | 3 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 1 | Param Value | 3 | Param Value | 26 | Param Value | 33 | Param Value | 59 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 5 | Param Value | 6 | Param Value | 11 | Param Value | 36 | Param Value | 40 | Param Value | 76 |
Param Value Num | 0.0 | Param Value Num | 40.4 | Param Value Num | 38.1 | Param Value Num | 39.3 | Param Value Num | 32.0 | Param Value Num | 39.0 | Param Value Num | 71.0 | Param Value Num | 4.0 | Param Value Num | 1.0 | Param Value Num | 5.0 | Param Value Num | 6.0 | Param Value Num | 4.0 | Param Value Num | 10.0 | Param Value Num | 30.0 | Param Value Num | 36.0 | Param Value Num | 66.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 3.0 | Param Value Num | 3.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 26.0 | Param Value Num | 33.0 | Param Value Num | 59.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 5.0 | Param Value Num | 6.0 | Param Value Num | 11.0 | Param Value Num | 36.0 | Param Value Num | 40.0 | Param Value Num | 76.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 12.3 | Dispersion Value | 12.1 | Dispersion Value | 12.2 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 12.3 | Dispersion Value Num | 12.1 | Dispersion Value Num | 12.2 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 40 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 | Number Analyzed | 36 | Number Analyzed | 40 | Number Analyzed | 76 |
]]>
https://zephyrnet.com/NCT03799198
2019-01-07
https://zephyrnet.com/?p=NCT03799198
NCT03799198https://www.clinicaltrials.gov/study/NCT03799198?tab=tableNANANAResearchers are doing this study to compare the effects of drugs approved for long-term weight loss combined with an employer-based weight management program with the effects of the weight management program without drugs for weight loss. If participants agree to be in this study, they will join the Cleveland Clinic Integrated Medical Weight Management Program (WMP). Participants will be assigned by chance (like flipping a coin) to one of two treatment groups: A) Group 1: Cleveland Clinic Integrated Medical WMP + medication for long-term weight loss. B) Group 2: Cleveland Clinic Integrated Medical WMP without medication for weight loss. Participants have an equal chance of being in either of the treatment groups. The total study duration for the individual participants will be approximately one year.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-11-14 |
Start Month Year | January 7, 2019 |
Primary Completion Month Year | May 22, 2020 |
Verification Month Year | November 2022 |
Verification Date | 2022-11-30 |
Last Update Posted Date | 2022-11-14 |
Results First Posted Date | 2021-06-18 |
Facilities
Sequence: | 199947291 |
Name | Novo Nordisk Investigational Site |
City | Cleveland |
State | Ohio |
Zip | 44195 |
Country | United States |
Conditions
Sequence: | 52133459 |
Name | Obesity |
Downcase Name | obesity |
Id Information
Sequence: | 40130936 | Sequence: | 40130937 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | NN8022-4432 | Id Value | U1111-1218-8104 |
Id Type | Other Identifier | ||
Id Type Description | World Health Organization (WHO) | ||
Countries
Sequence: | 42538538 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55553236 | Sequence: | 55553237 |
Group Type | Experimental | Group Type | Active Comparator |
Title | WMP + Rx | Title | WMP alone |
Description | Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately one year. After discussing with the study doctor, participants will receive one of the following listed 5 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) lorcaserin or lorcaserin extended-release, 3) phentermine/topiramate extended-release, 4) naltrexone/bupropion extended-release and 5) liraglutide 3.0 mg. | Description | Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately one year. |
Interventions
Sequence: | 52449619 | Sequence: | 52449620 |
Intervention Type | Other | Intervention Type | Drug |
Name | Weight Management Program (WMP) | Name | Medication for chronic weight management (Rx) |
Description | As part of usual care, participants will: 1) Discuss and choose one of three diet options: protein-sparing modified fast, Mediterranean, or meal replacement. 2) Be referred to a nutritionist appointment. 3) Initiate a series of twelve monthly study visits in the context of shared medical appointments (SMAs) covering nutrition, physical activity, appetite control, sleep issues, and anxiety/depression/stress. 4) Be referred to an exercise physiologist for a personalized physical activity program. 5) If assessed relevant by the study clinician, be referred to a mental health specialist and/or sleep clinic. | Description | Following listed 5 drugs will be administered as prescribed by the study doctor:
1) Orlistat (Xenical® pills, per os [p.o.; by mouth]). 2) Lorcaserin or lorcaserin extended-release (Belviq®/Belviq XR® pills, p.o.). 3) Phentermine/topiramate extended-release (Qsymia® pills, p.o.). 4) Naltrexone/bupropion extended-release (Contrave® pills, p.o.). 5) Liraglutide 3.0 mg (Saxenda® injections, subcutaneously [under the skin]). |
Design Outcomes
Sequence: | 177246914 | Sequence: | 177246915 | Sequence: | 177246916 | Sequence: | 177246917 | Sequence: | 177246918 | Sequence: | 177246919 | Sequence: | 177246920 | Sequence: | 177246921 | Sequence: | 177246922 | Sequence: | 177246923 | Sequence: | 177246924 | Sequence: | 177246925 | Sequence: | 177246926 | Sequence: | 177246927 | Sequence: | 177246928 | Sequence: | 177246929 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in Body Weight | Measure | Participants Achieving 5% or More Reduction in Body Weight | Measure | Participants Achieving 10% or More Reduction in Body Weight | Measure | Number of Shared Medical Appointments (SMAs) Attended | Measure | Participants Attending 9 or More SMAs | Measure | Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management | Measure | Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days | Measure | Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8) | Measure | Change in 'Time Management' as Measured by WLQ-8 | Measure | Change in 'Physical Tasks' as Measured by WLQ-8 | Measure | Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8 | Measure | Change in 'Output Tasks' as Measured by WLQ-8 | Measure | Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP) | Measure | Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP | Measure | Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP | Measure | Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP |
Time Frame | Month 0, month 12 | Time Frame | Month 12 | Time Frame | Month 12 | Time Frame | Months 0-12 | Time Frame | Months 0-12 | Time Frame | Months 0-12 | Time Frame | Months 0-12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 |
Description | Percentage change in body weight from baseline (month 0) to month 12 is presented. | Description | The percentage of participants achieving 5% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 5% or more reduction in body weight from baseline at month 12 is presented. | Description | The percentage of participants achieving 10% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 10% or more reduction in body weight from baseline at month 12 is presented. | Description | Shared medical appointments (SMAs) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. The mean number of SMAs attended by the participants are presented. | Description | Shared medical appointment (SMA) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. Number of participants who attended 9 or more SMAs is presented. | Description | Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Proportion of days covered by prescription claims for medication for chronic weight management is presented. This endpoint is applicable only for treatment arm, WMP + Rx. | Description | Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Number of participants covered by prescription claims for medication for chronic weight management for at least 80% of days is presented. This endpoint is applicable only for treatment arm, WMP + Rx. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. The WLQ-8 produces subscale scores as well as an index of overall at-work productivity loss. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'At-Work Productivity Loss Index' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'time management' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'physical tasks' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'mental/interpersonal tasks' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'output tasks' from month 0 to month 12 is presented. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. |
Browse Conditions
Sequence: | 193345553 | Sequence: | 193345554 | Sequence: | 193345555 | Sequence: | 193345556 | Sequence: | 193345557 |
Mesh Term | Obesity | Mesh Term | Overweight | Mesh Term | Overnutrition | Mesh Term | Nutrition Disorders | Mesh Term | Body Weight |
Downcase Mesh Term | obesity | Downcase Mesh Term | overweight | Downcase Mesh Term | overnutrition | Downcase Mesh Term | nutrition disorders | Downcase Mesh Term | body weight |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48285506 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Novo Nordisk A/S |
Overall Officials
Sequence: | 29265149 |
Role | Study Director |
Name | Clinical Reporting Anchor and Disclosure (1452) |
Affiliation | Novo Nordisk A/S |
Design Group Interventions
Sequence: | 68100615 | Sequence: | 68100616 | Sequence: | 68100617 |
Design Group Id | 55553236 | Design Group Id | 55553237 | Design Group Id | 55553236 |
Intervention Id | 52449619 | Intervention Id | 52449619 | Intervention Id | 52449620 |
Eligibilities
Sequence: | 30744449 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine eligibility for the study Exclusion Criteria: Contraindications to all of the medications approved by the FDA for chronic weight management according to the label |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254096827 |
Number Of Facilities | 1 |
Number Of Sae Subjects | 23 |
Registered In Calendar Year | 2019 |
Actual Duration | 16 |
Were Results Reported | True |
Months To Report Results | 11 |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 15 |
Designs
Sequence: | 30490746 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Drop Withdrawals
Sequence: | 28962950 | Sequence: | 28962951 | Sequence: | 28962952 | Sequence: | 28962953 |
Result Group Id | 56067797 | Result Group Id | 56067798 | Result Group Id | 56067797 | Result Group Id | 56067798 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Death | Reason | Death |
Count | 4 | Count | 8 | Count | 0 | Count | 1 |
Milestones
Sequence: | 40980557 | Sequence: | 40980558 | Sequence: | 40980559 | Sequence: | 40980560 | Sequence: | 40980561 | Sequence: | 40980562 | Sequence: | 40980563 | Sequence: | 40980564 |
Result Group Id | 56067797 | Result Group Id | 56067798 | Result Group Id | 56067797 | Result Group Id | 56067798 | Result Group Id | 56067797 | Result Group Id | 56067798 | Result Group Id | 56067797 | Result Group Id | 56067798 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | Full Analysis Set (FAS) | Title | Full Analysis Set (FAS) | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 96 | Count | 91 | Count | 4 | Count | 9 |
Outcome Analyses
Sequence: | 16556339 |
Outcome Id | 30783824 |
Non Inferiority Type | Superiority |
Param Type | Treatment Difference |
Param Value | -3.5 |
Dispersion Type | Standard Error of the Mean |
Dispersion Value | 1.02 |
P Value Modifier | < |
P Value | 0.001 |
Ci N Sides | 2-Sided |
Ci Percent | 95.0 |
Ci Lower Limit | -5.51 |
Ci Upper Limit | -1.5 |
Method | ANCOVA |
Groups Description | Analysis of in-trial data with missing observations for body weight at month 12 imputed from the WMP arm based on a jump to reference multiple (x=100) imputation approach. Percent change in body weight from baseline to month 12 was calculated for each study participant within the FAS and analyzed using an analysis of covariance model with randomized treatment as a factor and baseline body weight (kg) as a covariate. |
Outcome Analysis Groups
Sequence: | 32109410 | Sequence: | 32109411 |
Outcome Analysis Id | 16556339 | Outcome Analysis Id | 16556339 |
Result Group Id | 56067799 | Result Group Id | 56067800 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Participant Flows
Sequence: | 3919108 |
Recruitment Details | The trial was conducted at a single site in the United States. |
Pre Assignment Details | Participants were randomized in a 1:1 manner to receive either Cleveland Clinic's Integrated Medical Weight Management Program (WMP) with medication for chronic weight management (WMP + Rx) or Cleveland Clinic's Integrated Medical WMP alone (WMP). |
Outcome Counts
Sequence: | 73950351 | Sequence: | 73950352 | Sequence: | 73950353 | Sequence: | 73950354 | Sequence: | 73950355 | Sequence: | 73950356 | Sequence: | 73950357 | Sequence: | 73950358 | Sequence: | 73950359 | Sequence: | 73950360 | Sequence: | 73950361 | Sequence: | 73950362 | Sequence: | 73950363 | Sequence: | 73950364 | Sequence: | 73950365 | Sequence: | 73950366 | Sequence: | 73950367 | Sequence: | 73950368 | Sequence: | 73950369 | Sequence: | 73950370 | Sequence: | 73950371 | Sequence: | 73950372 | Sequence: | 73950373 | Sequence: | 73950374 | Sequence: | 73950375 | Sequence: | 73950376 | Sequence: | 73950377 | Sequence: | 73950378 | Sequence: | 73950379 | Sequence: | 73950380 |
Outcome Id | 30783824 | Outcome Id | 30783824 | Outcome Id | 30783825 | Outcome Id | 30783825 | Outcome Id | 30783826 | Outcome Id | 30783826 | Outcome Id | 30783827 | Outcome Id | 30783827 | Outcome Id | 30783828 | Outcome Id | 30783828 | Outcome Id | 30783829 | Outcome Id | 30783830 | Outcome Id | 30783831 | Outcome Id | 30783831 | Outcome Id | 30783832 | Outcome Id | 30783832 | Outcome Id | 30783833 | Outcome Id | 30783833 | Outcome Id | 30783834 | Outcome Id | 30783834 | Outcome Id | 30783835 | Outcome Id | 30783835 | Outcome Id | 30783836 | Outcome Id | 30783836 | Outcome Id | 30783837 | Outcome Id | 30783837 | Outcome Id | 30783838 | Outcome Id | 30783838 | Outcome Id | 30783839 | Outcome Id | 30783839 |
Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067799 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 100 | Count | 98 | Count | 98 | Count | 95 | Count | 99 | Count | 98 | Count | 98 | Count | 97 | Count | 97 | Count | 98 | Count | 95 | Count | 95 | Count | 95 | Count | 95 | Count | 95 | Count | 95 | Count | 100 | Count | 100 |
Provided Documents
Sequence: | 2576849 | Sequence: | 2576850 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2018-10-10 | Document Date | 2020-05-18 |
Url | https://ClinicalTrials.gov/ProvidedDocs/98/NCT03799198/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/98/NCT03799198/SAP_001.pdf |
Reported Event Totals
Sequence: | 27926830 | Sequence: | 27926831 | Sequence: | 27926832 | Sequence: | 27926833 | Sequence: | 27926834 | Sequence: | 27926835 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 8 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 11 | Subjects Affected | 0 | Subjects Affected | 1 |
Subjects At Risk | 100 | Subjects At Risk | 0 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 0 | Subjects At Risk | 100 |
Created At | 2023-08-08 19:39:46.931925 | Created At | 2023-08-08 19:39:46.931925 | Created At | 2023-08-08 19:39:46.931925 | Created At | 2023-08-08 19:39:46.931925 | Created At | 2023-08-08 19:39:46.931925 | Created At | 2023-08-08 19:39:46.931925 |
Updated At | 2023-08-08 19:39:46.931925 | Updated At | 2023-08-08 19:39:46.931925 | Updated At | 2023-08-08 19:39:46.931925 | Updated At | 2023-08-08 19:39:46.931925 | Updated At | 2023-08-08 19:39:46.931925 | Updated At | 2023-08-08 19:39:46.931925 |
Reported Events
Sequence: | 527811605 | Sequence: | 527811585 | Sequence: | 527811586 | Sequence: | 527811587 | Sequence: | 527811588 | Sequence: | 527811589 | Sequence: | 527811590 | Sequence: | 527811591 | Sequence: | 527811592 | Sequence: | 527811606 | Sequence: | 527811593 | Sequence: | 527811594 | Sequence: | 527811595 | Sequence: | 527811596 | Sequence: | 527811597 | Sequence: | 527811598 | Sequence: | 527811599 | Sequence: | 527811600 | Sequence: | 527811601 | Sequence: | 527811602 | Sequence: | 527811603 | Sequence: | 527811604 | Sequence: | 527811607 | Sequence: | 527811608 | Sequence: | 527811609 | Sequence: | 527811610 | Sequence: | 527811611 | Sequence: | 527811612 | Sequence: | 527811613 | Sequence: | 527811614 | Sequence: | 527811615 | Sequence: | 527811616 | Sequence: | 527811617 | Sequence: | 527811618 | Sequence: | 527811619 | Sequence: | 527811620 | Sequence: | 527811621 | Sequence: | 527811622 | Sequence: | 527811623 | Sequence: | 527811624 | Sequence: | 527811625 | Sequence: | 527811626 | Sequence: | 527811627 | Sequence: | 527811628 | Sequence: | 527811629 | Sequence: | 527811630 |
Result Group Id | 56067801 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 | Result Group Id | 56067801 | Result Group Id | 56067802 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 | Time Frame | Months 0 – 12 |
Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 |
Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 | Subjects At Risk | 100 |
Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. | Description | All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected. |
Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 1 | Event Count | 1 | Event Count | 0 |
Organ System | Blood and lymphatic system disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Blood and lymphatic system disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | General disorders | Organ System | General disorders | Organ System | Hepatobiliary disorders | Organ System | Hepatobiliary disorders | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Reproductive system and breast disorders | Organ System | Reproductive system and breast disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Social circumstances | Organ System | Social circumstances | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Vascular disorders | Organ System | Vascular disorders |
Adverse Event Term | Plasma Cell Myeloma | Adverse Event Term | Atrial Fibrillation | Adverse Event Term | Atrial Fibrillation | Adverse Event Term | Atrial Tachycardia | Adverse Event Term | Atrial Tachycardia | Adverse Event Term | Congestive Cardiomyopathy | Adverse Event Term | Congestive Cardiomyopathy | Adverse Event Term | Appendicitis | Adverse Event Term | Appendicitis | Adverse Event Term | Plasma Cell Myeloma | Adverse Event Term | Gastroenteritis Salmonella | Adverse Event Term | Gastroenteritis Salmonella | Adverse Event Term | Procedural Vomiting | Adverse Event Term | Procedural Vomiting | Adverse Event Term | Dehydration | Adverse Event Term | Dehydration | Adverse Event Term | Malnutrition | Adverse Event Term | Malnutrition | Adverse Event Term | Arthralgia | Adverse Event Term | Arthralgia | Adverse Event Term | Intervertebral Disc Protrusion | Adverse Event Term | Intervertebral Disc Protrusion | Adverse Event Term | Non-Cardiac Chest Pain | Adverse Event Term | Non-Cardiac Chest Pain | Adverse Event Term | Cholelithiasis | Adverse Event Term | Cholelithiasis | Adverse Event Term | Pyelonephritis | Adverse Event Term | Pyelonephritis | Adverse Event Term | Parathyroid Tumour Benign | Adverse Event Term | Parathyroid Tumour Benign | Adverse Event Term | Syncope | Adverse Event Term | Syncope | Adverse Event Term | Depression Suicidal | Adverse Event Term | Depression Suicidal | Adverse Event Term | Ovarian Mass | Adverse Event Term | Ovarian Mass | Adverse Event Term | Respiratory Failure | Adverse Event Term | Respiratory Failure | Adverse Event Term | Skin Lesion | Adverse Event Term | Skin Lesion | Adverse Event Term | Organ Donor | Adverse Event Term | Organ Donor | Adverse Event Term | Gastric Bypass | Adverse Event Term | Gastric Bypass | Adverse Event Term | Dizziness | Adverse Event Term | Dizziness |
Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 |
Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 | Vocab | 20.1 |
Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment | Assessment | Systematic Assessment |
Responsible Parties
Sequence: | 28857047 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3849852 |
Pi Employee | No |
Restriction Type | OTHER |
Other Details | At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property. |
Restrictive Agreement | At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property. |
Result Contacts
Sequence: | 3849817 |
Organization | Novo Nordisk A/S |
Name | Clinical Transparency and Medical Writing Office (1452) |
Phone | (+1) 866-867-7178 |
clinicaltrials@novonordisk.com | |
Outcomes
Sequence: | 30783824 | Sequence: | 30783825 | Sequence: | 30783826 | Sequence: | 30783827 | Sequence: | 30783828 | Sequence: | 30783829 | Sequence: | 30783830 | Sequence: | 30783831 | Sequence: | 30783832 | Sequence: | 30783833 | Sequence: | 30783834 | Sequence: | 30783835 | Sequence: | 30783837 | Sequence: | 30783836 | Sequence: | 30783838 | Sequence: | 30783839 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Change in Body Weight | Title | Participants Achieving 5% or More Reduction in Body Weight | Title | Participants Achieving 10% or More Reduction in Body Weight | Title | Number of Shared Medical Appointments (SMAs) Attended | Title | Participants Attending 9 or More SMAs | Title | Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management | Title | Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days | Title | Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8) | Title | Change in 'Time Management' as Measured by WLQ-8 | Title | Change in 'Physical Tasks' as Measured by WLQ-8 | Title | Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8 | Title | Change in 'Output Tasks' as Measured by WLQ-8 | Title | Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP | Title | Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP) | Title | Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP | Title | Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP |
Description | Percentage change in body weight from baseline (month 0) to month 12 is presented. | Description | The percentage of participants achieving 5% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 5% or more reduction in body weight from baseline at month 12 is presented. | Description | The percentage of participants achieving 10% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 10% or more reduction in body weight from baseline at month 12 is presented. | Description | Shared medical appointments (SMAs) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. The mean number of SMAs attended by the participants are presented. | Description | Shared medical appointment (SMA) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. Number of participants who attended 9 or more SMAs is presented. | Description | Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Proportion of days covered by prescription claims for medication for chronic weight management is presented. This endpoint is applicable only for treatment arm, WMP + Rx. | Description | Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Number of participants covered by prescription claims for medication for chronic weight management for at least 80% of days is presented. This endpoint is applicable only for treatment arm, WMP + Rx. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. The WLQ-8 produces subscale scores as well as an index of overall at-work productivity loss. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'At-Work Productivity Loss Index' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'time management' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'physical tasks' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'mental/interpersonal tasks' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'output tasks' from month 0 to month 12 is presented. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. |
Time Frame | Month 0, month 12 | Time Frame | Month 12 | Time Frame | Month 12 | Time Frame | Months 0-12 | Time Frame | Months 0-12 | Time Frame | Months 0-12 | Time Frame | Months 0-12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 | Time Frame | Month 0, month 12 |
Population | The FAS comprised of all randomized participants. | Population | The FAS comprised of all randomized participants. | Population | The FAS comprised of all randomized participants. | Population | The FAS comprised of all randomized participants. | Population | The FAS comprised of all randomized participants. | Population | The FAS comprised of all randomized participants. | Population | The FAS comprised of all randomized participants. | Population | The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. | Population | The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. | Population | The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. | Population | The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. | Population | The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. | Population | The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. | Population | The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. | Population | The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. | Population | The FAS comprised of all randomized participants. |
Units | Percent change of body weight | Units | Percentage of participants | Units | Percentage of participants | Units | SMAs | Units | Participants | Units | Proportion of days | Units | Participants | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale |
Dispersion Type | Standard Error | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | ||||||||
Param Type | Least Squares Mean | Param Type | Number | Param Type | Number | Param Type | Mean | Param Type | Count of Participants | Param Type | Mean | Param Type | Count of Participants | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean |
Outcome Measurements
Sequence: | 235487856 | Sequence: | 235487857 | Sequence: | 235487858 | Sequence: | 235487859 | Sequence: | 235487860 | Sequence: | 235487861 | Sequence: | 235487862 | Sequence: | 235487863 | Sequence: | 235487864 | Sequence: | 235487865 | Sequence: | 235487866 | Sequence: | 235487867 | Sequence: | 235487868 | Sequence: | 235487869 | Sequence: | 235487870 | Sequence: | 235487871 | Sequence: | 235487872 | Sequence: | 235487873 | Sequence: | 235487874 | Sequence: | 235487875 | Sequence: | 235487876 | Sequence: | 235487877 | Sequence: | 235487878 | Sequence: | 235487879 | Sequence: | 235487880 | Sequence: | 235487881 | Sequence: | 235487882 | Sequence: | 235487883 | Sequence: | 235487884 | Sequence: | 235487885 |
Outcome Id | 30783824 | Outcome Id | 30783824 | Outcome Id | 30783825 | Outcome Id | 30783825 | Outcome Id | 30783826 | Outcome Id | 30783826 | Outcome Id | 30783827 | Outcome Id | 30783827 | Outcome Id | 30783828 | Outcome Id | 30783828 | Outcome Id | 30783829 | Outcome Id | 30783830 | Outcome Id | 30783831 | Outcome Id | 30783831 | Outcome Id | 30783832 | Outcome Id | 30783832 | Outcome Id | 30783833 | Outcome Id | 30783833 | Outcome Id | 30783834 | Outcome Id | 30783834 | Outcome Id | 30783835 | Outcome Id | 30783835 | Outcome Id | 30783836 | Outcome Id | 30783836 | Outcome Id | 30783837 | Outcome Id | 30783837 | Outcome Id | 30783838 | Outcome Id | 30783838 | Outcome Id | 30783839 | Outcome Id | 30783839 |
Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067799 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 | Result Group Id | 56067799 | Result Group Id | 56067800 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Title | Change in Body Weight | Title | Change in Body Weight | Title | Participants Achieving 5% or More Reduction in Body Weight | Title | Participants Achieving 5% or More Reduction in Body Weight | Title | Participants Achieving 10% or More Reduction in Body Weight | Title | Participants Achieving 10% or More Reduction in Body Weight | Title | Number of Shared Medical Appointments (SMAs) Attended | Title | Number of Shared Medical Appointments (SMAs) Attended | Title | Participants Attending 9 or More SMAs | Title | Participants Attending 9 or More SMAs | Title | Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management | Title | Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days | Title | Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8) | Title | Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8) | Title | Change in 'Time Management' as Measured by WLQ-8 | Title | Change in 'Time Management' as Measured by WLQ-8 | Title | Change in 'Physical Tasks' as Measured by WLQ-8 | Title | Change in 'Physical Tasks' as Measured by WLQ-8 | Title | Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8 | Title | Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8 | Title | Change in 'Output Tasks' as Measured by WLQ-8 | Title | Change in 'Output Tasks' as Measured by WLQ-8 | Title | Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP) | Title | Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP) | Title | Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP | Title | Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP | Title | Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP | Title | Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP | Title | Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP | Title | Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP |
Description | Percentage change in body weight from baseline (month 0) to month 12 is presented. | Description | Percentage change in body weight from baseline (month 0) to month 12 is presented. | Description | The percentage of participants achieving 5% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 5% or more reduction in body weight from baseline at month 12 is presented. | Description | The percentage of participants achieving 5% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 5% or more reduction in body weight from baseline at month 12 is presented. | Description | The percentage of participants achieving 10% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 10% or more reduction in body weight from baseline at month 12 is presented. | Description | The percentage of participants achieving 10% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 10% or more reduction in body weight from baseline at month 12 is presented. | Description | Shared medical appointments (SMAs) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. The mean number of SMAs attended by the participants are presented. | Description | Shared medical appointments (SMAs) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. The mean number of SMAs attended by the participants are presented. | Description | Shared medical appointment (SMA) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. Number of participants who attended 9 or more SMAs is presented. | Description | Shared medical appointment (SMA) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. Number of participants who attended 9 or more SMAs is presented. | Description | Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Proportion of days covered by prescription claims for medication for chronic weight management is presented. This endpoint is applicable only for treatment arm, WMP + Rx. | Description | Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Number of participants covered by prescription claims for medication for chronic weight management for at least 80% of days is presented. This endpoint is applicable only for treatment arm, WMP + Rx. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. The WLQ-8 produces subscale scores as well as an index of overall at-work productivity loss. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'At-Work Productivity Loss Index' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. The WLQ-8 produces subscale scores as well as an index of overall at-work productivity loss. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'At-Work Productivity Loss Index' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'time management' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'time management' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'physical tasks' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'physical tasks' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'mental/interpersonal tasks' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'mental/interpersonal tasks' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'output tasks' from month 0 to month 12 is presented. | Description | The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'output tasks' from month 0 to month 12 is presented. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. | Description | The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline. |
Units | Percent change of body weight | Units | Percent change of body weight | Units | Percentage of participants | Units | Percentage of participants | Units | Percentage of participants | Units | Percentage of participants | Units | SMAs | Units | SMAs | Units | Participants | Units | Participants | Units | Proportion of days | Units | Participants | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale | Units | Score on a scale |
Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Count of Participants | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean |
Param Value | -7.69 | Param Value | -4.19 | Param Value | 62.5 | Param Value | 44.8 | Param Value | 34.7 | Param Value | 22.4 | Param Value | 9.7 | Param Value | 7.4 | Param Value | 79 | Param Value | 51 | Param Value | 66.48 | Param Value | 43 | Param Value | -0.06 | Param Value | -0.03 | Param Value | -0.10 | Param Value | -0.19 | Param Value | -0.09 | Param Value | -0.05 | Param Value | -0.06 | Param Value | -0.03 | Param Value | 0.07 | Param Value | 0.12 | Param Value | -0.43 | Param Value | -0.48 | Param Value | -1.88 | Param Value | -1.94 | Param Value | -1.84 | Param Value | -1.89 | Param Value | -9.95 | Param Value | -7.20 |
Param Value Num | -7.69 | Param Value Num | -4.19 | Param Value Num | 62.5 | Param Value Num | 44.8 | Param Value Num | 34.7 | Param Value Num | 22.4 | Param Value Num | 9.7 | Param Value Num | 7.4 | Param Value Num | 79.0 | Param Value Num | 51.0 | Param Value Num | 66.48 | Param Value Num | 43.0 | Param Value Num | -0.06 | Param Value Num | -0.03 | Param Value Num | -0.1 | Param Value Num | -0.19 | Param Value Num | -0.09 | Param Value Num | -0.05 | Param Value Num | -0.06 | Param Value Num | -0.03 | Param Value Num | 0.07 | Param Value Num | 0.12 | Param Value Num | -0.43 | Param Value Num | -0.48 | Param Value Num | -1.88 | Param Value Num | -1.94 | Param Value Num | -1.84 | Param Value Num | -1.89 | Param Value Num | -9.95 | Param Value Num | -7.2 |
Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | ||||||||||||||
Dispersion Value | 0.72 | Dispersion Value | 0.73 | Dispersion Value | 2.98 | Dispersion Value | 3.90 | Dispersion Value | 27.096 | Dispersion Value | 0.06 | Dispersion Value | 0.06 | Dispersion Value | 0.07 | Dispersion Value | 0.07 | Dispersion Value | 0.11 | Dispersion Value | 0.11 | Dispersion Value | 0.09 | Dispersion Value | 0.09 | Dispersion Value | 0.10 | Dispersion Value | 0.11 | Dispersion Value | 0.17 | Dispersion Value | 0.19 | Dispersion Value | 1.62 | Dispersion Value | 1.82 | Dispersion Value | 1.62 | Dispersion Value | 1.82 | Dispersion Value | 2.53 | Dispersion Value | 2.69 | ||||||||||||||
Dispersion Value Num | 0.72 | Dispersion Value Num | 0.73 | Dispersion Value Num | 2.98 | Dispersion Value Num | 3.9 | Dispersion Value Num | 27.096 | Dispersion Value Num | 0.06 | Dispersion Value Num | 0.06 | Dispersion Value Num | 0.07 | Dispersion Value Num | 0.07 | Dispersion Value Num | 0.11 | Dispersion Value Num | 0.11 | Dispersion Value Num | 0.09 | Dispersion Value Num | 0.09 | Dispersion Value Num | 0.1 | Dispersion Value Num | 0.11 | Dispersion Value Num | 0.17 | Dispersion Value Num | 0.19 | Dispersion Value Num | 1.62 | Dispersion Value Num | 1.82 | Dispersion Value Num | 1.62 | Dispersion Value Num | 1.82 | Dispersion Value Num | 2.53 | Dispersion Value Num | 2.69 | ||||||||||||||
Study References
Sequence: | 52027283 |
Pmid | 34255049 |
Reference Type | derived |
Citation | Pantalone KM, Smolarz BG, Ramasamy A, Baz Hecht M, Harty BJ, Rogen B, Griebeler ML, Borukh E, Young JB, Burguera B. Effectiveness of Combining Antiobesity Medication With an Employer-Based Weight Management Program for Treatment of Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116595. doi: 10.1001/jamanetworkopen.2021.16595. |
Baseline Counts
Sequence: | 11376893 | Sequence: | 11376894 | Sequence: | 11376895 |
Result Group Id | 56067794 | Result Group Id | 56067795 | Result Group Id | 56067796 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 100 | Count | 100 | Count | 200 |
Result Groups
Sequence: | 56067796 | Sequence: | 56067794 | Sequence: | 56067795 | Sequence: | 56067797 | Sequence: | 56067798 | Sequence: | 56067799 | Sequence: | 56067800 | Sequence: | 56067801 | Sequence: | 56067802 |
Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Total | Title | Weight Management Program (WMP) + Rx | Title | Weight Management Program (WMP) | Title | Weight Management Program (WMP) + Rx | Title | Weight Management Program (WMP) | Title | Weight Management Program (WMP) + Rx | Title | Weight Management Program (WMP) | Title | Weight Management Program (WMP) + Rx | Title | Weight Management Program (WMP) |
Description | Total of all reporting groups | Description | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®. | Description | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. | Description | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®. | Description | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. | Description | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®. | Description | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. | Description | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®. | Description | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. |
Baseline Measurements
Sequence: | 125504758 | Sequence: | 125504759 | Sequence: | 125504760 | Sequence: | 125504761 | Sequence: | 125504762 | Sequence: | 125504763 | Sequence: | 125504764 | Sequence: | 125504765 | Sequence: | 125504766 | Sequence: | 125504767 | Sequence: | 125504768 | Sequence: | 125504769 | Sequence: | 125504770 | Sequence: | 125504771 | Sequence: | 125504772 | Sequence: | 125504773 | Sequence: | 125504774 | Sequence: | 125504775 | Sequence: | 125504776 | Sequence: | 125504777 | Sequence: | 125504778 | Sequence: | 125504779 | Sequence: | 125504780 | Sequence: | 125504781 | Sequence: | 125504782 | Sequence: | 125504783 | Sequence: | 125504784 | Sequence: | 125504785 | Sequence: | 125504786 | Sequence: | 125504787 |
Result Group Id | 56067794 | Result Group Id | 56067795 | Result Group Id | 56067796 | Result Group Id | 56067794 | Result Group Id | 56067795 | Result Group Id | 56067796 | Result Group Id | 56067794 | Result Group Id | 56067795 | Result Group Id | 56067796 | Result Group Id | 56067794 | Result Group Id | 56067795 | Result Group Id | 56067796 | Result Group Id | 56067794 | Result Group Id | 56067795 | Result Group Id | 56067796 | Result Group Id | 56067794 | Result Group Id | 56067795 | Result Group Id | 56067796 | Result Group Id | 56067794 | Result Group Id | 56067795 | Result Group Id | 56067796 | Result Group Id | 56067794 | Result Group Id | 56067795 | Result Group Id | 56067796 | Result Group Id | 56067794 | Result Group Id | 56067795 | Result Group Id | 56067796 | Result Group Id | 56067794 | Result Group Id | 56067795 | Result Group Id | 56067796 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | White | Category | White | Category | White | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | Asian/White | Category | Asian/White | Category | Asian/White | Category | India | Category | India | Category | India | ||||||
Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized |
Description | Race | Description | Race | Description | Race | Description | Race | Description | Race | Description | Race | Description | Race | Description | Race | Description | Race | Description | Race | Description | Race | Description | Race | ||||||||||||||||||||||||||||||||||||
Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 51.0 | Param Value | 49.1 | Param Value | 50.0 | Param Value | 88 | Param Value | 89 | Param Value | 177 | Param Value | 12 | Param Value | 11 | Param Value | 23 | Param Value | 4 | Param Value | 0 | Param Value | 4 | Param Value | 96 | Param Value | 100 | Param Value | 196 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 80 | Param Value | 66 | Param Value | 146 | Param Value | 19 | Param Value | 33 | Param Value | 52 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 1 |
Param Value Num | 51.0 | Param Value Num | 49.1 | Param Value Num | 50.0 | Param Value Num | 88.0 | Param Value Num | 89.0 | Param Value Num | 177.0 | Param Value Num | 12.0 | Param Value Num | 11.0 | Param Value Num | 23.0 | Param Value Num | 4.0 | Param Value Num | 0.0 | Param Value Num | 4.0 | Param Value Num | 96.0 | Param Value Num | 100.0 | Param Value Num | 196.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 80.0 | Param Value Num | 66.0 | Param Value Num | 146.0 | Param Value Num | 19.0 | Param Value Num | 33.0 | Param Value Num | 52.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 10.43 | Dispersion Value | 10.11 | Dispersion Value | 10.29 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 10.43 | Dispersion Value Num | 10.11 | Dispersion Value Num | 10.29 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 100 | Number Analyzed | 100 | Number Analyzed | 200 | Number Analyzed | 100 | Number Analyzed | 100 | Number Analyzed | 200 | Number Analyzed | 100 | Number Analyzed | 100 | Number Analyzed | 200 | Number Analyzed | 100 | Number Analyzed | 100 | Number Analyzed | 200 | Number Analyzed | 100 | Number Analyzed | 100 | Number Analyzed | 200 | Number Analyzed | 100 | Number Analyzed | 100 | Number Analyzed | 200 | Number Analyzed | 100 | Number Analyzed | 100 | Number Analyzed | 200 | Number Analyzed | 100 | Number Analyzed | 100 | Number Analyzed | 200 | Number Analyzed | 100 | Number Analyzed | 100 | Number Analyzed | 200 | Number Analyzed | 100 | Number Analyzed | 100 | Number Analyzed | 200 |
]]>
https://zephyrnet.com/NCT03799185
2016-01-04
https://zephyrnet.com/?p=NCT03799185
NCT03799185https://www.clinicaltrials.gov/study/NCT03799185?tab=tableNANANAATERA Survey is a national cross sectional observational study, aiming to determine the prevalence of dyslipidemia and other conventional risk factors for CHD (Coronary Heart Disease), the relationship between environmental and lifestyle factors with dyslipidemia, the perception and the knowledge of cardiovascular risk factors by the population, and above all, to strengthen the national strategy for primary and secondary prevention against coronary heart disease.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-01-22 |
Start Month Year | January 4, 2016 |
Primary Completion Month Year | August 31, 2019 |
Verification Month Year | January 2020 |
Verification Date | 2020-01-31 |
Last Update Posted Date | 2020-01-22 |
Detailed Descriptions
Sequence: | 20762920 |
Description | ATERA Survey is carried on in a random sampling including 10 000 men and women from the seven regions of Tunisia (Great Tunis, North East, North West, central East, Central West, South East and South West. The screening is being assessed using surveys covering socioeconomic, nutritional and anthropometric measures in addition to biological assessments.
The target population is being recruited by random sampling drown by the National Institute of Statistics (Tunisia). The estimated number of participants at the end of recruitment amount to 10 000. The frame sampling uses a two stage cluster sampling (district and household). Interview with each eligible participant will be conducted mainly during assessment visit and after consenting the subject, it will be notified all the demographic, behavioral history, family history, cardiovascular risk factors and medical history. During the assessment visit, Physical examination/anthropometry data and Diet survey will be filled up by the investigator. Data capture will be performed by the DACIMA Clinical Suite according to FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation) |
Facilities
Sequence: | 200458031 |
Name | ATERA : Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose |
City | Tunis |
Zip | 1007 |
Country | Tunisia |
Conditions
Sequence: | 52277442 | Sequence: | 52277443 | Sequence: | 52277444 | Sequence: | 52277445 |
Name | Dyslipidemias | Name | Atherosclerosis | Name | Households | Name | Survey, Family Life |
Downcase Name | dyslipidemias | Downcase Name | atherosclerosis | Downcase Name | households | Downcase Name | survey, family life |
Id Information
Sequence: | 40235451 |
Id Source | org_study_id |
Id Value | ID5726367 |
Countries
Sequence: | 42653026 |
Name | Tunisia |
Removed | False |
Keywords
Sequence: | 80018939 | Sequence: | 80018940 | Sequence: | 80018941 | Sequence: | 80018942 | Sequence: | 80018943 | Sequence: | 80018944 | Sequence: | 80018945 | Sequence: | 80018946 | Sequence: | 80018947 | Sequence: | 80018948 | Sequence: | 80018949 |
Name | Coronary Heart Disease | Name | Hypercholesterolemia | Name | Triglycerides High | Name | LDL Hyperlipoproteinemia | Name | HDL Low | Name | Diabetes | Name | Cardiovascular Diseases | Name | Hypertension | Name | Risk Factor, Cardiovascular | Name | Diet Habit | Name | Smoking |
Downcase Name | coronary heart disease | Downcase Name | hypercholesterolemia | Downcase Name | triglycerides high | Downcase Name | ldl hyperlipoproteinemia | Downcase Name | hdl low | Downcase Name | diabetes | Downcase Name | cardiovascular diseases | Downcase Name | hypertension | Downcase Name | risk factor, cardiovascular | Downcase Name | diet habit | Downcase Name | smoking |
Design Outcomes
Sequence: | 177770615 | Sequence: | 177770616 | Sequence: | 177770617 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | other |
Measure | Prevalence of dyslipidemia | Measure | Prevalence of cardiovascular associated risk factors | Measure | Dietary assessment |
Time Frame | At inclusion | Time Frame | At inclusion | Time Frame | Up to 1 month |
Description | Frequency of subjects with hypercholesterolemia and/or hypertriglyceridaemia | Description | Frequency of subjects with cardiovascular risk factors (diabetes, hypertension, obesity, gender, smoking) | Description | Frequency of diet daily intake (fat, sugar, proteins, fiber) |
Browse Conditions
Sequence: | 193892697 | Sequence: | 193892698 | Sequence: | 193892699 | Sequence: | 193892700 | Sequence: | 193892701 | Sequence: | 193892702 | Sequence: | 193892703 | Sequence: | 193892704 |
Mesh Term | Atherosclerosis | Mesh Term | Dyslipidemias | Mesh Term | Arteriosclerosis | Mesh Term | Arterial Occlusive Diseases | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Lipid Metabolism Disorders | Mesh Term | Metabolic Diseases |
Downcase Mesh Term | atherosclerosis | Downcase Mesh Term | dyslipidemias | Downcase Mesh Term | arteriosclerosis | Downcase Mesh Term | arterial occlusive diseases | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | lipid metabolism disorders | Downcase Mesh Term | metabolic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48418622 | Sequence: | 48418623 | Sequence: | 48418624 | Sequence: | 48418625 | Sequence: | 48418626 | Sequence: | 48418627 | Sequence: | 48418628 | Sequence: | 48418629 | Sequence: | 48418630 |
Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | UNKNOWN | Agency Class | UNKNOWN | Agency Class | UNKNOWN | Agency Class | OTHER_GOV | Agency Class | UNKNOWN | Agency Class | UNKNOWN | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose | Name | Biochimie Clinique LR99ES11 | Name | Department of Biochemistry, La Rabta Hospital, Tunisia. | Name | Ministry of Health, Tunisia | Name | Ministry of Interior, Tunisia | Name | Direction des Soins de Santé de Base | Name | National Institute of Statistics | Name | National Institute of Public Health of Tunisia | Name | Dacima Consulting |
Overall Officials
Sequence: | 29342601 | Sequence: | 29342602 |
Role | Study Chair | Role | Study Chair |
Name | Amani Kallel, PhD | Name | Riadh Jemaa, PhD |
Affiliation | Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose | Affiliation | Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose |
Eligibilities
Sequence: | 30827021 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 25 Years |
Maximum Age | 75 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | All subjects aged between 25 and 75 years who accept to participate at the study |
Criteria | Inclusion Criteria:
All subjects Exclusion Criteria: Prescribed treatment for cancer |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254123693 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 44 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 25 |
Maximum Age Num | 75 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30572951 |
Observational Model | Family-Based |
Time Perspective | Cross-Sectional |
Links
Sequence: | 4396489 |
Url | http://atera1.org |
Description | ATERA official Website |
Responsible Parties
Sequence: | 28939373 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799172
2018-11-01
https://zephyrnet.com/?p=NCT03799172
NCT03799172https://www.clinicaltrials.gov/study/NCT03799172?tab=tableNANANACandidemia is the most frequent invasive fungal disease in intensive care units (ICUs). It remains a major health concern, considering its attributable mortality up to 40% in critically ill patients. Successful clinical outcome requires early diagnosis and effective antifungal therapy. Guidelines for the treatment of candidemia were published by the Infectious Diseases Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). According to these guidelines, echinocandins are the preferred first-line therapy for candidemia in critically ill patients. Considering the bibliography supporting this statement, the place of triazoles still needs to be defined in candidemia therapeutic arsenal. In this context, we are setting up a retrospective cohort study using Hospital database to compare the efficacy of echinocandins and azoles for the treatment of candidemia in intensive care units.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-03-04 |
Start Month Year | November 1, 2018 |
Primary Completion Month Year | February 1, 2019 |
Verification Month Year | March 2020 |
Verification Date | 2020-03-31 |
Last Update Posted Date | 2020-03-04 |
Facilities
Sequence: | 200053151 |
Name | Hospices Civils de Lyon, Hôpital de la Croix-Rousse |
City | Lyon |
Zip | 69004 |
Country | France |
Browse Interventions
Sequence: | 96027727 | Sequence: | 96027728 | Sequence: | 96027729 |
Mesh Term | Echinocandins | Mesh Term | Antifungal Agents | Mesh Term | Anti-Infective Agents |
Downcase Mesh Term | echinocandins | Downcase Mesh Term | antifungal agents | Downcase Mesh Term | anti-infective agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52156393 |
Name | Candidemia |
Downcase Name | candidemia |
Id Information
Sequence: | 40148159 |
Id Source | org_study_id |
Id Value | CRC_GHN_2019_001 |
Countries
Sequence: | 42557685 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55577824 | Sequence: | 55577825 |
Title | Echinocandin group | Title | Triazole group |
Description | Echinocandin group is the group of patients who received echinocandins as first-line therapy for candidemia | Description | Triazole group is the group of patients who received triazoles as first-line therapy for candidemia |
Interventions
Sequence: | 52471933 | Sequence: | 52471934 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Echinocandin treatment | Name | Triazole treatment |
Description | Patients received echinocandins as a first-line therapy after candidemia diagnosis according to the standard of care | Description | Patients received triazoles as a first-line therapy after candidemia diagnosis according to the standard of care.
Candidemia was defined as at least one blood culture positive for Candida. |
Design Outcomes
Sequence: | 177327653 | Sequence: | 177327654 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Comparison of all cause hospital mortality on day 90 between echinocandins and azoles | Measure | Comparison of treatment success on day 30 between echinocandins and azoles. |
Time Frame | Mortality on day 90 after antifungal initiation | Time Frame | Treatment success on day 30 after antifungal initiation |
Description | Comparison of all cause hospital mortality on day 90 between echinocandins and azoles | Description | Treatment success is defined as a complete response if the following two criteria were full-filled: survival and resolution of all attributable symptoms and signs of disease, and mycological success (documented clearance of pathogen from the blood). |
Browse Conditions
Sequence: | 193431817 | Sequence: | 193431818 | Sequence: | 193431819 | Sequence: | 193431820 | Sequence: | 193431821 | Sequence: | 193431822 | Sequence: | 193431823 | Sequence: | 193431824 | Sequence: | 193431825 | Sequence: | 193431826 | Sequence: | 193431827 | Sequence: | 193431828 |
Mesh Term | Candidemia | Mesh Term | Candidiasis, Invasive | Mesh Term | Candidiasis | Mesh Term | Mycoses | Mesh Term | Bacterial Infections and Mycoses | Mesh Term | Infections | Mesh Term | Invasive Fungal Infections | Mesh Term | Fungemia | Mesh Term | Sepsis | Mesh Term | Systemic Inflammatory Response Syndrome | Mesh Term | Inflammation | Mesh Term | Pathologic Processes |
Downcase Mesh Term | candidemia | Downcase Mesh Term | candidiasis, invasive | Downcase Mesh Term | candidiasis | Downcase Mesh Term | mycoses | Downcase Mesh Term | bacterial infections and mycoses | Downcase Mesh Term | infections | Downcase Mesh Term | invasive fungal infections | Downcase Mesh Term | fungemia | Downcase Mesh Term | sepsis | Downcase Mesh Term | systemic inflammatory response syndrome | Downcase Mesh Term | inflammation | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48305986 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Hospices Civils de Lyon |
Design Group Interventions
Sequence: | 68130773 | Sequence: | 68130774 |
Design Group Id | 55577824 | Design Group Id | 55577825 |
Intervention Id | 52471933 | Intervention Id | 52471934 |
Eligibilities
Sequence: | 30757310 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Patients with a diagnosis of candidemia during their ICU stay |
Criteria | Inclusion Criteria:
Patients who had a diagnosis of candidemia during ICU stay and were treated with echinocandins or azoles Exclusion Criteria: Patients with neutropenia |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254226293 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 3 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30503535 |
Observational Model | Cohort |
Time Perspective | Retrospective |
Responsible Parties
Sequence: | 28869813 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799159
2019-05-15
https://zephyrnet.com/?p=NCT03799159
NCT03799159https://www.clinicaltrials.gov/study/NCT03799159?tab=tableNANANAPopulations at high risk of Sepsis-Associated Acute Kidney Injury (SA-AKI) have been identified. Sources of sepsis, in particular, bloodstream infection, abdominal and genitourinary sepsis, and infective endocarditis, are associated with a higher likelihood of developing AKI. Similar to the poor outcome of patients with sepsis, delayed administration of appropriate antimicrobial therapy was shown to be an independent predictor of the development of AKI. Incremental delays in antimicrobial delivery after the onset of hypotension showed a direct relationship with the development of AKI. The need for sensitive, simple and time-applicable biomarker to predict AKI development after renal insult is urgent.
Serum creatinine (sCr) and urea are used routinely for the diagnosis of AKI. However, these parameters are not accurate for the diagnosis of AKI. Cystatin C. (CysC) is suggested to be a good biomarker because of its constant rate of production, almost filtered by glomeruli (99%), has no significant protein binding and not secreted by renal tubule. Neutrophil gelatinase-associated lipocalin (NGAL) is recently identified and extensively investigated as a most promising early marker of AKI. Urinary NGAL is not only effective in detection of AKI but also its degree of expression might distinguish among AKI, prerenal azotemia and chronic kidney disease, and it is detectable before the accumulation of serum creatinine.
Ultrasonography (US) is used routinely to assess renal morphology. Renal Resistive Index (RRI) is a non-invasive Doppler-measured parameter that is directly correlated with intra-renal arterial resistance. RRI is defined as [(peak systolic velocity – end diastolic velocity)/ peak systolic velocity]. It theoretically ranges from 0 to 1 and it is normally lower than 0.7 with age differences. RRI calculation was found to be useful as an early indicator of the vascular resistance changes and in the determination of the optimal systemic hemodynamics required for renal perfusion.
The aim of this study is to compare the ability of arterial renal resistive index (RRI), serum and urinary neutrophil gelatinase-associated lipocalin (NGAL), Cystatin C (CysC) in early diagnosis and predicting the persistence of acute kidney injury in septic patients.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-03-02 |
Start Month Year | May 15, 2019 |
Primary Completion Month Year | February 28, 2021 |
Verification Month Year | February 2021 |
Verification Date | 2021-02-28 |
Last Update Posted Date | 2021-03-02 |
Detailed Descriptions
Sequence: | 20780355 |
Description | All included patients in this study will be assessed for the following:
Data Collection Complete history taking (age, sex, illness, medications, etc.). Renal Biomarkers – Serum and urinary samples will be collected directly at time of enrollment (within 2 hours from admission). It will be assayed for serum creatinine, serum neutrophil gelatinase-associated lipocalin (NGAL), urinary NGAL and serum Cystatin C (CysC). Then, it will be repeated at day 3. Ultrasound evaluation of kidneys and renal Doppler In each patient, both kidneys will be examined with real-time ultrasound (US) with a 3.75-MHz transducer (ACUSON X 300). Pulsed Doppler US evaluation of the intrarenal arteries will be obtained at the same respective scanning frequencies. The color Doppler functions are set for a study focused on interlobar arteries, that is, the highest gains possible, the use of the lowest filters and a low pulse repetition frequency (PRF) of 1-1.5 kHz that must be preferred while always limiting the aliasing phenomenon. |
Facilities
Sequence: | 200594685 |
Name | Alexandria Main University Hospital |
City | Alexandria |
Zip | 21563 |
Country | Egypt |
Conditions
Sequence: | 52321396 | Sequence: | 52321394 | Sequence: | 52321395 |
Name | Acute Kidney Injury | Name | Sepsis | Name | Septic Shock |
Downcase Name | acute kidney injury | Downcase Name | sepsis | Downcase Name | septic shock |
Id Information
Sequence: | 40266127 |
Id Source | org_study_id |
Id Value | RRIBIOSAKI |
Countries
Sequence: | 42685642 |
Name | Egypt |
Removed | False |
Keywords
Sequence: | 80075987 | Sequence: | 80075988 | Sequence: | 80075989 | Sequence: | 80075990 | Sequence: | 80075991 |
Name | Sepsis | Name | Acute Kidney Injury | Name | Ultrasound | Name | Resistive Index | Name | Biomarkers |
Downcase Name | sepsis | Downcase Name | acute kidney injury | Downcase Name | ultrasound | Downcase Name | resistive index | Downcase Name | biomarkers |
Design Outcomes
Sequence: | 177934359 | Sequence: | 177934360 | Sequence: | 177934361 | Sequence: | 177934362 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary |
Measure | Acute Kidney Injury | Measure | Transient Acute Kidney Injury | Measure | Persistent Acute Kidney Injury | Measure | Mortality |
Time Frame | 7 days from inclusion | Time Frame | 7 days from inclusion | Time Frame | 7 days from inclusion | Time Frame | 28 days from inclusion |
Description | AKI is defined according to KDIGO (Kidney Disease Improving Global Outcomes) | Description | Transient AKI is defined as AKI with a cause of renal hypoperfusion and recovery within 3 days after inclusion. Recovery from AKI is defined as urine output normalization and/or serum creatinine decrease by 50% and/or serum creatinine normalization to its measured or estimated baseline level. | Description | Persistent AKI is defined as persistent serum creatinine rise or oliguria after 3 days. | Description | All cause 28-days mortality |
Browse Conditions
Sequence: | 194058765 | Sequence: | 194058766 | Sequence: | 194058767 | Sequence: | 194058768 | Sequence: | 194058769 | Sequence: | 194058770 | Sequence: | 194058771 | Sequence: | 194058772 | Sequence: | 194058773 | Sequence: | 194058774 | Sequence: | 194058775 | Sequence: | 194058776 | Sequence: | 194058777 | Sequence: | 194058778 | Sequence: | 194058779 |
Mesh Term | Sepsis | Mesh Term | Toxemia | Mesh Term | Acute Kidney Injury | Mesh Term | Wounds and Injuries | Mesh Term | Infections | Mesh Term | Systemic Inflammatory Response Syndrome | Mesh Term | Inflammation | Mesh Term | Pathologic Processes | Mesh Term | Renal Insufficiency | Mesh Term | Kidney Diseases | Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Male Urogenital Diseases |
Downcase Mesh Term | sepsis | Downcase Mesh Term | toxemia | Downcase Mesh Term | acute kidney injury | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | infections | Downcase Mesh Term | systemic inflammatory response syndrome | Downcase Mesh Term | inflammation | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | renal insufficiency | Downcase Mesh Term | kidney diseases | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | male urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48460004 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Islam Elsayed Mohamed Ahmed |
Overall Officials
Sequence: | 29365332 | Sequence: | 29365333 | Sequence: | 29365334 | Sequence: | 29365335 | Sequence: | 29365336 | Sequence: | 29365337 |
Role | Principal Investigator | Role | Study Director | Role | Study Director | Role | Study Chair | Role | Study Chair | Role | Study Chair |
Name | Ibrahim Ibrahim, MSc | Name | Taysser Zaitoun, MD | Name | Mohamed Megahed, MD | Name | Hisham Elghonemy, MD | Name | Doaa Emara, MD | Name | Islam Ahmed, PharmD |
Affiliation | Assistant Lecturer of Critical Care Medicine, Kafr Elsheikh University | Affiliation | Professor of Critical Care Medicine, Alexandria University | Affiliation | Professor of Critical Care Medicine, Alexandria University | Affiliation | Lecturer of Nephrology, Alexandria University | Affiliation | Lecturer of Radiodiagnosis, Alexandria University | Affiliation | Clinical Pharmacy Specialist, Alexandria University |
Eligibilities
Sequence: | 30852326 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Population | – Critically ill patients recently admitted with sepsis. |
Criteria | Inclusion Criteria:
Adult patients (aged above 18 years) recently admitted with sepsis Exclusion Criteria: Pregnant Females |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254272000 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 21 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30598178 |
Observational Model | Case-Only |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28964667 |
Responsible Party Type | Sponsor-Investigator |
Name | Islam Elsayed Mohamed Ahmed |
Title | Critical Care Clinical Pharmacy Specialist |
Affiliation | Alexandria University |
Study References
Sequence: | 52225870 | Sequence: | 52225871 | Sequence: | 52225872 | Sequence: | 52225873 | Sequence: | 52225874 | Sequence: | 52225875 | Sequence: | 52225876 | Sequence: | 52225877 | Sequence: | 52225878 | Sequence: | 52225879 | Sequence: | 52225880 | Sequence: | 52225881 | Sequence: | 52225882 |
Pmid | 18402655 | Pmid | 17699448 | Pmid | 19066848 | Pmid | 23042202 | Pmid | 24627874 | Pmid | 21601330 | Pmid | 15711640 | Pmid | 15811456 | Pmid | 18519927 | Pmid | 25895828 | Pmid | 19474273 | Pmid | 23001447 | Pmid | 21921613 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Bagshaw SM, George C, Bellomo R; ANZICS Database Management Committee. Early acute kidney injury and sepsis: a multicentre evaluation. Crit Care. 2008;12(2):R47. doi: 10.1186/cc6863. Epub 2008 Apr 10. | Citation | Bagshaw SM, Uchino S, Bellomo R, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Oudemans-van Straaten HM, Ronco C, Kellum JA; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Septic acute kidney injury in critically ill patients: clinical characteristics and outcomes. Clin J Am Soc Nephrol. 2007 May;2(3):431-9. doi: 10.2215/CJN.03681106. Epub 2007 Mar 21. | Citation | Bagshaw SM, Lapinsky S, Dial S, Arabi Y, Dodek P, Wood G, Ellis P, Guzman J, Marshall J, Parrillo JE, Skrobik Y, Kumar A; Cooperative Antimicrobial Therapy of Septic Shock (CATSS) Database Research Group. Acute kidney injury in septic shock: clinical outcomes and impact of duration of hypotension prior to initiation of antimicrobial therapy. Intensive Care Med. 2009 May;35(5):871-81. doi: 10.1007/s00134-008-1367-2. Epub 2008 Dec 9. | Citation | Schnell D, Deruddre S, Harrois A, Pottecher J, Cosson C, Adoui N, Benhamou D, Vicaut E, Azoulay E, Duranteau J. Renal resistive index better predicts the occurrence of acute kidney injury than cystatin C. Shock. 2012 Dec;38(6):592-7. doi: 10.1097/SHK.0b013e318271a39c. | Citation | Merrikhi A, Gheissari A, Mousazadeh H. Urine and serum neutrophil gelatinase-associated lipocalin cut-off point for the prediction of acute kidney injury. Adv Biomed Res. 2014 Jan 27;3:66. doi: 10.4103/2277-9175.125847. eCollection 2014. | Citation | Zhang Z, Lu B, Sheng X, Jin N. Cystatin C in prediction of acute kidney injury: a systemic review and meta-analysis. Am J Kidney Dis. 2011 Sep;58(3):356-65. doi: 10.1053/j.ajkd.2011.02.389. Epub 2011 May 20. Erratum In: Am J Kidney Dis. 2012 Apr;59(4):590-2. | Citation | Mori K, Lee HT, Rapoport D, Drexler IR, Foster K, Yang J, Schmidt-Ott KM, Chen X, Li JY, Weiss S, Mishra J, Cheema FH, Markowitz G, Suganami T, Sawai K, Mukoyama M, Kunis C, D'Agati V, Devarajan P, Barasch J. Endocytic delivery of lipocalin-siderophore-iron complex rescues the kidney from ischemia-reperfusion injury. J Clin Invest. 2005 Mar;115(3):610-21. doi: 10.1172/JCI23056. | Citation | Mishra J, Dent C, Tarabishi R, Mitsnefes MM, Ma Q, Kelly C, Ruff SM, Zahedi K, Shao M, Bean J, Mori K, Barasch J, Devarajan P. Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet. 2005 Apr 2-8;365(9466):1231-8. doi: 10.1016/S0140-6736(05)74811-X. | Citation | Nickolas TL, O'Rourke MJ, Yang J, Sise ME, Canetta PA, Barasch N, Buchen C, Khan F, Mori K, Giglio J, Devarajan P, Barasch J. Sensitivity and specificity of a single emergency department measurement of urinary neutrophil gelatinase-associated lipocalin for diagnosing acute kidney injury. Ann Intern Med. 2008 Jun 3;148(11):810-9. doi: 10.7326/0003-4819-148-11-200806030-00003. | Citation | Zwiers AJ, de Wildt SN, van Rosmalen J, de Rijke YB, Buijs EA, Tibboel D, Cransberg K. Urinary neutrophil gelatinase-associated lipocalin identifies critically ill young children with acute kidney injury following intensive care admission: a prospective cohort study. Crit Care. 2015 Apr 21;19(1):181. doi: 10.1186/s13054-015-0910-0. | Citation | Haase-Fielitz A, Bellomo R, Devarajan P, Bennett M, Story D, Matalanis G, Frei U, Dragun D, Haase M. The predictive performance of plasma neutrophil gelatinase-associated lipocalin (NGAL) increases with grade of acute kidney injury. Nephrol Dial Transplant. 2009 Nov;24(11):3349-54. doi: 10.1093/ndt/gfp234. Epub 2009 May 27. | Citation | Schnell D, Darmon M. Renal Doppler to assess renal perfusion in the critically ill: a reappraisal. Intensive Care Med. 2012 Nov;38(11):1751-60. doi: 10.1007/s00134-012-2692-z. Epub 2012 Sep 22. | Citation | Bougle A, Duranteau J. Pathophysiology of sepsis-induced acute kidney injury: the role of global renal blood flow and renal vascular resistance. Contrib Nephrol. 2011;174:89-97. doi: 10.1159/000329243. Epub 2011 Sep 9. |
]]>
https://zephyrnet.com/NCT03799146
2018-01-15
https://zephyrnet.com/?p=NCT03799146
NCT03799146https://www.clinicaltrials.gov/study/NCT03799146?tab=tableNANANAThe aim of this study is to investigate whether and how ‘MyPlan 2.0’ helps older adults to be more physically active or less sedentary. Two groups will be created, an intervention group and a waiting-list control group.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-12-06 |
Start Month Year | January 15, 2018 |
Primary Completion Month Year | August 15, 2018 |
Verification Month Year | December 2021 |
Verification Date | 2021-12-31 |
Last Update Posted Date | 2021-12-06 |
Detailed Descriptions
Sequence: | 20767536 |
Description | The aim of this study is to investigate whether and how 'MyPlan 2.0' helps older adults to be more physically active or less sedentary. Two groups will be created, an intervention group and a waiting-list control group. Both groups will be tested during three testing waves: pretest, posttest and follow-up test. Only the intervention group will be given acces to 'MyPlan 2.0'.
'MyPlan 2.0' consists of a website and mobile application targeting physical activity and sedentary behaviour. The intervention has a duration of five weeks. |
Facilities
Sequence: | 200488504 |
Name | Department of Movement and Sports Sciences |
City | Ghent |
Zip | 9000 |
Country | Belgium |
Conditions
Sequence: | 52289132 |
Name | Overweight |
Downcase Name | overweight |
Id Information
Sequence: | 40243618 |
Id Source | org_study_id |
Id Value | MyPlan2.0_older_adults_50 |
Countries
Sequence: | 42661452 |
Name | Belgium |
Removed | False |
Design Groups
Sequence: | 55724643 | Sequence: | 55724644 |
Group Type | Experimental | Group Type | Experimental |
Title | Intervention group | Title | Waiting List control group |
Description | Participants will receive the e- and mHealth intervention 'MyPlan 2.0'. | Description | Participants will not receive the e- and mHealth intervention 'MyPlan 2.0', but will be given access to the intervention after all testing phases. |
Interventions
Sequence: | 52600814 | Sequence: | 52600815 |
Intervention Type | Behavioral | Intervention Type | Other |
Name | MyPlan 2.0 | Name | Waiting List |
Description | MyPlan 2.0 consists of five sessions. During these five sessions the following behaviour change techniques are used to motivate users to be more physically active or to sit less: exploring risk perceptions and perceived benefits, exploring social support, providing feedback, action planning, coping planning and monitoring. | Description | Waiting List control group |
Keywords
Sequence: | 80034884 | Sequence: | 80034885 | Sequence: | 80034886 | Sequence: | 80034887 | Sequence: | 80034888 | Sequence: | 80034889 |
Name | physical activity | Name | sedentary behaviour | Name | eHealth | Name | mHealth | Name | self-regulation | Name | behaviour change techniques |
Downcase Name | physical activity | Downcase Name | sedentary behaviour | Downcase Name | ehealth | Downcase Name | mhealth | Downcase Name | self-regulation | Downcase Name | behaviour change techniques |
Design Outcomes
Sequence: | 177811906 | Sequence: | 177811907 | Sequence: | 177811908 | Sequence: | 177811909 | Sequence: | 177811910 | Sequence: | 177811911 | Sequence: | 177811912 | Sequence: | 177811913 | Sequence: | 177811914 | Sequence: | 177811915 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in objective total, light and moderate-to-vigorous physical activity (PA) | Measure | Change in objective sedentary behaviour | Measure | Change in self-reported total, moderate and moderate-to-vigorous physical activity (PA) as well as total work-related, transport-related, household-related and leisure time PA. | Measure | Change in self-reported sedentary behaviour | Measure | Change in self-efficacy | Measure | Change in outcome expectancies | Measure | Change in risk perception | Measure | Change in intention | Measure | Change in action planning | Measure | Change in coping planning |
Time Frame | Pretest, posttest (6 weeks) and follow-up (6 months) | Time Frame | Pretest, posttest (6 weeks) and follow-up (6 months) | Time Frame | Pretest, posttest (6 weeks) and follow-up (6 months) | Time Frame | Pretest, posttest (6 weeks) and follow-up (6 months) | Time Frame | Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months) | Time Frame | Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months | Time Frame | Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months | Time Frame | Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months | Time Frame | Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months | Time Frame | Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months |
Description | Change in amount of total, light and moderate-to-vigorous physical activity, measured via accelerometers | Description | Change in amount of total sitting time, measured via accelerometers | Description | Change in amount of total, light and moderate-to-vigorous PA well as total work-related, transport-related, household-related and leisure time PA will be measured via the International Physical Activity Questionnaire (IPAQ). The IPAQ measures physical activity in four domains: work, transport, household and leisure time. Higher scores indicate higher levels of physical activity. For each scale the minimum value is 0. We will use the method described by Dubuy et al. (2013) to truncate the data. | Description | Change in amount of total sitting time, measured via the LASA sedentary behaviour self-report questionnaire. The total score is calculated by summing all 10 items.The minimum value is 0 and the maximum value is 24 hours. However, data will be truncated at 16 hours. | Description | Change in amount of self-efficacy to change behaviour, measured via 5 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the five items will be considered the final score. | Description | Outcome expectancies regarding the behaviour change, measured via 5 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the five items will be considered the final score. | Description | Risk perception about the behaviour, measured via 4 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the four items will be considered the final score | Description | Amount of intention to change the behaviour, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score. | Description | Amount of action planning for behaviour change, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score. | Description | Amount of coping planning for behaviour change, measured via 3 validated items (questionnaire). These items were created by the involved research groups. For each item, the scale ranges from 1 to 10. The average score on the three items will be considered the final score. |
Browse Conditions
Sequence: | 193937413 | Sequence: | 193937414 | Sequence: | 193937415 | Sequence: | 193937416 |
Mesh Term | Overweight | Mesh Term | Overnutrition | Mesh Term | Nutrition Disorders | Mesh Term | Body Weight |
Downcase Mesh Term | overweight | Downcase Mesh Term | overnutrition | Downcase Mesh Term | nutrition disorders | Downcase Mesh Term | body weight |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48429630 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University Ghent |
Overall Officials
Sequence: | 29348815 | Sequence: | 29348816 |
Role | Principal Investigator | Role | Principal Investigator |
Name | Ilse De Bourdeaudhuij | Name | Geert Crombez |
Affiliation | University Ghent | Affiliation | University Ghent |
Design Group Interventions
Sequence: | 68307708 | Sequence: | 68307709 |
Design Group Id | 55724643 | Design Group Id | 55724644 |
Intervention Id | 52600814 | Intervention Id | 52600815 |
Eligibilities
Sequence: | 30833833 |
Gender | All |
Minimum Age | 50 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Have access to internet Exclusion Criteria: non Dutch speaking |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254145952 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 7 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 50 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30579746 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Randomized controlled trial with two groups: intervention group and waiting-list control group |
Responsible Parties
Sequence: | 28946164 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52189221 |
Pmid | 31376274 |
Reference Type | derived |
Citation | Poppe L, De Bourdeaudhuij I, Verloigne M, Shadid S, Van Cauwenberg J, Compernolle S, Crombez G. Efficacy of a Self-Regulation-Based Electronic and Mobile Health Intervention Targeting an Active Lifestyle in Adults Having Type 2 Diabetes and in Adults Aged 50 Years or Older: Two Randomized Controlled Trials. J Med Internet Res. 2019 Aug 2;21(8):e13363. doi: 10.2196/13363. |
]]>
https://zephyrnet.com/NCT03799133
2018-09-26
https://zephyrnet.com/?p=NCT03799133
NCT03799133https://www.clinicaltrials.gov/study/NCT03799133?tab=tableNANANAEvaluate the safety and effectiveness of the XL trend measured by Florence (Critical Perfusion Inc, Palo Alto, California) in the prediction of morbimortality of Mexican patients post-operated of elective cardiovascular surgery.
Hypothesis: 1. The gastric reactance measurement (XL) correlates with the morbimortality (postoperatory shock, excessive bleeding, vasoplegic syndrome and death) and with the risk predictors (APACHE II, STS, SOFA, and EUROSCORE II) with patients post-operated of elective cardiac surgery. 2. It is possible to identify the cut-off point of the values of the gastric reactance (XL) as a predictive tool of morbimortality in patients post-operated of elective cardiac surgery. 3. The gastric reactance (XL) is a safe measurement to patients undergoing cardiac surgery.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-20 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-01-23 |
Start Month Year | September 26, 2018 |
Primary Completion Month Year | December 28, 2019 |
Verification Month Year | January 2020 |
Verification Date | 2020-01-31 |
Last Update Posted Date | 2020-01-23 |
Detailed Descriptions
Sequence: | 20741133 |
Description | A maximum of 35 patients with age greater or equal to 18 years with elective surgery (valvular surgery, revascularization, or a combination of both) that comply with the inclusion/exclusion criteria of this protocol will be enrolled.
Investigational device: Florence (Gastric Impedance Spectrometer System or ISMO). Comparative with Risk scales SOFA, APACHE II, STS, Euroscore II, hemodynamic variables, lactate and mixed venous saturation. The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU. |
Facilities
Sequence: | 200280495 |
Name | Instituto Nacional de Cardiología Ignacio Chávez |
City | Tlalpan |
State | Ciudad De México |
Zip | 14080 |
Country | Mexico |
Conditions
Sequence: | 52221433 | Sequence: | 52221434 | Sequence: | 52221435 |
Name | Cardiac Failure | Name | Ventricular Dysfunction | Name | Valvular Heart Disease |
Downcase Name | cardiac failure | Downcase Name | ventricular dysfunction | Downcase Name | valvular heart disease |
Id Information
Sequence: | 40195566 | Sequence: | 40195567 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | ISM_VC_01_17 | Id Value | 17-1025 |
Id Type | Other Identifier | ||
Id Type Description | Instituto Nacional de Cardiología Ignacio Chávez | ||
Countries
Sequence: | 42609602 |
Name | Mexico |
Removed | False |
Design Groups
Sequence: | 55649708 |
Group Type | Experimental |
Title | Patients with Florence device |
Description | Patients with the Florence catheter placed and connected to the Florence monitor to measure XL trend. |
Interventions
Sequence: | 52535237 |
Intervention Type | Device |
Name | Florence device |
Description | The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU. |
Keywords
Sequence: | 79941628 | Sequence: | 79941629 | Sequence: | 79941630 | Sequence: | 79941631 | Sequence: | 79941632 | Sequence: | 79941633 | Sequence: | 79941634 |
Name | gastric reactance | Name | elective cardiac surgery | Name | morbimortality | Name | APACHE II | Name | STS | Name | SOFA | Name | EUROSCORE II |
Downcase Name | gastric reactance | Downcase Name | elective cardiac surgery | Downcase Name | morbimortality | Downcase Name | apache ii | Downcase Name | sts | Downcase Name | sofa | Downcase Name | euroscore ii |
Design Outcomes
Sequence: | 177561164 | Sequence: | 177561165 | Sequence: | 177561166 | Sequence: | 177561167 | Sequence: | 177561168 | Sequence: | 177561169 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Correlation between gastric reactance (XL) and morbimortality and risk predictors | Measure | Sensibility and specificity of the collected variables | Measure | Adverse events tracing with the use of Florence catheter | Measure | Correlations between XL measurements and medication | Measure | Correlations between laboratory parameters and XL | Measure | Usability of Florence device in a real environment. |
Time Frame | 72 hours | Time Frame | 72 hours | Time Frame | 30 days | Time Frame | 72 hours | Time Frame | 72 hours | Time Frame | 72 hours |
Description | Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting the risk scales, hemodynamic variables, lactate and mixed venous oxygen saturation, morbidity and mortality with central gastric reactance (XL). | Description | ROC curves will be calculated to determine sensibility and specificity of the variables. | Description | Serious Adverse Device Effects and Adverse Events assessment to evaluate device safety. | Description | Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting XL with amines, proton-pump inhibitors, and anesthesia medications. | Description | Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting XL with laboratory parameters. | Description | Questionnaire for the nurse and/or the physician regarding the use of Florence device at the Operating Room and Intensive Care Unit. |
Browse Conditions
Sequence: | 193678116 | Sequence: | 193678117 | Sequence: | 193678118 | Sequence: | 193678119 | Sequence: | 193678120 |
Mesh Term | Heart Diseases | Mesh Term | Ventricular Dysfunction | Mesh Term | Heart Valve Diseases | Mesh Term | Heart Failure | Mesh Term | Cardiovascular Diseases |
Downcase Mesh Term | heart diseases | Downcase Mesh Term | ventricular dysfunction | Downcase Mesh Term | heart valve diseases | Downcase Mesh Term | heart failure | Downcase Mesh Term | cardiovascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366338 | Sequence: | 48366339 | Sequence: | 48366340 | Sequence: | 48366341 | Sequence: | 48366342 |
Agency Class | INDUSTRY | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Critical Perfusion Inc. | Name | Instituto Nacional de Cardiologia Ignacio Chavez | Name | National Council of Science and Technology, Mexico | Name | Gerbera Capital | Name | Alandra Medical SAPI de CV |
Overall Officials
Sequence: | 29312866 | Sequence: | 29312867 |
Role | Principal Investigator | Role | Study Director |
Name | Rolando J. Álvarez Álvarez, MD | Name | Montserrat Godínez, MSc |
Affiliation | Instituto Nacional de Cardiologia Ignacio Chavez | Affiliation | Alandra Medical SAPI de CV |
Design Group Interventions
Sequence: | 68217256 |
Design Group Id | 55649708 |
Intervention Id | 52535237 |
Eligibilities
Sequence: | 30794656 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Women and men within an age equal or greater than 18 years old. Exclusion Criteria: Subjects with records of recent digestive tube bleeding (last 30 days). |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004215 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 15 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30540696 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Screening |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Eligible patients will be placed the Florence catheter. |
Intervention Other Names
Sequence: | 26696902 | Sequence: | 26696903 |
Intervention Id | 52535237 | Intervention Id | 52535237 |
Name | ISMO | Name | Gastric Impedance Spectrometer System |
Links
Sequence: | 4392139 | Sequence: | 4392140 | Sequence: | 4392141 | Sequence: | 4392142 | Sequence: | 4392143 | Sequence: | 4392144 | Sequence: | 4392145 | Sequence: | 4392146 | Sequence: | 4392147 | Sequence: | 4392148 | Sequence: | 4392149 | Sequence: | 4392150 | Sequence: | 4392151 | Sequence: | 4392152 | Sequence: | 4392153 | Sequence: | 4392154 | Sequence: | 4392155 | Sequence: | 4392156 | Sequence: | 4392157 | Sequence: | 4392158 | Sequence: | 4392159 | Sequence: | 4392160 | Sequence: | 4392161 | Sequence: | 4392162 | Sequence: | 4392163 | Sequence: | 4392164 | Sequence: | 4392165 | Sequence: | 4392166 | Sequence: | 4392167 | Sequence: | 4392168 | Sequence: | 4392169 | Sequence: | 4392170 | Sequence: | 4392171 | Sequence: | 4392172 | Sequence: | 4392173 | Sequence: | 4392174 | Sequence: | 4392175 | Sequence: | 4392176 | Sequence: | 4392177 | Sequence: | 4392178 | Sequence: | 4392179 | Sequence: | 4392180 | Sequence: | 4392181 | Sequence: | 4392182 | Sequence: | 4392183 | Sequence: | 4392184 | Sequence: | 4392185 | Sequence: | 4392186 | Sequence: | 4392187 | Sequence: | 4392188 | Sequence: | 4392189 |
Url | http://www.who.int/mediacentre/factsheets/fs317/es/ | Url | http://www.medigraphic.com/pdfs/cardio/h-2016/hs163a.pdf | Url | http://www.ncbi.nlm.nih.gov/pubmed/24055446 | Url | http://www.ncbi.nlm.nih.gov/pubmed/23361625 | Url | https://www.ncbi.nlm.nih.gov/pubmed/17285286 | Url | https://www.ncbi.nlm.nih.gov/pubmed/15681577 | Url | https://www.ncbi.nlm.nih.gov/pubmed/22611136 | Url | https://www.ncbi.nlm.nih.gov/pubmed/11445675 | Url | https://www.ncbi.nlm.nih.gov/pubmed/14997295 | Url | https://www.ncbi.nlm.nih.gov/pubmed/17323051 | Url | https://www.ncbi.nlm.nih.gov/pubmed/17414725 | Url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4968574/ | Url | https://www.ncbi.nlm.nih.gov/pubmed/16046651 | Url | https://www.ncbi.nlm.nih.gov/pubmed/12161222 | Url | https://www.ncbi.nlm.nih.gov/pubmed/17828438 | Url | https://www.ncbi.nlm.nih.gov/pubmed/11874305 | Url | https://www.ncbi.nlm.nih.gov/pubmed/12352031 | Url | https://www.ncbi.nlm.nih.gov/pubmed/20966436 | Url | https://jamanetwork.com/journals/jamasurgery/article-abstract/591550 | Url | https://www.ncbi.nlm.nih.gov/pubmed/24694282 | Url | https://www.ncbi.nlm.nih.gov/pubmed/25417158 | Url | https://www.ncbi.nlm.nih.gov/pubmed/23370829 | Url | https://www.ncbi.nlm.nih.gov/pubmed/17577136 | Url | https://www.ncbi.nlm.nih.gov/pubmed/27016162 | Url | https://www.ncbi.nlm.nih.gov/pubmed/17933153 | Url | https://www.ncbi.nlm.nih.gov/pubmed/8528108 | Url | http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.516.4685&rep=rep1&type=pdf | Url | https://www.ncbi.nlm.nih.gov/pubmed/2662632 | Url | https://ieeexplore.ieee.org/document/4067112 | Url | https://www.ncbi.nlm.nih.gov/pubmed/9196884 | Url | https://ieeexplore.ieee.org/document/415187 | Url | https://ieeexplore.ieee.org/document/758768 | Url | https://www.ncbi.nlm.nih.gov/pubmed/15798229 | Url | https://www.ncbi.nlm.nih.gov/pubmed/2651001 | Url | https://www.ncbi.nlm.nih.gov/pubmed/11713146 | Url | https://www.ncbi.nlm.nih.gov/pubmed/8087035 | Url | https://www.ncbi.nlm.nih.gov/pubmed/27687052 | Url | https://www.ncbi.nlm.nih.gov/pubmed/22378855 | Url | http://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S0188-21982014000100010&nrm=iso | Url | http://www.iccueducation.org.uk/uploads/2/3/1/0/23109338/sofa_score.pdf | Url | https://www.ncbi.nlm.nih.gov/pubmed/9824069 | Url | https://www.ncbi.nlm.nih.gov/pubmed/10470572 | Url | https://www.ncbi.nlm.nih.gov/pubmed/10990106 | Url | https://www.ncbi.nlm.nih.gov/pubmed/11594901 | Url | https://www.ncbi.nlm.nih.gov/pubmed/3928249 | Url | https://www.ncbi.nlm.nih.gov/pubmed/6851607 | Url | https://www.ncbi.nlm.nih.gov/pubmed/8087584 | Url | https://www.ncbi.nlm.nih.gov/pubmed/19559823 | Url | https://www.ncbi.nlm.nih.gov/pubmed/19559822 | Url | https://www.ncbi.nlm.nih.gov/pubmed/19559824 | Url | https://www.ncbi.nlm.nih.gov/pubmed/23522221 |
Description | WHO Cardiovascular illness; 2015 | Description | Arias AS, Serrano MEB, Altamirano BD, Ortega MG, Gonzalez GG. Cardiovascular illness: first cause of morbility in a third level hospital. Cardiology Mexican Journal; 2016 | Description | Mittal R, Coopersmith CM. Redefining the gut as the motor of critical illness. Trends in molecular medicine. 2014 Apr;20:214-223 | Description | Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, et al. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Critical care medicine. 2013 Feb;41:580-637 | Description | Antonelli M, Levy M, Andrews PJD, Chastre J, Hudson LD, Manthous C, et al. Hemodynamic monitoring in shock and implications for management. International Consensus Conference, Paris, France, 27-28 April 2006. Intensive care medicine. 2007 Apr;33:575-590 | Description | Nieminen MS, Boehm M, Cowie MR, Drexler H, Filippatos GS, Jondeau G, et al. Executive summary of the guidelines on the diagnosis and treatment of acute heart failure: the Task Force on Acute Heart Failure of the European Society of Cardiology. | Description | McMurray JJV, Adamopoulos S, Anker SD, Auricchio A, Boehm M, Dickstein K, et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure2012 | Description | Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Critical care medicine. 2001 Jul;29:1303-1310 | Description | Brun-Buisson C, Meshaka P, Pinton P, Vallet B, Group ES. EPISEPSIS: a reappraisal of the epidemiology and outcome of severe sepsis in French intensive care units. Intensive care medicine. 2004 Apr;30:580-588 | Description | Engel C, Brunkhorst FM, Bone HG, Brunkhorst R, Gerlach H, Grond S, et al. Epidemiology of sepsis in Germany: results from a national prospective multicenter study. Intensive care medicine. 2007 Apr;33:606-618 | Description | Esteban A, Frutos-Vivar F, Ferguson ND, Penuelas O, Lorente JA, Gordo F, et al. Sepsis incidence and outcome: contrasting the intensive care unit with the hospital ward. Critical care medicine. 2007 May;35:1284-1289 | Description | Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, et al.. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3); 2016 | Description | Babaev A, Frederick PD, Pasta DJ, Every N, Sichrovsky T, Hochman JS, et al. Trends in management and outcomes of patients with acute myocardial infarction complicated by cardiogenic shock. JAMA. 2005 Jul;294:448-454 | Description | Steg PG, Goldberg RJ, Gore JM, Fox KAA, Eagle KA, Flather MD, et al. Baseline characteristics, management practices, and in-hospital outcomes of patients hospitalized with acute coronary syndromes in the Global Registry of Acute Coronary Events (GRACE). | Description | Koek HL, Kardaun JWPF, Gevers E, de Bruin A, Reitsma JB, Grobbee DE, et al. Acute myocardial infarction incidence and hospital mortality: routinely collected national data versus linkage of national registers. European Journal of Epidemiology. 2007 | Description | Roger VL, Jacobsen SJ, Weston SA, Goraya TY, Killian J, Reeder GS, et al. Trends in the incidence and survival of patients with hospitalized myocardial infarction, Olmsted County, Minnesota, 1979 to 1994. Annals of internal medicine. 2002 Mar;136:341-348 | Description | Geppert A, Steiner A, Zorn G, Delle-Karth G, Koreny M, Haumer M, et al. Multiple organ failure in patients with cardiogenic shock is associated with high plasma levels of interleukin-6. Critical care medicine. 2002 Sep;30:1987-1994 | Description | Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesthesia and analgesia. 2011 Jun;112:1392-1402 | Description | Carrico CJ, Meakins JL, Marshall JC, Fry D, Maier RV. Multiple-organ-failure syndrome. Archives of surgery (Chicago, Ill : 1960). 1986 Feb;121:196-208 | Description | Helander HF, Fändriks L. Surface area of the digestive tract – revisited. Scandinavian journal of gastroenterology. 2014 Jun;49:681-689 | Description | Thome JJC, Yudanin N, Ohmura Y, Kubota M, Grinshpun B, Sathaliyawala T, et al. Spatial map of human T cell compartmentalization and maintenance over decades of life. Cell. 2014 Nov; 159:814-828 | Description | Reintam B, Poeze M, Malbrain ML, Björck M, Oudemans-van Straaten H. Starkopf J, et al. Gastrointestinal symptoms during the first week of intensive care are associated with poor outcome: a prospective multicentre study. Intensive Care Medicine. 2013 | Description | Clark JA, Coopersmith CM. Intestinal crosstalk: a new paradigm for understanding the gut as the "motor" of critical illness. Shock (Augusta, Ga). 2007 Oct; 28:384-393 | Description | Klingensmith NJ, Coopersmith CM. The Gut as the Motor of Multiple Organ Dysfunction in Critical Illness; 2016 | Description | van Haren FMP, Sleigh JW, Pickkers P, Van der Hoeven JG. Gastrointestinal perfusion in septic shock. Anaesth Intensive Care. 2007 Oct;35(5):679-694 | Description | McAdams ET, Jossinet J. Tissue impedance: a historical overview. Physiol Meas. 1995 Aug;16(3 Suppl A):A1-13. Historical Article Journal Article | Description | Ivorra A. Bioimpedance monitoring for physicians: an overview; 2003 | Description | Kim DW. Detection of physiological events by impedance. Yonsei Med J. 1989;30(1):1-11 | Description | Grimnes S, Martinsen OG. Comments on "Algorithm for Tissue Ischemia Estimation Based on Electrical Impedance Spectroscopy". IEEE Transactions on Biomedical Engineering. 2007 Feb;54(2):344-344 | Description | Rigaud B, Morucci JP, Chauveau N. Bioelectrical impedance techniques in medicine. Part I: Bioimpedance measurement. Second section: impedance spectrometry. Crit Rev Biomed Eng. 1996;24(4-6):257-351 | Description | Kun S, Peura RA. Tissue ischemia detection using impedance spectroscopy. In: Engineering in Medicine and Biology Society, 1994. Engineering Advances: New Opportunities for Biomedical Engineers. Proceedings of the 16th Annual International Conference | Description | Ristic B, Kun S, Peura RA. Muscle tissue ischemia monitoring using impedance spectroscopy: quantitative results of animal studies. In: Engineering in Medicine and Biology Society, 1997. Proceedings of the 19th Annual International Conference of the IEEE. | Description | Ivorra A, Genesca M, Sola A, Palacios L, Villa R, Hotter G, et al. Bioimpedance dispersion width as a parameter to monitor living tissues. Physiol Meas. 2005 Apr;26(2):S165-73. Comparative Study Journal Article Research Support, Non-U.S. Gov't | Description | Foster KR, Schwan HP. Dielectric properties of tissues and biological materials: a critical review. Critical reviews in biomedical engineering. 1989;17:25-104 | Description | Rackow EC, O'Neil P, Astiz ME, Carpati CM. Sublingual capnometry and indexes of tissue perfusion in patients with circulatory failure. Chest. 2001 Nov;120:1633-1638 | Description | Rigaud B, Hamzaoui L, Chauveau N, Granie M, Scotto Di Rinaldi JP, Morucci JP. Tissue characterization by impedance: a multifrequency approach. Physiol Meas. 1994 May;15 Suppl 2a:A13-20 | Description | Sullivan PG, Wallach JD, Ioannidis JPA. Meta-Analysis Comparing Established Risk Prediction Models (EuroSCORE II, STS Score, and ACEF Score) for Perioperative Mortality During Cardiac Surgery. The American journal of cardiology. 2016 Nov;118:1574-1582 | Description | Nashef SAM, Roques F, Sharples LD, Nilsson J, Smith C, Goldstone AR, et al. EuroSCORE II. European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. 2012 Apr;41:734-44; discussion 744-5 | Description | A GVO. EuroSCORE II: Como se usa en la practica actual. Revista Mexicana de Cardiologia. 2014 03;25:50 – 51 | Description | Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, et al. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Societ | Description | Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, et al. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related | Description | Moreno R, Vincent JL, Matos R, Mendoca A, Cantraine F, Thijs L, et al. The use of maximum SOFA score to quantify organ dysfunction/failure in intensive care. Results of a prospective, multicentre study. Working Group on Sepsis related Problems | Description | de Mendonca A, Vincent JL, Suter PM, Moreno R, Dearden NM, Antonelli M, et al. Acute renal failure in the ICU: risk factors and outcome evaluated by the SOFA score. Intensive care medicine. 2000 Jul;26:915-921 | Description | Ferreira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA. 2001 Oct;286:1754-1758 | Description | Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Critical care medicine. 1985 Oct;13:818-829 | Description | NIH. Consensus Development Conference on critical care medicine. Critical care medicine. 1983 Jun;11:466-469 | Description | Chalfin DB, Fein AM. Critical care medicine in managed competition and a managed care environment. New horizons (Baltimore, Md). 1994 Aug;2:275-282 | Description | O'Brien SM, Shahian DM, Filardo G, Ferraris VA, Haan CK, Rich JB, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2-isolated valve surgery. The Annals of thoracic surgery. 2009 Jul;88:S23-S42 | Description | Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 1-coronary artery bypass grafting surgery. The Annals of thoracic surgery. 2009 Jul;88:S2-22 | Description | Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 3-valve plus coronary artery bypass grafting surgery. The Annals of thoracic surgery. 2009 Jul;88:S43-S62 | Description | Rankin JS, He X, O'Brien SM, Jacobs JP, Welke KF, Filardo G, et al. The Society of Thoracic Surgeons risk model for operative mortality after multiple valve surgery. The Annals of thoracic surgery. 2013 Apr;95:1484-1490 |
Responsible Parties
Sequence: | 28907016 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799120
2019-02-18
https://zephyrnet.com/?p=NCT03799120
NCT03799120https://www.clinicaltrials.gov/study/NCT03799120?tab=tableNANANAA single-center prospective, randomized study to assess two different dosing regimens (0.4 mg QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort will be completed.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-02-25 |
Start Month Year | February 18, 2019 |
Primary Completion Month Year | December 2021 |
Verification Month Year | February 2019 |
Verification Date | 2019-02-28 |
Last Update Posted Date | 2019-02-25 |
Detailed Descriptions
Sequence: | 20709968 |
Description | Ureteral stents are commonly used to maintain patency of the ureter and are placed for several common reasons including ureteral obstruction due to nephrolithiasis, cancer, or fibrosis as well as after surgical interventions involving ureteroscopy, ureteral anastomoses or prophylactically prior to extracorporeal shock wave lithotripsy. Ureteral stents have been associated with significant discomfort and dissatisfaction among patients.5 Bosio and colleagues noted that among patients with indwelling stents, 59.1% reported daily urinary frequency ≥ 1 per hour, 90.1% reported ≥ 1 nocturnal micturition episodes, 86.6% reported urinary urgency, and 82.3% reported dysuria. Further, 83.2% complained of pain, mostly in the kidney (67.9%) or in the bladder area (31.3%), particularly during physical activity. Over 90% of patients reported that this pain interfered with their everyday life.
The Ureteric Stent Symptom Questionnaire (USSQ) was developed in 2003 by Joshi and colleagues to quantify patients' discomfort relating specifically to ureteral stents. The USSQ measures several domains relating to stent pain including general health, urinary issues, pain, work performance, sexual matters, and quality of life with stent in situ. The USSQ has been validated and translated and is currently a widely used measure. While commonly used for treatment of benign prostatic hyperplasia, several studies have evaluated the efficacy of α-blockers for stent pain and have demonstrated a significant improvement in USSQ scores using α-blockers (mean reduction of 8.4 in urinary symptom scores and 7.2 in body pain scores). To date, randomized controlled trials have used one of two types of α-blockers: tamsulosin (0.4mg) vs. alfuzosin (10 mg). In treating benign prostatic hyperplasia, a total maximum dose of 0.8mg tamsulosin is used (either 0.4mg BID or 0.8mg daily), which has shown increased efficacy compared to the 0.4mg QD dose without an increase in adverse effects. Currently, tamsulosin 0.4mg daily is the off-label dosage indicated for lower urinary tract symptoms for patients with an indwelling stent. No study to date, however, has evaluated the clinical impact of a higher daily dose of tamsulosin (0.8mg) on stent-related symptoms. The objective of this study is to assess two different dosing regimens (0.4 mg QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort. |
Facilities
Sequence: | 199964476 |
Name | Gundersen Health System |
City | La Crosse |
State | Wisconsin |
Zip | 54601 |
Country | United States |
Browse Interventions
Sequence: | 95996816 | Sequence: | 95996817 | Sequence: | 95996818 | Sequence: | 95996819 | Sequence: | 95996820 | Sequence: | 95996821 | Sequence: | 95996822 | Sequence: | 95996823 | Sequence: | 95996824 |
Mesh Term | Tamsulosin | Mesh Term | Adrenergic alpha-1 Receptor Antagonists | Mesh Term | Adrenergic alpha-Antagonists | Mesh Term | Adrenergic Antagonists | Mesh Term | Adrenergic Agents | Mesh Term | Neurotransmitter Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Physiological Effects of Drugs | Mesh Term | Urological Agents |
Downcase Mesh Term | tamsulosin | Downcase Mesh Term | adrenergic alpha-1 receptor antagonists | Downcase Mesh Term | adrenergic alpha-antagonists | Downcase Mesh Term | adrenergic antagonists | Downcase Mesh Term | adrenergic agents | Downcase Mesh Term | neurotransmitter agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | urological agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52138951 |
Name | Ureteral Diseases |
Downcase Name | ureteral diseases |
Id Information
Sequence: | 40135019 |
Id Source | org_study_id |
Id Value | 2-18-11-001 |
Countries
Sequence: | 42542640 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55559290 | Sequence: | 55559291 |
Group Type | Placebo Comparator | Group Type | Experimental |
Title | tamsulosin QD + Placebo | Title | tamsulosin BID |
Description | 0.4 mg tamsulosin QD + Placebo QD | Description | 0.4 mg tamsulosin BID |
Interventions
Sequence: | 52454852 | Sequence: | 52454853 |
Intervention Type | Drug | Intervention Type | Other |
Name | Tamsulosin BID | Name | Placebo |
Description | comparison of once daily versus twice daily tamsulosin | Description | Placebo |
Design Outcomes
Sequence: | 177263401 |
Outcome Type | primary |
Measure | Ureteric Stent Symptoms Questionnaire |
Time Frame | 1 week post-stent placement |
Description | Scales for each question are 1 to 5, with 5 indicated more severe symptoms. Subscale scores are the sum of all questions included in the subscale. |
Browse Conditions
Sequence: | 193366332 | Sequence: | 193366333 | Sequence: | 193366334 | Sequence: | 193366335 | Sequence: | 193366336 | Sequence: | 193366331 |
Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Male Urogenital Diseases | Mesh Term | Ureteral Diseases |
Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | male urogenital diseases | Downcase Mesh Term | ureteral diseases |
Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list |
Sponsors
Sequence: | 48290669 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Gundersen Lutheran Medical Foundation |
Overall Officials
Sequence: | 29268510 |
Role | Principal Investigator |
Name | Matthew Ferroni, MD |
Affiliation | Gundersen Health System |
Design Group Interventions
Sequence: | 68107382 | Sequence: | 68107383 | Sequence: | 68107384 |
Design Group Id | 55559291 | Design Group Id | 55559290 | Design Group Id | 55559290 |
Intervention Id | 52454852 | Intervention Id | 52454852 | Intervention Id | 52454853 |
Eligibilities
Sequence: | 30747693 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients between the ages of 18 and 70 years old. Exclusion Criteria: Patients who are unable to provide informed consent. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121786 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30493976 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | Triple |
Subject Masked | True |
Caregiver Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28860256 |
Responsible Party Type | Principal Investigator |
Name | Kara Kallies |
Title | Academic Researcher / study coordinator |
Affiliation | Gundersen Lutheran Medical Foundation |
Study References
Sequence: | 52032537 | Sequence: | 52032538 | Sequence: | 52032539 | Sequence: | 52032540 | Sequence: | 52032541 |
Pmid | 27125392 | Pmid | 29923014 | Pmid | 12576846 | Pmid | 21453351 | Pmid | 27809592 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Koprowski C, Kim C, Modi PK, Elsamra SE. Ureteral Stent-Associated Pain: A Review. J Endourol. 2016 Jul;30(7):744-53. doi: 10.1089/end.2016.0129. Epub 2016 May 23. | Citation | Bosio A, Alessandria E, Dalmasso E, Peretti D, Agosti S, Bisconti A, Destefanis P, Passera R, Gontero P. How bothersome double-J ureteral stents are after semirigid and flexible ureteroscopy: a prospective single-institution observational study. World J Urol. 2019 Jan;37(1):201-207. doi: 10.1007/s00345-018-2376-6. Epub 2018 Jun 19. | Citation | Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d. | Citation | Lamb AD, Vowler SL, Johnston R, Dunn N, Wiseman OJ. Meta-analysis showing the beneficial effect of alpha-blockers on ureteric stent discomfort. BJU Int. 2011 Dec;108(11):1894-902. doi: 10.1111/j.1464-410X.2011.10170.x. Epub 2011 Mar 31. | Citation | Dellis AE, Papatsoris AG, Keeley FX Jr, Bamias A, Deliveliotis C, Skolarikos AA. Tamsulosin, Solifenacin, and Their Combination for the Treatment of Stent-Related Symptoms: A Randomized Controlled Study. J Endourol. 2017 Jan;31(1):100-109. doi: 10.1089/end.2016.0663. Epub 2016 Nov 29. |
]]>
https://zephyrnet.com/NCT03799107
2017-07-14
https://zephyrnet.com/?p=NCT03799107
NCT03799107https://www.clinicaltrials.gov/study/NCT03799107?tab=tableNANANADESCRT will be a long-term study that both looks back in time, at successful pregnancies, and forward in time at early pregnancy and long-term as these children grow. Currently, there are limited data on the long-term effects of infertility and infertility treatments on children. There are some studies to suggest that these children may have altered metabolic profiles, but this study aims to be the largest study to answer this question.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-15 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-12-01 |
Start Month Year | July 14, 2017 |
Primary Completion Month Year | December 1, 2023 |
Verification Month Year | November 2022 |
Verification Date | 2022-11-30 |
Last Update Posted Date | 2022-12-01 |
Detailed Descriptions
Sequence: | 20769367 |
Description | Over the past 30 years, much of the research and clinical effort in the field of ART had to do with improving outcome in terms of successful pregnancy. However, as these rates have increased, attention is slowly turning to focus on the health of the resultant child. Short-term health complications, in particular birth defects,have been well-described. However, even this "hard" outcome has been difficult to characterize as studies used different methodologies, varied age of detection, and frequently didn't have an appropriate comparison group. When underlying parental factors and infertility are included in the analyses, the association is substantially weakened or disappears completely. This exemplifies the problems with much of the currently available research regarding childhood outcomes following ART. While the health of children born through these technologies is of critical public health interest, and of personal interest to families, only limited data exist.
In order to evaluate the potential risk to long-term health of children conceived through assisted reproductive technologies (ART) and non-IVF fertility treatments (NIFT), rigorous epidemiological methods, appropriate characterization of the exposure, standardized collection of outcome data, and appropriate comparison groups are required. The proposed Developmental Epidemiological Study of Children born through Reproductive Technology (DESCRT) is aimed to carefully address these important characteristics. |
Facilities
Sequence: | 200500712 |
Name | University of California, San Francisco |
City | San Francisco |
State | California |
Zip | 94115 |
Country | United States |
Conditions
Sequence: | 52293891 | Sequence: | 52293892 | Sequence: | 52293893 | Sequence: | 52293894 | Sequence: | 52293895 | Sequence: | 52293896 |
Name | Infertility | Name | Infertility, Female | Name | Infertility, Male | Name | Infertility Primary | Name | Infertility Secondary | Name | Infertility Unexplained |
Downcase Name | infertility | Downcase Name | infertility, female | Downcase Name | infertility, male | Downcase Name | infertility primary | Downcase Name | infertility secondary | Downcase Name | infertility unexplained |
Id Information
Sequence: | 40246923 |
Id Source | org_study_id |
Id Value | IRB 16-20474 |
Countries
Sequence: | 42664612 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55729869 | Sequence: | 55729870 |
Title | Retrospective | Title | Prospective |
Description | Children born with assistance | Description | People who have sought evaluation/treatment for infertility |
Design Outcomes
Sequence: | 177829867 | Sequence: | 177829868 | Sequence: | 177829859 | Sequence: | 177829860 | Sequence: | 177829861 | Sequence: | 177829862 | Sequence: | 177829863 | Sequence: | 177829864 | Sequence: | 177829865 | Sequence: | 177829866 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Metabolic testing of child – non-HDL cholesterol | Measure | Metabolic testing of child – Alanine Aminotransferase | Measure | Metabolic testing of child – fasting glucose | Measure | Metabolic testing of child – fasting insulin | Measure | Metabolic testing of child – uric acid | Measure | Metabolic testing of child – total cholesterol | Measure | Metabolic testing of child – HDL cholesterol | Measure | Metabolic testing of child – LDL cholesterol | Measure | Metabolic testing of child – Triglycerides | Measure | Metabolic testing of child – cholesterol ratio |
Time Frame | 1 day at study visit | Time Frame | 1 day at study visit | Time Frame | 1 day at study visit | Time Frame | 1 day at study visit | Time Frame | 1 day at study visit | Time Frame | 1 day at study visit | Time Frame | 1 day at study visit | Time Frame | 1 day at study visit | Time Frame | 1 day at study visit | Time Frame | 1 day at study visit |
Description | Non-HDL cholesterol mg/dL | Description | Alanine Aminotransferase (ALT) U/L | Description | Fasting glucose mg/dL | Description | Fasting insulin uIU/mL | Description | uric acid mg/dL | Description | Cholesterol, Total mg/dL | Description | HDL cholesterol mg/dL | Description | LDL cholesterol mg/dL | Description | Triglycerides mg/dL | Description | CHOL/HDLC ratio |
Browse Conditions
Sequence: | 193955209 | Sequence: | 193955210 | Sequence: | 193955211 | Sequence: | 193955212 | Sequence: | 193955213 | Sequence: | 193955214 | Sequence: | 193955215 | Sequence: | 193955216 | Sequence: | 193955217 | Sequence: | 193955218 |
Mesh Term | Infertility | Mesh Term | Infertility, Female | Mesh Term | Infertility, Male | Mesh Term | Genital Diseases | Mesh Term | Urogenital Diseases | Mesh Term | Genital Diseases, Female | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Genital Diseases, Male | Mesh Term | Male Urogenital Diseases |
Downcase Mesh Term | infertility | Downcase Mesh Term | infertility, female | Downcase Mesh Term | infertility, male | Downcase Mesh Term | genital diseases | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | genital diseases, female | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | genital diseases, male | Downcase Mesh Term | male urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48434205 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of California, San Francisco |
Eligibilities
Sequence: | 30836566 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 4 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Retrospective:
– children conceived by parent(s) who sought evaluation/treatment for infertility Prospective: – people seeking evaluation/treatment for infertility |
Criteria | Retrospective arm
Inclusion criteria: – children conceived by parent(s) who sought evaluation/treatment for infertility Exclusion criteria: – Children with chronic medical illnesses that prevent a study visit Prospective arm Inclusion criteria: – seeking evaluation/treatment for infertility Exclusion criteria: – none |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254157169 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 4 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 10 |
Designs
Sequence: | 30582467 |
Observational Model | Cohort |
Time Perspective | Other |
Responsible Parties
Sequence: | 28948901 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799094
2018-12-05
https://zephyrnet.com/?p=NCT03799094
NCT03799094https://www.clinicaltrials.gov/study/NCT03799094?tab=tableJunwen Ou, PhDoujunwen66@163.com86-13556021810This trial was to explore whether intravenous vitamin C can prolong resistance time of Tyrosine Kinase Inhibitor(TKI) on lung adenocarcinoma patients with Epidermal Growth Factor Receptor(EGFR) mutations, and can benefit NSCLC patients.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | December 5, 2018 |
Primary Completion Month Year | December 31, 2020 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20716265 |
Description | The effects of vitamin C in combination with tyrosine kinase inhibitor on tumor size, tumor markers, inflammatory factor levels, quality of life, duration of resistance, progression-free survival, and overall survival time were evaluated.
This trial is a low risk treatment, and has developed the appropriate safety measures and contingency plans to ensure patients' safety in the whole process. Patients will be followed up after the end of the trial, and follow-up observations will be performed every month during the first year. Followed every 3 months in the second year for 3 years. |
Facilities
Sequence: | 200053152 |
Status | Recruiting |
Name | Clifford Hospital |
City | Guangzhou |
Zip | 511495 |
Country | China |
Facility Contacts
Sequence: | 28097471 |
Facility Id | 200053152 |
Contact Type | primary |
Name | Junwen Ou, PhD |
oujunwen66@163.com | |
Phone | 86-13556021810 |
Facility Investigators
Sequence: | 18326397 |
Facility Id | 200053152 |
Role | Principal Investigator |
Name | Junwen Ou, PhD |
Browse Interventions
Sequence: | 96027730 | Sequence: | 96027731 | Sequence: | 96027732 | Sequence: | 96027733 | Sequence: | 96027734 | Sequence: | 96027735 | Sequence: | 96027736 | Sequence: | 96027737 | Sequence: | 96027738 | Sequence: | 96027739 |
Mesh Term | Ascorbic Acid | Mesh Term | Tyrosine Protein Kinase Inhibitors | Mesh Term | Vitamins | Mesh Term | Micronutrients | Mesh Term | Physiological Effects of Drugs | Mesh Term | Antioxidants | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Protective Agents | Mesh Term | Protein Kinase Inhibitors | Mesh Term | Enzyme Inhibitors |
Downcase Mesh Term | ascorbic acid | Downcase Mesh Term | tyrosine protein kinase inhibitors | Downcase Mesh Term | vitamins | Downcase Mesh Term | micronutrients | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | antioxidants | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | protective agents | Downcase Mesh Term | protein kinase inhibitors | Downcase Mesh Term | enzyme inhibitors |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52156394 |
Name | Carcinoma, Non-Small-Cell Lung |
Downcase Name | carcinoma, non-small-cell lung |
Id Information
Sequence: | 40148160 |
Id Source | org_study_id |
Id Value | 2/2018-19 |
Countries
Sequence: | 42557686 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55577826 | Sequence: | 55577827 |
Group Type | Experimental | Group Type | Experimental |
Title | Experimental group | Title | Control group |
Description | 75 patients received a weekly intravenous Vitamin C injection (dose: 30 g / time, once a week, treatment termination when the disease progress is confirmed) in combination with daily taking tyrosine kinase inhibitor. | Description | 75 patients received tyrosine kinase inhibitor daily. (dose: Osimertinib 80 mg/d, or Tarceva 150 mg/d, or Iressa 0.25 g/d.) |
Interventions
Sequence: | 52471935 | Sequence: | 52471936 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Vitamin C | Name | Tyrosine kinase inhibitor |
Description | Participants will receive intravenous vitamin C therapy at the indicated dose. | Description | Participants will receive Tyrosine kinase inhibitor therapy in cycles: continuous treatment at the indicated dose. |
Keywords
Sequence: | 79847982 | Sequence: | 79847983 | Sequence: | 79847984 | Sequence: | 79847985 | Sequence: | 79847986 |
Name | tyrosine kinase inhibitor | Name | Vitamin C | Name | non-small cell lung cancer | Name | progression-free survival | Name | overall survival |
Downcase Name | tyrosine kinase inhibitor | Downcase Name | vitamin c | Downcase Name | non-small cell lung cancer | Downcase Name | progression-free survival | Downcase Name | overall survival |
Design Outcomes
Sequence: | 177327655 | Sequence: | 177327656 | Sequence: | 177327657 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | other |
Measure | Progression free survival | Measure | Overall survival | Measure | Changes in Health Related Quality of Life: European Organisation for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ)-C30 |
Time Frame | From the start date of treatment until the date of first documented progression or death, assessed up to 2 years | Time Frame | From the start date of treatment until the date of death from any cause, assessed up to 2 years. | Time Frame | From the start date of treatment until the date of first documented progression or death, assessed up to 2 years |
Description | From the start of treatment until the patient has tumor progression or death | Description | The length of time from the start of treatment for a disease until death | Description | Using QLQ-C30: Function subscales, (include physical, role, emotional, cognitive, social, global) (averaged, 0-100, higher value represent a better outcome); Symptoms subscales (include fatigue, nausea, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) (averaged, 0-100, lower value represent a better outcome). Given at basal, 1, 2, 3, 6, 12 months. |
Browse Conditions
Sequence: | 193431829 | Sequence: | 193431830 | Sequence: | 193431831 | Sequence: | 193431832 | Sequence: | 193431833 | Sequence: | 193431834 | Sequence: | 193431835 | Sequence: | 193431836 | Sequence: | 193431837 | Sequence: | 193431838 |
Mesh Term | Carcinoma, Non-Small-Cell Lung | Mesh Term | Carcinoma, Bronchogenic | Mesh Term | Bronchial Neoplasms | Mesh Term | Lung Neoplasms | Mesh Term | Respiratory Tract Neoplasms | Mesh Term | Thoracic Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases |
Downcase Mesh Term | carcinoma, non-small-cell lung | Downcase Mesh Term | carcinoma, bronchogenic | Downcase Mesh Term | bronchial neoplasms | Downcase Mesh Term | lung neoplasms | Downcase Mesh Term | respiratory tract neoplasms | Downcase Mesh Term | thoracic neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48305987 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Clifford Hospital, Guangzhou, China |
Overall Officials
Sequence: | 29277891 |
Role | Study Chair |
Name | Junwen Ou, PhD |
Affiliation | Clifford Hospital |
Central Contacts
Sequence: | 12004723 |
Contact Type | primary |
Name | Junwen Ou, PhD |
Phone | 86-13556021810 |
oujunwen66@163.com | |
Role | Contact |
Design Group Interventions
Sequence: | 68130775 | Sequence: | 68130776 | Sequence: | 68130777 |
Design Group Id | 55577826 | Design Group Id | 55577827 | Design Group Id | 55577826 |
Intervention Id | 52471935 | Intervention Id | 52471936 | Intervention Id | 52471936 |
Eligibilities
Sequence: | 30757311 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 75 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Primary non-small cell lung cancer (adenocarcinoma) with EGFR mutations on exons 19 and 21. Exclusion Criteria: Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), and uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254226296 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 75 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30503536 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26665861 |
Intervention Id | 52471935 |
Name | Sodium Ascorbate |
Provided Documents
Sequence: | 2578356 | Sequence: | 2578357 |
Document Type | Study Protocol and Statistical Analysis Plan | Document Type | Informed Consent Form |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | True |
Has Sap | True | Has Sap | False |
Document Date | 2018-11-14 | Document Date | 2018-11-14 |
Url | https://ClinicalTrials.gov/ProvidedDocs/94/NCT03799094/Prot_SAP_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/94/NCT03799094/ICF_001.pdf |
Responsible Parties
Sequence: | 28869814 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799081
2019-01-31
https://zephyrnet.com/?p=NCT03799081
NCT03799081https://www.clinicaltrials.gov/study/NCT03799081?tab=tableEmiliya Ilizirov, MDemiliyailizirova@gmal.com972-532323246The purpose of this study is to evaluate the use of hysteroscopic embryoscopy or fetoscopy as a powerful diagnostic tool to provide better counseling for couples having experienced pregnancy loss.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-05 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | January 2019 |
Primary Completion Month Year | January 2021 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Facilities
Sequence: | 200244222 |
Name | Hille Yaffe Medical Center |
City | Hadera |
Zip | 38100 |
Country | Israel |
Facility Contacts
Sequence: | 28128012 |
Facility Id | 200244222 |
Contact Type | primary |
Name | Emiliya Ilizirov, MD |
emiliyailizirova@gmail.com | |
Conditions
Sequence: | 52208099 |
Name | Abortion, Missed |
Downcase Name | abortion, missed |
Id Information
Sequence: | 40186142 |
Id Source | org_study_id |
Id Value | HYMC-00056-18 |
Countries
Sequence: | 42599637 |
Name | Israel |
Removed | False |
Design Groups
Sequence: | 55634661 |
Group Type | Other |
Title | Fetoscopy in missed abortion |
Description | Women who have decided to undergo fetoscopy in missed abortion |
Interventions
Sequence: | 52522069 |
Intervention Type | Procedure |
Name | Fetoscopy |
Description | Fetoscopy is a procedure that enables viewing of the fetus through use of a hysteroscope |
Design Outcomes
Sequence: | 177511202 | Sequence: | 177511203 | Sequence: | 177511204 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Macroscopic anatomic malformations in missed abortions | Measure | Minimize intrauterine adhesions through observation | Measure | Prevention of retained conception products |
Time Frame | Two years | Time Frame | Two years | Time Frame | Two years |
Description | The number and type of macroscopic anatomic malformations in missed abortions will be determined through visual observation using a fetoscope | Description | To minimize intrauterine adhesions that might occur after curettage through the ability to visualize the womb and pregnancy site through a hysteroscope before the surgical procedure so that inadvertent intrauterine adhesions are minimized. After one year, if pregnancy is not achieved (due to intrauterine adhesions that cause infertility), a follow-up hysteroscopy will be performed and intrauterine adhesions can be visualized if they have occurred. | Description | Prevention of retained conception products by hysteroscopy after curettage and visualization and observation of the contents of the womb |
Browse Conditions
Sequence: | 193626995 | Sequence: | 193626996 | Sequence: | 193626997 | Sequence: | 193626998 | Sequence: | 193626999 |
Mesh Term | Abortion, Missed | Mesh Term | Abortion, Spontaneous | Mesh Term | Pregnancy Complications | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases |
Downcase Mesh Term | abortion, missed | Downcase Mesh Term | abortion, spontaneous | Downcase Mesh Term | pregnancy complications | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48353691 |
Agency Class | OTHER_GOV |
Lead Or Collaborator | lead |
Name | Hillel Yaffe Medical Center |
Overall Officials
Sequence: | 29305976 |
Role | Principal Investigator |
Name | Sergio Haimovich, MD, PhD |
Affiliation | Hillel Yaffe Medical Center |
Central Contacts
Sequence: | 12017213 |
Contact Type | primary |
Name | Emiliya Ilizirov, MD |
Phone | 972-532323246 |
emiliyailizirova@gmal.com | |
Role | Contact |
Design Group Interventions
Sequence: | 68199184 |
Design Group Id | 55634661 |
Intervention Id | 52522069 |
Eligibilities
Sequence: | 30786866 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Women diagnosed with missed abortion during the first trimester of pregnancy Exclusion Criteria: Women diagnosed with missed abortion after the first trimester of pregnancy |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989621 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30532936 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Diagnostic |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Women who have undergone a missed abortion in the first trimester who want a surgical treatment option |
Responsible Parties
Sequence: | 28899230 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799068
2018-10-01
https://zephyrnet.com/?p=NCT03799068
NCT03799068https://www.clinicaltrials.gov/study/NCT03799068?tab=tableNANANAThe aim of this study is to evaluate the efficacy and duration of effect of bupivacaine given preoperatively as a bilateral suprazygomatic maxillary nerve block and to compare it with peri-incisional infiltration with the same agent for perioperative analgesia in children undergoing cleft palate repair.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-27 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | October 1, 2018 |
Primary Completion Month Year | March 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20721629 |
Description | Congenital cleft palate (CP) occurs in children at a rate of about 1.5 per 10 000 births, Early surgery is necessary to reduce phonation and feeding difficulties and reduce complications such as frequent sinusitis and other respiratory tract infections. The surgical procedure can be complicated by airway obstruction and respiratory complications. CP is painful in the first 24-48 h following surgery.
Different treatment modalities have been used for reducing or ameliorating the pain following cleft palate repair. These include opioids, paracetamol, non steroidal anti-inflammatory drugs (NSAIDs), surgical site infiltration and various nerve blocks However, the analgesic drugs may provide inadequate analgesia and have side effects such as respiratory depression and bleeding. The inherent disadvantages of analgesic pharmacotherapy in children promoted interest in nerve blocking techniques for operative analgesia. These became established in paediatric anaesthetic practice with the accumulating evidence of advantages such as postoperative pain relief, reduced use of potent narcotics, rapid return of alertness, early feeding and moving about, and early discharge in day care surgery. The maxillary nerve, the second division of the trigeminal nerve, leaves the cranial part of the face through the foramen rotundum, and then passes forward and laterally through the pterygopalatine fossa, at the bottom of the pterygomaxillary fossa, and reaches the floor of the orbit by the infra- orbital foramen. This sensory nerve supplies innervation of the lower eyelid, the upper lip, the skin between them, the roof of the mouth, and the palate. Maxillary nerve block through the infrazygomatic route, used for the treatment of trigeminal neuralgia in adults, permits anesthesia of the entire palatine territory. However, this nerve block has lead to complications such as orbital puncture, intracranial injection, maxillary artery puncture, or posterior pharyngeal wall injury In adults, approach to the suprazygomatic MN block (SMB) seems to minimize the risks of the infrazygomatic route providing effective anaesthesia of the entire sensory territory of the MN and its terminal branches. Bupivacaine, a long-acting amide local anaesthetic has been used widely in infants, particularly for infiltration of wound-edges and nerve blocking. Pre-incisional infiltration of local anaesthetics has been used both in adults and children in a variety of surgeries with variable results. submucosal infiltration performed by the surgeon seems to alter surgical conditions. Maxillary nerve block using the suprazygomatic approach has demonstrated beneficial effects in adults for trigeminal neuralgia. |
Facilities
Sequence: | 200108117 |
Name | Assiut university hospital |
City | Assiut |
Zip | 71515 |
Country | Egypt |
Conditions
Sequence: | 52171227 | Sequence: | 52171228 |
Name | Cleft Palate Children | Name | Block |
Downcase Name | cleft palate children | Downcase Name | block |
Id Information
Sequence: | 40158626 |
Id Source | org_study_id |
Id Value | Cleft Palate |
Countries
Sequence: | 42568937 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55593162 | Sequence: | 55593163 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | suprazygomatic maxillary nerve block | Title | surgical site infiltraion |
Description | the group were given a bilateral suprazygomatic maxillary nerve block with 0.125% bupivacaine, 2 ml on each side, the total dose of bupivacaine not exceeding 2 mg/kg. | Description | the group were given peri-incisional infiltration with 0.125% bupivacaine, 2 ml on each side. In all cases the block was given by the anaesthetist and the infiltration by the surgeon. |
Interventions
Sequence: | 52485469 | Sequence: | 52485470 |
Intervention Type | Other | Intervention Type | Other |
Name | suprazygomatic maxillary nerve block | Name | surgical site infiltration |
Description | bilateral Suprazygomatic maxillary nerve block is performed before surgery in anaesthetized children, after aseptic preparation of the skin. The patient is in supine position with the head in neutral position. The puncture site is at the frontozygomatic angle, at the junction of the upper edge of the zygomatic arch and the frontal process. A 24G needle is attached to a syringe containing the local anaesthetic. It is advanced to reach the greater wing of sphenoid at approximately 20 mm depth, then withdrawn a few millimetres and redirected toward the nasolabial fold in a 20° forward and 10° downward direction. The progression in the pterygopalatine fossa is 35 to 45 mm. Loss of resistance after passing through the temporalis muscle assisted in determining the puncture depth. After a negative blood aspiration test, the calculated dose of the local anaesthetic is injected on each side. | Description | peri-incisional infiltration of bupivacaine around the incision site given by the surgeon on an anesthetized patient before the incision is done. |
Keywords
Sequence: | 79868530 | Sequence: | 79868531 |
Name | bupivacaine | Name | suprazygomatic nerve block |
Downcase Name | bupivacaine | Downcase Name | suprazygomatic nerve block |
Design Outcomes
Sequence: | 177378837 |
Outcome Type | primary |
Measure | Pain assessment |
Time Frame | 24 hours postoperative |
Description | By Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) in Young Children (1-7 years) is a behavioral scale for evaluating postoperative pain in young children.
Cry No crying +1 Moaning,crying +2 Screaming+3 Facial expression: Smiling +1 Composed, neutral +2 Grimace +3 Verbal responses Positive statements +1 Negative statement +2 Suffering from pain +3 Torso Neutral/resting +1 Shifting, shivering, upright +2 Restrained +3 Legs Neutral position+1 Squirming/kicking, drawn up, tensed legs +2 Restrained +3 Cheops score of 4 or less indicates no pain. Rescue analgesic consisting of paracetamol 10-15 mg/kg will be given rectally when CHEOPS is > 4. |
Browse Conditions
Sequence: | 193486680 | Sequence: | 193486681 | Sequence: | 193486682 | Sequence: | 193486683 | Sequence: | 193486684 | Sequence: | 193486685 | Sequence: | 193486686 | Sequence: | 193486687 | Sequence: | 193486688 | Sequence: | 193486689 | Sequence: | 193486690 | Sequence: | 193486691 |
Mesh Term | Cleft Palate | Mesh Term | Jaw Abnormalities | Mesh Term | Jaw Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Maxillofacial Abnormalities | Mesh Term | Craniofacial Abnormalities | Mesh Term | Musculoskeletal Abnormalities | Mesh Term | Stomatognathic Diseases | Mesh Term | Mouth Abnormalities | Mesh Term | Mouth Diseases | Mesh Term | Stomatognathic System Abnormalities | Mesh Term | Congenital Abnormalities |
Downcase Mesh Term | cleft palate | Downcase Mesh Term | jaw abnormalities | Downcase Mesh Term | jaw diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | maxillofacial abnormalities | Downcase Mesh Term | craniofacial abnormalities | Downcase Mesh Term | musculoskeletal abnormalities | Downcase Mesh Term | stomatognathic diseases | Downcase Mesh Term | mouth abnormalities | Downcase Mesh Term | mouth diseases | Downcase Mesh Term | stomatognathic system abnormalities | Downcase Mesh Term | congenital abnormalities |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319286 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Assiut University |
Design Group Interventions
Sequence: | 68149118 | Sequence: | 68149119 |
Design Group Id | 55593162 | Design Group Id | 55593163 |
Intervention Id | 52485469 | Intervention Id | 52485470 |
Eligibilities
Sequence: | 30765345 |
Gender | All |
Minimum Age | 1 Year |
Maximum Age | 5 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
ASA grade I-III. Exclusion Criteria: Patient's refusal. |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253883355 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 1 |
Maximum Age Num | 5 |
Minimum Age Unit | Year |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30511512 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Subject Masked | True |
Responsible Parties
Sequence: | 28877806 |
Responsible Party Type | Principal Investigator |
Name | Maha Nasser Abdellatif Elshimy |
Title | Clinical physician |
Affiliation | Assiut University |
]]>
https://zephyrnet.com/NCT03799055
2019-06-10
https://zephyrnet.com/?p=NCT03799055
NCT03799055https://www.clinicaltrials.gov/study/NCT03799055?tab=tableNANANAThe aim of this study to assess and compare between methods of prediction of difficult airway including Mallmpati score , thyromental distance and us measured distance from skin to epiglottis(DES) t the level of thyrohyoid membrane in adult patients requiring endotracheal intubation for an elective surgical procedure.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-04-22 |
Start Month Year | June 10, 2019 |
Primary Completion Month Year | December 29, 2019 |
Verification Month Year | April 2020 |
Verification Date | 2020-04-30 |
Last Update Posted Date | 2020-04-22 |
Facilities
Sequence: | 200617894 |
Name | Benha University Hospital |
City | Banhā |
State | Banha |
Zip | 13518 |
Country | Egypt |
Conditions
Sequence: | 52328229 |
Name | Difficult Intubation |
Downcase Name | difficult intubation |
Id Information
Sequence: | 40271035 |
Id Source | org_study_id |
Id Value | Us in difficult airway |
Countries
Sequence: | 42691070 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55768046 | Sequence: | 55768047 |
Title | easy intubation | Title | difficult intubation |
Description | Cormack _Lehane : 1&2 | Description | Cormack _Lehane : 3&4 |
Design Outcomes
Sequence: | 177959709 |
Outcome Type | primary |
Measure | Prediction of difficult airway |
Time Frame | Preoperative |
Description | Assess which method is better for prediction of difficult airway DES or conventional |
Sponsors
Sequence: | 48466358 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Benha University |
Overall Officials
Sequence: | 29368827 |
Role | Study Director |
Name | Faculty Of Medicine |
Affiliation | faculty of medicine |
Eligibilities
Sequence: | 30856288 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | Patients at Benha University Surgical Hospital scheduled for elective surgical procedures requiring endotracheal tube |
Criteria | Inclusion Criteria:
American Society of Anaesthesia class 1,2and 3. Exclusion Criteria: patients refusal. |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254313007 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 6 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30602127 |
Observational Model | Other |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28968642 |
Responsible Party Type | Principal Investigator |
Name | Baher Said Elshahat Mohamed Abdelhady |
Title | Principal investigator |
Affiliation | Benha University |
]]>
https://zephyrnet.com/NCT03799042
2018-08-01
https://zephyrnet.com/?p=NCT03799042
NCT03799042https://www.clinicaltrials.gov/study/NCT03799042?tab=tableNANANAVirtual Reality (VR) is a technology that combines virtual technology and real-world scenario. In recent years, more and more neuroscience and psychology scientists utilised VR technology in their research. In Hong Kong, many of the community-dwelling elders are immobile. Long-term homestay may negatively affect the emotional state. Measuring the emotional change after administration of VR may prove it as an alternative tool for emotion intervention.
The primary objective is to compare the improvement in the emotional changes between intergeneration interaction and the use of VR technology.
The secondary objective is to evaluate the side effect after using VR technology.
This is a randomized, open label-controlled trial with a crossover design. The subject will be randomized in a ratio of 1:1 into two different intervention groups, the VR group and the Intergeneration Interaction group. After 2 weeks of washout period, the VR group will receive Intergeneration Interaction and vice versa. The intervention phases last approximately 2 hours. The change in the emotional state will be assessed using the Positive and Negative Affect Scale. Any adverse event that causes by the VR will be recorded using the Simulator Sickness Questionnaire(SSQ).
This trial is the first study in Hong Kong to investigate the change of emotional state after the administration of VR technology, targeting community-dwelling elders in Hong Kong.
<![CDATA[
Studies
Study First Submitted Date | 2018-08-10 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | August 1, 2018 |
Primary Completion Month Year | September 30, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Facilities
Sequence: | 199965042 |
Name | Caritas Elderly Centre – Sai Kung |
City | Hong Kong |
State | HK |
Country | Hong Kong |
Conditions
Sequence: | 52138964 | Sequence: | 52138965 |
Name | Virtual Reality | Name | Emotions |
Downcase Name | virtual reality | Downcase Name | emotions |
Id Information
Sequence: | 40135030 |
Id Source | org_study_id |
Id Value | CUHKHKT0818 |
Countries
Sequence: | 42542665 |
Name | Hong Kong |
Removed | False |
Design Groups
Sequence: | 55559302 | Sequence: | 55559303 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Vitural Reality | Title | Inter-generation interaction |
Description | Virtual Reality 3D glass | Description | Elders-teenager interaction |
Interventions
Sequence: | 52454863 | Sequence: | 52454864 |
Intervention Type | Device | Intervention Type | Behavioral |
Name | Virtual Reality | Name | Inter-generation interaction |
Description | Subjects will wear a 3D glass and watch 3D pictures (or video) of landscapes or tourist sites in Hong Kong. | Description | Secondary school student will play games and chats with secondary school students. Games involve identifying famous landscapes or tourist sites in Hong Kong |
Design Outcomes
Sequence: | 177263517 | Sequence: | 177263518 | Sequence: | 177263519 | Sequence: | 177263520 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Positive and Negative Affect Schedule (PANAS) | Measure | Simulator Sickness Questionnaire | Measure | Positive and Negative Affect Schedule (PANAS) | Measure | Simulator Sickness Questionnaire |
Time Frame | Major assessment points are scheduled prior to intervention(baseline), post intervention of the first visit (approximate 2 hours after baseline), and post intervention of the second visit (2 weeks after first intervention.) | Time Frame | Major assessment points are scheduled prior to intervention(baseline), post intervention of the first visit (approximate 2 hours after baseline), and post intervention of the second visit (2 weeks after first intervention.) | Time Frame | Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline) | Time Frame | Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline) |
Description | Measure the difference in mean score between the two intervention groups. The Positive and Negative Affect Schedule (PANAS) is consist of 20 emotions. Positive Affect Score consists of 10 positive emotions, while Negative Affect Score consists of 10 negative emotions. Positive Affect Score ranges from 10 to 50, a score of 30 indicates a higher level of positive emotion. Negative Affect Score ranges from 10 to 50, a score of 15 indicates a higher level of negative emotion. Total PANAS score is 100, added up by both Positive Affect Score and Negative Affect Score. | Description | Measure the difference in mean score between the two intervention groups. The Simulator Sickness Questionnaire (SSQ) is consist of 16 symptoms. Each symptom includes four level, none (0 marks), slight(1mark), moderate (2 marks) and severe(3). Three subscore are included, Nausea-related subscore (Symptom 1,6,7,8,9,15,16), Oculomotor-related subscore (Symptom 1,2,3,4,5,9,11), and Disorientation-related subscore (5,8,10,11,12,13,14). Adding Nausea subscore, oculomotor subscore, and disorientation subscore and multiply by 3.74. Total score larger than 15 indicated a significant level of adverse reaction. | Description | Measure the changes from baseline to first intervention | Description | Measure the changes from baseline to first intervention |
Sponsors
Sequence: | 48290677 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Chinese University of Hong Kong |
Overall Officials
Sequence: | 29268516 |
Role | Principal Investigator |
Name | Kelvin KF Tsoi, BSc, PhD |
Affiliation | Chinese University of Hong Kong |
Design Group Interventions
Sequence: | 68107396 | Sequence: | 68107397 |
Design Group Id | 55559302 | Design Group Id | 55559303 |
Intervention Id | 52454863 | Intervention Id | 52454864 |
Eligibilities
Sequence: | 30747700 |
Gender | All |
Minimum Age | 50 Years |
Maximum Age | 99 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Native Cantonese Speaker Exclusion Criteria: – |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121794 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 2 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 50 |
Maximum Age Num | 99 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30493983 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28860263 |
Responsible Party Type | Principal Investigator |
Name | Kelvin KF Tsoi |
Title | Associate Professor |
Affiliation | Chinese University of Hong Kong |
]]>
https://zephyrnet.com/NCT03799029
2019-02-20
https://zephyrnet.com/?p=NCT03799029
NCT03799029https://www.clinicaltrials.gov/study/NCT03799029?tab=tableChantal Martin Soelch, Prchantal.martinsoelch@unifr.ch+41 26 300 7687This study examines the impact of cognitive training among participants with ADHD in Switzerland
<![CDATA[
Studies
Study First Submitted Date | 2018-05-28 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | February 20, 2019 |
Primary Completion Month Year | June 1, 2021 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20727138 |
Description | The main aim of the experimental study is to investigate cognitive functioning, behavioral and neural levels in ADHD, both before and after cognitive training where there has been the addition of motivation elements. Near and far transfers effects of this new program are evaluated. For far transfers, ambulatory assessment is used to improve ecological validity. Neural activity has rarely been examined in cognitive training with ADHD participants, and that is why this study also includes FMRI measures. Long-term effects, defined as three and six months following the completion of cognitive training, are also investigated. This study focuses on children, adolescents and adults with ADHD. Indeed, cognitive training effects have been rarely studied over the lifespan. |
Facilities
Sequence: | 200159077 |
Name | Dentz Amélie |
City | Montréal |
State | Quebec |
Zip | 2000 |
Country | Canada |
Conditions
Sequence: | 52185366 |
Name | ADHD |
Downcase Name | adhd |
Id Information
Sequence: | 40168994 |
Id Source | org_study_id |
Id Value | University of Fribourg |
Countries
Sequence: | 42580602 |
Name | Canada |
Removed | False |
Design Groups
Sequence: | 55609009 | Sequence: | 55609010 | Sequence: | 55609011 |
Group Type | Active Comparator | Group Type | Experimental | Group Type | No Intervention |
Title | active control group low-intensity | Title | experimental training group cognitive training | Title | control healthy participants |
Description | Low intensity version of the same cognitive training program Exercice are realized at home using a computer 25 sessions of 30-45 minutes are realized five days per week during 5 weeks | Description | a multifactorial cognitive program that tackles working memory, attention, inhibition, planification and reasoning Exercice are realized at home using a computer 25 sessions of 30-45 minutes are realized five days per week during 5 weeks | Description | Just a control group including healthy participants No intervention |
Interventions
Sequence: | 52499330 |
Intervention Type | Other |
Name | Cognitive training |
Description | Participants will train at home during 25 sessions (about 45 minutes each) over a maximum of 5 weeks. Investigators will verify compliance via Internet and call participants and their legal guardians once a week. A reward system will be established with participants. Five sessions of metacognition (1 hour each) are added. |
Keywords
Sequence: | 79888564 | Sequence: | 79888565 | Sequence: | 79888566 |
Name | Cognitive training | Name | treatment | Name | ADHD |
Downcase Name | cognitive training | Downcase Name | treatment | Downcase Name | adhd |
Design Outcomes
Sequence: | 177431700 | Sequence: | 177431701 | Sequence: | 177431702 | Sequence: | 177431703 | Sequence: | 177431704 | Sequence: | 177431705 | Sequence: | 177431706 | Sequence: | 177431707 | Sequence: | 177431708 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | ADHD symptoms for adults | Measure | ADHD symptoms for children | Measure | Impulsivity | Measure | executive function | Measure | Reward | Measure | Reward | Measure | Memory | Measure | Memory | Measure | Neural activity |
Time Frame | Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 | Time Frame | Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 | Time Frame | Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 | Time Frame | Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 | Time Frame | Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 | Time Frame | Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 | Time Frame | Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 training 4. Six months after cognitive training | Time Frame | Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 training 4. Six months after cognitive training | Time Frame | Change between two time points from baseline T1 to six week later T2 after cognitive training is assessed. Follow up is assessed at 3 months T3 and 6 months T4 |
Description | The Conners' Adult ADHD Rating Scales (CAARS) higher values represent worse outcome The Conners' Adult ADHD Rating Scales (CAARS) is used to assess ADHD symptoms among adults (Conners et al., 1999) depending on the DSM-IV-TR (APA, 2000). This short version includes 26 items and 4 possible ratings from from 0 (not at all) to 3 (very much). This scale comprises four factors: (1) inattention, memory problems, (2) hyperactivity, restlessness, (3) impulsivity, emotional lability, (4) problems with self-concept and one ADHD index. score are summed. Range 0 to 100. | Description | The Conners Scale, 3rd edition higher values represent a worse outcome Questionnaire is rated by the legal guardian. This questionnaire assesses ADHD symptoms.Score are summed. Score range 0 to 100. | Description | The Impulsivity Behavior Scale (UPPS) higher values represent a worse outcome. score are summed short version contains 20 items measuring the following five dimensions of impulsivity: positive urgency, negative urgency, lack of perseverance, lack of premeditation and sensation seeking. This scale is based on Cyder and Smith (2007) and Whiteside and Lynam (2001) theory of impulsivity. Range 0 to 50. | Description | The Behavior Rating Inventory of Executive Function higher values represent a worse outcome Score are summed. This questionnaire measures executive functionning in everyday life. The BRIEF includes 75 questions and eight sub-domains: Inhibit Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Organization of Materials and Monitor. Score range 0 to 100 | Description | Subjects will perform a reward under stress task adapted from the spatial delayed response task from (Glahn et al., 2002) measure reward (Martin-Soelch, C., et al.,2009: Gaillac et al., 2016). Reaction time is calculated.
The sensitivity to Punishment and Sensitivity to Reward questionnaire for Children, adolescents (SPSRQ-C) (Colder and O'Connor 2004) and adults (SPSRQ, Torrubia, Ávila, Moltó, & Caseras, 2001) are used. These questionnaires are based on Gray's reinforcement sensitivity theory of personality (1981, 1987, 2000). Reward task higher values represent a better outcome. Score range 0 to 110. |
Description | The sensitivity to Punishment and Sensitivity to Reward questionnaire for Children, adolescents (SPSRQ-C) (Colder and O'Connor 2004) and adults (SPSRQ, Torrubia, Ávila, Moltó, & Caseras, 2001) are used. These questionnaires are based on Gray's reinforcement sensitivity theory of personality (1981, 1987, 2000). Reward task higher values represent a better outcome. Score range 0 to 110. | Description | WISC-IV higher values represent a better outcome. The Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV, Wechsler, 2003) Score are standardized from 0 to 20 for subtest and summed from 0 to 150.
The Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV, Wechsler, 2003) and the Weschler adult intelligent scale measure verbal memory. Score are standardized from 0 to 20 for subtest and summed from 0 to 150. |
Description | WAIS-IV higher values represent a better outcome .the Weschler adult intelligent scale to (WAIS-IV; Wechsler, 2008). Score are standardized from 0 to 20 for subtest and summed from 0 to 150.
The Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV, Wechsler, 2003) and the Weschler adult intelligent scale measure verbal memory. Score are standardized from 0 to 20 for subtest and summed from 0 to 150. |
Description | The fMRI measure include. Resting-state functional MRI.Task-free. Subjects are instructed to just lie quietly in the scanner and to think of nothing in particular and let their mind wander.- binding potential (ΔBP) is measured. |
Browse Conditions
Sequence: | 193539712 | Sequence: | 193539713 | Sequence: | 193539714 | Sequence: | 193539711 |
Mesh Term | Attention Deficit and Disruptive Behavior Disorders | Mesh Term | Neurodevelopmental Disorders | Mesh Term | Mental Disorders | Mesh Term | Attention Deficit Disorder with Hyperactivity |
Downcase Mesh Term | attention deficit and disruptive behavior disorders | Downcase Mesh Term | neurodevelopmental disorders | Downcase Mesh Term | mental disorders | Downcase Mesh Term | attention deficit disorder with hyperactivity |
Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list |
Sponsors
Sequence: | 48332227 | Sequence: | 48332228 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Fribourg | Name | Paris West University Nanterre La Défense |
Overall Officials
Sequence: | 29292926 | Sequence: | 29292927 |
Role | Principal Investigator | Role | Principal Investigator |
Name | Amélie Dentz, Ph.D | Name | Martin Soelch Chantal, PR |
Affiliation | University of Fribourg | Affiliation | University of Fribourg |
Central Contacts
Sequence: | 12012282 | Sequence: | 12012283 |
Contact Type | primary | Contact Type | backup |
Name | amelie dentz, Ph.D | Name | Chantal Martin Soelch, Pr |
Phone | 0676951881 | Phone | +41 26 300 7687 |
ameliedentz@hotmail.com | chantal.martinsoelch@unifr.ch | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68168052 | Sequence: | 68168053 |
Design Group Id | 55609009 | Design Group Id | 55609010 |
Intervention Id | 52499330 | Intervention Id | 52499330 |
Eligibilities
Sequence: | 30773519 |
Gender | All |
Minimum Age | 6 Years |
Maximum Age | 65 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
– Participants fulfilling all of the following inclusion criteria are eligible for the study for the patients'group: Age between 6 and 65 years' old Participants fulfilling all of the following inclusion criteria are eligible for the study for the control group of healthy participants: Age between 6 and 65 years' old Exclusion Criteria: Exclusion criteria The exclusion criteria for the participants in the patient's group are: Age younger than 6 and older than 65 years' old (7) FMRI exclusion: claustrophobia, Pregnancy known or suspected,metallic implants in their bodies (e.g: pacemakers, aneurism clips, metal Prosthetic, cochlear implant) (8) In case of suicidal risk, the participant is encouraged to consult the medical staff (9) Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant (10) Participation in another study on cognitive training (11) Previous enrolment into the current study (12) Enrolment of the investigator, his/her family members, employees and other dependent persons The exclusion criteria for the participants in the control group of healthy participants are: Age younger than 6 and older than 65 years' old |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 253952483 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 6 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 7 |
Designs
Sequence: | 30519650 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Masking Description | Participant are blind on their group assignation. Investigator are blind on group assignation |
Intervention Model Description | will compare the ADHD group with a control group including healthy participants .The experimental study uses a pseudo-randomized, double-blind, controlled multi-center design.Participants will be assigned to an experimental group (cognitive training ) or in a control active group. |
Subject Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28885951 |
Responsible Party Type | Principal Investigator |
Name | Amelie Dentz |
Title | principal investigator Ph.D |
Affiliation | University of Fribourg |
Study References
Sequence: | 52078781 | Sequence: | 52078782 |
Pmid | 27875585 | Pmid | 24438534 |
Reference Type | background | Reference Type | result |
Citation | Spencer-Smith M, Klingberg T. Correction: Benefits of a Working Memory Training Program for Inattention in Daily Life: A Systematic Review and Meta-Analysis. PLoS One. 2016 Nov 22;11(11):e0167373. doi: 10.1371/journal.pone.0167373. eCollection 2016. | Citation | Gathercole SE. Commentary: Working memory training and ADHD – where does its potential lie? Reflections on Chacko et al. (2014). J Child Psychol Psychiatry. 2014 Mar;55(3):256-7. doi: 10.1111/jcpp.12196. Epub 2014 Jan 20. |
]]>
https://zephyrnet.com/NCT03799016
2016-12-15
https://zephyrnet.com/?p=NCT03799016
NCT03799016https://www.clinicaltrials.gov/study/NCT03799016?tab=tableNANANAThe research question addressed by this study is primarily on the clinical epidemiology of VTE in Taiwan. The study aims to estimate the incidence of VTE and describe natural history of VTE, including long term clinical outcomes in adult Taiwanese population, utilizing population-based electronic health data in Taiwan.
<![CDATA[
Studies
Study First Submitted Date | 2018-10-25 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | December 15, 2016 |
Primary Completion Month Year | July 1, 2017 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Facilities
Sequence: | 200352050 |
City | Taipei |
Country | Taiwan |
Conditions
Sequence: | 52244445 |
Name | Venous Thromboembolism |
Downcase Name | venous thromboembolism |
Id Information
Sequence: | 40212161 |
Id Source | org_study_id |
Id Value | 18787 |
Countries
Sequence: | 42627117 |
Name | Taiwan |
Removed | False |
Design Outcomes
Sequence: | 177648648 | Sequence: | 177648649 | Sequence: | 177648650 | Sequence: | 177648651 | Sequence: | 177648652 | Sequence: | 177648653 | Sequence: | 177648654 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Incident VTE | Measure | Potential risk factors that occurred before the incident VTE events | Measure | Usage patterns of anticoagulants among incident VTE patients were evaluated during incident VTE hospital admission and after discharge | Measure | All-cause mortality | Measure | Major bleeding | Measure | Recurrent VTE | Measure | Adherence of oral anticoagulant treatment was also evaluated with the calculation of MPR within 6 months and 12 months after discharge. |
Time Frame | 4 years | Time Frame | 4 years | Time Frame | 4 years | Time Frame | 4 years | Time Frame | 4 years | Time Frame | 4 years | Time Frame | Up to 6 and 12 month |
Description | Incident VTE cases were those who had a first VTE diagnosis after 1 January 2005 and with at least 5 years of look-back period. Those with a first VTE diagnosis less than 5 years of look-period were considered as undetermined VTE cases. | Description | Events during the 3 months before the first VTE recurrence will be described. Potential risk factors that will be evaluated include age, gender, and treatment regimen for VTE, adherence to treatment regimen, concomitant medications, and comorbidity. The analysis will be stratified by the nature of the first VTE (provoked and unprovoked). Due to the unknown number of repeated recurrence and complex clinical nature of patients with multiple VTE recurrence, risk factors for multiple recurrences will be evaluated at a less detailed level than that for the first recurrence. | Description | All deaths before 31 December 2014 among the incident VTE patients were identified through the mortality records. Patients were followed from incident VTE index date, and the patients were censored on 31 December 2014 or termination of NHI coverage without further medical or mortality records. If the patient died during the same hospitalization during the incident VTE, the death date was defined as the discharge date of that specific hospitalization. | Description | Major bleeding (intracranial bleed and gastrointestinal bleed) was the major morbidity of interest and incident VTE patients were followed from incident VTE index date till 31 December 2014, death or termination of NHI coverage without any further medical records. Patients died during the incident VTE hospitalization were excluded for major bleeding follow up. | Description | Recurrent VTE events after the incident VTE diagnosis were evaluated during the follow-up period through 31 December 2014 or until the patient died or NHI coverage terminated without any further medical records after the termination. The same VTE operational definitions according to different algorithm in incident VTE were consistently applied in recurrent VTE. |
Browse Conditions
Sequence: | 193766196 | Sequence: | 193766197 | Sequence: | 193766198 | Sequence: | 193766199 | Sequence: | 193766200 |
Mesh Term | Thromboembolism | Mesh Term | Venous Thromboembolism | Mesh Term | Embolism and Thrombosis | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases |
Downcase Mesh Term | thromboembolism | Downcase Mesh Term | venous thromboembolism | Downcase Mesh Term | embolism and thrombosis | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48388131 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Bayer |
Overall Officials
Sequence: | 29325245 |
Role | Study Director |
Name | Bayer Study Director |
Affiliation | Bayer |
Eligibilities
Sequence: | 30808193 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 20 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
The source population was the adult population in Taiwan. The legal age for definition as an adult (without additional research ethics review requirement) in Taiwan is 20; therefore all National Health Insurance (NHI) enrollees age 20 or older at any time during the study period were evaluated for VTE. Exclusion Criteria: Person-time before an eligible subject turned 20 were not evaluated. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254032302 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 6 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 20 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 7 |
Designs
Sequence: | 30554190 |
Observational Model | Cohort |
Time Perspective | Retrospective |
Links
Sequence: | 4393856 |
Url | https://clinicaltrials.bayer.com/ |
Description | Click here to learn more about Bayer clinical study results. |
Responsible Parties
Sequence: | 28920553 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03799003
2019-01-14
https://zephyrnet.com/?p=NCT03799003
NCT03799003https://www.clinicaltrials.gov/study/NCT03799003?tab=tableNANANAThe primary purpose of this study is to evaluate the tolerability and safety profile of ASP1951 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1951 when administered as a single agent and in combination with pembrolizumab; and determine the recommended phase 2 dose (RP2D) of ASP1951 and/or maximum tolerated dose (MTD) when administered as a single agent and in combination with pembrolizumab. This study will also evaluate the anti-tumor effect of ASP1951 when administered as a single agent and in combination with pembrolizumab.
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Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-08-04 |
Start Month Year | January 14, 2019 |
Primary Completion Month Year | July 6, 2023 |
Verification Month Year | July 2023 |
Verification Date | 2023-07-31 |
Last Update Posted Date | 2023-08-04 |
Detailed Descriptions
Sequence: | 20787083 |
Description | This is a dose-escalation and expansion study of ASP1951. The study consists of 3 periods for monotherapy and combination therapy: screening, treatment and follow up, followed by an optional Re-treatment period for participants that qualify.
The monotherapy escalation cohorts will evaluate escalating dose levels of ASP1951 in participants with locally advanced (unresectable) or metastatic solid tumor malignancies including but not limited to squamous cell carcinoma of the head and neck (SCCHN), colorectal cancer, metastatic castration-resistant prostate cancer (mCRPC) and cervical cancer. The combination escalation cohorts will evaluate escalating dose levels of ASP1951 in combination with a fixed dose of pembrolizumab. For dose expansion, the tumor-specific cohorts will include participants with squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC) (all PD-L1 status), NSCLC PDL1 high, and cervical cancer, as well as participants with any tumor types that respond to study drug treatment during dose escalation. Participants may reinitiate study drug treatment in the optional Re-treatment period after confirmation that the participant meets all the re-treatment eligibility criteria. After discontinuation of study drug, all participants will complete an end-of-treatment visit, along with 30-day and 90 day safety follow-up visits from the last dose of study drug. |
Facilities
Sequence: | 200650001 | Sequence: | 200650002 | Sequence: | 200650003 | Sequence: | 200650004 | Sequence: | 200650005 | Sequence: | 200650006 | Sequence: | 200650007 | Sequence: | 200650008 | Sequence: | 200650009 | Sequence: | 200650010 | Sequence: | 200650011 | Sequence: | 200650012 | Sequence: | 200650013 | Sequence: | 200650014 | Sequence: | 200650015 | Sequence: | 200650016 | Sequence: | 200650017 | Sequence: | 200650018 | Sequence: | 200650019 | Sequence: | 200650020 | Sequence: | 200650021 | Sequence: | 200650022 | Sequence: | 200650023 | Sequence: | 200650024 | Sequence: | 200650025 | Sequence: | 200650026 | Sequence: | 200650027 | Sequence: | 200650028 | Sequence: | 200650029 | Sequence: | 200650030 | Sequence: | 200650031 | Sequence: | 200650032 |
Name | Arizona Clinical Research Cent | Name | University of California | Name | University of Florida, Davis C | Name | Emory University | Name | Augusta University | Name | Northwestern University | Name | Rush University Medical Center | Name | University of Iowa Hospitals | Name | Henry Ford Health System | Name | Nebraska Cancer Specialists | Name | Comprehensive Cancer Nevada | Name | Rutgers Cancer Institute | Name | Icahn school of Medicine at Mount Sinai | Name | Columbia University Medical Center | Name | Duke University Medical Center | Name | Hollings Cancer Center | Name | South Texas Accelerated Research Therapeutics, LLC | Name | Huntsman Cancer Institute | Name | Virginia Cancer Specialists | Name | Multicare Regional Cancer Center Tacoma | Name | Site CA15002 | Name | Site CA15005 | Name | Site CA15004 | Name | Site KR82002 | Name | Site KR82005 | Name | Site KR82001 | Name | Site KR82003 | Name | Site KR82004 | Name | Site KR82006 | Name | Site KR82007 | Name | Site TW88603 | Name | Site TW88604 |
City | Tucson | City | Sacramento | City | Gainesville | City | Atlanta | City | Augusta | City | Chicago | City | Chicago | City | Iowa City | City | Detroit | City | Omaha | City | Las Vegas | City | New Brunswick | City | New York | City | New York | City | Durham | City | Charleston | City | San Antonio | City | Salt Lake City | City | Fairfax | City | Tacoma | City | Montreal | City | Montreal | City | Ontario | City | Chungcheongbukdo | City | Daegu | City | Gyeonggi-do | City | Seoul | City | Seoul | City | Seoul | City | Seoul | City | Taichung | City | Taipei |
State | Arizona | State | California | State | Florida | State | Georgia | State | Georgia | State | Illinois | State | Illinois | State | Iowa | State | Michigan | State | Nebraska | State | Nevada | State | New Jersey | State | New York | State | New York | State | North Carolina | State | South Carolina | State | Texas | State | Utah | State | Virginia | State | Washington | ||||||||||||||||||||||||
Zip | 85715 | Zip | 95817 | Zip | 326102 | Zip | 30322 | Zip | 30912 | Zip | 60611 | Zip | 60612 | Zip | 52242 | Zip | 48202 | Zip | 68130 | Zip | 89169 | Zip | 08903 | Zip | 10029 | Zip | 10032 | Zip | 27705 | Zip | 29425 | Zip | 78229 | Zip | 84112 | Zip | 22031 | Zip | 98405 | ||||||||||||||||||||||||
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | Canada | Country | Canada | Country | Canada | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Taiwan | Country | Taiwan |
Browse Interventions
Sequence: | 96313809 | Sequence: | 96313810 | Sequence: | 96313811 | Sequence: | 96313812 | Sequence: | 96313813 |
Mesh Term | Pembrolizumab | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Antineoplastic Agents | Mesh Term | Immune Checkpoint Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | pembrolizumab | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | immune checkpoint inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52338617 |
Name | Advanced Solid Tumors |
Downcase Name | advanced solid tumors |
Id Information
Sequence: | 40278245 | Sequence: | 40278246 | Sequence: | 40278247 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | 1951-CL-0101 | Id Value | 2019-002287-27 | Id Value | KEYNOTE KN-B02 |
Id Type | EudraCT Number | Id Type | Other Identifier | ||
Id Type Description | Merck | ||||
Countries
Sequence: | 42698485 | Sequence: | 42698486 | Sequence: | 42698487 | Sequence: | 42698488 |
Name | United States | Name | Canada | Name | Korea, Republic of | Name | Taiwan |
Removed | False | Removed | False | Removed | False | Removed | False |
Design Groups
Sequence: | 55779600 | Sequence: | 55779601 | Sequence: | 55779602 | Sequence: | 55779603 | Sequence: | 55779604 | Sequence: | 55779605 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | ASP1951 Monotherapy Escalation | Title | ASP1951 Monotherapy Expansion | Title | ASP1951 Optional Monotherapy Retreatment Period | Title | ASP1951 plus pembrolizumab Combination Escalation | Title | ASP1951 plus pembrolizumab Combination Expansion | Title | ASP1951 plus pembrolizumab Optional Retreatment Period |
Description | The monotherapy escalation cohort will evaluate escalating dose levels of ASP1951.Dose escalation to the next level will be made based on the Bayesian Continual Reassessment Method (CRM). | Description | If a confirmed response (partial Response (PR) or complete response (CR)) occurs in a monotherapy or combination escalation cohort, a tumor-specific expansion cohort may be opened in that tumor type, at the dose level in which the confirmed response was observed and at all subsequent dose levels once each dose level has been deemed tolerable. | Description | Participants may reinitiate study drug treatment after confirmation that the participant meets all the re-treatment eligibility criteria. | Description | The combination escalation cohort will evaluate escalating dose levels of ASP1951 in combination with a fixed dose of pembrolizumab. Dose escalation to the next level will be made based on the Bayesian Continual Reassessment Method (CRM). | Description | If a confirmed response (partial Response (PR) or complete response (CR)) occurs in the combination escalation cohort, a tumor-specific expansion cohort may be opened in that tumor type, at the dose level in which the confirmed response was observed and at all subsequent dose levels once each dose level has been deemed tolerable. Once the high dose RP2D and schedule of ASP1951 in combination with pembrolizumab has been determined, expansion cohorts may be opened to enroll participants with NSCLC (all PD-L1 status), NSCLC PD-L1 high, SCCHN and cervical cancer (if any of these tumor specific expansion cohorts are not already opened). Also, low dose cohorts of ASP1951 in combination will be opened in NSCLC (all PD-L1 status), SCCHN and cervical cancer for further evaluation of response and safety and establishing a possible low dose RP2D based on clinical and biomarker activity. | Description | Participants may reinitiate study drug treatment after confirmation that the participant meets all the re-treatment eligibility criteria. |
Interventions
Sequence: | 52649263 | Sequence: | 52649264 |
Intervention Type | Drug | Intervention Type | Drug |
Name | ASP1951 | Name | pembrolizumab |
Description | Intravenously (IV) | Description | Intravenously (IV) |
Keywords
Sequence: | 80099535 | Sequence: | 80099536 | Sequence: | 80099537 | Sequence: | 80099538 | Sequence: | 80099539 | Sequence: | 80099540 | Sequence: | 80099541 | Sequence: | 80099542 | Sequence: | 80099543 | Sequence: | 80099544 | Sequence: | 80099545 |
Name | ASP1951 | Name | cervical cancer | Name | Oncology | Name | squamous cell carcinoma of the head and neck (SCCHN) | Name | metastatic castration-resistant prostate cancer (mCRPC) | Name | melanoma | Name | Tumors | Name | pembrolizumab | Name | colorectal cancer | Name | Advanced (unresectable) or metastatic solid tumor malignancies | Name | Advanced solid tumors |
Downcase Name | asp1951 | Downcase Name | cervical cancer | Downcase Name | oncology | Downcase Name | squamous cell carcinoma of the head and neck (scchn) | Downcase Name | metastatic castration-resistant prostate cancer (mcrpc) | Downcase Name | melanoma | Downcase Name | tumors | Downcase Name | pembrolizumab | Downcase Name | colorectal cancer | Downcase Name | advanced (unresectable) or metastatic solid tumor malignancies | Downcase Name | advanced solid tumors |
Design Outcomes
Sequence: | 177997504 | Sequence: | 177997486 | Sequence: | 177997487 | Sequence: | 177997488 | Sequence: | 177997489 | Sequence: | 177997505 | Sequence: | 177997490 | Sequence: | 177997491 | Sequence: | 177997492 | Sequence: | 177997493 | Sequence: | 177997494 | Sequence: | 177997495 | Sequence: | 177997496 | Sequence: | 177997497 | Sequence: | 177997498 | Sequence: | 177997499 | Sequence: | 177997500 | Sequence: | 177997501 | Sequence: | 177997502 | Sequence: | 177997503 | Sequence: | 177997506 | Sequence: | 177997507 | Sequence: | 177997508 | Sequence: | 177997509 | Sequence: | 177997510 | Sequence: | 177997511 | Sequence: | 177997512 | Sequence: | 177997513 | Sequence: | 177997514 | Sequence: | 177997515 | Sequence: | 177997516 | Sequence: | 177997517 | Sequence: | 177997518 | Sequence: | 177997519 | Sequence: | 177997520 | Sequence: | 177997521 | Sequence: | 177997522 | Sequence: | 177997523 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Pharmacokinetics (PK) of ASP1951 in serum: tlast | Measure | Safety and tolerability assessed by Dose Limiting Toxicity (DLT) | Measure | Safety and tolerability assessed by adverse events (AEs) | Measure | Safety and tolerability assessed by immune-related AEs (irAEs) | Measure | Safety and tolerability assessed by infusion-related reactions (IRRs) | Measure | Pharmacokinetics (PK) of ASP1951 in serum: CL | Measure | Safety and tolerability assessed by serious adverse events (SAEs) | Measure | Number of participants with laboratory value abnormalities and/or adverse events related to treatment | Measure | Safety and tolerability assessed by 12- lead electrocardiogram (ECG) | Measure | Number of participants with vital signs abnormalities and/or adverse events related to treatment | Measure | Number of participants with Physical Exam abnormalities and/or adverse events related to treatment | Measure | Safety and tolerability assessed by ECOG performance status | Measure | Pharmacokinetics (PK) of ASP1951 in serum: AUClast | Measure | Pharmacokinetics (PK) of ASP1951 in serum: AUCinf | Measure | Pharmacokinetics (PK) of ASP1951 in serum: AUCinf%extrap | Measure | Pharmacokinetics (PK) of ASP1951 in serum: AUCtau | Measure | Pharmacokinetics (PK) of ASP1951 in serum: Cmax | Measure | Pharmacokinetics (PK) of ASP1951 in serum: Ctrough | Measure | Pharmacokinetics (PK) of ASP1951 in serum: tmax | Measure | Pharmacokinetics (PK) of ASP1951 in serum: t 1/2 | Measure | Pharmacokinetics (PK) of ASP1951 in serum: Vz | Measure | Pharmacokinetics (PK) of ASP1951 in serum: Vss | Measure | Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: AUClast | Measure | Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: AUCinf | Measure | Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: AUCinf%extrap | Measure | Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: AUCtau | Measure | Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: Cmax | Measure | Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: Ctrough | Measure | Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: tmax | Measure | Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: t 1/2 | Measure | Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: tlast | Measure | Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: CL | Measure | Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: Vz | Measure | Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: Vss | Measure | Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) V1.1 and modified RECIST 1.1 for immune-based therapeutics (iRECIST) | Measure | Duration of Response (DOR) per RECIST V1.1 and iRECIST | Measure | Persistence of response after discontinuation per RECIST V1.1 and iRECIST | Measure | Disease Control Rate (DCR) per RECIST V1.1 and iRECIST |
Time Frame | Up to 10 weeks | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 10 weeks | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 48 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 48 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 10 weeks | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 5 years |
Description | Initial monotherapy escalation treatment only. Time of last measurable concentration (tlast) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | A DLT is defined as any of the prespecified Adverse Events (AEs) (graded using National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.03) that the investigator (or sponsor) cannot clearly attribute to a cause other than study drug. | Description | Initial and retreatment. An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. AEs will be coded using the medical dictionary for regulatory activities (MedDRA) and graded using NCI-CTCAE 4.03. | Description | Initial and retreatment. Most frequent immune-related AEs include rash, oral mucositis, dry mouth, colitis/diarrhea, hepatitis, pneumonitis, and endocrinopathies (hypophysitis, hypothyroidism, hyperthyroidism, adrenal insufficiency and Type 1 diabetes mellitus). In the event a participant is diagnosed with an irAE, then it should be reported as an AE. | Description | Initial and retreatment. IRRs are considered AEs of special interest. In the event a participant is diagnosed with an IRR, then it should be reported as an AE. | Description | Initial monotherapy escalation treatment only. Total clearance after intravenous dosing (CL) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial and retreatment. An AE is considered "serious" if it results in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures as allowed per study) or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE). Hospitalization for treatment/observation/examination caused by AE is to be considered as serious; and other medically important events. | Description | Initial and retreatment. Number of participants with potentially clinically significant laboratory values. | Description | Initial and retreatment. ECGs should be obtained after the participant has rested in supine position (or semi-recumbent, if supine is not tolerated) for 10 minutes. Any clinically significant adverse changes on the ECG will be reported as AEs. | Description | Initial and retreatment. Number of participants with potentially clinically significant vital sign values. | Description | Initial and retreatment. Number of participants with potentially clinically significant physical exam values. | Description | Initial and retreatment. The Eastern Cooperative Oncology Group (ECOG) scale will be used to assess performance status. Grades range from 0 (fully active) to 4 (completely disabled). Negative change scores indicate an improvement. Positive scores indicate a decline in performance. | Description | Initial monotherapy escalation treatment only. Area under the concentration time curve from the time of dosing to the last measurable concentration (AUClast) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial monotherapy escalation treatment only. Area under the concentration time curve from the time of dosing extrapolated to time infinity (AUCinf) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial monotherapy escalation treatment only. Percentage of AUCinf due to extrapolation from time of the last measurable concentration to time infinity (AUCinf %extrap) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial monotherapy escalation treatment only. Area under the concentration time curve from the time of dosing to the start of next dosing interval (AUCtau) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial monotherapy escalation treatment only. Maximum concentration (Cmax) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial monotherapy escalation and retreatment. Concentration immediately prior to dosing at multiple dosing (Ctrough) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial monotherapy escalation treatment only. Time of the maximum concentration (tmax) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial monotherapy escalation treatment only. Terminal elimination half-life (t1/2) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial monotherapy escalation treatment only. Volume of distribution after intravenous dosing during the terminal elimination phase (Vz) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial monotherapy escalation treatment only. Volume of distribution at steady state after intravenous dosing (Vss) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial combination escalation treatment only. Area under the concentration time curve from the time of dosing to the last measurable concentration (AUClast) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial combination escalation treatment only. Area under the concentration time curve from the time of dosing extrapolated to time infinity (AUCinf) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial combination escalation treatment only. Percentage of AUCinf due to extrapolation from time of the last measurable concentration to time infinity (AUCinf %extrap) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial combination escalation treatment only. Area under the concentration time curve from the time of dosing to the start of next dosing interval (AUCtau) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial combination escalation treatment only. Maximum concentration (Cmax) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial combination escalation and retreatment. Concentration immediately prior to dosing at multiple dosing (Ctrough) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial combination escalation treatment only. Time of the maximum concentration (tmax) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial combination escalation treatment only. Terminal elimination half-life (t1/2) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial combination escalation treatment only. Time of last measurable concentration (tlast) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial combination escalation treatment only. Total clearance after intravenous dosing (CL) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial combination escalation treatment only. Volume of distribution after intravenous dosing during the terminal elimination phase (Vz) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial combination escalation treatment only. Volume of distribution at steady state after intravenous dosing (Vss) will be recorded from the pharmacokinetic (PK) serum samples collected. | Description | Initial and retreatment. ORR is defined as the proportion of participants for each dose level whose best overall response is rated as confirmed complete response (CR) or partial response (PR). | Description | Initial and retreatment. DOR is defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date of radiographical progression/death or date of censoring. | Description | Initial and retreatment. Persistence of response is defined as the time from the date of treatment discontinuation to the date of radiographical progression or date of censoring. | Description | Initial and retreatment. DCR is defined as the proportion of participants for each dose level whose best overall response is rated as confirmed CR, PR or stable disease (SD). |
Browse Conditions
Sequence: | 194123954 |
Mesh Term | Neoplasms |
Downcase Mesh Term | neoplasms |
Mesh Type | mesh-list |
Sponsors
Sequence: | 48475873 | Sequence: | 48475874 |
Agency Class | INDUSTRY | Agency Class | INDUSTRY |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Astellas Pharma Global Development, Inc. | Name | Merck Sharp & Dohme LLC |
Overall Officials
Sequence: | 29374185 |
Role | Study Director |
Name | Medical Monitor |
Affiliation | Astellas Pharma Global Development, Inc. |
Design Group Interventions
Sequence: | 68376194 | Sequence: | 68376195 | Sequence: | 68376196 | Sequence: | 68376197 | Sequence: | 68376198 | Sequence: | 68376199 | Sequence: | 68376200 | Sequence: | 68376201 | Sequence: | 68376202 |
Design Group Id | 55779600 | Design Group Id | 55779601 | Design Group Id | 55779602 | Design Group Id | 55779603 | Design Group Id | 55779604 | Design Group Id | 55779605 | Design Group Id | 55779603 | Design Group Id | 55779604 | Design Group Id | 55779605 |
Intervention Id | 52649263 | Intervention Id | 52649263 | Intervention Id | 52649263 | Intervention Id | 52649263 | Intervention Id | 52649263 | Intervention Id | 52649263 | Intervention Id | 52649264 | Intervention Id | 52649264 | Intervention Id | 52649264 |
Eligibilities
Sequence: | 30862288 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Subject has locally-advanced (unresectable) or metastatic solid tumor malignancy (no limit to the number of prior treatment regimens) that is confirmed by available pathology records or current biopsy as well as the following: Subject in the escalation cohort has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit the subject's specific tumor type. OR [Taiwan only]: Subject has locally-advanced (unresectable) or metastatic solid tumor malignancy (no limit to the number of prior treatment regimens) that is confirmed by available pathology records or current biopsy and has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit in the opinion of the treating investigator for his/her specific tumor type. Note: Subjects in the combination expansion cohort with tumor types that pembrolizumab is not approved for can only enroll if their standard treatment is ineffective, unsuitable per investigator's judgment or if the subject is unwilling to receive the standard therapy. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Subject with metastatic castration-resistant prostate cancer (mCRPC) (positive bone scan and/or soft tissue disease documented by computed tomography [CT]/magnetic resonance imaging [MRI]) meets both of the following: Subject has serum testosterone ≤ 50 ng/dL at Screening. A female subject is eligible to participate if she is not pregnant and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP); OR Additional Inclusion Criteria for Subjects in the Expansion Cohorts: Subject has at least 1 measureable lesion per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Subjects with mC RPC who do not have measurable lesions must have at least 1 of the following: Progression with 2 or more new bone lesions; or Subject meets one of the following: Subject has the tumor type for which a confirmed response was observed in a monotherapy or combination therapy cohort; or Low dose RP2D combination therapy expansion cohorts are opened and subject has NSCLC (all PD-L1 status), SCCHN and cervical cancer. NSCLC with PD-L1 high expressing tumor (tumor proportion score ≥ 50%) as determined by 22C3 PD-L1 immunohistochemistry assay at a local/central laboratory during the screening period. Note: Local 22C3 PD-L1 IHC assay results available within 60 days prior study drug administration may be used for evaluating this entry criterion. Additional Inclusion Criteria for Re-treatment: Subject stopped initial treatment with ASP1951 or ASP1951 in combination with pembrolizumab after attaining a confirmed CR, PR or SD. Exclusion Criteria: Subject weighs < 45 kg. Additional Exclusion Criterion for Subjects in Expansion Cohorts: Subject has a prior malignancy, other than the current malignancy for which the subject is seeking treatment, active (i.e., requiring treatment of intervention) within the previous 2 years except for locally curable malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast. Additional Exclusion Criteria for Re-treatment: Subjects who have completed 45 weeks in monotherapy or 57 weeks in combination therapy follow-up with disease control are not eligible for re-treatment. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253920823 |
Number Of Facilities | 32 |
Registered In Calendar Year | 2019 |
Actual Duration | 54 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 34 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30608114 |
Allocation | Non-Randomized |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28974648 |
Responsible Party Type | Sponsor |
Ipd Information Types
Sequence: | 3347577 | Sequence: | 3347578 | Sequence: | 3347579 |
Name | Study Protocol | Name | Statistical Analysis Plan (SAP) | Name | Clinical Study Report (CSR) |
]]>
https://zephyrnet.com/NCT03798990
2015-01-31
https://zephyrnet.com/?p=NCT03798990
NCT03798990https://www.clinicaltrials.gov/study/NCT03798990?tab=tableDavid Chupindavid.chupin@cerema.fr33 4 72 14 31 52On the first July 2018, the French government lowered the maximum authorized speeds on two-way roads without a central separator from 90 km/h to 80 km/h. The network concerned represents approximately 400 000 km of roads outside the built-up area, accounting for 55% of road deaths.
The objective of the measure is to reduce the number of deaths on the roads concerned by encouraging the reduction of the average speed practiced by drivers.
The analysis deals with a comparison of the number of killed persons on the network concerned, before and after the reduction of the speed limits. The “before” period is 2015-2017. The “after” period is from July 2018 to June 2019.
The data used are extracted from the national bodily injury accident file (BAAC). The police fills this file for each road accidents occurring on a road open to public traffic and causing at least one victim (i.e., one user requiring medical care and involving at least one vehicle).
<![CDATA[
Studies
Study First Submitted Date | 2018-12-21 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | January 2015 |
Primary Completion Month Year | July 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20721631 |
Description | This measure was intended general and concerns a type of roads in its entirety. The rest of the road network is too heterogeneous (urban, highways …), leading to an accidentology very far in terms of severity, users concerned and families of accidents to allow the establishment of control groups that would not be affected by a reduction in the speed limit. As a result, the principle of an assessment of "before-and-after" effects has been retained. |
Facilities
Sequence: | 200108119 |
Status | Recruiting |
Name | Cerema |
City | Lyon |
Country | France |
Facility Contacts
Sequence: | 28106416 |
Facility Id | 200108119 |
Contact Type | primary |
Name | David Chupin |
Conditions
Sequence: | 52171231 | Sequence: | 52171232 |
Name | Health Risks | Name | Death |
Downcase Name | health risks | Downcase Name | death |
Id Information
Sequence: | 40158628 |
Id Source | org_study_id |
Id Value | 2018-12 |
Countries
Sequence: | 42568939 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55593166 |
Title | users of French roads |
Description | all road users circulating on French roads outside over-seas |
Keywords
Sequence: | 79868533 | Sequence: | 79868534 |
Name | Speed | Name | Road safety |
Downcase Name | speed | Downcase Name | road safety |
Design Outcomes
Sequence: | 177378844 | Sequence: | 177378845 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Evolution of the number of fatalities in road accidents before and after the implementation of the measure | Measure | Sub-groups analysis of road fatalities, by type of road users, before and after the implementation of the measure |
Time Frame | before period: 2015-2017 / after period: July 2018- June 2019 | Time Frame | before period: 2015-2017 / after period: July 2018- June 2019 |
Description | the number of fatalities in road accidents on non-motorway non-urban roads during the period July 2018-June 2019 ("after" the measure) compared to the number of fatalities during the period 2015-2017 ("before" the measure) | Description | For each type of road users, the number of fatalities in road accidents on non-motorway non-urban roads during the period July 2018-June 2019 ("after" the measure) compared to the number of fatalities during the period 2015-2017 ("before" the measure) |
Sponsors
Sequence: | 48319288 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Centre d'études et d'expertise sur les risques, l'environnement, la mobilité et l'aménagement |
Overall Officials
Sequence: | 29285347 |
Role | Study Director |
Name | Marine Millot, PhD |
Affiliation | Centre d'études et d'expertise sur les risques, l'environnement, la mobilité et l'aménagement |
Central Contacts
Sequence: | 12008877 |
Contact Type | primary |
Name | David Chupin |
Phone | 33 4 72 14 31 52 |
david.chupin@cerema.fr | |
Role | Contact |
Eligibilities
Sequence: | 30765347 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | All the population who circulate on French non-motorway non-urban roads during the period of the study may be potentially concerned |
Criteria | Inclusion Criteria:
people who circulate on French non-motorway non-urban roads during the period of the study Exclusion Criteria: all persons involved in an accident on a private road |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 253883417 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30511514 |
Observational Model | Ecologic or Community |
Time Perspective | Other |
Responsible Parties
Sequence: | 28877808 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798977
2018-02-01
https://zephyrnet.com/?p=NCT03798977
NCT03798977https://www.clinicaltrials.gov/study/NCT03798977?tab=tableHenri MONTAUDIE, Drmontaudie.h@chu-nice.fr492036083This research program is in keeping with the chemistry/biology/clinical interface and gathers 4 teams with complementary expertise in these respective fields. It will allow deciphering the mechanism(s) of action of new Thiazole-Benzenesulfonamide family (TZB) derivatives on metastatic melanoma sensitive and resistant to BRAF and MEK inhibitors. Investigators will use melanoma cell lines and primary cells from patients to validate these compounds in collaboration with clinical team 2 and 4. In conclusion, the investigators expect to establish the proof of concept that this new class of bioactive molecules (first in class) we developed in collaboration with Team 3 have the potential to go to the clinic for the treatment of highly aggressive cancers and particularly metastatic melanoma sensitive and resistant B-Raf and MEK inhibitors. Furthermore, the realization of this project can undoubtedly increase the knowledge of mechanisms and signaling pathways that are involved in resistant to BRAF and MEK inhibitors, and allow the selection of drug candidates capable of restoring the sensitivity of these melanoma cells.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-27 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | February 1, 2018 |
Primary Completion Month Year | December 2019 |
Verification Month Year | December 2018 |
Verification Date | 2018-12-31 |
Last Update Posted Date | 2019-01-10 |
Facilities
Sequence: | 200280524 |
Status | Recruiting |
Name | Nice hospital |
City | Nice |
Zip | 06000 |
Country | France |
Facility Contacts
Sequence: | 28132850 |
Facility Id | 200280524 |
Contact Type | primary |
Name | Thierry Passeron, Pr |
passeron.t@chu-nice.fr | |
Phone | 492036488 |
Phone Extension | 33 |
Conditions
Sequence: | 52221464 |
Name | Melanoma |
Downcase Name | melanoma |
Id Information
Sequence: | 40195586 |
Id Source | org_study_id |
Id Value | 17-PRTK-01 |
Countries
Sequence: | 42609621 |
Name | France |
Removed | False |
Keywords
Sequence: | 79941662 | Sequence: | 79941663 | Sequence: | 79941664 | Sequence: | 79941665 |
Name | Skin metastasis | Name | Resistance | Name | Endoplasmic reticulum stress | Name | Metastasis |
Downcase Name | skin metastasis | Downcase Name | resistance | Downcase Name | endoplasmic reticulum stress | Downcase Name | metastasis |
Design Outcomes
Sequence: | 177561265 |
Outcome Type | primary |
Measure | BRAF mutation |
Time Frame | 24 months |
Description | The status of the BRAF mutation will be expressed through laboratory analysis of the samples collected, i.e. positive or negative. |
Browse Conditions
Sequence: | 193678217 | Sequence: | 193678218 | Sequence: | 193678219 | Sequence: | 193678220 | Sequence: | 193678221 | Sequence: | 193678222 | Sequence: | 193678223 | Sequence: | 193678224 |
Mesh Term | Melanoma | Mesh Term | Neuroendocrine Tumors | Mesh Term | Neuroectodermal Tumors | Mesh Term | Neoplasms, Germ Cell and Embryonal | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Neoplasms, Nerve Tissue | Mesh Term | Nevi and Melanomas |
Downcase Mesh Term | melanoma | Downcase Mesh Term | neuroendocrine tumors | Downcase Mesh Term | neuroectodermal tumors | Downcase Mesh Term | neoplasms, germ cell and embryonal | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | neoplasms, nerve tissue | Downcase Mesh Term | nevi and melanomas |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366367 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Centre Hospitalier Universitaire de Nice |
Central Contacts
Sequence: | 12020576 | Sequence: | 12020577 |
Contact Type | primary | Contact Type | backup |
Name | Thierry PASSERON, Pr | Name | Henri MONTAUDIE, Dr |
Phone | 492036488 | Phone | 492036083 |
passeron.t@chu-nice.fr | montaudie.h@chu-nice.fr | ||
Phone Extension | +33 | Phone Extension | +33 |
Role | Contact | Role | Contact |
Eligibilities
Sequence: | 30794672 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Patient with metastatic melanoma |
Criteria | Inclusion Criteria:
Patient with metastatic melanoma Exclusion Criteria: Primary resistance, |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004259 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30540712 |
Observational Model | Other |
Time Perspective | Cross-Sectional |
Responsible Parties
Sequence: | 28907032 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798964
2019-01-23
https://zephyrnet.com/?p=NCT03798964
NCT03798964https://www.clinicaltrials.gov/study/NCT03798964?tab=tableNANANAHeparanase is an endo-β-glucuronidase that cleaves heparin-sulfate (HS) side chains of heparan sulfate proteoglycans, an integral constituent of the extra cellular matrix (ECM).
This study aims to investigate the association between heparanase expression in the human placenta and preterm birth (PTB) .
The investigators hypothesize that an abnormal placentation causes relative placental ischemia that induces higher rates of heparanase expression.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-06-28 |
Start Month Year | January 23, 2019 |
Primary Completion Month Year | November 24, 2020 |
Verification Month Year | June 2022 |
Verification Date | 2022-06-30 |
Last Update Posted Date | 2022-06-28 |
Facilities
Sequence: | 199635900 |
Name | Hille Yaffe Medical Center |
City | Hadera |
Zip | 38100 |
Country | Israel |
Conditions
Sequence: | 52068890 |
Name | Preterm Birth |
Downcase Name | preterm birth |
Id Information
Sequence: | 40077199 |
Id Source | org_study_id |
Id Value | HYMC-0119-18 |
Countries
Sequence: | 42475381 |
Name | Israel |
Removed | False |
Design Groups
Sequence: | 55480736 | Sequence: | 55480737 | Sequence: | 55480738 |
Title | Elective term cesarean | Title | Term vaginal delivery | Title | Preterm vaginal delivery |
Description | Low-risk women undergoing elective term cesarean section | Description | Low-risk women undergoing term vaginal delivery | Description | Women undergoing preterm vaginal delivery |
Interventions
Sequence: | 52381274 |
Intervention Type | Other |
Name | Placental analysis |
Description | Analysis of placenta to determine expression of heparanase |
Design Outcomes
Sequence: | 177027080 |
Outcome Type | primary |
Measure | Heparanase expression |
Time Frame | Six months |
Description | Heparanase expression in the human placenta following delivery will be evaluated by western blot analysis in the three groups and will be compared to determine differences in the levels. |
Browse Conditions
Sequence: | 193078196 | Sequence: | 193078197 | Sequence: | 193078198 | Sequence: | 193078199 | Sequence: | 193078200 | Sequence: | 193078201 |
Mesh Term | Premature Birth | Mesh Term | Obstetric Labor, Premature | Mesh Term | Obstetric Labor Complications | Mesh Term | Pregnancy Complications | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases |
Downcase Mesh Term | premature birth | Downcase Mesh Term | obstetric labor, premature | Downcase Mesh Term | obstetric labor complications | Downcase Mesh Term | pregnancy complications | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48224000 |
Agency Class | OTHER_GOV |
Lead Or Collaborator | lead |
Name | Hillel Yaffe Medical Center |
Overall Officials
Sequence: | 29225271 |
Role | Principal Investigator |
Name | Rinat Gabbay-Benziv, MD |
Affiliation | Hillel Yaffe Medical Center |
Design Group Interventions
Sequence: | 68012521 | Sequence: | 68012522 | Sequence: | 68012523 |
Design Group Id | 55480736 | Design Group Id | 55480738 | Design Group Id | 55480737 |
Intervention Id | 52381274 | Intervention Id | 52381274 | Intervention Id | 52381274 |
Eligibilities
Sequence: | 30705493 |
Sampling Method | Non-Probability Sample |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 40 Years |
Healthy Volunteers | No |
Population | Pregnant women attending our obstetrical unit |
Criteria | Inclusion Criteria:
Singleton pregnancy Exclusion Criteria: High-risk patients |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253924934 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 22 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 40 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30452105 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28818583 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798951
2019-06-05
https://zephyrnet.com/?p=NCT03798951
NCT03798951https://www.clinicaltrials.gov/study/NCT03798951?tab=tableStefano Turi, MDturi.stefano@hsr.it+39022643Despite important clinical improvements, esophageal cancer surgery is still associated to a high rate of postoperative complications. Recent ERAS (Enhanced Recovery After Surgery) Society guidelines underline the possible role of prehabilitations’ programs in reducing postoperative morbidity. In this trial, 200 patients, scheduled for esophageal cancer resection, will be randomly assigned to two groups (100 patients for each group). In both groups, patients will perform a basal evaluation with a physiotherapist, a nutritionist and a psychologist. In the treatment group, each patient will receive a tailored prehabilitative program and, during the 4 weeks before surgery, will be monitored constantly by each single specialist. A preoperative revaluation (the day before surgery) and follow up visits at 3 and 6 months will be performed for all patients. The incidence of postoperative complications, the length of hospital stay, and the reach of discharge criteria will be registered.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-12-27 |
Start Month Year | June 5, 2019 |
Primary Completion Month Year | January 2025 |
Verification Month Year | December 2022 |
Verification Date | 2022-12-31 |
Last Update Posted Date | 2022-12-27 |
Detailed Descriptions
Sequence: | 20738804 |
Description | Multi-modal prehabilitation programs reported positive results in patients undergoing colonic resection. These protocols are, generally, based on physiotherapist, nutritional and psychological implementation programs. Nevertheless, the conflicting results obtained in previous trials demonstrate how many elements have still to be clarified and that, probably, the pre-habilitation interventions must be tailored, as much as possible, on the peculiar characteristics of each single patient, modifying the approach as a function of the clinical specific response. All these considerations suggest a strong basis for tailored interventions in patients undergoing esophageal surgery, highlighting at the same time, as concluded in a recent review, the need of further studies to better define specific peri-operative strategies. This study will be a randomized, not blind, monocentric trial, that will be conducted at Ospedale San Raffaele, Milano, Italia, between January 2018 and January 2021 (three years). 200 patients will be randomly assigned to two different groups. All the patients, included in the study, will receive a preliminary evaluation performed by different professional figures.
Physiotherapist evaluation: All the patients of both groups will be classified according to specific tests in order to establish their basal condition. Spirometry examination, 6-minute walking test, time up and go test, steep ramp test strength tests (target muscles will be the quadriceps and the handgrip muscles: in both cases a specific dynamometer will be utilized) and Modified Iowa Level of Assistance Scale (MILAS) evaluation will be performed. The experimental group will follow a home-based prehabilitation program for four weeks; this will be tailored on the patient on the bases of the first functional evaluation and the identified needs. On day 1 the patients will attend a hospital session and will be instructed by a physiotherapist on exercises and program to follow. The patients will then receive instruction support in order to better follow and adjust the program at home. Patients will also record what they do on a diary. The physiotherapist will make phone calls in order to supervise patients' adherence to the program and help them in adjusting it. Prehabilitation program will comprise aerobic exercise (cyclette or treadmill, 3 times a week) and IMT (inspiration muscle training, IMT respironics Philips, daily). In adjunction to these ones, further exercises will be prescribed on the bases of the functional assessment and the identification of deficits in any functional capacity assessed and will include two of the following: airway clearance (two sessions 10' a day for 7 days a week), skeletal muscles strengthening (3 days a week), stretching (three times a week), transfer and mobility training. The control group will follow the actual procedure usually administered prior to surgery: this comprises inspiration exercises through a spirometer incentive without any monitoring and some recommendations aimed at staying active during the preoperative period. Nutritional evaluation: All patients will undergo a comprehensive nutritional assessment at baseline, 4 weeks prior to surgery, the day before or the day of surgery and 3 and 6 months after surgery. At baseline, a complete medical and nutrition history will be collected, and physical examination will be performed. Anthropometric parameters including body weight (kg) and height (cm), waist and hip circumference will be measured, and body mass index (kg/m2) calculated. The Malnutrition Universal Screening Tool (MUST) will be used to screen patients for nutrition risk. Standard biochemical markers of malnutrition and inflammation, including albumin, prealbumin, retinol-binding protein, total lymphocyte count, transferrin and C-reactive protein will be measured in all patients. The Prognostic Nutritional Index (PNI) will also be calculated using serum albumin concentration and total lymphocyte count. Single frequency-bio-impedance analysis (SF-BIA) will be used to estimate total body water (TBW), fat free mass (FFM) and BIA-derived phase angle. Basal energy expenditure (BEE) will be estimated using the Harris-Benedict equation. Energy and protein needs (ranging from 1 to 1.5 g/kg/day) will be established according to age, BEE, disease and degree of protein depletion. At baseline, all patients will receive nutrition counselling to help manage symptoms and encourage the intake of energy-enriched foods and fluids that are better tolerated, as per the European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines on nutrition in cancer patients. Patients in the treatment group will be provided with a dietary plan based on their energy and protein needs. Patients will be monitored by a follow-up phone call at two weeks after the baseline visit. Furthermore, patients in the treatment group will receive an immune-enhancing formula (7.6% protein, 18.9% carbohydrate, 3.9% fat) enriched with arginine, RNA, ω3 fatty acids and soluble fibre (partially hydrolysed guar gum, PHGG) 5 days before surgery (237 ml TID). Patients in the control group will receive nutritional counselling at baseline and will be managed according to standard protocols in use at our Institution. Psychologist evaluation: All the patients will perform a psychological interview and specific assessment tests to define their: quality of life (SF-36 and EORTC), specific disorders anxiety and depression Hads (Hospital anxiety and Depression Scale) and coping strategies (MAC mental Adjustment to Cancer). The assessment test will be performed at the recruitment of the patients, the day before surgery and 3 and 6 months after surgery. In the treatment group, periodical re-evaluations, trough phone calls, will be performed to support patients in their adjustment path to surgery. It will be, also, necessary to sustain them to accept possible changes and pressures deriving from prehabilitative programs. Treated patients will also receive a post-operative evaluation to define possible symptoms and adaptive reactions, developed to overcome the physiologic and metabolic modifications deriving from surgery. The intra and post-operative treatment will be developed according to the same principles of ERAS in both groups. The authors will record all post-operative complications; the length of hospital stays and the reach of the criteria for the discharge (free solid intake, adequate pain control with oral analgesics, autonomous mobilization, restarting of bowel function and no evidence of possible post-surgical complications). Postoperative complications will be defined and registered according Calvien- Dindo classification criteria. The primary outcome of our study will be the reduction of post-operative complications, from 70% to 50%. Secondary outcomes will be a reduction in the length of hospital stay and a faster return to the pre-operative physical conditions, through a comparison with the basal evaluation, in the treatment group. Patients will be evaluated the day before surgery, during hospital stay and trough a follow-up visit at 3 and 6 months after surgery. |
Facilities
Sequence: | 200263386 |
Status | Recruiting |
Name | IRCCS San Raffaele Scientific Institute |
City | Milan |
State | MI |
Zip | 20132 |
Country | Italy |
Facility Contacts
Sequence: | 28130569 |
Facility Id | 200263386 |
Contact Type | primary |
Name | Giovanni Landoni |
landoni.giovanni@hsr.it | |
Facility Investigators
Sequence: | 18345055 | Sequence: | 18345056 |
Facility Id | 200263386 | Facility Id | 200263386 |
Role | Sub-Investigator | Role | Principal Investigator |
Name | Stefano Turi, MD | Name | Riccardo Rosati, Prof |
Conditions
Sequence: | 52215749 |
Name | Esophageal Cancer Surgery |
Downcase Name | esophageal cancer surgery |
Id Information
Sequence: | 40191425 |
Id Source | org_study_id |
Id Value | PRESS 152/INT/2018 |
Countries
Sequence: | 42604989 |
Name | Italy |
Removed | False |
Design Groups
Sequence: | 55643218 | Sequence: | 55643219 |
Group Type | Experimental | Group Type | No Intervention |
Title | Prehabilitation program | Title | Control |
Description | The patients included in the treatment group will follow a prehabilitation program, based on a physiotherapist, nutritionist and psychologist evaluation. All the treatments will be tailored according the characteristics of each single patient. The program will have a duration of, at least, 4 weeks. | Description | The patients included in this group will, also, receive a basal evaluation by a physiotherapist, a nutritionist and a psychologist. These patients will not receive a tailored prehabilitation program and will be revaluated the day before surgery. |
Interventions
Sequence: | 52529415 |
Intervention Type | Other |
Name | Prehabilitation |
Description | The patients included in the treatment group will follow a prehabilitation program, based on a physiotherapist, nutritionist and psychologist evaluation. All the treatments will be tailored according the characteristics of each single patient.
The program will have a duration of, at least, 4 weeks. |
Keywords
Sequence: | 79933375 | Sequence: | 79933376 | Sequence: | 79933377 |
Name | Esophageal cancer surgery | Name | Prehabilitation | Name | Enhanced recovery after surgery |
Downcase Name | esophageal cancer surgery | Downcase Name | prehabilitation | Downcase Name | enhanced recovery after surgery |
Design Outcomes
Sequence: | 177539242 |
Outcome Type | primary |
Measure | Post-operative complications |
Time Frame | Hospital discharge (10-15 days) |
Description | Reduction of incidence of post-operative complications, registered according to Clavien-Dindo's Classification criteria |
Browse Conditions
Sequence: | 193656271 | Sequence: | 193656272 | Sequence: | 193656273 | Sequence: | 193656274 | Sequence: | 193656275 | Sequence: | 193656276 | Sequence: | 193656277 | Sequence: | 193656278 | Sequence: | 193656279 |
Mesh Term | Esophageal Neoplasms | Mesh Term | Gastrointestinal Neoplasms | Mesh Term | Digestive System Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Head and Neck Neoplasms | Mesh Term | Digestive System Diseases | Mesh Term | Esophageal Diseases | Mesh Term | Gastrointestinal Diseases |
Downcase Mesh Term | esophageal neoplasms | Downcase Mesh Term | gastrointestinal neoplasms | Downcase Mesh Term | digestive system neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | head and neck neoplasms | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | esophageal diseases | Downcase Mesh Term | gastrointestinal diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48360904 | Sequence: | 48360905 | Sequence: | 48360906 | Sequence: | 48360907 | Sequence: | 48360908 |
Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | UNKNOWN | Agency Class | UNKNOWN | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Università Vita-Salute San Raffaele | Name | Stefano Turi | Name | Luigi Beretta | Name | Paolo Parise | Name | Riccardo Rosati |
Central Contacts
Sequence: | 12019029 | Sequence: | 12019030 |
Contact Type | primary | Contact Type | backup |
Name | Riccardo Rosati, Prof | Name | Stefano Turi, MD |
Phone | +39022643 | Phone | +39022643 |
rosati.riccardo@hsr.it | turi.stefano@hsr.it | ||
Phone Extension | 2270 | Phone Extension | 2656 |
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68209212 |
Design Group Id | 55643218 |
Intervention Id | 52529415 |
Eligibilities
Sequence: | 30791246 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Written informed consent; Exclusion Criteria: Patient refusal |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253998224 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30537301 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28903608 |
Responsible Party Type | Principal Investigator |
Name | Giovanni Landoni |
Title | MD, Asociate Professor |
Affiliation | Università Vita-Salute San Raffaele |
Study References
Sequence: | 52111321 | Sequence: | 52111322 | Sequence: | 52111323 | Sequence: | 52111324 | Sequence: | 52111325 | Sequence: | 52111326 |
Pmid | 30276441 | Pmid | 30193337 | Pmid | 29754828 | Pmid | 15533269 | Pmid | 23884382 | Pmid | 27637832 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Low DE, Allum W, De Manzoni G, Ferri L, Immanuel A, Kuppusamy M, Law S, Lindblad M, Maynard N, Neal J, Pramesh CS, Scott M, Mark Smithers B, Addor V, Ljungqvist O. Guidelines for Perioperative Care in Esophagectomy: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations. World J Surg. 2019 Feb;43(2):299-330. doi: 10.1007/s00268-018-4786-4. | Citation | Minnella EM, Awasthi R, Loiselle SE, Agnihotram RV, Ferri LE, Carli F. Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2018 Dec 1;153(12):1081-1089. doi: 10.1001/jamasurg.2018.1645. | Citation | Minnella EM, Carli F. Prehabilitation and functional recovery for colorectal cancer patients. Eur J Surg Oncol. 2018 Jul;44(7):919-926. doi: 10.1016/j.ejso.2018.04.016. Epub 2018 Apr 30. | Citation | Stratton RJ, Hackston A, Longmore D, Dixon R, Price S, Stroud M, King C, Elia M. Malnutrition in hospital outpatients and inpatients: prevalence, concurrent validity and ease of use of the 'malnutrition universal screening tool' ('MUST') for adults. Br J Nutr. 2004 Nov;92(5):799-808. doi: 10.1079/bjn20041258. | Citation | Mohri Y, Inoue Y, Tanaka K, Hiro J, Uchida K, Kusunoki M. Prognostic nutritional index predicts postoperative outcome in colorectal cancer. World J Surg. 2013 Nov;37(11):2688-92. doi: 10.1007/s00268-013-2156-9. | Citation | Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6. |
]]>
https://zephyrnet.com/NCT03798938
2019-01-10
https://zephyrnet.com/?p=NCT03798938
NCT03798938https://www.clinicaltrials.gov/study/NCT03798938?tab=tableNANANACardiovascular disease (CVD), a condition predominantly caused by atherosclerosis, is the leading cause of morbidity and mortality in the investigator’s society. Peripheral arterial disease (PAD), a subset of CVD, occurs when the atherosclerosis progresses to compromise the lower extremity circulation resulting in ischemic symptoms. Although atherosclerosis has been generally regarded as a disease of developed or affluent countries, recent evidence showed a progressive rise in the prevalence of CVD in developing countries where an epidemiological shift of disease prevalence patterns from infectious illnesses to atherosclerotic disease has occurred. Management of CVD, particularly with an emphasis of disease prevention, will undoubtedly play an increasing vital role in the health care system around the world.
Endothelial dysfunction, as reflected by the impaired arterial vasodilatory capacity, represents one of the pathogenic mechanisms linking atherosclerosis and cardiovascular mortality. The ability of arteries to dilate in response to stimuli is a significant indicator of underlying vascular endothelial function and associated CVD. Factors modulating vasodilatory response include the release of vasoactive compounds such as nitric oxide (NO) from the endothelium and vascular compliance. In healthy individuals, a major mechanism responsible for vasodilation is the hyperemic-stimulated release of NO from the endothelium, resulting in vascular smooth muscle relaxation with subsequent vasodilation.
Vascular endothelial function can be assessed using a non-invasive technique to determine brachial artery reactivity whereby a high-resolution ultrasound is used to measure changes in brachial artery diameter to endogenous production of endothelium-derived NO via flow-mediated dilation (FMD). Therefore, reduced FMD has been described as a reliable indicator of vascular endothelial dysfunction as well as presence of underlying CVD risk factors and related diseases. Recent studies have similarly shown that arterial pulse-wave velocity (PWV), which is a non-invasive evaluation of arterial stiffness, is a reliable indicator of vascular function. While numerous studies have documented the benefit of dietary intervention in the reduction of CVD related sequelae, limited data is available regarding whether the beneficial effect of dietary intervention are reflected in vascular endothelial function. The present study was therefore conducted to assess the effects of plant-based diet (PBD) on vascular endothelial function as assessed by FMD and PWV in patients with peripheral arterial disease (PAD).
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | January 10, 2019 |
Primary Completion Month Year | June 10, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20750432 |
Description | Patients with peripheral arterial disease (PAD) will be included in the study. Inclusion criteria for PAD included an ankle brachial index (ABI) of 0.90 or less at baseline. Those with an ABI greater than 0.90 at baseline were eligible if a non-invasive vascular ultrasound demonstrated PAD, lower extremity angiography showed arterial stenosis of 70% or greater, or medical records documented prior revascularization of lower extremities.9 Additionally, subjects must be willing and able to maintain an on-line food journal using smartphone-based dietary apps. Once enrolled, all participants underwent baseline evaluation, after which they were enrolled in either dietary advice for plant-based diet (PBD group) or no specific dietary advice (control group). The dietary intervention was continued for four months, at the end of which a follow up evaluation was performed. |
Facilities
Sequence: | 200352057 |
Name | University Vascular Associates |
City | Alhambra |
State | California |
Zip | 90212 |
Country | United States |
Conditions
Sequence: | 52244448 |
Name | Peripheral Arterial Disease |
Downcase Name | peripheral arterial disease |
Id Information
Sequence: | 40212165 |
Id Source | org_study_id |
Id Value | 01012019 |
Countries
Sequence: | 42627120 |
Name | United States |
Removed | False |
Interventions
Sequence: | 52557927 |
Intervention Type | Other |
Name | plant-based diet |
Description | subjects will be placed in plant-based diet and the effect of plant-based diet to the endothelial function will be monitored |
Design Outcomes
Sequence: | 177648664 |
Outcome Type | primary |
Measure | endothelial function |
Time Frame | 10 minutes |
Description | brachial artery reactivity test, flow-mediated vasodilation |
Browse Conditions
Sequence: | 193766203 | Sequence: | 193766204 | Sequence: | 193766205 | Sequence: | 193766206 | Sequence: | 193766207 | Sequence: | 193766208 | Sequence: | 193766209 |
Mesh Term | Peripheral Arterial Disease | Mesh Term | Peripheral Vascular Diseases | Mesh Term | Atherosclerosis | Mesh Term | Arteriosclerosis | Mesh Term | Arterial Occlusive Diseases | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases |
Downcase Mesh Term | peripheral arterial disease | Downcase Mesh Term | peripheral vascular diseases | Downcase Mesh Term | atherosclerosis | Downcase Mesh Term | arteriosclerosis | Downcase Mesh Term | arterial occlusive diseases | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48388134 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Vascular Institute of Texas |
Eligibilities
Sequence: | 30808196 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 80 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | peripheral arterial disease as defined by an ankle brachial index (ABI) of 0.90 or less at baseline. Those with an ABI greater than 0.90 at baseline will be eligible if a non-invasive vascular ultrasound demonstrated PAD, lower extremity angiography showed arterial stenosis of 70% or greater, or medical records documented prior revascularization of lower extremities |
Criteria | Inclusion Criteria:
peripheral arterial disease Exclusion Criteria: none |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254032387 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30554193 |
Observational Model | Cohort |
Time Perspective | Cross-Sectional |
Responsible Parties
Sequence: | 28920556 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798925
2018-08-19
https://zephyrnet.com/?p=NCT03798925
NCT03798925https://www.clinicaltrials.gov/study/NCT03798925?tab=tableNANANAPulmonary infections remain the leading causes of morbidity and mortality among patients worldwide. Pathogen identification is crucial yet difficult for the majority of the cases. Metagenomic Next-generation Sequencing provides a potential technology for rapid and untargeted pathogen detection for pulmonary infection. The study is designed observationally to investigate if mNGS is superior to traditional paradigm of serial tests in the aspect of diagnostic performance. Patients whose primary diagnosis is pulmonary infetion and bronchoalveolar lavage fluid can be obtained will be enrolled. Both mNGS and traditional paradigm of serial tests wil be performed.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-29 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | August 19, 2018 |
Primary Completion Month Year | February 2019 |
Verification Month Year | December 2018 |
Verification Date | 2018-12-31 |
Last Update Posted Date | 2019-01-10 |
Facilities
Sequence: | 200244224 |
Status | Recruiting |
Name | Sir Run Run Shaw Hospital |
City | Hangzhou |
State | Zhejiang |
Zip | 310016 |
Country | China |
Facility Contacts
Sequence: | 28128013 |
Facility Id | 200244224 |
Contact Type | primary |
Name | Ying-zhi Fang |
Phone | +86 571 86006987 |
Facility Investigators
Sequence: | 18343592 |
Facility Id | 200244224 |
Role | Principal Investigator |
Name | Yun-song Yu, M.D. |
Conditions
Sequence: | 52208101 |
Name | Pulmonary Infection |
Downcase Name | pulmonary infection |
Id Information
Sequence: | 40186144 |
Id Source | org_study_id |
Id Value | SRRSH-mNGS-respiratory |
Countries
Sequence: | 42599639 |
Name | China |
Removed | False |
Interventions
Sequence: | 52522071 |
Intervention Type | Other |
Name | None Intervention |
Description | It is observational study |
Design Outcomes
Sequence: | 177511206 |
Outcome Type | primary |
Measure | microbiological diagnosis (pathogen of pulmonary infection) |
Time Frame | through study completion, up to 6 months |
Description | the final microbiological diagnosis (pathogen of pulmonary infection) after using of every detection method and combined with clinical manifestations. |
Browse Conditions
Sequence: | 193627007 | Sequence: | 193627006 | Sequence: | 193627008 | Sequence: | 193627009 |
Mesh Term | Communicable Diseases | Mesh Term | Infections | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | communicable diseases | Downcase Mesh Term | infections | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48353693 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Sir Run Run Shaw Hospital |
Eligibilities
Sequence: | 30786868 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | patients whose primary diagnosis is pulmonary infetion and bronchoalveolar lavage fluid can be obtained |
Criteria | Inclusion Criteria:
Pulmonary infection as the primary diagnosis Exclusion Criteria: when the primary diagnosis is tumor or connective tissue diseases |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 253989623 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30532938 |
Observational Model | Case-Only |
Time Perspective | Other |
Responsible Parties
Sequence: | 28899232 |
Responsible Party Type | Principal Investigator |
Name | Jian-cang Zhou M.D. |
Title | Department of Infectious Diseases |
Affiliation | Sir Run Run Shaw Hospital |
]]>
https://zephyrnet.com/NCT03798912
2019-07-09
https://zephyrnet.com/?p=NCT03798912
NCT03798912https://www.clinicaltrials.gov/study/NCT03798912?tab=tableNANANAThe objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers
<![CDATA[
Studies
Study First Submitted Date | 2018-12-13 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-10-08 |
Start Month Year | July 9, 2019 |
Primary Completion Month Year | February 17, 2020 |
Verification Month Year | October 2020 |
Verification Date | 2020-10-31 |
Last Update Posted Date | 2020-10-08 |
Detailed Descriptions
Sequence: | 20721632 |
Description | The RaniPill device is capsule-like ingestible device, which injects a microneedle containing a microtablet (payload/drug) into the intestinal wall. This is a phase I (first-in-human) open-label study in healthy volunteers. In 6 subjects, 100 mcg of octreotide (Sandostatin®) will be injected intravenously. Three versions of the RaniPill (A, B and C) will be tested in additional three groups of healthy volunteers (N=20 each). All devices will contain 100 mcg of octreotide. The bioavailability of octreotide will be determined by serial blood sampling in Groups A and B. Performance of the RaniPill will be evaluated in all groups. |
Facilities
Sequence: | 200108122 |
Name | Nucleus Network |
City | Melbourne |
Country | Australia |
Browse Interventions
Sequence: | 96050235 | Sequence: | 96050236 | Sequence: | 96050237 | Sequence: | 96050238 |
Mesh Term | Octreotide | Mesh Term | Gastrointestinal Agents | Mesh Term | Antineoplastic Agents, Hormonal | Mesh Term | Antineoplastic Agents |
Downcase Mesh Term | octreotide | Downcase Mesh Term | gastrointestinal agents | Downcase Mesh Term | antineoplastic agents, hormonal | Downcase Mesh Term | antineoplastic agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52171236 |
Name | Healthy Volunteers |
Downcase Name | healthy volunteers |
Id Information
Sequence: | 40158631 |
Id Source | org_study_id |
Id Value | TST-0114 |
Countries
Sequence: | 42568942 |
Name | Australia |
Removed | False |
Design Groups
Sequence: | 55593171 | Sequence: | 55593172 | Sequence: | 55593173 | Sequence: | 55593174 |
Group Type | Active Comparator | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | Intravenous octreotide group | Title | RaniPill A group | Title | RaniPill B group | Title | RaniPill C group |
Description | Octreotide 100 mcg will be injected intravenously and serial blood samples will be collected for PK analysis | Description | In 20 subjects, a RaniPill with a small balloon size will be administered and serial blood samples will be collected for PK analysis | Description | In 20 subjects, a RaniPill with a larger balloon size will be administered and serial blood samples will be collected for PK analysis | Description | In 20 subjects, a RaniPill with a different size will be administered and blood samples will be collected for the presence of drug |
Interventions
Sequence: | 52485476 |
Intervention Type | Combination Product |
Name | RaniPill capsule containing octreotide |
Description | Administration of a RaniPill capsule loaded with 100 mcg of octreotide. Serial blood samples will be collected over the following 4 h for pharmacokinetic analysis of octreotide a) injected intravenously and b) delivered directly into the jejunal wall by the RaniPill capsule. |
Keywords
Sequence: | 79868542 |
Name | RaniPill capsule, drug delivery, octreotide, pharmacokinetic |
Downcase Name | ranipill capsule, drug delivery, octreotide, pharmacokinetic |
Design Outcomes
Sequence: | 177378852 | Sequence: | 177378853 | Sequence: | 177378854 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Incidence and kind of adverse events possibly related to the RaniPill capsule | Measure | Pharmacokinetic profile of octreotide delivered by the RaniPill capsule | Measure | Confirmation of the excretion of all RaniPill device components |
Time Frame | Up to 30 days after ingestion of the device | Time Frame | 4 to 8 hours | Time Frame | up to 7 days |
Description | All adverse events possibly related to the device, including abdominal pain, nausea and vomiting, injuries to the gastrointestinal tract and abnormal changes in blood tests results will be monitored and recorded | Description | Measurements of octreotide concentration in plasma samples collected serially over 4 h following the deployment of the RaniPill | Description | Stool examinations to verify that all components of the RaniPill capsule have been defecated |
Sponsors
Sequence: | 48319291 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | RANI Therapeutics |
Overall Officials
Sequence: | 29285349 |
Role | Study Director |
Name | Arvinder K Dhalla, PhD |
Affiliation | RANI Therapeutics |
Design Group Interventions
Sequence: | 68149127 | Sequence: | 68149128 | Sequence: | 68149129 | Sequence: | 68149130 |
Design Group Id | 55593171 | Design Group Id | 55593172 | Design Group Id | 55593173 | Design Group Id | 55593174 |
Intervention Id | 52485476 | Intervention Id | 52485476 | Intervention Id | 52485476 | Intervention Id | 52485476 |
Eligibilities
Sequence: | 30765350 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 55 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Signed and dated informed consent form Exclusion Criteria: Unable to swallow an intact 000 capsule with water |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253883527 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 7 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 55 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30511517 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Healthy men and women volunteers |
Responsible Parties
Sequence: | 28877811 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798899
2018-05-14
https://zephyrnet.com/?p=NCT03798899
NCT03798899https://www.clinicaltrials.gov/study/NCT03798899?tab=tableNANANAA phase 4 randomised, double-blind study to assess the efficacy and safety of Penthrox® used from the outset in multimodal analgesia, in combination with the standard analgesic protocol used in the department, for conscious adult patients presenting in an emergency department with moderate to severe pain associated with a trauma
<![CDATA[
Studies
Study First Submitted Date | 2018-11-09 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | May 14, 2018 |
Primary Completion Month Year | December 20, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20741149 |
Description | On admission, the patient pain score will be measured using a numerical scale (NRS-11) to verify the eligibility of the patient in the study (NRS ≥ 4).
At the time of randomisation, the patient's pain score will be measured using a VAS in order to verify the patient's eligibility for randomisation (VAS ≥ 40). Admissible patients will be randomised by IWRS (Interactive Web Response System) to receive: Either Penthrox® + SoC The IWRS system will be based on the fact of including 50% patients with moderate pain and 50% patients with severe pain. Close weekly monitoring of this ratio will be set up. The decision to no longer include patients in one of the study subgroups according to pain, if necessary, or to change this ratio, will be made by the Study Sponsor and in agreement with the study investigator-coordinator and the study scientific committee. A minimum of 150 patients will be included in the severe pain subgroup (EN 6-10). The treatment (preparation of two inhalers, the second only being given to the patient on request) will only be administered once intermittently or continuously to patients on admission to the study (D0, T0). The pain score will be assessed using the VAS every 5 minutes up to 20 minutes, then at 30, 60, 90, and 120 minutes after the start of study treatment (T0). Patients will be assessed until their discharge from the emergency departments (hospitalization, transfer home, transfer to the operating room) or up to 120 minutes after the initial administration. A telephone interview will take place 14 (± 2) days after the first treatment administration to assess the medium-term safety of the product. |
Facilities
Sequence: | 200280546 | Sequence: | 200280547 | Sequence: | 200280548 | Sequence: | 200280549 | Sequence: | 200280550 | Sequence: | 200280551 | Sequence: | 200280552 | Sequence: | 200280553 |
Name | CH Annecy Genevois | Name | GH Carnelle Porte de l'Oise | Name | Hôpital Avicenne – APHP | Name | CHRU Lille | Name | Hôpital Edouard Herriot | Name | Hospice civil de Lyon | Name | CH René Dubos | Name | CHU Purpan |
City | Annecy | City | Beaumont-sur-Oise | City | Bobigny | City | Lille | City | Lyon | City | Pierre Bénite | City | Pontoise | City | Toulouse |
Zip | 74374 | Zip | 95260 | Zip | 93000 | Zip | 59037 | Zip | 69437 | Zip | 69495 | Zip | 95300 | Zip | 31059 |
Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France | Country | France |
Browse Interventions
Sequence: | 96132959 | Sequence: | 96132960 | Sequence: | 96132961 | Sequence: | 96132962 | Sequence: | 96132963 | Sequence: | 96132964 |
Mesh Term | Methoxyflurane | Mesh Term | Anesthetics, Inhalation | Mesh Term | Anesthetics, General | Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | methoxyflurane | Downcase Mesh Term | anesthetics, inhalation | Downcase Mesh Term | anesthetics, general | Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52221481 |
Name | Pain, Acute |
Downcase Name | pain, acute |
Id Information
Sequence: | 40195596 | Sequence: | 40195597 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | MR311-4501 | Id Value | 2017-004469-28 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42609631 |
Name | France |
Removed | False |
Design Groups
Sequence: | 55649755 | Sequence: | 55649756 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Penthrox® (Methoxyflurane) | Title | Normal Saline |
Description | Patients will be asked to inhale Penthrox® intermittently or continuously to obtain adequate analgesia.
Penthrox® or placebo will be administered in combination with standard analgesic treatments usually used according to the emergency department protocol (SoC). Duration of treatment: 1 administration (with a maximum of 2 inhalers) during passage to emergency. |
Description | Patients will be asked to inhale Penthrox® intermittently or continuously to obtain adequate analgesia.
Penthrox® or placebo will be administered in combination with standard analgesic treatments usually used according to the emergency department protocol (SoC). Duration of treatment: 1 administration (with a maximum of 2 inhalers) during passage to emergency. |
Interventions
Sequence: | 52535292 | Sequence: | 52535293 |
Intervention Type | Drug | Intervention Type | Drug |
Name | Methoxyflurane | Name | Normal Saline |
Description | PENTHROX 3mL inhalation vapour, liquid | Description | Placebo |
Design Outcomes
Sequence: | 177561320 | Sequence: | 177561321 | Sequence: | 177561322 | Sequence: | 177561323 | Sequence: | 177561324 | Sequence: | 177561325 | Sequence: | 177561327 | Sequence: | 177561326 | Sequence: | 177561328 | Sequence: | 177561329 | Sequence: | 177561330 | Sequence: | 177561331 | Sequence: | 177561332 | Sequence: | 177561333 | Sequence: | 177561334 | Sequence: | 177561335 | Sequence: | 177561336 | Sequence: | 177561337 | Sequence: | 177561338 | Sequence: | 177561339 | Sequence: | 177561340 | Sequence: | 177561341 | Sequence: | 177561342 | Sequence: | 177561343 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | time until pain relief defined by the duration between the start of the study treatment (T0) and pain relief | Measure | Duration between the start of study treatment (T0) and pain relief reported by the patient | Measure | Absolute Pain Intensity Difference (PID) measured using the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0 | Measure | Relative Pain Intensity Difference measured using the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0 | Measure | Pain relief defined by pain intensity < 40 mm on the PI-VAS scale at 5, 10, 15, 20 and 30 minutes after T0 | Measure | Response defined by pain reduction of 20 mm on the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0 | Measure | Summed Pain Intensity Difference (SPID) measured on the PI-VAS at 5, 10, 15, 20 and 30 minutes | Measure | Response defined by pain reduction of 30% mm on the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0 | Measure | Proportion of patients attaining an SPID of at least 33% | Measure | Quantity of opioids received (in milligrams of morphine) | Measure | Description of the Standard of Care and concomitant analgesic treatments | Measure | Sedation score (Ramsay scale) | Measure | Patient satisfaction score (Likert 0-5 scale) | Measure | Physician satisfaction scale (Likert 0-5 scale) | Measure | Nurse satisfaction scale (Likert 0-5 scale) | Measure | Length of stay (LOS) in emergency | Measure | Assess the time until medical decision to discharge | Measure | Incidence of adverse events (AE) not associated with the underlying trauma and occurring during treatment | Measure | Change in blood pressure | Measure | Change in oxygen saturation | Measure | Change in respiration rate | Measure | Change in heart rate | Measure | Incidence of tachycardia, hypotension, hypertension and respiratory depression | Measure | Incidence of premature withdrawal of patients for safety or tolerability reasons |
Time Frame | through study completion, maximum of 2 hours | Time Frame | through study completion, maximum of 2 hours | Time Frame | baseline to 5, 10, 15, 20 and 30 minutes | Time Frame | baseline to 5, 10, 15, 20 and 30 minutes | Time Frame | baseline to 5, 10, 15, 20 and 30 minutes | Time Frame | baseline to 5, 10, 15, 20 and 30 minutes | Time Frame | baseline to 30 minutes | Time Frame | baseline to 5, 10, 15, 20 and 30 minutes | Time Frame | through study completion, maximum of 2 hours | Time Frame | through study completion, maximum of 2 hours | Time Frame | through study completion, maximum of 2 hours | Time Frame | through study completion, maximum of 2 hours | Time Frame | through study completion, maximum of 2 hours | Time Frame | through study completion, maximum of 2 hours | Time Frame | through study completion, maximum of 2 hours | Time Frame | through study completion, maximum of 2 hours | Time Frame | through study completion, maximum of 2 hours | Time Frame | through study completion, maximum of 2 hours | Time Frame | baseline to 30 minutes | Time Frame | baseline to 30 minutes | Time Frame | baseline to 30 minutes | Time Frame | baseline to 30 minutes | Time Frame | through study completion, maximum of 2 hours | Time Frame | through study completion, maximum of 2 hours |
Description | Measured on Pain intensity visual analogue scale (PI-VAS) 0-100 where 100 is the highest pain | Description | Pain measured on PI-VAS, 0-100 where 100 is the highest pain | Description | PID for a given assessment time is equal to the VAS score at T0 minus the VAS score at each assessment time provided in the study. Pain measured on PI-VAS, 0-100 where 100 is the highest pain | Description | Relative pain intensity difference for a given assessment time is equal to the VAS score at T0 minus the VAS score at each assessment time provided in the study divided by the VAS score at T0. Pain measured on PI-VAS, 0-100 where 100 is the highest pain | Description | Pain measured on PI-VAS, 0-100 where 100 is the highest pain | Description | Pain measured on PI-VAS, 0-100 where 100 is the highest pain | Description | SPID will be calculated by using the pain intensity difference (PID) at each of these assessment times provided in the study. SPID is the sum of the PID at each study assessment time, weighted by using the time elapsed since the previous assessment, and approaches the area under the curve for the PID over time. Relative to the VAS score, the SPID measurement has the advantage of considering individual differences at the level of initial pain intensity (baseline) as well as time. | Description | Pain measured on PI-VAS, 0-100 where 100 is the highest pain | Description | The proportion of patients attaining an SPID of at least 33% of the maximum possible SPID will be calculated (maximum possible SPID is the the value that would be obtained if the patient was pain free (VAS=0) for the entire study period); this will be considered as corresponding to the responder rate. A % SPID of 33% was previously established as being a clinically significant measurement in pain results. | Description | Descriptions from the World Health Organization (http://www.who.int/cancer/palliative/painladder/en/): Type of drug, doses, administration periods, and treatment duration | Description | Measured using the Ramsay sedation scale | Description | Satisfaction is rated by patient as Poor, Fair, Good, Very Good or Excellent | Description | Satisfaction is rated by Physician as Poor, Fair, Good, Very Good or Excellent | Description | Satisfaction is rated by Nurse as Poor, Fair, Good, Very Good or Excellent | Description | The Blood Systolic and Diastolic pressure (mmHg) will be measured at baseline and 30 minutes. The difference between the values will be calculated. | Description | Oxygen saturation (%) will be measured at baseline and 30 minutes. The difference between the values will be calculated. | Description | Respiration rate (breaths/min) will be measured at baseline and 30 minutes. The difference between the values will be calculated. | Description | Heart rate (beats/min) will be measured at baseline and 30 minutes. The difference between the values will be calculated. |
Browse Conditions
Sequence: | 193678270 | Sequence: | 193678271 | Sequence: | 193678272 | Sequence: | 193678273 | Sequence: | 193678274 | Sequence: | 193678275 |
Mesh Term | Emergencies | Mesh Term | Acute Pain | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes | Mesh Term | Pain | Mesh Term | Neurologic Manifestations |
Downcase Mesh Term | emergencies | Downcase Mesh Term | acute pain | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | pain | Downcase Mesh Term | neurologic manifestations |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366378 | Sequence: | 48366379 | Sequence: | 48366380 |
Agency Class | INDUSTRY | Agency Class | UNKNOWN | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Mundipharma SAS | Name | AXONAL | Name | Exystat |
Overall Officials
Sequence: | 29312894 |
Role | Principal Investigator |
Name | A Ricard-Hibon, Dr |
Affiliation | CHG Pontoise / SAMU 95 |
Design Group Interventions
Sequence: | 68217336 | Sequence: | 68217337 |
Design Group Id | 55649755 | Design Group Id | 55649756 |
Intervention Id | 52535292 | Intervention Id | 52535293 |
Eligibilities
Sequence: | 30794681 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Men and women aged 18 or older Exclusion Criteria: Life-threatening conditions requiring immediate admission to the operating theatre or the intensive care unit; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004278 |
Number Of Facilities | 8 |
Registered In Calendar Year | 2018 |
Actual Duration | 7 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 23 |
Designs
Sequence: | 30540721 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26696928 |
Intervention Id | 52535292 |
Name | Penthrox® |
Responsible Parties
Sequence: | 28907041 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798886
2018-01-01
https://zephyrnet.com/?p=NCT03798886
NCT03798886https://www.clinicaltrials.gov/study/NCT03798886?tab=tableNANANAThere has been a recent significant increase in the frozen embryo replacement (FER) cycles due to freeze-all cycles to decrease the risk of ovarian hyperstimulation syndrome. Now a days making frozen embryo transfers (FETs) a viable alternative to fresh embryo transfer
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-03-13 |
Start Month Year | January 1, 2018 |
Primary Completion Month Year | December 1, 2019 |
Verification Month Year | March 2019 |
Verification Date | 2019-03-31 |
Last Update Posted Date | 2019-03-13 |
Detailed Descriptions
Sequence: | 20709973 |
Description | There has been a recent significant increase in the frozen embryo replacement (FER) cycles due to freeze-all cycles to decrease the risk of ovarian hyperstimulation syndrome. Now a days making frozen embryo transfers (FETs) a viable alternative to fresh embryo transfer, with reports from observational studies and randomized controlled trials suggesting that:
The endometrium in stimulated cycles is not optimal for implantation We will compare success rate between natural and modified natural cycles |
Facilities
Sequence: | 199965043 |
Name | Acibadem MAA University Atakent Hospital |
City | Istanbul |
Zip | 34457 |
Country | Turkey |
Conditions
Sequence: | 52138966 |
Name | Infertility, Female |
Downcase Name | infertility, female |
Id Information
Sequence: | 40135031 |
Id Source | org_study_id |
Id Value | ATADEK-2018/20 |
Countries
Sequence: | 42542666 |
Name | Turkey |
Removed | False |
Design Groups
Sequence: | 55559304 | Sequence: | 55559305 |
Title | Natural frozen embryo transfer group | Title | modified natural embryo transfer group |
Description | In this group all embryos will be frozen when transfer planned sonographic follicle diameter measured. After spontaneous ovulation, embryo transfer will be planned. Luteal phase support will not be used. | Description | In this group all embryos will be frozen when transfer planned sonographic follicle diameter measured. When follicle diameter is 16-17 mm we will apply hCG (recombinant hCG). After ovulation, embryo transfer will be done. Luteal phase support will not be used. |
Interventions
Sequence: | 52454865 | Sequence: | 52454866 | Sequence: | 52454867 |
Intervention Type | Other | Intervention Type | Other | Intervention Type | Other |
Name | natural cycle | Name | modified natural cycle | Name | embryo transfer |
Description | When follicle is ready for ovulation, we will use this injection by intra-dermal route | Description | we will use that drug in the natural modified transfer group after embryo transfer | Description | we will do transfer when the endometrium is ready |
Keywords
Sequence: | 79822767 |
Name | Frozen embryo replacement, IVF success, ovarian stimulation |
Downcase Name | frozen embryo replacement, ivf success, ovarian stimulation |
Design Outcomes
Sequence: | 177263521 | Sequence: | 177263522 | Sequence: | 177263523 | Sequence: | 177263524 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | birth | Measure | pregnancy rate | Measure | clinical pregnancy rate | Measure | abortion rate |
Time Frame | bigger than 24 weeks pregnancy | Time Frame | 10th day after embryo transfer | Time Frame | 8 weeks | Time Frame | 8 weeks |
Description | live birth | Description | hcg blood test | Description | positive fetal cardiac activity | Description | abortion after visualization of fetal cardiac activity |
Browse Conditions
Sequence: | 193366379 | Sequence: | 193366380 | Sequence: | 193366381 | Sequence: | 193366382 | Sequence: | 193366383 | Sequence: | 193366384 | Sequence: | 193366385 |
Mesh Term | Infertility | Mesh Term | Infertility, Female | Mesh Term | Genital Diseases | Mesh Term | Urogenital Diseases | Mesh Term | Genital Diseases, Female | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications |
Downcase Mesh Term | infertility | Downcase Mesh Term | infertility, female | Downcase Mesh Term | genital diseases | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | genital diseases, female | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290678 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Acibadem University |
Overall Officials
Sequence: | 29268517 | Sequence: | 29268518 | Sequence: | 29268519 | Sequence: | 29268520 |
Role | Study Director | Role | Study Chair | Role | Study Chair | Role | Study Chair |
Name | Turgut Aydın | Name | Elif Ganime Aydeniz | Name | Emine Karabük | Name | Burak Yücel |
Affiliation | acıbadem university atakent hospital | Affiliation | acıbadem university atakent hospital | Affiliation | acıbadem university atakent hospital | Affiliation | Kanuni Sultan SüleymanHospital |
Design Group Interventions
Sequence: | 68107398 | Sequence: | 68107399 | Sequence: | 68107400 | Sequence: | 68107401 | Sequence: | 68107402 | Sequence: | 68107403 |
Design Group Id | 55559304 | Design Group Id | 55559305 | Design Group Id | 55559304 | Design Group Id | 55559305 | Design Group Id | 55559304 | Design Group Id | 55559305 |
Intervention Id | 52454865 | Intervention Id | 52454865 | Intervention Id | 52454866 | Intervention Id | 52454866 | Intervention Id | 52454867 | Intervention Id | 52454867 |
Eligibilities
Sequence: | 30747701 |
Sampling Method | Probability Sample |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 40 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | This study will bw carried out as a prospective randomized clinical trial on regular menstruating patients arriving for transfer of frozen embryo to the center in a single IVF center. Results will collected and recorded daily during the study. With 80% power analysis minimum number of patients 0.05% significance level is 240.
Study will be designed in 1 year. |
Criteria | Inclusion Criteria:
Patient who are admitted to the IVF center and who will be transferred to frozen embryos. Exclusion Criteria: Patients who made intrauterin surgery. |
Gender Description | woman who is infertile at reproductive age |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254121795 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 40 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30493984 |
Observational Model | Other |
Time Perspective | Prospective |
Intervention Other Names
Sequence: | 26655392 | Sequence: | 26655393 | Sequence: | 26655394 |
Intervention Id | 52454865 | Intervention Id | 52454866 | Intervention Id | 52454867 |
Name | natural LH surge | Name | recombinant hcg | Name | frozen embryo transfer |
Responsible Parties
Sequence: | 28860264 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52032689 | Sequence: | 52032690 | Sequence: | 52032691 | Sequence: | 52032692 |
Pmid | 21840758 | Pmid | 23820515 | Pmid | 25069504 | Pmid | 20097333 |
Reference Type | background | Reference Type | background | Reference Type | result | Reference Type | result |
Citation | Weissman A, Horowitz E, Ravhon A, Steinfeld Z, Mutzafi R, Golan A, Levran D. Spontaneous ovulation versus HCG triggering for timing natural-cycle frozen-thawed embryo transfer: a randomized study. Reprod Biomed Online. 2011 Oct;23(4):484-9. doi: 10.1016/j.rbmo.2011.06.004. Epub 2011 Jun 15. | Citation | Groenewoud ER, Cantineau AE, Kollen BJ, Macklon NS, Cohlen BJ. What is the optimal means of preparing the endometrium in frozen-thawed embryo transfer cycles? A systematic review and meta-analysis. Hum Reprod Update. 2013 Sep-Oct;19(5):458-70. doi: 10.1093/humupd/dmt030. Epub 2013 Jul 2. Erratum In: Hum Reprod Update. 2017 Mar 1;23(2):255-261. | Citation | Kupka MS, Ferraretti AP, de Mouzon J, Erb K, D'Hooghe T, Castilla JA, Calhaz-Jorge C, De Geyter C, Goossens V; European IVF-Monitoring Consortium, for the European Society of Human Reproduction and Embryology. Assisted reproductive technology in Europe, 2010: results generated from European registers by ESHREdagger. Hum Reprod. 2014 Oct 10;29(10):2099-113. doi: 10.1093/humrep/deu175. Epub 2014 Jul 27. | Citation | Fatemi HM, Kyrou D, Bourgain C, Van den Abbeel E, Griesinger G, Devroey P. Cryopreserved-thawed human embryo transfer: spontaneous natural cycle is superior to human chorionic gonadotropin-induced natural cycle. Fertil Steril. 2010 Nov;94(6):2054-8. doi: 10.1016/j.fertnstert.2009.11.036. Epub 2010 Jan 25. |
]]>
https://zephyrnet.com/NCT03798873
2019-02-13
https://zephyrnet.com/?p=NCT03798873
NCT03798873https://www.clinicaltrials.gov/study/NCT03798873?tab=tableRachel Trope, MSrtrope@wtmgmt.com7038070037To assess the effect of wearing a custom-fitted, FDA-registered, Class I device, compression garment (Obesinov, S.A.R.L.) by an individual with a BMI ≥ 35 on his/her day-to-day quality of life over a period of one year. Various measures of quality of life will be taken, including assessing an individual’s level of pain, mood, self-stigma and comfort with the use of a compression garment. Additionally, to assess the impact of the compression garment on activity, strength, posture and movement of an individual with a BMI ≥35 over the period of one year.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-13 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-02-19 |
Start Month Year | February 13, 2019 |
Primary Completion Month Year | July 2020 |
Verification Month Year | February 2019 |
Verification Date | 2019-02-28 |
Last Update Posted Date | 2019-02-19 |
Detailed Descriptions
Sequence: | 20727140 |
Description | Individuals suffering with obesity often experience daily pain and discomfort which limits movement, a critical factor in managing weight, cardio-metabolic health, mood, sleep, self-esteem and ultimately overall quality of life. Many individuals who experience weight gain have an abdominal or central distribution of weight which affects body mechanics leading to back pain, poor posture, difficulty walking with altered gait, knee, foot, ankle and leg pain (IT band, meralgia paresthetica) and other non-specific chronic pain. Chronic pain impedes mobility often incorporating depression and low motivation in an endless cycle. Furthermore, as individuals are losing weight, they often suffer from excess skin which also aggravates by chafing (arms, inner thighs), hanging down and interfering with gait.
The Investigators will examine the effect of wearing a custom-fitted, FDA-registered, Class I device, compression garment (Obesinov, S.A.R.L.) by participants with a BMI ≥ 35 on day-to-day quality of life over a period of one year. Various measures of quality of life will be taken, including assessing the participant's level of pain, mood, self-stigma and comfort with the use of a compression garment. Additional assessments include impact of the compression garment on activity, strength, posture and movement as well as potential impact of the use of this garment on weight loss and change in laboratory measures of metabolic health. |
Facilities
Sequence: | 200159080 |
Status | Recruiting |
Name | Washington Center for Weight Management and Research, Inc. |
City | Shirlington |
State | Virginia |
Zip | 22206 |
Country | United States |
Facility Contacts
Sequence: | 28113709 | Sequence: | 28113710 |
Facility Id | 200159080 | Facility Id | 200159080 |
Contact Type | primary | Contact Type | backup |
Name | Michelle Vaughan, MBA | Name | Rachel Trope, MS |
mvaughan@wtmgmt.com | rtrope@wtmgmt.com | ||
Phone | 703-807-0037 | Phone | 7038070037 |
Facility Investigators
Sequence: | 18336337 | Sequence: | 18336338 | Sequence: | 18336339 |
Facility Id | 200159080 | Facility Id | 200159080 | Facility Id | 200159080 |
Role | Principal Investigator | Role | Sub-Investigator | Role | Sub-Investigator |
Name | Domenica Rubino, MD | Name | Rachel Trope, MS | Name | Mike Reing, MS |
Conditions
Sequence: | 52185369 | Sequence: | 52185370 | Sequence: | 52185371 | Sequence: | 52185372 | Sequence: | 52185373 | Sequence: | 52185374 | Sequence: | 52185375 | Sequence: | 52185376 | Sequence: | 52185377 | Sequence: | 52185378 | Sequence: | 52185379 |
Name | Obesity | Name | Obesity, Abdominal | Name | Mobility Limitation | Name | Quality of Life | Name | Back Pain | Name | Pain, Chronic | Name | Weight Change, Body | Name | Inactivity | Name | Exercise | Name | Body Composition | Name | Redundant Skin |
Downcase Name | obesity | Downcase Name | obesity, abdominal | Downcase Name | mobility limitation | Downcase Name | quality of life | Downcase Name | back pain | Downcase Name | pain, chronic | Downcase Name | weight change, body | Downcase Name | inactivity | Downcase Name | exercise | Downcase Name | body composition | Downcase Name | redundant skin |
Id Information
Sequence: | 40168996 |
Id Source | org_study_id |
Id Value | FeelWell2018 |
Countries
Sequence: | 42580604 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55609014 | Sequence: | 55609015 |
Group Type | Experimental | Group Type | Other |
Title | FeelWell™ Compression garment use with increase mobility | Title | Increase mobility |
Description | Subjects are randomized to wear custom-fitted FeelWell™ Compression garment daily during regular and exercise activities.
Subjects will work with physical therapist and exercise physiologist to increase strength, mobility and activity. |
Description | For the control group, subjects will work with physical therapist and exercise physiologist to increase strength, mobility and activity. The control group will not be assigned a compression garment during the trial. |
Interventions
Sequence: | 52499332 | Sequence: | 52499333 |
Intervention Type | Device | Intervention Type | Behavioral |
Name | FeelWell™ Compression garment | Name | Increase Mobility |
Description | Registered FDA class I device:
The FeelWell™ Compression garment is a custom-made orthopedic abdominal binder with full or half-body support. The garments are made of 70% polyamide and 30% elastane and OEKO-TEX certified confirming human-ecological safety of textiles. The company uses a wrap knitting to ensure an optimal compression and durability. The garment has two 360 degrees whalebones in the front and two in the back to provide support for the posture, reinforcing compression on the abdomen and lower-back. |
Description | Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity |
Keywords
Sequence: | 79888573 | Sequence: | 79888574 | Sequence: | 79888575 | Sequence: | 79888576 | Sequence: | 79888577 |
Name | Compression garment | Name | Physical therapy | Name | Obesity | Name | Movement | Name | Abdominal binder |
Downcase Name | compression garment | Downcase Name | physical therapy | Downcase Name | obesity | Downcase Name | movement | Downcase Name | abdominal binder |
Design Outcomes
Sequence: | 177431729 | Sequence: | 177431730 | Sequence: | 177431731 | Sequence: | 177431732 | Sequence: | 177431733 | Sequence: | 177431734 | Sequence: | 177431735 | Sequence: | 177431736 | Sequence: | 177431737 | Sequence: | 177431738 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | 6- minute walk test- distance walked | Measure | 6- minute walk test- Perceived exertion | Measure | SF-36 physical component sub-score | Measure | 30 Second Chair Stand | Measure | Brief Pain Inventory-Interference sub-score | Measure | Steps per day measured by accelerometer | Measure | Weight Self Stigma questionnaire | Measure | Lean body mass | Measure | Fat mass | Measure | Bone density |
Time Frame | baseline, 1, 3, 6 and 12 months | Time Frame | baseline, 1, 3, 6 and 12 months | Time Frame | baseline, 3, 6 and 12 months | Time Frame | baseline, 1, 3, 6 and 12 months | Time Frame | baseline, 1, 3, 6 and 12 months | Time Frame | baseline, 6 months and 1 year | Time Frame | baseline, 1, 3, 6 and 12 months | Time Frame | baseline, 12 months | Time Frame | baseline, 12 months | Time Frame | baseline, 12 months |
Description | 6-min walk test is a sub-maximal exercise test measuring the total distance walked by a subject in a period of 6 minutes to assess functional capacity of a subject's cardio-respiratory systems and reflects their ability to perform Activities of Daily Living. Total distance walked will be measured and change recorded from baseline. | Description | The Borg Rate of Perceived Exertion scale of 1-10 will be used for the subject to record their exertion level from 1 (no exertion)-10 (maximal exertion) and change will be noted from baseline. | Description | SF-36 consists of 8 sub-scales of health-related quality of life measuring various aspects of functioning. The summary score for physical component includes physical functioning, physical role, bodily pain and general health scores. This sub-score is reported on a scale from 0-100 with higher numbers indicating better physical functioning. | Description | A test of leg strength and endurance. The number of times a patient stands from a sitting position in 30 seconds is recorded. | Description | A measure of pain and the interference of such pain on daily function. A sub-score on a scale of 0 (no interference)- 10 (maximal interference) will be recorded. The mean score of the 7 items will be recorded. | Description | The number of steps per day will be recorded as a measure of daily activity and averaged at various time points throughout the trial. | Description | A questionnaire designed to explore both internalized self stigma (internalized self-devaluation) and enacted stigma (directly experienced stigma) on function will be administered. The scale is comprised of 12 questions, and the subject responds on a scale from 1-5 with a greater score indicating greater experienced stigma. | Description | Using DXA (Dual-energy X-ray Absorptiometry), lean body mass (LBM) or fat-free mass will be measured at baseline and at end of study. Percent change will be reported. | Description | Using DXA (Dual-energy X-ray Absorptiometry), fat mass will be measured at baseline and at end of study. Percent change will be reported. | Description | Using DXA (Dual-energy X-ray Absorptiometry), bone density will be measured at baseline and at end of study. Percent change will be reported. |
Browse Conditions
Sequence: | 193539727 | Sequence: | 193539728 | Sequence: | 193539729 | Sequence: | 193539730 | Sequence: | 193539731 | Sequence: | 193539732 | Sequence: | 193539733 | Sequence: | 193539734 | Sequence: | 193539735 | Sequence: | 193539736 | Sequence: | 193539737 |
Mesh Term | Obesity | Mesh Term | Obesity, Abdominal | Mesh Term | Chronic Pain | Mesh Term | Body Weight Changes | Mesh Term | Mobility Limitation | Mesh Term | Overweight | Mesh Term | Overnutrition | Mesh Term | Nutrition Disorders | Mesh Term | Body Weight | Mesh Term | Pain | Mesh Term | Neurologic Manifestations |
Downcase Mesh Term | obesity | Downcase Mesh Term | obesity, abdominal | Downcase Mesh Term | chronic pain | Downcase Mesh Term | body weight changes | Downcase Mesh Term | mobility limitation | Downcase Mesh Term | overweight | Downcase Mesh Term | overnutrition | Downcase Mesh Term | nutrition disorders | Downcase Mesh Term | body weight | Downcase Mesh Term | pain | Downcase Mesh Term | neurologic manifestations |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332230 | Sequence: | 48332231 |
Agency Class | INDUSTRY | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Feelwell Compression | Name | Washington Center for Weight Management and Research, Inc. |
Overall Officials
Sequence: | 29292930 |
Role | Principal Investigator |
Name | Domenica Rubino, MD |
Affiliation | Washington Center for Weight Management and Research |
Central Contacts
Sequence: | 12012284 | Sequence: | 12012285 |
Contact Type | primary | Contact Type | backup |
Name | Domenica Rubino, MD | Name | Rachel Trope, MS |
Phone | 17038070037 | Phone | 7038070037 |
mvaughan@wtmgmt.com | rtrope@wtmgmt.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68168056 | Sequence: | 68168057 | Sequence: | 68168058 |
Design Group Id | 55609014 | Design Group Id | 55609014 | Design Group Id | 55609015 |
Intervention Id | 52499332 | Intervention Id | 52499333 | Intervention Id | 52499333 |
Eligibilities
Sequence: | 30773521 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Male or female, over 18 years old. Exclusion Criteria: Inability to put on or have help in putting on garment. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952512 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 7 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30519652 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Test group treated with the FeelWell™ Compression garment and control group without compression garment. All subjects will receive the same intervention working with exercise physiologist and physical therapist in order to improve mobility. |
Responsible Parties
Sequence: | 28885953 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52078783 | Sequence: | 52078784 | Sequence: | 52078785 | Sequence: | 52078786 | Sequence: | 52078787 |
Pmid | 12091180 | Pmid | 16229997 | Pmid | 25175697 | Pmid | 29158251 | Pmid | 28886865 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185. | Citation | Camarri B, Eastwood PR, Cecins NM, Thompson PJ, Jenkins S. Six minute walk distance in healthy subjects aged 55-75 years. Respir Med. 2006 Apr;100(4):658-65. doi: 10.1016/j.rmed.2005.08.003. Epub 2005 Oct 17. | Citation | Grodin JL, Hammadah M, Fan Y, Hazen SL, Tang WH. Prognostic value of estimating functional capacity with the use of the duke activity status index in stable patients with chronic heart failure. J Card Fail. 2015 Jan;21(1):44-50. doi: 10.1016/j.cardfail.2014.08.013. Epub 2014 Aug 28. | Citation | Jakicic JM, Rogers RJ, Davis KK, Collins KA. Role of Physical Activity and Exercise in Treating Patients with Overweight and Obesity. Clin Chem. 2018 Jan;64(1):99-107. doi: 10.1373/clinchem.2017.272443. Epub 2017 Nov 20. | Citation | Hebert-Losier K, Wessman C, Alricsson M, Svantesson U. Updated reliability and normative values for the standing heel-rise test in healthy adults. Physiotherapy. 2017 Dec;103(4):446-452. doi: 10.1016/j.physio.2017.03.002. Epub 2017 Mar 21. |
Ipd Information Types
Sequence: | 3335313 | Sequence: | 3335314 | Sequence: | 3335315 | Sequence: | 3335316 | Sequence: | 3335317 |
Name | Study Protocol | Name | Statistical Analysis Plan (SAP) | Name | Informed Consent Form (ICF) | Name | Clinical Study Report (CSR) | Name | Analytic Code |
]]>
https://zephyrnet.com/NCT03798860
2018-10-01
https://zephyrnet.com/?p=NCT03798860
NCT03798860https://www.clinicaltrials.gov/study/NCT03798860?tab=tableSusanne Freytfreyt.susanne@mh-hannover.de+49 511-532-3450Single-arm, prospective observational study
<![CDATA[
Studies
Study First Submitted Date | 2018-09-26 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-03-02 |
Start Month Year | October 1, 2018 |
Primary Completion Month Year | July 2024 |
Verification Month Year | March 2023 |
Verification Date | 2023-03-31 |
Last Update Posted Date | 2023-03-02 |
Detailed Descriptions
Sequence: | 20564028 |
Description | This is an observational study to monitor the treatment of donor-specific antibodies in lung transplant recipients with detection of donor-specific antibodies. All consented subjects will be approached for participation. The study will evaluate the effectiveness of the treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation. |
Facilities
Sequence: | 198534388 |
Status | Recruiting |
Name | Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery |
City | Hannover |
Country | Germany |
Facility Contacts
Sequence: | 27933745 |
Facility Id | 198534388 |
Contact Type | primary |
Name | Susanne Freyt |
freyt.susanne@mh-hannover.de | |
Phone | +49 511-532-3450 |
Facility Investigators
Sequence: | 18223508 |
Facility Id | 198534388 |
Role | Principal Investigator |
Name | Fabio Ius, Dr. |
Conditions
Sequence: | 51765551 | Sequence: | 51765552 |
Name | Lung Transplantation | Name | Donor-specific Anti-human Leukocyte Antigen(HLA) Antibodies |
Downcase Name | lung transplantation | Downcase Name | donor-specific anti-human leukocyte antigen(hla) antibodies |
Id Information
Sequence: | 39834520 |
Id Source | org_study_id |
Id Value | DSA-2018 |
Countries
Sequence: | 42233572 |
Name | Germany |
Removed | False |
Interventions
Sequence: | 52086937 |
Intervention Type | Diagnostic Test |
Name | blood samples |
Description | For performing the Luminex solid phase assay (SPA) test, 7.5 ml of patient whole blood are collected from a peripheral vein. |
Design Outcomes
Sequence: | 176070992 | Sequence: | 176070993 | Sequence: | 176070994 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Donor-specific Antibodies Clearance | Measure | Graft survival | Measure | Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD) |
Time Frame | 6, 12, 18, 24 months | Time Frame | 1, 3, 5 years | Time Frame | 1, 3, 5 years |
Description | The DSA clearance is defined as absence of DSA in the Luminex test, which is performed every 6 months after treatment end. | Description | Graft survival is defined as freedom from mortality and re-transplantation |
Sponsors
Sequence: | 47941787 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Hannover Medical School |
Overall Officials
Sequence: | 29047169 |
Role | Principal Investigator |
Name | Fabio Ius, Dr. |
Affiliation | Hannover Medical School |
Central Contacts
Sequence: | 11927299 | Sequence: | 11927300 |
Contact Type | primary | Contact Type | backup |
Name | Fabio Ius, Dr. | Name | Susanne Freyt |
Phone | +49 511-532-2125 | Phone | +49 511-532-3450 |
Ius.Fabio@mh-hannover.de | freyt.susanne@mh-hannover.de | ||
Role | Contact | Role | Contact |
Eligibilities
Sequence: | 30527958 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | All patients after lung transplantation with detection of donor-specific antibodies |
Criteria | Inclusion Criteria:
all patients after lung transplantation with detection of donor-specific antibodies Exclusion Criteria: none |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254097212 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30276802 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28656387 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798847
2018-11-01
https://zephyrnet.com/?p=NCT03798847
NCT03798847https://www.clinicaltrials.gov/study/NCT03798847?tab=tableNANANAThe objective of this study is to estimate the safety and performance of Journey II XR TKS based on retrospective data.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-27 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-07-14 |
Start Month Year | November 1, 2018 |
Primary Completion Month Year | September 10, 2020 |
Verification Month Year | July 2023 |
Verification Date | 2023-07-31 |
Last Update Posted Date | 2023-07-14 |
Facilities
Sequence: | 198409859 | Sequence: | 198409860 | Sequence: | 198409861 | Sequence: | 198409862 | Sequence: | 198409863 | Sequence: | 198409864 | Sequence: | 198409865 | Sequence: | 198409866 | Sequence: | 198409867 | Sequence: | 198409868 | Sequence: | 198409869 | Sequence: | 198409870 |
Name | Orthopedic Institute of the West | Name | Rush Copley Orthopaedics | Name | Jerry Orthopaedic Institute | Name | Reno Orthopedic Clinic | Name | Orthopaedic Center of New Jersey | Name | Hospital for Joint Diseases Orthopaedics Institute | Name | Regenerative Orthopedic Center (ROC) | Name | Oregon Health & Science University | Name | San Antonio Orthopaedic Specialists | Name | Anderson Orthopaedic Clinic | Name | Scott Orthopedic Center | Name | Aurora Medical Center |
City | Phoenix | City | Aurora | City | Port Huron | City | Reno | City | Somerset | City | New York | City | Oregon City | City | Portland | City | San Antonio | City | Alexandria | City | Huntington | City | Kenosha |
State | Arizona | State | Illinois | State | Michigan | State | Nevada | State | New Jersey | State | New York | State | Oregon | State | Oregon | State | Texas | State | Virginia | State | West Virginia | State | Wisconsin |
Zip | 85054 | Zip | 60504 | Zip | 48060 | Zip | 89503 | Zip | 08873 | Zip | 10003 | Zip | 97045 | Zip | 97239 | Zip | 78258 | Zip | 22306 | Zip | 25702 | Zip | 53142 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States |
Conditions
Sequence: | 51728843 |
Name | Journey II XR Total Knee System |
Downcase Name | journey ii xr total knee system |
Id Information
Sequence: | 39806932 |
Id Source | org_study_id |
Id Value | JIIXR.PMCF.2018.13 |
Countries
Sequence: | 42205856 |
Name | United States |
Removed | False |
Interventions
Sequence: | 52050546 |
Intervention Type | Device |
Name | Journey II XR TKA |
Description | Journey II XR Total Knee System |
Keywords
Sequence: | 79147520 |
Name | Journey II XR Total Knee System |
Downcase Name | journey ii xr total knee system |
Design Outcomes
Sequence: | 175940758 | Sequence: | 175940759 | Sequence: | 175940760 | Sequence: | 175940761 | Sequence: | 175940762 | Sequence: | 175940763 | Sequence: | 175940764 | Sequence: | 175940765 | Sequence: | 175940766 | Sequence: | 175940767 | Sequence: | 175940768 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Revision of one or more study device components | Measure | Adverse Events | Measure | Health care utilization: Hospitalization | Measure | Health care utilization: Hospitalization | Measure | Health care utilization: Rehabilitation | Measure | Health care utilization: Outpatient visits | Measure | Health Care Utilization: Re-operations | Measure | Quality of Life: EQ-5D-3L | Measure | Quality of Life: KSS | Measure | Return to Work | Measure | Technical Difficulties Encountered During Device Implantation |
Time Frame | 12 weeks follow up | Time Frame | 12 weeks follow up | Time Frame | implantation through study completion, approximately 3 years | Time Frame | Implantation through study completion, approximately 3 years | Time Frame | Implantation through study completion, approximately 3 years | Time Frame | Implantation through study completion, approximately 3 years | Time Frame | Implantation through study completion, approximately 3 years | Time Frame | Implantation through study completion, approximately 3 years | Time Frame | Implantation through study completion, approximately 3 years | Time Frame | Implantation through study completion, approximately 3 years | Time Frame | Implantation through study completion, approximately 3 years |
Description | Measure of the number of revision cases | Description | All collected and reported AEs | Description | Length of hospital stay for primary (index) surgery | Description | Hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery (number and length of stay) | Description | number of sessions and duration of rehabilitation in weeks | Description | Number and type of outpatient visits | Description | Number of re-operations and revisions | Description | EuroQol Five Dimensions Questionnaire | Description | 2011 Knee Society Score | Description | Changes in employment status will be recorded with the date on which the change occurred and the change status. | Description | Number of technical difficulties encountered with the device |
Sponsors
Sequence: | 47908586 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Smith & Nephew, Inc. |
Eligibilities
Sequence: | 30507529 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication |
Criteria | Inclusion Criteria:
Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II XR TKS for approved indication; Exclusion Criteria: – None |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254054594 |
Number Of Facilities | 12 |
Registered In Calendar Year | 2018 |
Actual Duration | 22 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 10 |
Designs
Sequence: | 30256607 |
Observational Model | Other |
Time Perspective | Retrospective |
Responsible Parties
Sequence: | 28637104 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798834
2018-11-17
https://zephyrnet.com/?p=NCT03798834
NCT03798834https://www.clinicaltrials.gov/study/NCT03798834?tab=tableNANANAThe fascia iliaca block (FIB) is an anterior approach to block the lumbar plexus. It disturbed mainly to the anterior region of the thigh by blocking the femoral nerve (LFC) and the lateral femoral cutaneous nerve. Moreover, FIB may possibly be extended to the obturator, ilioinguinal, genitofemoral, lateral cutaneous nerve of the thigh and over the psoas muscle but, rarely reaches the lumbar plexus.
The fascia iliaca compartment could be detected by bony landmarks palpation and the loss of resistance technique. Feeling two tactile ”pops” due to loss of resistance occurred during the needle passage through the fascia lata and the fascia iliaca. Ultrasound (US) guidance of FIB will increase the success rate and the efficacy of sensory blockade by decreasing the needed local anesthetic amount.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-09-22 |
Start Month Year | November 17, 2018 |
Primary Completion Month Year | February 1, 2019 |
Verification Month Year | September 2020 |
Verification Date | 2020-09-30 |
Last Update Posted Date | 2020-09-22 |
Detailed Descriptions
Sequence: | 20721637 |
Description | This study was conducted to demonstrate the success incidence (to evaluate the efficacy) of preoperative 0.25% bupivacaine FIB as a sole anesthetic technique in thromboembolectomy of unilateral chronic lower limb ischemia compared to neuraxial anesthesiaas a primary goal. Intraoperative hemodynamics variation, postoperative pain score, total analgesic rescue requests and the total amount of systemic rescue analgesia used in the first postoperative day in addition to any detected postoperative complications were secondary goals. The hypothesis is that; FIB will provide adequate anesthesia as neuraxial anesthesia. |
Facilities
Sequence: | 200108131 |
Name | Mansoura University |
City | Mansourah |
State | DK |
Zip | 050 |
Country | Egypt |
Browse Interventions
Sequence: | 96050239 | Sequence: | 96050240 | Sequence: | 96050241 |
Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52171244 |
Name | Chronic Lower Limb Ischemia |
Downcase Name | chronic lower limb ischemia |
Id Information
Sequence: | 40158638 |
Id Source | org_study_id |
Id Value | R/17.07.111 |
Countries
Sequence: | 42568948 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55593181 | Sequence: | 55593182 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Fascia iliaca block (FIB) | Title | Spinal anesthesia |
Description | ultrasound-guided Fascia iliaca block | Description | Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5% |
Interventions
Sequence: | 52485482 | Sequence: | 52485483 |
Intervention Type | Drug | Intervention Type | Other |
Name | Fascia iliaca block (FIB) | Name | Spinal anesthesia |
Description | ultrasound-guided Fascia iliaca block | Description | Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5% |
Design Outcomes
Sequence: | 177378876 | Sequence: | 177378872 | Sequence: | 177378873 | Sequence: | 177378874 | Sequence: | 177378875 | Sequence: | 177378870 | Sequence: | 177378871 |
Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary |
Measure | bradycardia | Measure | Heart rate | Measure | mean arterial pressure (MAP | Measure | hypotension | Measure | Any observed adverse effects | Measure | The proportion of the patients who did not require conversion to general anesthesia | Measure | Postoperative pain |
Time Frame | For 24 hours from the block | Time Frame | For 6 hours after the intervention | Time Frame | For 6 hours after the intervention | Time Frame | For 24 hours from the block | Time Frame | over the 24 hours postoperative | Time Frame | for 30 minutes | Time Frame | For 24 hours after the intervention |
Description | Incidents if bradycardia | Description | changes in Heart rate | Description | changes in mean arterial pressure (MAP | Description | Incidents of hypotension | Description | ny adverse effects will be observed over the 24 hours postoperative for local skin hematoma ,sensory deficits or local bleeding | Description | The post-operative pain will recorded using 10-point Visual Analog Scale (VAS) |
Browse Conditions
Sequence: | 193486753 | Sequence: | 193486754 |
Mesh Term | Ischemia | Mesh Term | Pathologic Processes |
Downcase Mesh Term | ischemia | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319298 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mansoura University |
Overall Officials
Sequence: | 29285354 |
Role | Study Chair |
Name | Reem A Elsharkawy, MD |
Affiliation | Lecturer of Anesthesia and Surgical Intensive Care |
Design Group Interventions
Sequence: | 68149137 | Sequence: | 68149138 |
Design Group Id | 55593181 | Design Group Id | 55593182 |
Intervention Id | 52485482 | Intervention Id | 52485483 |
Eligibilities
Sequence: | 30765356 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 80 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
ASA physical status I or II. Exclusion Criteria: Patients with previous same lower limb surgery |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253883940 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 2 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30511523 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | Single |
Subject Masked | True |
Responsible Parties
Sequence: | 28877817 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798821
2018-01-08
https://zephyrnet.com/?p=NCT03798821
NCT03798821https://www.clinicaltrials.gov/study/NCT03798821?tab=tableNANANADetermine the efficacy of the investigational product versus placebo in reducing stress oxidative during the performance of a physical exercise of a certain intensity and duration.
<![CDATA[
Studies
Study First Submitted Date | 2018-03-15 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | January 8, 2018 |
Primary Completion Month Year | July 30, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20741157 |
Description | The effectiveness of a probiotic for oxidative stress after eight weeks of the product to study will be checked. the sample will be formed by cyclists that will submit to a baseline exercise and after the product is taken. |
Facilities
Sequence: | 200280563 |
Name | Catholic University of Murcia |
City | Murcia |
Zip | 30107 |
Country | Spain |
Browse Interventions
Sequence: | 96132970 | Sequence: | 96132971 | Sequence: | 96132972 | Sequence: | 96132973 | Sequence: | 96132974 | Sequence: | 96132975 |
Mesh Term | Sulfalene | Mesh Term | Anti-Infective Agents | Mesh Term | Anti-Infective Agents, Urinary | Mesh Term | Antimalarials | Mesh Term | Antiprotozoal Agents | Mesh Term | Antiparasitic Agents |
Downcase Mesh Term | sulfalene | Downcase Mesh Term | anti-infective agents | Downcase Mesh Term | anti-infective agents, urinary | Downcase Mesh Term | antimalarials | Downcase Mesh Term | antiprotozoal agents | Downcase Mesh Term | antiparasitic agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52221496 |
Name | Oxidative Stress |
Downcase Name | oxidative stress |
Id Information
Sequence: | 40195608 |
Id Source | org_study_id |
Id Value | UCAM-CFE-0003 |
Countries
Sequence: | 42609639 |
Name | Spain |
Removed | False |
Design Groups
Sequence: | 55649773 | Sequence: | 55649774 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | Experimental | Title | Comparator |
Description | One capsule a day will be consumed. At breakfast for the six weeks. | Description | One capsule a day will be consumed. At breakfast for the six weeks. |
Interventions
Sequence: | 52535307 | Sequence: | 52535308 | Sequence: | 52535309 |
Intervention Type | Dietary Supplement | Intervention Type | Dietary Supplement | Intervention Type | Dietary Supplement |
Name | Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG) | Name | Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG) | Name | maltodextrin and sucrose (PLACEBO) |
Description | six weeks of consumption | Description | six weeks of consumption | Description | six weeks of consumption |
Design Outcomes
Sequence: | 177561386 | Sequence: | 177561387 | Sequence: | 177561388 | Sequence: | 177561389 | Sequence: | 177561390 | Sequence: | 177561391 | Sequence: | 177561392 | Sequence: | 177561393 | Sequence: | 177561394 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Oxidative damage to lipids | Measure | Oxidative damage to DNA | Measure | Oxidative damage to proteins. | Measure | Oxidative damage to lipids | Measure | Blood analysis | Measure | Blood analysis | Measure | Blood analysis | Measure | Blood analysis | Measure | Blood analysis |
Time Frame | Oxidative lipid damage will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. | Time Frame | Oxidative damage to DNA will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. | Time Frame | Oxidative damage to protein will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. | Time Frame | Oxidative damage to lipids will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. | Time Frame | Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. | Time Frame | Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. | Time Frame | Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. | Time Frame | Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. | Time Frame | Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. |
Description | It will be measured by isoprostanes in urine 24 hours. | Description | Analysis of 8-oxo 2'-deoxyguanosine in 24-hour urine. | Description | Analysis of serum carbonyl groups | Description | analysis of malondialdehyde in plasma | Description | serum carbonyls. It is measured in nmol / mg proteins | Description | Malondialdehyde in plasma | Description | Oxidized LDL. | Description | Antioxidant capacity. | Description | glutathione metabolism. It is measured in nmol / mg proteins |
Sponsors
Sequence: | 48366396 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Universidad Católica San Antonio de Murcia |
Design Group Interventions
Sequence: | 68217353 | Sequence: | 68217354 | Sequence: | 68217355 |
Design Group Id | 55649773 | Design Group Id | 55649773 | Design Group Id | 55649774 |
Intervention Id | 52535307 | Intervention Id | 52535308 | Intervention Id | 52535309 |
Eligibilities
Sequence: | 30794691 |
Gender | Male |
Minimum Age | 18 Years |
Maximum Age | 45 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Age: between 18 and 45 years Exclusion Criteria: Subjects with a history of any chronic disease. |
Gender Based | True |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254004306 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 6 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 45 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30540731 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Subject Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28907051 |
Responsible Party Type | Principal Investigator |
Name | Francisco Javier López Román |
Title | Principal Investigator |
Affiliation | Universidad Católica San Antonio de Murcia |
Study References
Sequence: | 52118171 |
Pmid | 33671691 |
Reference Type | derived |
Citation | Sanchez Macarro M, Avila-Gandia V, Perez-Pinero S, Canovas F, Garcia-Munoz AM, Abellan-Ruiz MS, Victoria-Montesinos D, Luque-Rubia AJ, Climent E, Genoves S, Ramon D, Chenoll E, Lopez-Roman FJ. Antioxidant Effect of a Probiotic Product on a Model of Oxidative Stress Induced by High-Intensity and Duration Physical Exercise. Antioxidants (Basel). 2021 Feb 22;10(2):323. doi: 10.3390/antiox10020323. |
]]>
https://zephyrnet.com/NCT03798808
2016-02-01
https://zephyrnet.com/?p=NCT03798808
NCT03798808https://www.clinicaltrials.gov/study/NCT03798808?tab=tableNANANAConsidering the high prevalence of childhood obesity worldwide, effective interventions are needed . Parental involvement in interventions and the use of web-based modalities appear to be promising approaches. The aim of the study was to evaluate the efficacy of an innovative family and Web-based nutrition intervention called “Family Nutriathlon” on consumption of vegetables and fruit and dairy products and/or alternatives and on diet quality among children and their parents.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-11 |
Start Month Year | February 1, 2016 |
Primary Completion Month Year | March 1, 2017 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-11 |
Detailed Descriptions
Sequence: | 20709974 |
Description | Forty-three families, with at least one child with a BMI >85th percentile, participated in either the intervention (n=24) or control group (n=19) over an 8-week period. Families in the intervention (Family Nutriathlon) will participated in a nutrition challenge that aimed to increase their consumption and variety of fruits and vegetables and dairy products by recording their daily intakes using a Web-based platform. Families in the control group received recommendations based on general nutrition guidelines. Three follow-ups with a dietitian once every two weeks via Skype to assess progress were scheduled. A three-day food record was completed at baseline (week 0), immediately after (week 8) and 6 months after the intervention. A two-way repeated measures analysis of variance was used to assess changes in consumption of fruits and vegetables and dairy products, diet quality and dietary intakes between groups and over time. |
Conditions
Sequence: | 52138967 |
Name | Diet Habit |
Downcase Name | diet habit |
Id Information
Sequence: | 40135032 |
Id Source | org_study_id |
Id Value | NUTRIATHLON-2015-259 R-2 |
Design Groups
Sequence: | 55559306 | Sequence: | 55559307 |
Group Type | Experimental | Group Type | No Intervention |
Title | Family Nutriathlon group | Title | Control group |
Description | Web-based nutrition program (encouraging consumption of fruits, vegetables and dairy products through an online platform) | Description | General nutrition guidelines (e.g. following Canada's Food Guide) |
Interventions
Sequence: | 52454868 |
Intervention Type | Other |
Name | Consumption of fruits, vegetables and dairy products |
Description | Family Nutriathlon was an eight-week, family-based nutrition program where children and their parents were encouraged to reach individual and team goals with respect to the quantity and variety of fruit, vegetable and dairy product consumption. |
Keywords
Sequence: | 79822768 |
Name | vegetables, fruits, dairy, children, habits |
Downcase Name | vegetables, fruits, dairy, children, habits |
Design Outcomes
Sequence: | 177263525 | Sequence: | 177263526 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Dietary intakes and diet quality | Measure | Anthropometric measurements |
Time Frame | 8 weeks | Time Frame | Weeks 0, 9 and 18-36 (follow-up) |
Description | Fruit, vegetable and dairy product consumption and diet quality as measured by the Nutrient-Rich Foods Index | Description | Body weight, height and body mass index |
Sponsors
Sequence: | 48290679 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Laval University |
Design Group Interventions
Sequence: | 68107404 |
Design Group Id | 55559306 |
Intervention Id | 52454868 |
Eligibilities
Sequence: | 30747702 |
Gender | All |
Minimum Age | 8 Years |
Maximum Age | 16 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | All inclusion/exclusion criterion were the same between the two projects (including the intervention) except for the inclusion of a child living with obesity or overweight.
Children were aged between 8 and 16 years, but there was no age limit for parents. |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254121796 |
Registered In Calendar Year | 2019 |
Actual Duration | 13 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 8 |
Maximum Age Num | 16 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30493985 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Investigator Masked | True |
Responsible Parties
Sequence: | 28860265 |
Responsible Party Type | Principal Investigator |
Name | Vicky Drapeau |
Title | Professor |
Affiliation | Laval University |
]]>
https://zephyrnet.com/NCT03798795
2017-10-01
https://zephyrnet.com/?p=NCT03798795
NCT03798795https://www.clinicaltrials.gov/study/NCT03798795?tab=tableNANANARadiomics is defined as a quantitative high-throughput analysis of imaging data combined with model development aiming to predict biological correlates or clinical endpoints. The investigators of this study hypothesize that radiomic features may correlate with pathology-defined tumor grading in soft tissue sarcoma patients. The aim of this study is to develop a predictive radiomics model for tumor grading determination.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-04-10 |
Start Month Year | October 1, 2017 |
Primary Completion Month Year | March 31, 2018 |
Verification Month Year | April 2019 |
Verification Date | 2019-04-30 |
Last Update Posted Date | 2019-04-10 |
Detailed Descriptions
Sequence: | 20762921 |
Description | Soft tissue sarcomas (STS) constitute an overall rare malignant entity comprising 1% of all cancers with a yearly incidence rate of 3.8 per 100.000 inhabitants. Therapy decisions are made using clinical and pathological determinants defined by the American Joint Committee on Cancer (AJCC). It involves the TNM staging system that classifies STS by their tumor size (measured as maximal diameter), pathological tumor grading defined by the French Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC) and the occurrence of nodal or distant metastases.
For the guidance of therapy, the most important factor constitutes tumor grading. In "low-grade" sarcomas (G1), surgical resection is often sufficient for durable tumor control. In "high risk" STS, however, resection of the tumor is combined with radiotherapy improving locoregional control and eventually survival. Currently, invasive biopsies followed by pathological work-up are necessary to determine tumor grading. However, bioptic specimens are always restricted to small tumor subvolume. Medical imaging-based analyses constitutes an alternative tool to characterize tissue. Recent developments in quantitative image analysis and data science have led to the evolvement of "Radiomics". It is defined as an algorithm-based large-scale quantitative analysis of imaging features. It should be considered as a two-step process with (1) extraction of relevant imaging features, and (2) incorporating these features into a mathematical model to ultimately predict patient or tumor-specific outcomes. In previous scientific studies, radiomic models have been associated with survival, tumor progression, and molecular changes including genetic mutations or expression profiles as shown in multiple malignant entities. In addition, radiomic models were able to predict tumor grading e.g. for gliomas, meningiomas, hepatocellular carcinoma or pancreatic neuroendocrine tumors. In contrast to pathology, quantitative image analysis (radiomics) has the principal advantage of analyzing the whole tumor. In this study, the investigators are aiming to correlate radiomic features with tumor grading of STS. The ultimate goal is to develop a prediction model to non-invasively classify tumor grading. In a first step, the focus will be laid on differentiating "low-grade" and "high-grade" STS. In a second step, "high-grade" STS will be divided into G2 and G3 tumors. To this end, the investigators will retrospectively analyze a patient cohort of 138 patients (139 tumors) with known tumor grading and available pre-therapeutic MRI-scans. As secondary endpoint overall survival will be determined for all patients. An independent patient cohort from the University of Washington (139 patients) will be used for external validation of the developed models. |
Facilities
Sequence: | 200458041 |
Name | Klinik für RadioOnkologie Strahlentherapie |
City | Munich |
State | Bavaria |
Zip | 81675 |
Country | Germany |
Conditions
Sequence: | 52277447 |
Name | Sarcoma, Soft Tissue |
Downcase Name | sarcoma, soft tissue |
Id Information
Sequence: | 40235454 |
Id Source | org_study_id |
Id Value | Sarcoma_Grading_Radiomics |
Countries
Sequence: | 42653031 |
Name | Germany |
Removed | False |
Design Outcomes
Sequence: | 177770623 | Sequence: | 177770624 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Pathological tumor grading | Measure | Overall Survival |
Time Frame | Baseline | Time Frame | From initial pathologic diagnosis to the time point of death or the time point of censoring up to 100 months. |
Description | Defined by the French Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC) | Description | Overall Survival |
Browse Conditions
Sequence: | 193892720 | Sequence: | 193892721 | Sequence: | 193892722 | Sequence: | 193892723 |
Mesh Term | Sarcoma | Mesh Term | Neoplasms, Connective and Soft Tissue | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms |
Downcase Mesh Term | sarcoma | Downcase Mesh Term | neoplasms, connective and soft tissue | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48418632 | Sequence: | 48418633 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Technical University of Munich | Name | University of Washington |
Overall Officials
Sequence: | 29342604 |
Role | Principal Investigator |
Name | Stephanie E Combs, MD |
Affiliation | Technical University of Munich |
Eligibilities
Sequence: | 30827023 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Patients with histologically proven soft tissue sarcomas with known FNCLCC tumor grading determined by biopsy prior to therapy. |
Criteria | Inclusion Criteria:
Histologically proven soft tissue sarcoma Exclusion Criteria: Indeterminate tumor grading |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254123702 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 6 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30572953 |
Observational Model | Cohort |
Time Perspective | Retrospective |
Responsible Parties
Sequence: | 28939375 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52177362 | Sequence: | 52177363 | Sequence: | 52177364 |
Pmid | 30397175 | Pmid | 24892406 | Pmid | 31522983 |
Reference Type | background | Reference Type | background | Reference Type | derived |
Citation | Liang W, Yang P, Huang R, Xu L, Wang J, Liu W, Zhang L, Wan D, Huang Q, Lu Y, Kuang Y, Niu T. A Combined Nomogram Model to Preoperatively Predict Histologic Grade in Pancreatic Neuroendocrine Tumors. Clin Cancer Res. 2019 Jan 15;25(2):584-594. doi: 10.1158/1078-0432.CCR-18-1305. Epub 2018 Nov 5. | Citation | Aerts HJ, Velazquez ER, Leijenaar RT, Parmar C, Grossmann P, Carvalho S, Bussink J, Monshouwer R, Haibe-Kains B, Rietveld D, Hoebers F, Rietbergen MM, Leemans CR, Dekker A, Quackenbush J, Gillies RJ, Lambin P. Decoding tumour phenotype by noninvasive imaging using a quantitative radiomics approach. Nat Commun. 2014 Jun 3;5:4006. doi: 10.1038/ncomms5006. Erratum In: Nat Commun. 2014;5:4644. Cavalho, Sara [corrected to Carvalho, Sara]. | Citation | Peeken JC, Spraker MB, Knebel C, Dapper H, Pfeiffer D, Devecka M, Thamer A, Shouman MA, Ott A, von Eisenhart-Rothe R, Nusslin F, Mayr NA, Nyflot MJ, Combs SE. Tumor grading of soft tissue sarcomas using MRI-based radiomics. EBioMedicine. 2019 Oct;48:332-340. doi: 10.1016/j.ebiom.2019.08.059. Epub 2019 Sep 12. |
]]>
https://zephyrnet.com/NCT03798782
2019-04-29
https://zephyrnet.com/?p=NCT03798782
NCT03798782https://www.clinicaltrials.gov/study/NCT03798782?tab=tableNANANAThis study evaluates two methods of aortic heart valve replacement in adults aged 18-60, the Ross procedure versus conventional aortic valve replacement using a biologic or mechanical heart valve. The Ross procedure replaces a patient’s diseased aortic valve with his/her own pulmonary valve and uses a donor valve in the pulmonary position which receives less stress than the aortic valve. Mechanical valves tend to form blood clots so they need long-term blood thinners that increase risk of bleeding and lower quality of life. Animal tissue valves reduce clotting and bleeding risks but wear out sooner and shorten patient life-span.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-18 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-02-24 |
Start Month Year | April 29, 2019 |
Primary Completion Month Year | October 1, 2022 |
Verification Month Year | February 2023 |
Verification Date | 2023-02-28 |
Last Update Posted Date | 2023-02-24 |
Detailed Descriptions
Sequence: | 20549475 |
Description | Heart valves help control blood flow through the heart and, if diseased, may need to be replaced. After having a heart valve replaced, patients have a higher risk of death than people who have not had a valve replaced. In young adult patients, replacing the aortic heart valve with a mechanical valve halves their life-span compared to other people their age. Mechanical valves tend to form blood clots so they need long-term blood thinners that increase risk of bleeding and lower quality of life. Animal tissue valves reduce clotting and bleeding risks but wear out sooner and shorten patient life-span. An operation, called the Ross procedure, replaces a patient's diseased aortic valve with his/her own pulmonary valve and uses a donor valve in the pulmonary position which receives less stress than the aortic valve. The Ross procedure aims to improve valve durability with less clotting, avoiding use of blood thinners. Patients and physicians need a large, high-quality study comparing the Ross procedure and standard valve replacement to know if either approach is better.
The investigators will perform a 3-year feasibility study in seven sites, in Canada and abroad, to test the study design and ability to do a larger, conclusive study comparing the impact of the Ross procedure to standard valve replacement on survival without valve-related life-threatening complications. Patients will be randomized, like flipping a coin, to receive the Ross or standard valve surgery. The goals are 1) to evaluate if the investigators can recruit 6 patients per site per year, 2) to test if the assigned procedure is performed in over 90% of study patients, and 3) to see how many mechanical vs. tissue valves are used in the standard valve group. Patients eligible but not enrolled in the trial will be asked if the investigators can collect some data on how they do after their surgery. If the investigators show the study is feasible, they will proceed to the full study and will include the feasibility patients in the full study. |
Facilities
Sequence: | 198413911 |
Name | Hamilton General Hospital |
City | Hamilton |
State | Ontario |
Zip | L8L 2X2 |
Country | Canada |
Conditions
Sequence: | 51729101 |
Name | Aortic Valve Disease |
Downcase Name | aortic valve disease |
Id Information
Sequence: | 39807126 |
Id Source | org_study_id |
Id Value | REVIVAL-2018 |
Countries
Sequence: | 42206284 |
Name | Canada |
Removed | False |
Design Groups
Sequence: | 55149161 | Sequence: | 55149162 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Ross procedure | Title | Conventional aortic valve replacement |
Description | The patient will undergo the Ross procedure where the surgeon will replace the aortic valve using a pulmonary autograft (Ross procedure) with pulmonary homograft replacement of the pulmonary root. | Description | The patient will undergo Conventional aortic valve replacement where the surgeon will replace the aortic valve with another prosthesis which can include a mechanical prosthesis, a stented biological prosthesis, a stentless biological valve or root, or a catheter valve. |
Interventions
Sequence: | 52050747 | Sequence: | 52050748 |
Intervention Type | Procedure | Intervention Type | Procedure |
Name | Ross procedure | Name | Conventional aortic valve replacement |
Description | The patient will undergo the Ross procedure where the surgeon will replace the aortic valve using a pulmonary autograft (Ross procedure) with pulmonary homograft replacement of the pulmonary root. Identified Ross experts will perform all Ross procedures. | Description | The patient will undergo Conventional aortic valve replacement where the surgeon will replace the aortic valve with another prosthesis which can include a mechanical prosthesis, a stented biological prosthesis, a stentless biological valve or root, or a catheter valve. |
Keywords
Sequence: | 79147984 | Sequence: | 79147985 | Sequence: | 79147986 |
Name | Cardiac surgery | Name | Aortic valve replacement | Name | Ross procedure |
Downcase Name | cardiac surgery | Downcase Name | aortic valve replacement | Downcase Name | ross procedure |
Design Outcomes
Sequence: | 175941658 | Sequence: | 175941659 | Sequence: | 175941660 | Sequence: | 175941661 | Sequence: | 175941662 | Sequence: | 175941663 | Sequence: | 175941664 | Sequence: | 175941665 | Sequence: | 175941666 | Sequence: | 175941667 | Sequence: | 175941668 | Sequence: | 175941669 | Sequence: | 175941670 | Sequence: | 175941671 | Sequence: | 175941672 | Sequence: | 175941673 | Sequence: | 175941674 | Sequence: | 175941675 | Sequence: | 175941676 | Sequence: | 175941677 | Sequence: | 175941678 | Sequence: | 175941679 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Full trial primary outcome – The rate of survival free of a composite of life-threatening valve-related complications (major bleeding, stroke or systemic thromboembolism, valve thrombosis, and operated-on valve reintervention) | Measure | Measure the pilot trial capacity to enrol a mean of 6 patients per centre per year to determine the feasibility of a full trial | Measure | The rate of compliance with allocation in the pilot trial to determine the feasibility of a full trial | Measure | Measure the proportions of type of conventional valve used in the pilot trial | Measure | The rate of perioperative and non-perioperative major bleeding over the duration of patient follow-up | Measure | The rate of stroke or systemic thromboembolism over the duration of patient follow-up | Measure | The rate of valve thrombosis per VARC criteria over the duration of patient follow-up | Measure | The rate of operated-on valve reintervention over the duration of patient follow-up | Measure | Rate of mortality within 30 days post-operatively | Measure | Measure health related quality of life using the 36-Item Short Form Survey (SF-36) questionnaire over the duration of patient follow-up | Measure | The rate of operated-valve endocarditis over the duration of patient follow-up | Measure | The rate of aortic valve re-intervention over the duration of patient follow-up | Measure | The rate of pulmonary valve re-intervention over the duration of patient follow-up | Measure | Mean aortic valve gradient | Measure | Mean pulmonic valve gradient | Measure | Severity of aortic valve regurgitation | Measure | Severity of pulmonic valve regurgitation | Measure | Rate of myocardial infarction | Measure | Rate of acute renal failure by Acute Kidney Injury Network classification | Measure | Rate of need for acute renal replacement therapy | Measure | Rate of surgical re-exploration of the mediastinum for bleeding | Measure | Rate of deep mediastinal wound infection |
Time Frame | Through trial completion, estimated to be 10 years | Time Frame | Through completion of the pilot trial, estimated to be 3 years | Time Frame | Through completion of the pilot trial, estimated to be 3 years | Time Frame | Through completion of the pilot trial, estimated to be 3 years | Time Frame | Through trial completion, estimated to be 10 years | Time Frame | Through trial completion, estimated to be 10 years | Time Frame | Through trial completion, estimated to be 10 years | Time Frame | Through trial completion, estimated to be 10 years | Time Frame | 30 days | Time Frame | Annually through trial completion, estimated to be 10 years | Time Frame | Through trial completion, estimated to be 10 years | Time Frame | Through trial completion, estimated to be 10 years | Time Frame | Through trial completion, estimated to be 10 years | Time Frame | Through trial completion, estimated to be 10 years | Time Frame | Through trial completion, estimated to be 10 years | Time Frame | Through trial completion, estimated to be 10 years | Time Frame | Through trial completion, estimated to be 10 years | Time Frame | 30 days postoperatively | Time Frame | 30 days postoperatively | Time Frame | 30 days postoperatively | Time Frame | 30 days postoperatively | Time Frame | 30 days postoperatively |
Description | The primary outcome is the rate of survival free of life-threatening valve-related complications (major bleeding, stroke or systemic thromboembolism, valve thrombosis, and operated-on valve reintervention) over duration of follow-up. Assessment of this composite over time is particularly important, as the Ross procedure may show initial benefit secondary to thromboembolic and bleeding reduction, however should the technique show high late rates of reoperation as suggested in some observational literature, the effect magnitude may change significantly over time. | Description | The outcome measures of the pilot trial, in order of importance, are:
To evaluate the capacity to enroll a mean of 6 patients per centre per year. |
Description | To determine the rate of compliance with randomization allocation. | Description | To validate the proportion of mechanical (at least 65%) versus biological (at most 35%) valves in the conventional arm. | Description | Perioperative (index surgery only) Intraoperative: After administration of protamine, delay of chest closure for bleeding > 500 mL/hr requiring packing and transfusion of more than 3 units red blood cells /whole blood.
Upon leaving OR to 48hrs postop (modified BARC type 4) Intracranial bleeding within 48hrs Non-perioperative Per the International Society of Thrombosis and Hemostasis (ISTH) major bleeding definition. |
Description | Stroke is acute focal brain dysfunction due to a vascular cause lasting ≥ 24 hrs in the absence of brain imaging or requires evidence of acute stroke on brain imaging (if there is a stroke documented by CT or MRI or at autopsy, the duration of symptoms/signs may be < 24 hours). Stroke is divided into 3 types: ischemic stroke, hemorrhagic stroke, and undetermined stroke. If death occurs within 24 hours, the neurological deficit must persist up to the time of death.
Systemic arterial embolism is an abrupt vascular insufficiency associated with evidence of arterial occlusion in the absence of other likely mechanisms. Clinical signs/symptoms must be consistent with embolic arterial occlusion, there must be clear evidence of abrupt occlusion of a systemic artery, with at least one type of supporting evidence (surgical report indicating evidence of arterial embolism, pathological specimens related to embolism removal, imaging evidence consistent with arterial embolism, or autopsy report). |
Description | Valve thrombosis is defined as any thrombus not caused by infection attached to or near an operated valve that occludes part of the blood flow path, interferes with valve function, or is large enough to warrant treatment. Valve thrombus found at autopsy in a patient whose cause of death was not valve related or found at operation for and unrelated indication is to be counted as valve thrombosis. | Description | Rate of valve reintervention Any surgical or percutaneous procedure that repairs, or otherwise alters or adjusts, or replaces a previously implanted prosthesis or valve. | Description | Rate of mortality within 30 days post-operatively | Description | The SF-36 is a health related quality of life questionnaire that measure eight health domains and each survey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores. The domains are physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The questionnaire is calibrated such that scored values of 50 represent the norm and higher scored values according to the scoring key represent a more favourable health state. A baseline score will be obtained prior to the patient's surgery and the SF-36 will be administered annually thereafter over the duration of patient follow-up. | Description | Defined as any infection involving a valve on which an operation has been performed. The diagnosis is based on one or more of the following: 1) reoperation with evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histologic or bacteriologic studies; 2) autopsy findings of abscess, pus, or vegetation involving an operated-on valve; or 3) the meeting of Duke criteria for endocarditis. | Description | Any surgical or percutaneous procedure that repairs, or otherwise alters or adjusts, or replaces a previously implanted prosthesis or valve in the aortic position. | Description | Any surgical or percutaneous procedure that repairs, or otherwise alters or adjusts, or replaces a previously implanted prosthesis or valve in the pulmonary position. | Description | Measured through echocardiography | Description | Measured through echocardiography | Description | Measured through echocardiography, categorized as mild, moderate, or severe | Description | Measured through echocardiography, categorized as mild, moderate, or severe | Description | Myocardial infarction (Fourth universal definition)
Occurring after 48 hrs post-operative, clinical evidence of acute myocardial injury with detection of a rise and/or fall of cTn values with at least one value above the 99th percentile URL and at least one of: Symptoms of myocardial ischemia |
Description | Acute renal failure By AKIN classification – An abrupt (within 48 hours) reduction in kidney function currently defined as an absolute increase in serum creatinine of more than or equal to 0.3 mg/dl (≥ 26.4 μmol/l), a percentage increase in serum creatinine of more than or equal to 50% (1.5-fold from baseline), or a reduction in urine output (documented oliguria of less than 0.5 ml/kg per hour for more than six hours). | Description | The rate of patients requiring new renal replacement therapy within 30 days of surgery. | Description | Surgical re-exploration of the mediastinum for bleeding | Description | Deep mediastinal wound infection |
Browse Conditions
Sequence: | 191708275 | Sequence: | 191708276 | Sequence: | 191708277 | Sequence: | 191708278 |
Mesh Term | Aortic Valve Disease | Mesh Term | Heart Valve Diseases | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases |
Downcase Mesh Term | aortic valve disease | Downcase Mesh Term | heart valve diseases | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47908759 | Sequence: | 47908760 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Population Health Research Institute | Name | Hamilton Health Sciences Corporation |
Overall Officials
Sequence: | 29028038 |
Role | Principal Investigator |
Name | Richard Whitlock, MD, PhD |
Affiliation | Population Health Research Institute |
Design Group Interventions
Sequence: | 67610602 | Sequence: | 67610603 |
Design Group Id | 55149161 | Design Group Id | 55149162 |
Intervention Id | 52050747 | Intervention Id | 52050748 |
Eligibilities
Sequence: | 30507631 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age 18-60 years Exclusion Criteria: Previous valve replacement not in the aortic position |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254054785 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 41 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 13 |
Number Of Other Outcomes To Measure | 5 |
Designs
Sequence: | 30256709 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28637206 |
Responsible Party Type | Principal Investigator |
Name | Richard Whitlock |
Title | Associate Professor |
Affiliation | McMaster University |
Study References
Sequence: | 51620023 |
Pmid | 34531204 |
Reference Type | derived |
Citation | Whitlock R, Belley-Cote E, Rega F, Chu MWA, McClure GR, Hronyecz H, Verbrugghe P, Devereaux PJ, Bangdiwala S, Eikelboom J, Brady K, Sharifulin R, Bogachev-Prokophiev A, Stoica S. Ross for Valve replacement In AduLts (REVIVAL) pilot trial: rationale and design of a randomised controlled trial. BMJ Open. 2021 Sep 16;11(9):e046198. doi: 10.1136/bmjopen-2020-046198. |
]]>
https://zephyrnet.com/NCT03798769
2019-01-31
https://zephyrnet.com/?p=NCT03798769
NCT03798769https://www.clinicaltrials.gov/study/NCT03798769?tab=tableNANANAThe goal of this research is to study an intervention, which the investigators call “Supportive Oncology Care at Home,” that entails both remote patient monitoring (e.g. patient-reported symptoms, home monitored vital signs, and body weight) and a Medically Home care model (e.g. triggers for phone calls and visits to patients’ homes to address and manage any concerning issues identified). Specifically, the investigators will conduct a single arm pilot study (N=20) in patients with pancreatic cancer who sign consent for parent trial of neoadjuvant FOLFIRINOX (18-179) receiving preoperative FOLFIRINOX to assess the feasibility and acceptability of Supportive Oncology Care at Home.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-27 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-11-22 |
Start Month Year | January 31, 2019 |
Primary Completion Month Year | June 1, 2022 |
Verification Month Year | November 2022 |
Verification Date | 2022-11-30 |
Last Update Posted Date | 2022-11-22 |
Detailed Descriptions
Sequence: | 20730278 |
Description | Preoperative treatment can cause significant morbidity and often result in hospitalizations. Patients receiving preoperative FOLFIRINOX often experience numerous side effects, including nausea, vomiting, diarrhea, fatigue, fever, neuropathy, and loss of appetite. Frequently, patients require hospital admissions to help address uncontrolled symptoms related to their cancer and side effects related to the treatment,
Interventions targeting patients' symptoms and delivering care to patients at their homes have the potential to improve patient outcomes. Studies show that interventions targeting patients' symptoms can improve symptom management, enhance quality of life (QOL), and prevent hospitalizations. Medically Home interventions have shown the potential to enhance patient outcomes. The Medically Home model of care is an alternative to a hospital admission for acute care and treatment of a clinical condition. Medically Home interventions entail providing medical care to acutely ill patients in their home. In addition, research in the general medicine literature has demonstrated that interventions involving remote patient monitoring with 'triggers' for visits to patients' homes for worrisome symptoms can enhance care outcomes. Although this research demonstrates promising results, these studies have not been conducted among patients with cancer. Notably, the prior work involving home monitoring with visits as needed has lacked patient-reported outcomes, such as symptom monitoring. Thus, efforts are needed to develop and test interventions containing both symptom monitoring and the potential for home visits when necessary in a population of patients with cancer. |
Facilities
Sequence: | 200189881 |
Name | Ryan Nipp |
City | Boston |
State | Massachusetts |
Zip | 02114 |
Country | United States |
Conditions
Sequence: | 52193556 |
Name | Pancreas Cancer |
Downcase Name | pancreas cancer |
Id Information
Sequence: | 40175456 |
Id Source | org_study_id |
Id Value | 18-532 |
Countries
Sequence: | 42587803 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55618925 |
Group Type | Experimental |
Title | Supportive Oncology Care at Home |
Description | The Supportive Oncology Care at Home intervention entails the following:
patient-reported symptoms, vital sign, and weight monitoring with appropriate triggers for phone calls and home visits by Medically Home based on a clinician-derived algorithm |
Interventions
Sequence: | 52508198 |
Intervention Type | Other |
Name | Supportive Oncology Care at Home |
Description | Entails the following:
patient-reported symptoms, vital sign, and weight monitoring with appropriate triggers to phone calls and home visits by Medically Home based on a clinician-derived algorithm; |
Keywords
Sequence: | 79901536 |
Name | Pancreas Cancer |
Downcase Name | pancreas cancer |
Design Outcomes
Sequence: | 177462003 | Sequence: | 177461995 | Sequence: | 177461996 | Sequence: | 177461997 | Sequence: | 177461998 | Sequence: | 177461999 | Sequence: | 177462000 | Sequence: | 177462001 | Sequence: | 177462002 | Sequence: | 177462004 | Sequence: | 177462005 | Sequence: | 177462006 | Sequence: | 177462007 | Sequence: | 177462008 | Sequence: | 177462009 | Sequence: | 177462010 | Sequence: | 177462011 | Sequence: | 177462012 | Sequence: | 177462013 | Sequence: | 177462014 | Sequence: | 177462015 | Sequence: | 177462016 | Sequence: | 177462017 | Sequence: | 177462018 | Sequence: | 177462019 | Sequence: | 177462020 | Sequence: | 177462021 | Sequence: | 177462022 | Sequence: | 177462023 | Sequence: | 177462024 | Sequence: | 177462025 | Sequence: | 177462026 | Sequence: | 177462027 | Sequence: | 177462028 | Sequence: | 177462029 | Sequence: | 177462030 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Patient acceptability | Measure | Rates of study enrollment | Measure | Rates of completion | Measure | Rates of completion of daily symptom monitoring | Measure | Rates of completion of daily vital signs | Measure | Rates of completion of weekly body weight | Measure | Number of home visits required | Measure | Number of phone calls required | Measure | Number of emails required | Measure | Family caregiver acceptability | Measure | Clinician acceptability | Measure | Number of emergency department visits | Measure | Number of urgent visits | Measure | Number of hospital admissions | Measure | Change in symptom burden longitudinally throughout the study | Measure | Change in psychological distress | Measure | Change in quality of life longitudinally throughout the study | Measure | Number of cycles of FOLFIRINOX received | Measure | Number of treatment delays | Measure | Cumulative dose of FOLFIRINOX received | Measure | Proportion of patients requiring a hospital admission | Measure | Number of hospital admissions | Measure | Proportion of patients requiring an emergency department visit | Measure | Number of emergency department visits | Measure | Proportion of patients requiring an urgent care visit | Measure | Number of urgent care visits | Measure | Proportion of patients requiring a hospital admission or emergency department visit | Measure | Number of hospital admissions or emergency department visits | Measure | Proportion of patients requiring a treatment delay | Measure | Proportion of days in hospital or emergency department | Measure | Proportion of days in hospital, emergency department, or urgent care | Measure | Number of cycles of chemotherapy completed | Measure | Numbers of treatment delays | Measure | Dose intensity | Measure | Overall survival | Measure | Progression free survival |
Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 Years | Time Frame | 2 Years | Time Frame | 2 Years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 Years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years | Time Frame | 2 years |
Description | Qualitative acceptability ratings from patients regarding helpfulness, convenience, and perceptions of the study. | Description | Proportion of patients who agree to participate in the study and sign informed consent. | Description | Proportion of patients who complete daily patient-reported symptom assessments within the first two weeks of enrollment. | Description | Proportion of participants completing daily symptom monitoring throughout the study | Description | Proportion of participants completing daily reporting of vital signs throughout the study | Description | Proportion of participants completing weekly reporting of body weight throughout the study | Description | Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to patients at their home | Description | Number of phone calls required per patient as well as average duration of these calls | Description | Number of emails from Medically Home to the primary oncology team | Description | Qualitative acceptability ratings from family caregivers regarding helpfulness, convenience, and perceptions of the study. | Description | Qualitative acceptability ratings from clinicians regarding helpfulness, convenience, and perceptions of the study. | Description | The number of emergency department [ED] visits and the proportion of patients needing an emergency department [ED] visit | Description | The number of urgent visits to clinic and the proportion of patients needing an urgent visit to clinic | Description | The number of hospital admissions and the proportion of patients needing a hospital admission | Description | Change in symptom burden (assessed using Edmonton Symptom Assessment System-revised [ESAS-r], range 0-10 for each symptom with higher scores indicating worse symptom burden) throughout the study. | Description | Change in psychological distress (assessed using the Patient Health Questionnaire-4 [PHQ-4], range 0-12 with higher scores indicating greater distress, and subscales for depression/anxiety ranging 0-6 with higher scores indicating greater distress) throughout the study. | Description | Change in quality of life (assessed using the Functional Assessment of Cancer Therapy-General [FACT-G], with range of 0-108 and higher scores indicating better quality of life) throughout the study. | Description | Describe the number of cycles of FOLFIRINOX chemotherapy received by patients | Description | Describe the number of treatment delays for patients | Description | Describe the cumulative dose of FOLFIRINOX received | Description | Compare difference in proportion of patients with hospital admissions between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home | Description | Compare difference in number of hospital admissions between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home | Description | Compare difference in proportion of patients with emergency department visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home | Description | Compare difference in number of emergency department visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home | Description | Compare difference in proportion of patients with urgent care visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home | Description | Compare difference in number of urgent care visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home | Description | Compare difference in proportion of patients with a hospital admission or emergency department visit between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home | Description | Compare difference in number of hospital admissions or emergency department visits between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home | Description | Compare difference in proportion of patients with a treatment delay between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home | Description | Compare difference in proportion of days in hospital or emergency department between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home | Description | Compare difference in proportion of days in hospital, emergency department, or urgent care between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home | Description | Compare difference in number of cycles of chemotherapy completed between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home | Description | Compare difference in number of treatment delays between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home | Description | Compare difference in chemotherapy dose intensity between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home | Description | Compare difference in overall survival between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home | Description | Compare difference in progression free survival between patients with pancreatic cancer receiving preoperative FOLFIRINOX who did and did not receive Supportive Oncology Care at Home |
Browse Conditions
Sequence: | 193571877 | Sequence: | 193571878 | Sequence: | 193571879 | Sequence: | 193571880 | Sequence: | 193571881 | Sequence: | 193571882 | Sequence: | 193571883 | Sequence: | 193571884 |
Mesh Term | Pancreatic Neoplasms | Mesh Term | Digestive System Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Endocrine Gland Neoplasms | Mesh Term | Digestive System Diseases | Mesh Term | Pancreatic Diseases | Mesh Term | Endocrine System Diseases |
Downcase Mesh Term | pancreatic neoplasms | Downcase Mesh Term | digestive system neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | endocrine gland neoplasms | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | pancreatic diseases | Downcase Mesh Term | endocrine system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48340195 | Sequence: | 48340196 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Massachusetts General Hospital | Name | Stand Up To Cancer |
Overall Officials
Sequence: | 29297920 |
Role | Principal Investigator |
Name | Ryan Nipp, MD, MPH |
Affiliation | Massachusetts General Hospital |
Design Group Interventions
Sequence: | 68180096 |
Design Group Id | 55618925 |
Intervention Id | 52508198 |
Eligibilities
Sequence: | 30778534 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age 18 or older Exclusion Criteria: -Uncontrolled psychiatric illness or impaired cognition |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253971231 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 40 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 18 |
Number Of Other Outcomes To Measure | 16 |
Designs
Sequence: | 30524637 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28890947 |
Responsible Party Type | Principal Investigator |
Name | Ryan Nipp |
Title | Primary Investigator |
Affiliation | Massachusetts General Hospital |
Study References
Sequence: | 52087716 |
Pmid | 35830625 |
Reference Type | derived |
Citation | Nipp RD, Gaufberg E, Vyas C, Azoba C, Qian CL, Jaggers J, Weekes CD, Allen JN, Roeland EJ, Parikh AR, Miller L, Wo JY, Smith MH, Brown PMC, Shulman E, Fernandez-Del Castillo C, Kimmelman AC, Ting D, Hong TS, Greer JA, Ryan DP, Temel JS, El-Jawahri A. Supportive Oncology Care at Home Intervention for Patients With Pancreatic Cancer. JCO Oncol Pract. 2022 Oct;18(10):e1587-e1593. doi: 10.1200/OP.22.00088. Epub 2022 Jul 13. |
Ipd Information Types
Sequence: | 3335812 | Sequence: | 3335813 |
Name | Study Protocol | Name | Statistical Analysis Plan (SAP) |
]]>
https://zephyrnet.com/NCT03798756
2019-01-14
https://zephyrnet.com/?p=NCT03798756
NCT03798756https://www.clinicaltrials.gov/study/NCT03798756?tab=tableNANANAThe aim of this study is to examine patient acceptability, for providing brief research information, whilst self-completing an automated check-in screen prior to any general practice consultation.
<![CDATA[
Studies
Study First Submitted Date | 2018-09-14 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-04-19 |
Start Month Year | January 14, 2019 |
Primary Completion Month Year | April 14, 2019 |
Verification Month Year | March 2021 |
Verification Date | 2021-03-31 |
Last Update Posted Date | 2021-04-19 |
Results First Posted Date | 2021-04-19 |
Detailed Descriptions
Sequence: | 20754946 |
Description | The Automated Check-in Data Collection (AC DC) Study, is a pilot feasibility study, observing patients consulting in general practice and completing an automated check-in screen prior to their booked appointment, to confirm their attendance. Participants will be recruited over three weeks from approximately 11 participating general practices.
The primary objective of the study is to assess patient acceptability for answering brief research questions in the general practice waiting room, using an automated check-in screen. This will be measured by observing the percentage of completed automated check-in screens with entered research data. Secondary objectives will assess check-in completion of self-reported pain and willingness to be contacted about future research studies of relevance. Reported severity of bodily pain experienced over the last 4 weeks and the proportion of patients agreeing to be contacted about future research studies of relevance, will be observed. |
Facilities
Sequence: | 200390365 |
Name | New Cross Hospital |
City | Wolverhampton |
Zip | WV10 0QP |
Country | United Kingdom |
Conditions
Sequence: | 52256650 |
Name | Primary Care |
Downcase Name | primary care |
Id Information
Sequence: | 40220877 |
Id Source | org_study_id |
Id Value | RG-0275-18 V1.0 |
Countries
Sequence: | 42636502 |
Name | United Kingdom |
Removed | False |
Design Outcomes
Sequence: | 177692558 | Sequence: | 177692559 | Sequence: | 177692560 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Self-reported Bodily Pain | Measure | Bodily Pain Response | Measure | Consent to Contact Response |
Time Frame | Through study completion at 1st visit (Day 1) | Time Frame | Through study completion at 1st visit (Day 1) | Time Frame | Through study completion at 1st visit (Day 1) |
Description | To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. | Description | Proportion of participants answering the bodily pain research question using an automated check-in screen. | Description | Proportion of participants answering the consent to contact research question using an automated check-in screen. |
Sponsors
Sequence: | 48399214 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Keele University |
Overall Officials
Sequence: | 29331629 |
Role | Study Director |
Name | Christian D Mallen |
Affiliation | University of Keele |
Eligibilities
Sequence: | 30815056 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | All patients of age 18 and over, who can read and respond in English and with a booked appointment, consulting with any Health Care Professional (HCP) at their general practice, during the recruitment period will be eligible to participate. All patients are required to confirm their attendance at the general practice by using the automated check-in screen. If the patient completing the automated check-in screen is 18 years of age or over, the additional two research questions will appear for completion. |
Criteria | Inclusion Criteria:
Patients 18 years of age or over attending participating general practices for a consultation with any healthcare professional. Exclusion Criteria: • Patients under the age of 18 attending the general practice for a consultation with a healthcare professional. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254076406 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 3 |
Were Results Reported | True |
Months To Report Results | 22 |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30561019 |
Observational Model | Cohort |
Time Perspective | Prospective |
Milestones
Sequence: | 41075729 | Sequence: | 41075730 | Sequence: | 41075731 |
Result Group Id | 56156932 | Result Group Id | 56156932 | Result Group Id | 56156932 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG000 |
Title | STARTED | Title | COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 9274 | Count | 9274 | Count | 0 |
Participant Flows
Sequence: | 3926520 |
Outcome Counts
Sequence: | 74126858 | Sequence: | 74126859 | Sequence: | 74126860 |
Outcome Id | 30855932 | Outcome Id | 30855933 | Outcome Id | 30855934 |
Result Group Id | 56156933 | Result Group Id | 56156934 | Result Group Id | 56156933 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants |
Count | 9274 | Count | 9274 | Count | 9274 |
Provided Documents
Sequence: | 2587837 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2018-11-05 |
Url | https://ClinicalTrials.gov/ProvidedDocs/56/NCT03798756/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27985117 | Sequence: | 27985118 | Sequence: | 27985119 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 0 | Subjects At Risk | 0 | Subjects At Risk | 0 |
Created At | 2023-08-09 14:43:35.046965 | Created At | 2023-08-09 14:43:35.046965 | Created At | 2023-08-09 14:43:35.046965 |
Updated At | 2023-08-09 14:43:35.046965 | Updated At | 2023-08-09 14:43:35.046965 | Updated At | 2023-08-09 14:43:35.046965 |
Responsible Parties
Sequence: | 28927423 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3857264 |
Pi Employee | Yes |
Result Contacts
Sequence: | 3857229 |
Organization | Keele University |
Name | Mrs Sarah Lawton |
Phone | 01782 734887 |
s.a.lawton@keele.ac.uk | |
Outcomes
Sequence: | 30855932 | Sequence: | 30855933 | Sequence: | 30855934 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Self-reported Bodily Pain | Title | Bodily Pain Response | Title | Consent to Contact Response |
Description | To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. | Description | Proportion of participants answering the bodily pain research question using an automated check-in screen. | Description | Proportion of participants answering the consent to contact research question using an automated check-in screen. |
Time Frame | Through study completion at 1st visit (Day 1) | Time Frame | Through study completion at 1st visit (Day 1) | Time Frame | Through study completion at 1st visit (Day 1) |
Units | Participants | Units | Participants | Units | Participants |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Outcome Measurements
Sequence: | 236078567 | Sequence: | 236078568 | Sequence: | 236078569 | Sequence: | 236078570 | Sequence: | 236078571 | Sequence: | 236078572 | Sequence: | 236078573 | Sequence: | 236078574 | Sequence: | 236078575 |
Outcome Id | 30855932 | Outcome Id | 30855932 | Outcome Id | 30855932 | Outcome Id | 30855932 | Outcome Id | 30855932 | Outcome Id | 30855932 | Outcome Id | 30855932 | Outcome Id | 30855933 | Outcome Id | 30855934 |
Result Group Id | 56156933 | Result Group Id | 56156933 | Result Group Id | 56156933 | Result Group Id | 56156933 | Result Group Id | 56156933 | Result Group Id | 56156933 | Result Group Id | 56156933 | Result Group Id | 56156934 | Result Group Id | 56156933 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Category | None | Category | Very mild | Category | Mild | Category | Moderate | Category | Severe | Category | Very Severe | Category | Not documented | ||||
Title | Self-reported Bodily Pain | Title | Self-reported Bodily Pain | Title | Self-reported Bodily Pain | Title | Self-reported Bodily Pain | Title | Self-reported Bodily Pain | Title | Self-reported Bodily Pain | Title | Self-reported Bodily Pain | Title | Bodily Pain Response | Title | Consent to Contact Response |
Description | To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. | Description | To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. | Description | To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. | Description | To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. | Description | To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. | Description | To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. | Description | To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen. | Description | Proportion of participants answering the bodily pain research question using an automated check-in screen. | Description | Proportion of participants answering the consent to contact research question using an automated check-in screen. |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 2937 | Param Value | 1061 | Param Value | 1446 | Param Value | 2344 | Param Value | 1125 | Param Value | 9 | Param Value | 352 | Param Value | 8922 | Param Value | 8285 |
Param Value Num | 2937.0 | Param Value Num | 1061.0 | Param Value Num | 1446.0 | Param Value Num | 2344.0 | Param Value Num | 1125.0 | Param Value Num | 9.0 | Param Value Num | 352.0 | Param Value Num | 8922.0 | Param Value Num | 8285.0 |
Baseline Counts
Sequence: | 11399690 |
Result Group Id | 56156931 |
Ctgov Group Code | BG000 |
Units | Participants |
Scope | overall |
Count | 9274 |
Result Groups
Sequence: | 56156931 | Sequence: | 56156932 | Sequence: | 56156933 | Sequence: | 56156934 | Sequence: | 56156935 |
Ctgov Group Code | BG000 | Ctgov Group Code | FG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 |
Result Type | Baseline | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event |
Title | Cohort | Title | Cohort | Title | Bodily Pain | Title | Cohort | Title | Cohort |
Description | This was a Cohort, there were no arms. It was an entire group. | Description | Automated check-in | Description | To assess patient acceptability of answering a research question on bodily pain, in the general practice waiting room using an automated check-in screen. | Description | Automated check-in | Description | All those patients checking-in for a pre-booked consultation using an automated check-in screen and answering at least one research question |
Baseline Measurements
Sequence: | 125816605 | Sequence: | 125816606 | Sequence: | 125816607 | Sequence: | 125816608 | Sequence: | 125816609 | Sequence: | 125816610 | Sequence: | 125816611 |
Result Group Id | 56156931 | Result Group Id | 56156931 | Result Group Id | 56156931 | Result Group Id | 56156931 | Result Group Id | 56156931 | Result Group Id | 56156931 | Result Group Id | 56156931 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 |
Classification | United Kingdom | ||||||||||||
Category | <=18 years | Category | Between 18 and 65 years | Category | >=65 years | Category | Female | Category | Male | ||||
Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Region of Enrollment | Title | Patients checking in for a consultation, answering a research question, using check-in sceen |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | Participants |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Count of Participants |
Param Value | 0 | Param Value | 5982 | Param Value | 3292 | Param Value | 5653 | Param Value | 3621 | Param Value | 9274 | Param Value | 9274 |
Param Value Num | 0.0 | Param Value Num | 5982.0 | Param Value Num | 3292.0 | Param Value Num | 5653.0 | Param Value Num | 3621.0 | Param Value Num | 9274.0 | Param Value Num | 9274.0 |
Number Analyzed | 9274 | Number Analyzed | 9274 | Number Analyzed | 9274 | Number Analyzed | 9274 | Number Analyzed | 9274 | Number Analyzed | 9274 | Number Analyzed | 9274 |
]]>
https://zephyrnet.com/NCT03798743
2019-01-01
https://zephyrnet.com/?p=NCT03798743
NCT03798743https://www.clinicaltrials.gov/study/NCT03798743?tab=tableNANANAThe study aim to Evaluate the combination of ididilimumab and docetaxel alone in the treatment of previous platinum-containing double-drug chemotherapy according to RECIST 1.1Objective remission rate of advanced or metastatic non-small cell lung cancer with negative, driving gene negative (EGFR, ALK, ROS1); (ORR).
<![CDATA[
Studies
Study First Submitted Date | 2019-01-05 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-03-02 |
Start Month Year | January 1, 2019 |
Primary Completion Month Year | December 30, 2021 |
Verification Month Year | March 2022 |
Verification Date | 2022-03-31 |
Last Update Posted Date | 2022-03-02 |
Detailed Descriptions
Sequence: | 20790132 |
Description | This study is a single case of syndilizumab plus docetaxel monotherapy in a Chinese-negative late-stage or metastatic non-small cell lung cancer (NSCLC) failed platinum-containing dual-drug chemotherapy. Center, single arm phase II study. In this study, 30 patients with advanced or metastatic non-small cell lung cancer who had failed platinum-containing dual-drug chemotherapy were treated with rituximab plus docetaxel every 3 weeks until disease progression and intolerance. Toxicity, withdrawal of informed consent, death or other cessation of treatment as prescribed by the program, whichever occurs first. The primary end point was the ORR based on RECIS 1.1, which was evaluated by the Independent Imaging Review Board (IRRC). The longest treatment time for ididibizumab is 24 months. An interim analysis will be conducted during the course of the study. The results and reports will be provided to the Independent Data Audit Committee (IDMC), which determines whether the trial is valid based on the valid cut-off value of the trial and whether the study data can be submitted in advance. Make recommendations to the sponsor. Prior to the interim analysis, the IDMC charter will be finalized and approved by IDMC and the sponsor. The responsibilities and related procedures of IDMC members will be defined in the IDMC charter. |
Facilities
Sequence: | 200680789 |
Name | Hunan Provincal Tumor Hospital |
City | Changsha |
State | Hunan |
Zip | 410013 |
Country | China |
Browse Interventions
Sequence: | 96327338 | Sequence: | 96327339 | Sequence: | 96327340 | Sequence: | 96327341 | Sequence: | 96327342 | Sequence: | 96327343 |
Mesh Term | Docetaxel | Mesh Term | Antineoplastic Agents | Mesh Term | Tubulin Modulators | Mesh Term | Antimitotic Agents | Mesh Term | Mitosis Modulators | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | docetaxel | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | tubulin modulators | Downcase Mesh Term | antimitotic agents | Downcase Mesh Term | mitosis modulators | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52346402 |
Name | Non-small Cell Lung Cancer |
Downcase Name | non-small cell lung cancer |
Id Information
Sequence: | 40284229 |
Id Source | org_study_id |
Id Value | SUCCESS |
Countries
Sequence: | 42705271 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55788743 |
Group Type | Experimental |
Title | Sintilimab Combined With Docetaxel |
Description | Sintilimab Combined With Docetaxel for Double Platinum-based Chemotherapy Failure Advanced Non-small Cell Lung Cancer |
Interventions
Sequence: | 52657519 |
Intervention Type | Drug |
Name | Sintilimab Combined With Docetaxel |
Description | Sintilimab 200mgi.v q3w Docetaxel 75mg/m2 i.v q3w |
Keywords
Sequence: | 80110991 | Sequence: | 80110992 | Sequence: | 80110993 |
Name | Non-small Cell Lung Cancer | Name | Sintilimab | Name | Docetaxel |
Downcase Name | non-small cell lung cancer | Downcase Name | sintilimab | Downcase Name | docetaxel |
Design Outcomes
Sequence: | 178026315 | Sequence: | 178026316 | Sequence: | 178026317 | Sequence: | 178026318 | Sequence: | 178026319 | Sequence: | 178026320 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | ORR (Overall response rate) | Measure | PFS (progression free survival time) | Measure | OS (overall survival time) | Measure | DOR (duration of response) | Measure | DCR (disease control rate) | Measure | TTR (time to response) |
Time Frame | Approximately 1 years | Time Frame | Approximately 1 years | Time Frame | Approximately 1 years | Time Frame | Approximately 1 years | Time Frame | Approximately 1 years | Time Frame | Approximately 1 years |
Description | Evaluation of objective response rates in patients with advanced or metastatic non-small cell lung cancer who failed to receive platinum-based dual-drug chemotherapy in response to RECIST 1.1 and in combination with docetaxel and docetaxel | Description | Assessment of the disease-free progression of the subject according to RECIST 1.1 | Description | Assess the overall survival of the subject according to RECIST 1.1 | Description | Assessment of subject's duration of remission according to RECIST 1.1 | Description | Assessment of subject's disease control rate according to RECIST 1.1 | Description | Assessment of subject's objective response time according to RECIST 1.1 |
Browse Conditions
Sequence: | 194154796 | Sequence: | 194154797 | Sequence: | 194154798 | Sequence: | 194154799 | Sequence: | 194154800 | Sequence: | 194154801 | Sequence: | 194154802 | Sequence: | 194154803 | Sequence: | 194154804 | Sequence: | 194154805 |
Mesh Term | Lung Neoplasms | Mesh Term | Carcinoma, Non-Small-Cell Lung | Mesh Term | Respiratory Tract Neoplasms | Mesh Term | Thoracic Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Carcinoma, Bronchogenic | Mesh Term | Bronchial Neoplasms |
Downcase Mesh Term | lung neoplasms | Downcase Mesh Term | carcinoma, non-small-cell lung | Downcase Mesh Term | respiratory tract neoplasms | Downcase Mesh Term | thoracic neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | carcinoma, bronchogenic | Downcase Mesh Term | bronchial neoplasms |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48483096 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Hunan Province Tumor Hospital |
Overall Officials
Sequence: | 29378430 |
Role | Principal Investigator |
Name | Yongchang Zhang, MD |
Affiliation | Hunan Cancer Hospital |
Design Group Interventions
Sequence: | 68387504 |
Design Group Id | 55788743 |
Intervention Id | 52657519 |
Eligibilities
Sequence: | 30866920 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 75 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Sign written informed consent before any trial-related processes are implemented Subjects must have previously been treated with a platinum-containing dual chemotherapy (carboplatin or cisplatin) regimen for advanced or metastatic tumorsisease progression occurred during or after the period. i) receiving maintenance therapy (referring to treatment with no progress after treatment with a platinum-containing dual chemotherapy regimen) and progress Subjects are eligible for inclusion. Ii) treatment of locally advanced disease with platinum-containing adjuvant, neoadjuvant therapy or radical chemoradiotherapy, and completion of treatment Subjects with tumor recurrence or metastasis within 6 months after treatment are eligible.selected. Iii) administration of platinum-containing adjuvant, neoadjuvant therapy or radical chemoradiotherapy for treatment of locally advanced disease >6 months laterTumor recurrence, and later progressed during or after treatment of a recurrent tumor with a platinum-based regimen Subjects are eligible for inclusion. Patients confirmed by histological specimens who are not eligible for EGFR, ALK or ROS1 targeted therapy (with no tumor) EGFR-sensitive mutations and no evidence of ALK, ROS1 gene rearrangement); Exclusion Criteria: Small cell lung cancer |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253996042 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 36 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 75 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30612734 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26757161 |
Intervention Id | 52657519 |
Name | SCD |
Responsible Parties
Sequence: | 28979268 |
Responsible Party Type | Principal Investigator |
Name | Yongchang Zhang |
Title | Professor |
Affiliation | Hunan Province Tumor Hospital |
Study References
Sequence: | 52251261 |
Pmid | 36064386 |
Reference Type | derived |
Citation | Zhang Y, Song L, Zeng L, Xiong Y, Liu L, Zhou C, Yang H, Wang Z, Xia Q, Jiang W, Xu Q, Yang N. Sintilimab plus docetaxel as second-line therapy of advanced non-small cell lung cancer without targetable mutations: a phase II efficacy and biomarker study. BMC Cancer. 2022 Sep 5;22(1):952. doi: 10.1186/s12885-022-10045-0. |
]]>
https://zephyrnet.com/NCT03798730
2019-01-07
https://zephyrnet.com/?p=NCT03798730
NCT03798730https://www.clinicaltrials.gov/study/NCT03798730?tab=tableNANANAThis study aims to investigate whether protein fortification of foods and beverages causes mouthdrying and mucoadhesion and whether this is influenced by age and saliva flow.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-18 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-02-12 |
Start Month Year | January 7, 2019 |
Primary Completion Month Year | July 10, 2019 |
Verification Month Year | February 2020 |
Verification Date | 2020-02-29 |
Last Update Posted Date | 2020-02-12 |
Detailed Descriptions
Sequence: | 20709975 |
Description | To investigate, by using protein fortified foods and beverages, whether mucoadhesion to the oral cavity is greater for older adults compared to younger adults and determine whether it is related to salivary flow rate. To determine whether protein fortification of foods and beverages causes mouthdrying and whether perception and acceptance are influenced by age and individual differences in saliva flow. These aims will be investigated using two different models: a liquid model using whey protein and a solid model using protein fortified biscuits and cakes. |
Facilities
Sequence: | 199965044 |
Name | Sensory Science Centre, Department of Food and Nutritional Sciences, University of Reading |
City | Reading |
State | Berkshire |
Zip | R66 6UR |
Country | United Kingdom |
Conditions
Sequence: | 52138968 | Sequence: | 52138969 | Sequence: | 52138970 |
Name | Individual Difference | Name | Food Sensitivity | Name | Food Preferences |
Downcase Name | individual difference | Downcase Name | food sensitivity | Downcase Name | food preferences |
Id Information
Sequence: | 40135033 |
Id Source | org_study_id |
Id Value | UREC 18/46 |
Countries
Sequence: | 42542667 |
Name | United Kingdom |
Removed | False |
Design Groups
Sequence: | 55559308 | Sequence: | 55559309 |
Group Type | Experimental | Group Type | Experimental |
Title | Solid Model | Title | Liquid Model |
Description | Cake
-Control Vanilla Cake and Protein Fortified Vanilla Cake Biscuit -Control Lemon Biscuit and Protein Fortified Lemon Biscuit |
Description | Whey Protein Beverages
Native sample (protein unheated) |
Interventions
Sequence: | 52454869 | Sequence: | 52454870 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Solid Model | Name | Liquid Model |
Description | Cake and biscuit will be used, with the amount of protein varied to study the effect on perception of the products (using sensory methods of rating drying and discrimination tests "which is the stronger in drying") | Description | Intervention Description: To study the effect of protein denaturation on perception of whey protein beverages using sensory methods (rating drying as well as discrimination tests "which is the stronger in drying"). Measuring mucoadhesion via protein content remaining in saliva following swallowing of whey protein beverages. |
Keywords
Sequence: | 79822769 | Sequence: | 79822770 | Sequence: | 79822771 | Sequence: | 79822772 | Sequence: | 79822773 |
Name | Older Adults | Name | Oral Nutritional Supplements | Name | Saliva Flow | Name | Mucoadhesion | Name | Mouthdrying |
Downcase Name | older adults | Downcase Name | oral nutritional supplements | Downcase Name | saliva flow | Downcase Name | mucoadhesion | Downcase Name | mouthdrying |
Design Outcomes
Sequence: | 177263527 | Sequence: | 177263528 | Sequence: | 177263529 | Sequence: | 177263531 | Sequence: | 177263530 | Sequence: | 177263532 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Saliva sample to examine change over time of protein remaining in mouth (Mucoadhesion) | Measure | Mouthdrying from cake | Measure | Mouthdrying from biscuits | Measure | Saliva Collection | Measure | Mouthdrying from whey protein | Measure | Questionnaire |
Time Frame | Saliva collection at 4 timepoints post swallowing of each sample (15s, 30s, 60s, 120s) at study visits two and three, reported at 1 year. | Time Frame | At one time point (visit 3) reported at 1 year. | Time Frame | At one time point (visit 2) reported at 1 year. | Time Frame | Reported at 1 year (Unstimulated saliva flow taken at the start of every study visit. Stimulated saliva flow taken at the start of study visit one.) | Time Frame | At one time point (visit 1) reported at 1 year. | Time Frame | At one time point (visit 1) reported at 1 year. |
Description | Participants drink whey protein beverages (unheated and heated protein) then after different time points post swallowing (15 seconds to 5 minutes) expectorated saliva is collected to analyse protein for the extent of mucoadhesion) | Description | Perceived mouth drying from protein fortified vanilla cake and control vanilla cake using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying") | Description | Perceived mouth drying from protein fortified lemon biscuits and control lemon biscuit using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying") | Description | Salivary flow rates from unstimulated and stimulated saliva samples. | Description | Perceived mouth drying from whey protein beverages (unheated and heated whey protein) using data from sensory methods (rating drying as well as discrimination tests "which is the stronger in drying") | Description | Dental status and mouth behaviour categorisation via a questionnaire. Category data (ie participants check boxes that apply). The dental status questionnaire is adapted from the WHO oral health questionnaire, it indicates where a participant has poor dental status. The mouth behaviour questionnaire is a validated questionnaire (JMBM, trademarked), we are investigating whether it relates to perception of protein fortified foods. |
Browse Conditions
Sequence: | 193366386 | Sequence: | 193366387 |
Mesh Term | Hypersensitivity | Mesh Term | Immune System Diseases |
Downcase Mesh Term | hypersensitivity | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290680 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Reading |
Overall Officials
Sequence: | 29268521 |
Role | Principal Investigator |
Name | Lisa Methven |
Affiliation | University of Reading |
Design Group Interventions
Sequence: | 68107405 | Sequence: | 68107406 |
Design Group Id | 55559308 | Design Group Id | 55559309 |
Intervention Id | 52454869 | Intervention Id | 52454870 |
Eligibilities
Sequence: | 30747703 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Age 18-30 years or over 65 years Exclusion Criteria: Cognitively impaired |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121797 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 6 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30493986 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Single |
Masking Description | All samples provided to the participant are labelled with 3 digit random codes |
Intervention Model Description | This study involves both a crossover design where each participant tastes both the control product (not fortified) and the protein fortified product with an appropriate break between the two sessions. It is also both a within and between groups design as the responses from the older participants will be compared to the younger participants. The study will be conducted single blind as it not feasible to blind the researcher. Each participant will attend 3 study visits and all foods will be presented with random blinding codes. |
Subject Masked | True |
Responsible Parties
Sequence: | 28860266 |
Responsible Party Type | Principal Investigator |
Name | Lisa Methven |
Title | Professor in Food and Sensory Science |
Affiliation | University of Reading |
Study References
Sequence: | 52032695 | Sequence: | 52032696 | Sequence: | 52032697 | Sequence: | 52032693 | Sequence: | 52032694 | Sequence: | 52032698 |
Pmid | 26456531 | Pmid | 12859786 | Pmid | 20861088 | Pmid | 28260840 | Pmid | 24092277 | Pmid | 24440265 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Affoo RH, Foley N, Garrick R, Siqueira WL, Martin RE. Meta-Analysis of Salivary Flow Rates in Young and Older Adults. J Am Geriatr Soc. 2015 Oct;63(10):2142-51. doi: 10.1111/jgs.13652. Epub 2015 Oct 12. | Citation | Gosney M. Are we wasting our money on food supplements in elder care wards? J Adv Nurs. 2003 Aug;43(3):275-80. doi: 10.1046/j.1365-2648.2003.02710.x. | Citation | Kennedy O, Law C, Methven L, Mottram D, Gosney M. Investigating age-related changes in taste and affects on sensory perceptions of oral nutritional supplements. Age Ageing. 2010 Nov;39(6):733-8. doi: 10.1093/ageing/afq104. Epub 2010 Sep 22. | Citation | Bull SP, Hong Y, Khutoryanskiy VV, Parker JK, Faka M, Methven L. Whey protein mouth drying influenced by thermal denaturation. Food Qual Prefer. 2017 Mar;56(Pt B):233-240. doi: 10.1016/j.foodqual.2016.03.008. | Citation | Withers CA, Cook MT, Methven L, Gosney MA, Khutoryanskiy VV. Investigation of milk proteins binding to the oral mucosa. Food Funct. 2013 Nov;4(11):1668-74. doi: 10.1039/c3fo60291e. | Citation | Withers CA, Lewis MJ, Gosney MA, Methven L. Potential sources of mouth drying in beverages fortified with dairy proteins: A comparison of casein- and whey-rich ingredients. J Dairy Sci. 2014 Mar;97(3):1233-47. doi: 10.3168/jds.2013-7273. Epub 2014 Jan 17. |
]]>
https://zephyrnet.com/NCT03798717
2019-02-20
https://zephyrnet.com/?p=NCT03798717
NCT03798717https://www.clinicaltrials.gov/study/NCT03798717?tab=tableNANANAType 2 diabetes mellitus (T2DM) is characterised by chronic high blood sugar concentration (hyperglycaemia) and insulin resistance leading to a reduction in insulin sensitivity. These hyperglycaemic excursions can seriously impact metabolic, micro and macrovascular health. The total cost of the direct and indirect care of individuals with diabetes (~90% T2DM) in the UK (United Kingdom) is £23.7 billion, equating to ~20% of the annual national health service (NHS) budget, with this projected to become unsustainable. Low-cost interventions to improve glycaemic control in these individuals are therefore warranted. Current interventions include pharmaceuticals, exercise and calorie restrictive diets. Pharmaceutical interventions carry a high financial cost, while exercise and diet programmes have a low adherence rate in individuals with T2DM.
Heat therapy offers one potential low cost therapy. Immersion in a hot tub for 30 mins.day-1 for 10 days has been shown to reduce fasting plasma [glucose] and HbA1c in individuals with T2DM, which may be explained by acute (e.g. muscle) and chronic (e.g. reduced inflammatory status and increased heat shock proteins (HSP)) adaptations, although experimental evidence for these hypothesis are sparse. Other potential benefits include improved glycaemic control, insulin sensitivity, elevated resting metabolic rate and improved micro- and macrovascular function.
The aim of the present study is to determine whether acute hot water immersion can improve glucose tolerance in individuals with T2DM and whether it is more beneficial to undertake this before or after a OGTT (oral glucose tolerance test).
<![CDATA[
Studies
Study First Submitted Date | 2018-12-20 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-07-21 |
Start Month Year | February 20, 2019 |
Primary Completion Month Year | March 9, 2020 |
Verification Month Year | July 2021 |
Verification Date | 2021-07-31 |
Last Update Posted Date | 2021-07-21 |
Results First Posted Date | 2021-07-19 |
Detailed Descriptions
Sequence: | 20724573 |
Description | Visit 1 (consent, screening and familiarisation) During visit 1, participants will give their informed consent, followed by a health screening questionnaire. In addition to the health screening questionnaire, medical history and a blood sample will be collected and analysed for a full blood count, glycated haemoglobin (HbA1c), liver and kidney function. Finally, a resting electrocardiogram (ECG) will also be recorded and then examined for irregularities, where a clinical decision will be made on further participation to the study by consultants at QA (Queen Alexandra) hospital. Participants will then be shown the rest of the equipment and taken through the procedure for the next 3 visits and, if the participant is happy to continue the study, the next visit will be organised.
Visit 2, 3 and 4 Participants will arrive at the laboratory at ~9 am for conditions 1 and 2 and 8 am for condition 3. Prior to a 15 min resting period (supine) before any measures are taken participants will be asked to insert a rectal thermistor (participants will be given clear instructions using the investigator's SoPs (standard operating procedure)). Condition 1, 2 and 3 will be balanced and participants randomly allocated to begin the study in either visit 2, 3 or 4 using a blinded member of the team. For all visits (see figure 2), participants will lie in a semi recumbent position in minimal clothing (bathing shorts and a t-shirt) for the entirety of the visit. Initially, participants will be cannulated (Versatus winged and ported IV cannula, Terumo, Japan) and blood samples drawn for analysis of osmolality (Lithium Heparin (LH) tubes BD (Becton, Dickinson and Company), USA) plasma [glucose] (Fluoride/Oxalate tubes, BD, USA), [insulin] (Ethylenediaminetetraacetic acid (EDTA) K2, BD, USA), and [eHSP70 (extracellular heat shock protein 70)] (EDTA K2, BD, USA) at baseline and every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) (Rapilose OGTT solution, Penlan healthcare, Japan) will commence in a thermoneutral room (~ 23oC). A maximum of 18 mL of blood being drawn at each time point (max 126 mL per visit). To maintain the patency of the cannula and to reduce the risk of infection, after every sample is taken, 5 mL of saline will be flushed through the cannula. Then before every sample is taken, 2.5 mL of blood will be drawn out of the cannula to ensure any remaining saline will not interfere with the samples and data interpretation (additional 17.5mL per visit). During the OGTT, HR (heart rate) (via electrocardiogram) will be measured continuously, whilst blood pressure (M5-1, Omron, Japan), deep body temperature (rectal probe) and resting metabolic rate (indirect calorimetry) (Quark CPET (cardiopulmonary exercise test), Cosmed, Italy) will be assessed every 30 min. Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear. Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min (see figure 2 for a schematic). |
Facilities
Sequence: | 200141289 |
Name | Department of Sport and Exercise Science |
City | Portsmouth |
State | Hampshire |
Zip | PO1 2ER |
Country | United Kingdom |
Conditions
Sequence: | 52178903 |
Name | Diabetes Mellitus, Type 2 |
Downcase Name | diabetes mellitus, type 2 |
Id Information
Sequence: | 40164254 |
Id Source | org_study_id |
Id Value | 003AS |
Countries
Sequence: | 42575663 |
Name | United Kingdom |
Removed | False |
Design Groups
Sequence: | 55601789 | Sequence: | 55601790 | Sequence: | 55601791 |
Group Type | No Intervention | Group Type | Experimental | Group Type | Experimental |
Title | Control | Title | Pre OGTT | Title | Post OGTT |
Description | Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn.every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (~ 23C). During the OGTT, HR will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min. | Description | Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear. | Description | Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min. |
Interventions
Sequence: | 52493074 |
Intervention Type | Diagnostic Test |
Name | Heating |
Description | Warm water immersion |
Design Outcomes
Sequence: | 177409859 | Sequence: | 177409860 | Sequence: | 177409861 | Sequence: | 177409862 | Sequence: | 177409863 | Sequence: | 177409864 | Sequence: | 177409865 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Mean AUC (Area Under the Curve) Plasma [Glucose] | Measure | Change in Plasma [Insulin] | Measure | Mean Insulin Sensitivity | Measure | Change in Fuel Utilisation | Measure | Change in Cardiovascular Status | Measure | Change in eHSP70 (Extracellular Heat Shock Protein 70) | Measure | Change in Inflammatory Status |
Time Frame | Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks | Time Frame | Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks | Time Frame | Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks | Time Frame | Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks | Time Frame | Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks | Time Frame | Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks | Time Frame | Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks |
Description | Does an acute bout of passive, warm water therapy reduce plasma [glucose]? Units for AUC are AU (arbitrary units) which have been derived from the trapezoidal method and have been published as such. Trapezoidal method: AUC = Δx ((y0/2)+y1+y2+y3+…+(yn/2)). | Description | Does plasma [insulin] reduce more if the passive, warm water therapy is conducted before or after the OGTT? | Description | Does insulin sensitivity increase following an acute bout of warm water therapy? Calculation of insulin sensitivity is measured in AU which have been derived from the Gutt method and have been published as such. Gutt insulin sensitivity = [75,000 + (G0-G120) × 0.19 × BW]/(120 × log [(I0 + I120)/2] × [(G0 + G120)/2]). Where G = plasma [glucose], I = plasma [insulin] and BW = body weight. | Description | Does carbohydrate and fat (RER) utilisation alter during and following an acute bout of warm water therapy? | Description | Does heart rate (variability) change during or after an acute bout of warm water therapy? | Description | Does eHSP increases during and following an acute bout of warm water therapy? | Description | Does inflammatory status (IL-6 & IL-10) change during or after an acute bout of warm water therapy? |
Browse Conditions
Sequence: | 193515886 | Sequence: | 193515887 | Sequence: | 193515888 | Sequence: | 193515889 | Sequence: | 193515890 |
Mesh Term | Diabetes Mellitus | Mesh Term | Diabetes Mellitus, Type 2 | Mesh Term | Glucose Metabolism Disorders | Mesh Term | Metabolic Diseases | Mesh Term | Endocrine System Diseases |
Downcase Mesh Term | diabetes mellitus | Downcase Mesh Term | diabetes mellitus, type 2 | Downcase Mesh Term | glucose metabolism disorders | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | endocrine system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48326163 | Sequence: | 48326164 |
Agency Class | OTHER | Agency Class | OTHER_GOV |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Portsmouth | Name | Portsmouth Hospitals NHS Trust |
Design Group Interventions
Sequence: | 68159872 | Sequence: | 68159873 |
Design Group Id | 55601791 | Design Group Id | 55601790 |
Intervention Id | 52493074 | Intervention Id | 52493074 |
Eligibilities
Sequence: | 30769672 |
Gender | All |
Minimum Age | 35 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | The participants must meet all of the following criteria to be considered eligible for the study:
Male or female (either post-menopausal or in the early-follicular phase (3-5 days after the onset of menstruation) of the menstrual cycle), aged 35 years or above. Exclusion Criteria The participant may not enter / be withdrawn from the study if any of the following apply: Severe peripheral neuropathy (to the point to which they cannot sense temperature) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253936836 |
Number Of Facilities | 1 |
Number Of Nsae Subjects | 3 |
Registered In Calendar Year | 2018 |
Actual Duration | 12 |
Were Results Reported | True |
Months To Report Results | 13 |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 35 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30515826 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Drop Withdrawals
Sequence: | 28993690 | Sequence: | 28993691 | Sequence: | 28993692 | Sequence: | 28993693 | Sequence: | 28993694 | Sequence: | 28993695 | Sequence: | 28993696 | Sequence: | 28993697 | Sequence: | 28993698 | Sequence: | 28993699 | Sequence: | 28993700 | Sequence: | 28993701 | Sequence: | 28993702 | Sequence: | 28993703 | Sequence: | 28993704 | Sequence: | 28993705 | Sequence: | 28993706 | Sequence: | 28993707 | Sequence: | 28993708 | Sequence: | 28993709 | Sequence: | 28993710 | Sequence: | 28993711 | Sequence: | 28993712 | Sequence: | 28993713 | Sequence: | 28993714 | Sequence: | 28993715 | Sequence: | 28993716 | Sequence: | 28993717 | Sequence: | 28993718 | Sequence: | 28993719 | Sequence: | 28993720 | Sequence: | 28993721 | Sequence: | 28993722 | Sequence: | 28993723 | Sequence: | 28993724 | Sequence: | 28993725 |
Result Group Id | 56100807 | Result Group Id | 56100808 | Result Group Id | 56100809 | Result Group Id | 56100810 | Result Group Id | 56100811 | Result Group Id | 56100812 | Result Group Id | 56100807 | Result Group Id | 56100808 | Result Group Id | 56100809 | Result Group Id | 56100810 | Result Group Id | 56100811 | Result Group Id | 56100812 | Result Group Id | 56100807 | Result Group Id | 56100808 | Result Group Id | 56100809 | Result Group Id | 56100810 | Result Group Id | 56100811 | Result Group Id | 56100812 | Result Group Id | 56100807 | Result Group Id | 56100808 | Result Group Id | 56100809 | Result Group Id | 56100810 | Result Group Id | 56100811 | Result Group Id | 56100812 | Result Group Id | 56100807 | Result Group Id | 56100808 | Result Group Id | 56100809 | Result Group Id | 56100810 | Result Group Id | 56100811 | Result Group Id | 56100812 | Result Group Id | 56100807 | Result Group Id | 56100808 | Result Group Id | 56100809 | Result Group Id | 56100810 | Result Group Id | 56100811 | Result Group Id | 56100812 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Failed Screening | Reason | Failed Screening | Reason | Failed Screening | Reason | Failed Screening | Reason | Failed Screening | Reason | Failed Screening | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Physician Decision | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | Adverse Event | Reason | COVID-19 (coronavirus disease) Lockdown | Reason | COVID-19 (coronavirus disease) Lockdown | Reason | COVID-19 (coronavirus disease) Lockdown | Reason | COVID-19 (coronavirus disease) Lockdown | Reason | COVID-19 (coronavirus disease) Lockdown | Reason | COVID-19 (coronavirus disease) Lockdown |
Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 1 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 |
Intervention Other Names
Sequence: | 26678029 |
Intervention Id | 52493074 |
Name | Bath |
Milestones
Sequence: | 41014439 | Sequence: | 41014440 | Sequence: | 41014441 | Sequence: | 41014442 | Sequence: | 41014443 | Sequence: | 41014444 | Sequence: | 41014445 | Sequence: | 41014446 | Sequence: | 41014447 | Sequence: | 41014448 | Sequence: | 41014449 | Sequence: | 41014450 | Sequence: | 41014451 | Sequence: | 41014452 | Sequence: | 41014453 | Sequence: | 41014454 | Sequence: | 41014455 | Sequence: | 41014456 |
Result Group Id | 56100807 | Result Group Id | 56100808 | Result Group Id | 56100809 | Result Group Id | 56100810 | Result Group Id | 56100811 | Result Group Id | 56100812 | Result Group Id | 56100807 | Result Group Id | 56100808 | Result Group Id | 56100809 | Result Group Id | 56100810 | Result Group Id | 56100811 | Result Group Id | 56100812 | Result Group Id | 56100807 | Result Group Id | 56100808 | Result Group Id | 56100809 | Result Group Id | 56100810 | Result Group Id | 56100811 | Result Group Id | 56100812 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 |
Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 4 | Count | 3 | Count | 3 | Count | 4 | Count | 3 | Count | 3 | Count | 2 | Count | 2 | Count | 2 | Count | 2 | Count | 2 | Count | 2 | Count | 2 | Count | 1 | Count | 1 | Count | 2 | Count | 1 | Count | 1 |
Participant Flows
Sequence: | 3921905 |
Recruitment Details | 440 individuals were screened for eligibility (200 clinical letters, 40 from day events and 200 from local diabetes education group). 420 declined and 0 were excluded. Once participants were randomly allocated to arm sequence 5 withdrew before starting. Three in-between experimental visits. Twelve completed the study and data analysed. |
Pre Assignment Details | Participants were excluded from the study before assignment to groups if they did not pass screening criteria. Balanced randomisation of order in which individuals completed each arm (cross-over) was carried out. Therefore there was an equal number of individuals completing all combinations of arms. |
Outcome Counts
Sequence: | 74016528 | Sequence: | 74016529 | Sequence: | 74016530 | Sequence: | 74016531 | Sequence: | 74016532 | Sequence: | 74016533 | Sequence: | 74016534 | Sequence: | 74016535 | Sequence: | 74016536 | Sequence: | 74016537 | Sequence: | 74016538 | Sequence: | 74016539 | Sequence: | 74016540 | Sequence: | 74016541 | Sequence: | 74016542 | Sequence: | 74016543 | Sequence: | 74016544 | Sequence: | 74016545 | Sequence: | 74016546 | Sequence: | 74016547 | Sequence: | 74016548 |
Outcome Id | 30811310 | Outcome Id | 30811310 | Outcome Id | 30811310 | Outcome Id | 30811311 | Outcome Id | 30811311 | Outcome Id | 30811311 | Outcome Id | 30811312 | Outcome Id | 30811312 | Outcome Id | 30811312 | Outcome Id | 30811313 | Outcome Id | 30811313 | Outcome Id | 30811313 | Outcome Id | 30811314 | Outcome Id | 30811314 | Outcome Id | 30811314 | Outcome Id | 30811315 | Outcome Id | 30811315 | Outcome Id | 30811315 | Outcome Id | 30811316 | Outcome Id | 30811316 | Outcome Id | 30811316 |
Result Group Id | 56100813 | Result Group Id | 56100814 | Result Group Id | 56100815 | Result Group Id | 56100816 | Result Group Id | 56100814 | Result Group Id | 56100815 | Result Group Id | 56100816 | Result Group Id | 56100814 | Result Group Id | 56100815 | Result Group Id | 56100816 | Result Group Id | 56100814 | Result Group Id | 56100815 | Result Group Id | 56100813 | Result Group Id | 56100814 | Result Group Id | 56100815 | Result Group Id | 56100816 | Result Group Id | 56100814 | Result Group Id | 56100815 | Result Group Id | 56100813 | Result Group Id | 56100814 | Result Group Id | 56100815 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 12 | Count | 0 | Count | 0 | Count | 0 | Count | 8 | Count | 8 | Count | 8 | Count | 0 | Count | 0 | Count | 0 |
Provided Documents
Sequence: | 2580331 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2019-04-05 |
Url | https://ClinicalTrials.gov/ProvidedDocs/17/NCT03798717/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27948250 | Sequence: | 27948251 | Sequence: | 27948252 | Sequence: | 27948253 | Sequence: | 27948254 | Sequence: | 27948255 | Sequence: | 27948256 | Sequence: | 27948257 | Sequence: | 27948258 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 | Ctgov Group Code | EG002 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 |
Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 |
Created At | 2023-08-09 01:48:56.292404 | Created At | 2023-08-09 01:48:56.292404 | Created At | 2023-08-09 01:48:56.292404 | Created At | 2023-08-09 01:48:56.292404 | Created At | 2023-08-09 01:48:56.292404 | Created At | 2023-08-09 01:48:56.292404 | Created At | 2023-08-09 01:48:56.292404 | Created At | 2023-08-09 01:48:56.292404 | Created At | 2023-08-09 01:48:56.292404 |
Updated At | 2023-08-09 01:48:56.292404 | Updated At | 2023-08-09 01:48:56.292404 | Updated At | 2023-08-09 01:48:56.292404 | Updated At | 2023-08-09 01:48:56.292404 | Updated At | 2023-08-09 01:48:56.292404 | Updated At | 2023-08-09 01:48:56.292404 | Updated At | 2023-08-09 01:48:56.292404 | Updated At | 2023-08-09 01:48:56.292404 | Updated At | 2023-08-09 01:48:56.292404 |
Reported Events
Sequence: | 528319393 | Sequence: | 528319394 | Sequence: | 528319395 | Sequence: | 528319396 | Sequence: | 528319397 | Sequence: | 528319398 |
Result Group Id | 56100817 | Result Group Id | 56100818 | Result Group Id | 56100819 | Result Group Id | 56100817 | Result Group Id | 56100818 | Result Group Id | 56100819 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 |
Time Frame | 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks. | Time Frame | 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks. | Time Frame | 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks. | Time Frame | 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks. | Time Frame | 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks. | Time Frame | 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks. |
Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other |
Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 2 |
Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 |
Description | Safety population included all participants who underwent the OGTT and passive heating. | Description | Safety population included all participants who underwent the OGTT and passive heating. | Description | Safety population included all participants who underwent the OGTT and passive heating. | Description | Safety population included all participants who underwent the OGTT and passive heating. | Description | Safety population included all participants who underwent the OGTT and passive heating. | Description | Safety population included all participants who underwent the OGTT and passive heating. |
Event Count | 0 | Event Count | 1 | Event Count | 0 | Event Count | 0 | Event Count | 0 | Event Count | 2 |
Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Surgical and medical procedures | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations |
Adverse Event Term | Pain on cannulation | Adverse Event Term | Pain on cannulation | Adverse Event Term | Pain on cannulation | Adverse Event Term | Vasovagal syncope | Adverse Event Term | Vasovagal syncope | Adverse Event Term | Vasovagal syncope |
Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 |
Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment |
Responsible Parties
Sequence: | 28882133 |
Responsible Party Type | Principal Investigator |
Name | Ant Shepherd |
Title | Senior Lecturer |
Affiliation | University of Portsmouth |
Result Agreements
Sequence: | 3852649 |
Pi Employee | Yes |
Result Contacts
Sequence: | 3852614 |
Organization | University of Portsmouth |
Name | Dr. Ant Shepherd |
Phone | 02392845289 |
ant.shepherd@port.ac.uk | |
Outcomes
Sequence: | 30811316 | Sequence: | 30811310 | Sequence: | 30811311 | Sequence: | 30811315 | Sequence: | 30811312 | Sequence: | 30811313 | Sequence: | 30811314 |
Outcome Type | Secondary | Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Change in Inflammatory Status | Title | Mean AUC (Area Under the Curve) Plasma [Glucose] | Title | Change in Plasma [Insulin] | Title | Change in eHSP70 (Extracellular Heat Shock Protein 70) | Title | Mean Insulin Sensitivity | Title | Change in Fuel Utilisation | Title | Change in Cardiovascular Status |
Description | Does inflammatory status (IL-6 & IL-10) change during or after an acute bout of warm water therapy? | Description | Does an acute bout of passive, warm water therapy reduce plasma [glucose]? Units for AUC are AU (arbitrary units) which have been derived from the trapezoidal method and have been published as such. Trapezoidal method: AUC = Δx ((y0/2)+y1+y2+y3+…+(yn/2)). | Description | Does plasma [insulin] reduce more if the passive, warm water therapy is conducted before or after the OGTT? | Description | Does eHSP increases during and following an acute bout of warm water therapy? | Description | Does insulin sensitivity increase following an acute bout of warm water therapy? Calculation of insulin sensitivity is measured in AU which have been derived from the Gutt method and have been published as such. Gutt insulin sensitivity = [75,000 + (G0-G120) × 0.19 × BW]/(120 × log [(I0 + I120)/2] × [(G0 + G120)/2]). Where G = plasma [glucose], I = plasma [insulin] and BW = body weight. | Description | Does carbohydrate and fat (RER) utilisation alter during and following an acute bout of warm water therapy? | Description | Does heart rate (variability) change during or after an acute bout of warm water therapy? |
Time Frame | Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks | Time Frame | Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks | Time Frame | Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks | Time Frame | Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks | Time Frame | Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks | Time Frame | Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks | Time Frame | Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks |
Population | 0 participants analysed due to lack of funds as a result of the COVID-19 pandemic. Data for this has not been collected and will not be in the future. | Population | Individuals with T2DM (type 2 diabetes mellitus) | Population | Individuals with T2DM | Population | Individuals with T2DM | Population | Individuals with T2DM | Population | Individuals with T2DM | Population | 0 participants analysed due to immersion for passive heating causing too much noise in the data for it to be valid. |
Units | AU | Units | µU/mL | Units | pg/mL | Units | AU | Units | kcal | ||||
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 235724863 | Sequence: | 235724864 | Sequence: | 235724865 | Sequence: | 235724866 | Sequence: | 235724867 | Sequence: | 235724868 | Sequence: | 235724869 | Sequence: | 235724870 | Sequence: | 235724871 | Sequence: | 235724872 | Sequence: | 235724873 | Sequence: | 235724874 | Sequence: | 235724875 | Sequence: | 235724876 | Sequence: | 235724877 |
Outcome Id | 30811310 | Outcome Id | 30811310 | Outcome Id | 30811310 | Outcome Id | 30811311 | Outcome Id | 30811311 | Outcome Id | 30811311 | Outcome Id | 30811312 | Outcome Id | 30811312 | Outcome Id | 30811312 | Outcome Id | 30811313 | Outcome Id | 30811313 | Outcome Id | 30811313 | Outcome Id | 30811315 | Outcome Id | 30811315 | Outcome Id | 30811315 |
Result Group Id | 56100813 | Result Group Id | 56100814 | Result Group Id | 56100815 | Result Group Id | 56100816 | Result Group Id | 56100814 | Result Group Id | 56100815 | Result Group Id | 56100816 | Result Group Id | 56100814 | Result Group Id | 56100815 | Result Group Id | 56100816 | Result Group Id | 56100814 | Result Group Id | 56100815 | Result Group Id | 56100816 | Result Group Id | 56100814 | Result Group Id | 56100815 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 |
Title | Mean AUC (Area Under the Curve) Plasma [Glucose] | Title | Mean AUC (Area Under the Curve) Plasma [Glucose] | Title | Mean AUC (Area Under the Curve) Plasma [Glucose] | Title | Change in Plasma [Insulin] | Title | Change in Plasma [Insulin] | Title | Change in Plasma [Insulin] | Title | Mean Insulin Sensitivity | Title | Mean Insulin Sensitivity | Title | Mean Insulin Sensitivity | Title | Change in Fuel Utilisation | Title | Change in Fuel Utilisation | Title | Change in Fuel Utilisation | Title | Change in eHSP70 (Extracellular Heat Shock Protein 70) | Title | Change in eHSP70 (Extracellular Heat Shock Protein 70) | Title | Change in eHSP70 (Extracellular Heat Shock Protein 70) |
Description | Does an acute bout of passive, warm water therapy reduce plasma [glucose]? Units for AUC are AU (arbitrary units) which have been derived from the trapezoidal method and have been published as such. Trapezoidal method: AUC = Δx ((y0/2)+y1+y2+y3+…+(yn/2)). | Description | Does an acute bout of passive, warm water therapy reduce plasma [glucose]? Units for AUC are AU (arbitrary units) which have been derived from the trapezoidal method and have been published as such. Trapezoidal method: AUC = Δx ((y0/2)+y1+y2+y3+…+(yn/2)). | Description | Does an acute bout of passive, warm water therapy reduce plasma [glucose]? Units for AUC are AU (arbitrary units) which have been derived from the trapezoidal method and have been published as such. Trapezoidal method: AUC = Δx ((y0/2)+y1+y2+y3+…+(yn/2)). | Description | Does plasma [insulin] reduce more if the passive, warm water therapy is conducted before or after the OGTT? | Description | Does plasma [insulin] reduce more if the passive, warm water therapy is conducted before or after the OGTT? | Description | Does plasma [insulin] reduce more if the passive, warm water therapy is conducted before or after the OGTT? | Description | Does insulin sensitivity increase following an acute bout of warm water therapy? Calculation of insulin sensitivity is measured in AU which have been derived from the Gutt method and have been published as such. Gutt insulin sensitivity = [75,000 + (G0-G120) × 0.19 × BW]/(120 × log [(I0 + I120)/2] × [(G0 + G120)/2]). Where G = plasma [glucose], I = plasma [insulin] and BW = body weight. | Description | Does insulin sensitivity increase following an acute bout of warm water therapy? Calculation of insulin sensitivity is measured in AU which have been derived from the Gutt method and have been published as such. Gutt insulin sensitivity = [75,000 + (G0-G120) × 0.19 × BW]/(120 × log [(I0 + I120)/2] × [(G0 + G120)/2]). Where G = plasma [glucose], I = plasma [insulin] and BW = body weight. | Description | Does insulin sensitivity increase following an acute bout of warm water therapy? Calculation of insulin sensitivity is measured in AU which have been derived from the Gutt method and have been published as such. Gutt insulin sensitivity = [75,000 + (G0-G120) × 0.19 × BW]/(120 × log [(I0 + I120)/2] × [(G0 + G120)/2]). Where G = plasma [glucose], I = plasma [insulin] and BW = body weight. | Description | Does carbohydrate and fat (RER) utilisation alter during and following an acute bout of warm water therapy? | Description | Does carbohydrate and fat (RER) utilisation alter during and following an acute bout of warm water therapy? | Description | Does carbohydrate and fat (RER) utilisation alter during and following an acute bout of warm water therapy? | Description | Does eHSP increases during and following an acute bout of warm water therapy? | Description | Does eHSP increases during and following an acute bout of warm water therapy? | Description | Does eHSP increases during and following an acute bout of warm water therapy? |
Units | AU | Units | AU | Units | AU | Units | µU/mL | Units | µU/mL | Units | µU/mL | Units | AU | Units | AU | Units | AU | Units | kcal | Units | kcal | Units | kcal | Units | pg/mL | Units | pg/mL | Units | pg/mL |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 1677 | Param Value | 1797 | Param Value | 1662 | Param Value | 75.18 | Param Value | 48.79 | Param Value | 79.86 | Param Value | 52.00 | Param Value | 47.45 | Param Value | 56.51 | Param Value | 263 | Param Value | 278 | Param Value | 304 | Param Value | 324 | Param Value | 507 | Param Value | 364 |
Param Value Num | 1677.0 | Param Value Num | 1797.0 | Param Value Num | 1662.0 | Param Value Num | 75.18 | Param Value Num | 48.79 | Param Value Num | 79.86 | Param Value Num | 52.0 | Param Value Num | 47.45 | Param Value Num | 56.51 | Param Value Num | 263.0 | Param Value Num | 278.0 | Param Value Num | 304.0 | Param Value Num | 324.0 | Param Value Num | 507.0 | Param Value Num | 364.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation |
Dispersion Value | 386 | Dispersion Value | 340 | Dispersion Value | 364 | Dispersion Value | 68.94 | Dispersion Value | 35.11 | Dispersion Value | 63.91 | Dispersion Value | 11.56 | Dispersion Value | 13.86 | Dispersion Value | 13.85 | Dispersion Value | 33 | Dispersion Value | 40 | Dispersion Value | 38 | Dispersion Value | 154 | Dispersion Value | 112 | Dispersion Value | 81 |
Dispersion Value Num | 386.0 | Dispersion Value Num | 340.0 | Dispersion Value Num | 364.0 | Dispersion Value Num | 68.94 | Dispersion Value Num | 35.11 | Dispersion Value Num | 63.91 | Dispersion Value Num | 11.56 | Dispersion Value Num | 13.86 | Dispersion Value Num | 13.85 | Dispersion Value Num | 33.0 | Dispersion Value Num | 40.0 | Dispersion Value Num | 38.0 | Dispersion Value Num | 154.0 | Dispersion Value Num | 112.0 | Dispersion Value Num | 81.0 |
Baseline Counts
Sequence: | 11385352 | Sequence: | 11385353 | Sequence: | 11385354 | Sequence: | 11385355 | Sequence: | 11385356 | Sequence: | 11385357 | Sequence: | 11385358 |
Result Group Id | 56100800 | Result Group Id | 56100801 | Result Group Id | 56100802 | Result Group Id | 56100803 | Result Group Id | 56100804 | Result Group Id | 56100805 | Result Group Id | 56100806 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall | Scope | overall |
Count | 4 | Count | 3 | Count | 3 | Count | 4 | Count | 3 | Count | 3 | Count | 20 |
Result Groups
Sequence: | 56100802 | Sequence: | 56100803 | Sequence: | 56100800 | Sequence: | 56100801 | Sequence: | 56100804 | Sequence: | 56100805 | Sequence: | 56100806 | Sequence: | 56100807 | Sequence: | 56100808 | Sequence: | 56100809 | Sequence: | 56100810 | Sequence: | 56100811 | Sequence: | 56100812 | Sequence: | 56100813 | Sequence: | 56100814 | Sequence: | 56100815 | Sequence: | 56100816 | Sequence: | 56100817 | Sequence: | 56100818 | Sequence: | 56100819 |
Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG002 | Ctgov Group Code | FG003 | Ctgov Group Code | FG004 | Ctgov Group Code | FG005 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG002 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG002 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event | Result Type | Reported Event |
Title | Pre OGTT – Control – Post OGTT | Title | Pre OGTT – Post OGTT – Control | Title | Control – Pre OGTT – Post OGTT | Title | Control – Post OGTT – Pre OGTT | Title | Post OGTT – Control – Pre OGTT | Title | Post OGTT – Pre OGTT – Control | Title | Total | Title | Control – Pre OGTT – Post OGTT | Title | Control – Post OGTT – Pre OGTT | Title | Pre OGTT – Control – Post OGTT | Title | Pre OGTT – Post OGTT – Control | Title | Post OGTT – Control – Pre OGTT | Title | Post OGTT – Pre OGTT – Control | Title | Control | Title | Pre OGTT | Title | Post OGTT | Title | Control | Title | Control | Title | Pre OGTT | Title | Post OGTT |
Description | Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. | Description | Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. | Description | Participants first underwent a 3 h OGTT with no passive heating. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. | Description | Participants first underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. | Description | Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. | Description | Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. | Description | Total of all reporting groups | Description | Participants first underwent a 3 h OGTT (oral glucose tolerance test) with no passive heating. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. | Description | Participants first underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. | Description | Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. | Description | Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. | Description | Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. | Description | Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. | Description | Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (~ 23C). During the OGTT, HR (heart rate) will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min. | Description | Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear.
Heating: Warm water immersion |
Description | Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min.
Heating: Warm water immersion |
Description | Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn.every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (~ 23C). During the OGTT, HR will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min. | Description | Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn.every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (~ 23C). During the OGTT, HR will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min. | Description | Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear.
Heating: Warm water immersion |
Description | Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min.
Heating: Warm water immersion |
Baseline Measurements
Sequence: | 125616062 | Sequence: | 125616063 | Sequence: | 125616064 | Sequence: | 125616065 | Sequence: | 125616066 | Sequence: | 125616067 | Sequence: | 125616068 | Sequence: | 125616069 | Sequence: | 125616070 | Sequence: | 125616071 | Sequence: | 125616072 | Sequence: | 125616073 | Sequence: | 125616074 | Sequence: | 125616075 | Sequence: | 125616076 | Sequence: | 125616077 | Sequence: | 125616078 | Sequence: | 125616079 | Sequence: | 125616080 | Sequence: | 125616081 | Sequence: | 125616082 | Sequence: | 125616083 | Sequence: | 125616084 | Sequence: | 125616085 | Sequence: | 125616086 | Sequence: | 125616087 | Sequence: | 125616088 | Sequence: | 125616089 | Sequence: | 125616090 | Sequence: | 125616091 | Sequence: | 125616092 | Sequence: | 125616093 | Sequence: | 125616094 | Sequence: | 125616095 | Sequence: | 125616096 | Sequence: | 125616097 |
Result Group Id | 56100800 | Result Group Id | 56100801 | Result Group Id | 56100802 | Result Group Id | 56100803 | Result Group Id | 56100804 | Result Group Id | 56100805 | Result Group Id | 56100806 | Result Group Id | 56100800 | Result Group Id | 56100801 | Result Group Id | 56100802 | Result Group Id | 56100803 | Result Group Id | 56100804 | Result Group Id | 56100805 | Result Group Id | 56100806 | Result Group Id | 56100800 | Result Group Id | 56100801 | Result Group Id | 56100802 | Result Group Id | 56100803 | Result Group Id | 56100804 | Result Group Id | 56100805 | Result Group Id | 56100806 | Result Group Id | 56100800 | Result Group Id | 56100801 | Result Group Id | 56100802 | Result Group Id | 56100803 | Result Group Id | 56100804 | Result Group Id | 56100805 | Result Group Id | 56100806 | Result Group Id | 56100800 | Result Group Id | 56100801 | Result Group Id | 56100802 | Result Group Id | 56100803 | Result Group Id | 56100804 | Result Group Id | 56100805 | Result Group Id | 56100806 | Result Group Id | 56100806 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG003 | Ctgov Group Code | BG004 | Ctgov Group Code | BG005 | Ctgov Group Code | BG006 | Ctgov Group Code | BG006 |
Category | <=18 years | Category | <=18 years | Category | <=18 years | Category | <=18 years | Category | <=18 years | Category | <=18 years | Category | <=18 years | Category | Between 18 and 65 years | Category | Between 18 and 65 years | Category | Between 18 and 65 years | Category | Between 18 and 65 years | Category | Between 18 and 65 years | Category | Between 18 and 65 years | Category | Between 18 and 65 years | Category | >=65 years | Category | >=65 years | Category | >=65 years | Category | >=65 years | Category | >=65 years | Category | >=65 years | Category | >=65 years | Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | Category | Male | ||
Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race and Ethnicity Not Collected |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 2 | Param Value | 1 | Param Value | 1 | Param Value | 2 | Param Value | 1 | Param Value | 2 | Param Value | 9 | Param Value | 2 | Param Value | 2 | Param Value | 2 | Param Value | 2 | Param Value | 2 | Param Value | 1 | Param Value | 11 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 5 | Param Value | 3 | Param Value | 2 | Param Value | 2 | Param Value | 3 | Param Value | 3 | Param Value | 2 | Param Value | 15 | Param Value | 0 |
Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 9.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 11.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 5.0 | Param Value Num | 3.0 | Param Value Num | 2.0 | Param Value Num | 2.0 | Param Value Num | 3.0 | Param Value Num | 3.0 | Param Value Num | 2.0 | Param Value Num | 15.0 | Param Value Num | 0.0 |
Number Analyzed | 4 | Number Analyzed | 3 | Number Analyzed | 3 | Number Analyzed | 4 | Number Analyzed | 3 | Number Analyzed | 3 | Number Analyzed | 20 | Number Analyzed | 4 | Number Analyzed | 3 | Number Analyzed | 3 | Number Analyzed | 4 | Number Analyzed | 3 | Number Analyzed | 3 | Number Analyzed | 20 | Number Analyzed | 4 | Number Analyzed | 3 | Number Analyzed | 3 | Number Analyzed | 4 | Number Analyzed | 3 | Number Analyzed | 3 | Number Analyzed | 20 | Number Analyzed | 4 | Number Analyzed | 3 | Number Analyzed | 3 | Number Analyzed | 4 | Number Analyzed | 3 | Number Analyzed | 3 | Number Analyzed | 20 | Number Analyzed | 4 | Number Analyzed | 3 | Number Analyzed | 3 | Number Analyzed | 4 | Number Analyzed | 3 | Number Analyzed | 3 | Number Analyzed | 20 | Number Analyzed | 20 |
Population Description | Race and Ethnicity were not collected from any participant. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
]]>
https://zephyrnet.com/NCT03798704
2019-01-29
https://zephyrnet.com/?p=NCT03798704
NCT03798704https://www.clinicaltrials.gov/study/NCT03798704?tab=tableNANANAThe aim of this study is to compare two different serological tests, IFA and LIAISON, for detection of Borrelia burgdorferi sensu lato IgM and IgG antibiodies in children with early disseminated Lyme borreliosis.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-17 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-04-30 |
Start Month Year | January 29, 2019 |
Primary Completion Month Year | December 31, 2020 |
Verification Month Year | April 2021 |
Verification Date | 2021-04-30 |
Last Update Posted Date | 2021-04-30 |
Detailed Descriptions
Sequence: | 20750439 |
Description | Slovenia is highly endemic region for Lyme borreliosis (LB). LB is a tick – borne multisystem infectious disease caused by Borrelia burgdorferi sensu lato.
Solitary erythema migrans (SEM) is a typical clinical manifestation of early localized LB and microbiological confirmation of borrelial infection is not required for diagnosis. Clinical manifestations of early disseminated LB (multiple erythema migrans (MEM), peripheral facial palsy and meningitis) are not characteristic enough to enable a reliable diagnosis, indicating the need for laboratory demonstration of borrelial infection which is mainly accomplished with serological tests. For detection of borrelial antibodies several methods are used, such as immunofluorescent assay (IFA), enzyme immunoassay (EIA) and immunoblots. Serological tests are not standardized and have limited sensitivity and specificity. The aim of this study is to specify and compare the sensitivity of IFA and LIAISON serological tests in early disseminated LB in children in Slovenia. The secondary aim is to determine the influence of early antibiotic treatment of early disseminated LB on serological results in children with LB in Slovenia and to compare the serological results in children who are treated with antibiotics immediately and those who are treated later in the course of the study. |
Facilities
Sequence: | 200352070 |
Name | University clinical center |
City | Ljubljana |
Country | Slovenia |
Conditions
Sequence: | 52244470 |
Name | Lyme Disease |
Downcase Name | lyme disease |
Id Information
Sequence: | 40212178 |
Id Source | org_study_id |
Id Value | Arnez 0120-134/2018 |
Countries
Sequence: | 42627132 |
Name | Slovenia |
Removed | False |
Interventions
Sequence: | 52557944 |
Intervention Type | Diagnostic Test |
Name | IFA, LIAISON |
Description | Comparison of two diagnostic serological tests – IFA and LIAISON. |
Keywords
Sequence: | 79972573 | Sequence: | 79972574 | Sequence: | 79972575 | Sequence: | 79972576 | Sequence: | 79972577 |
Name | Lyme disease | Name | IFA | Name | LIAISON | Name | children | Name | Slovenia |
Downcase Name | lyme disease | Downcase Name | ifa | Downcase Name | liaison | Downcase Name | children | Downcase Name | slovenia |
Design Outcomes
Sequence: | 177648746 |
Outcome Type | primary |
Measure | Sensitivity IFA vs. LIAISON |
Time Frame | 2 years |
Description | LIAISON test (E/ml) is expected to be more sensitive than IFA (titer) in detection of Borrelial antibodies in children with early disseminated LB. In all patients both asseys (LIAISON and IFA) are going to be done from the same samples. The difference in the proportion of positive tests between the two assays will be statisticaly analyzed for IgM and IgG antibodies of each patient group. P values < 0,05 will be interpreted as statistically significant.
IFA: Titres >256 in serum and >4 in CSF will be considered positive. LIAISON values in serum: the values of IgM and IgG in serum <18 in <10 E/ml will be considered as negative, 18-22 and 10-15 E/ml will be considerd as border values and >22 in >15 E/ml will be considered as positive. LIAISON in cerebral fluid: the values of IgM in IgG in cerebral fluid <2,5 and <4,5 E/ml will be considered as negative, values 2,5-3,5 and 4,5-5,5 E/ml will be considered as border values and >2,5 in >5,5 E/ml will be considered as positive. |
Browse Conditions
Sequence: | 193766272 | Sequence: | 193766273 | Sequence: | 193766274 | Sequence: | 193766275 | Sequence: | 193766276 | Sequence: | 193766277 | Sequence: | 193766278 | Sequence: | 193766279 | Sequence: | 193766280 |
Mesh Term | Lyme Disease | Mesh Term | Gram-Negative Bacterial Infections | Mesh Term | Bacterial Infections | Mesh Term | Bacterial Infections and Mycoses | Mesh Term | Infections | Mesh Term | Borrelia Infections | Mesh Term | Spirochaetales Infections | Mesh Term | Tick-Borne Diseases | Mesh Term | Vector Borne Diseases |
Downcase Mesh Term | lyme disease | Downcase Mesh Term | gram-negative bacterial infections | Downcase Mesh Term | bacterial infections | Downcase Mesh Term | bacterial infections and mycoses | Downcase Mesh Term | infections | Downcase Mesh Term | borrelia infections | Downcase Mesh Term | spirochaetales infections | Downcase Mesh Term | tick-borne diseases | Downcase Mesh Term | vector borne diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48388154 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University Medical Centre Ljubljana |
Eligibilities
Sequence: | 30808209 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | 18 Years |
Healthy Volunteers | No |
Population | Younger then 18 years |
Criteria | Children younger than 18 years with early disseminated Lyme disease:
multiple erythema migrans |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 254032419 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 23 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Maximum Age Num | 18 |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30554206 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28920569 |
Responsible Party Type | Principal Investigator |
Name | Maja Arnez |
Title | izr. prof. dr. Maja Arnez, dr. med |
Affiliation | University Medical Centre Ljubljana |
]]>
https://zephyrnet.com/NCT03798691
2019-05-28
https://zephyrnet.com/?p=NCT03798691
NCT03798691https://www.clinicaltrials.gov/study/NCT03798691?tab=tableNANANAInflammatory bowel disease (IBD) is a chronic inflammatory state of the gastrointestinal tract(1) affecting 1.6-3.1 million people in the United States. Patients with IBD are treated with immunosuppressants that increase their risk of herpes zoster (HZ), also known as shingles.
Those with IBD have a two-fold increased risk for HZ compared to age matched controls. Because most IBD patients are treated with systemic immunosuppressants, which are an independent risk factor for HZ, the live attenuated HZ vaccine was not recommended. However, the release of the new inactivated HZ vaccine, Shingrix (GlaxoSmithKline), presents new opportunities for preventive care.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-07-11 |
Start Month Year | May 28, 2019 |
Primary Completion Month Year | September 2023 |
Verification Month Year | July 2023 |
Verification Date | 2023-07-31 |
Last Update Posted Date | 2023-07-11 |
Detailed Descriptions
Sequence: | 20647896 |
Description | The purpose of this study is to determine the immunogenicity of the herpes zoster subunit vaccine in inflammatory bowel disease patients on vedolizumab compared to those on anti-tumor necrosis factor (TNF) monotherapy.
The study will evaluate humoral and cell mediated immunity in patients with IBD on vedolizumab who receive the two-dose herpes zoster vaccine. The investigators will evaluate short term, one month after second vaccination dose and sustained immunogenicity at 6 and 12 months post vaccination. The central hypothesis of this proposal is that IBD patients on vedolizumab should be able to mount a normal vaccine response comparable to those on anti-TNF monotherapy who might benefit from a third dose of the subunit vaccine as has been evaluated in HIV and transplant populations. The hypothesis is that IBD patients on vedolizumab will be able to mount a superior response to those on anti-TNF therapy. A recent study showed that hepatitis B vaccine immunogenicity was not affected by vedolizumab. The study population will include adult patients aged 50 or older with IBD(diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria) receiving care at University of Wisconsin Hospital and Clinics or Boston Medical Center. There is no randomization or use of placebo in this study. Two study groups (each containing 15 subjects) will be established Group A: Patients with IBD on anti-TNF monotherapy and Group B patients with IBD on vedolizumab monotherapy. Methods: Eligible patients with IBD will be recruited from the University of Wisconsin Hospital and Clinics or from Center for Digestive Diseases at Boston Medical Center. |
Facilities
Sequence: | 199300710 |
Name | University of Wisconsin Digestive Health Center |
City | Madison |
State | Wisconsin |
Zip | 53705 |
Country | United States |
Browse Interventions
Sequence: | 95682476 | Sequence: | 95682477 | Sequence: | 95682478 |
Mesh Term | Vaccines | Mesh Term | Immunologic Factors | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | vaccines | Downcase Mesh Term | immunologic factors | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51980449 | Sequence: | 51980450 | Sequence: | 51980451 | Sequence: | 51980452 |
Name | Inflammatory Bowel Diseases | Name | Crohn Disease | Name | Ulcerative Colitis | Name | Herpes Zoster |
Downcase Name | inflammatory bowel diseases | Downcase Name | crohn disease | Downcase Name | ulcerative colitis | Downcase Name | herpes zoster |
Id Information
Sequence: | 40010000 | Sequence: | 40010001 | Sequence: | 40010002 | Sequence: | 40010003 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | 2018-1037 | Id Value | SMPH/MEDICINE/GASTROENT | Id Value | A534250 | Id Value | Protocol Version 9/22/2021 |
Id Type | Other Identifier | Id Type | Other Identifier | Id Type | Other Identifier | ||
Id Type Description | UW Madison | Id Type Description | UW Madison | Id Type Description | UW Madison | ||
Countries
Sequence: | 42403985 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55382227 | Sequence: | 55382228 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | Anti-TNF monotherapy | Title | Vedolizumab |
Description | Patients with IBD on Anti-TNF monotherapy will be given the shingrix vaccine. Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later. | Description | Patients with IBD on vedolizumab monotherapy will be given the shingrix vaccine.
Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later. |
Interventions
Sequence: | 52291549 |
Intervention Type | Biological |
Name | Shingrix |
Description | Biological: SHINGRIX
SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 18 years and older. SHINGRIX is a suspension for injection supplied as a single-dose vial of lyophilized glycoprotein e (ge) antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. A single dose after reconstitution is 0.5 mL. Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later. |
Design Outcomes
Sequence: | 176703110 | Sequence: | 176703111 | Sequence: | 176703112 | Sequence: | 176703113 | Sequence: | 176703114 | Sequence: | 176703115 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in cell mediated immunity | Measure | Percent of participants with sustained cell mediated immunity measured via ELISPOT after immunization. | Measure | Percent of participants with a change in antibody concentration post immunization | Measure | Percent of participants with a change in antibody concentration that is sustained at 6 months | Measure | Incidence of Vaccine related adverse effects | Measure | Incidence of change in disease activity post immunization |
Time Frame | It will be measured from pre-immunization to 1 month after receiving second dose of booster vaccine post-immunization. | Time Frame | Baseline to 6 months post-immunization 2nd dose of vaccine. | Time Frame | pre-immunization to one month 2nd dose post-immunization | Time Frame | Baseline to 6 months post-immunization | Time Frame | This will be done at months 1, 2 and 3. | Time Frame | at the baseline visit and one month after receipt of each vaccine |
Description | The primary objective will be the change in cell mediated immunity (CMI) as measured by ELISPOT from pre-immunization to one month after receiving second dose of vaccine. | Description | Sustained change in CMI at 6 months will be assessed after receiving a second dose of booster vaccine post-immunization. CMI will be measured via ELISPOT | Description | A secondary outcome will be the change in varicella zoster virus (VZV) antibody concentration comparing pre-immunization to post immunization antibody concentration. | Description | Sustained change in VZV antibody concentration at 6 months after receiving a second dose of booster vaccine post-immunization will be assessed. | Description | To evaluate for adverse effects following immunization patients will receive phone calls from study personnel to ascertain vaccine-related adverse effects. | Description | The Simple Clinical Colitis Activity Index (SCCAI) will be used to measure disease activity. It is a questionnaire with six subscore topics with scores defined by UC signs and symptoms from 0 to 4 for a range of scores from 0 to 17. Total scores are interpreted as: Remission = score of 0 to 4 points, Mild Activity = score of 5 to 7 points, Moderate Activity = Score of 8 to 16 points, and Severe Activity = Score of > 16 points. |
Browse Conditions
Sequence: | 192731834 | Sequence: | 192731835 | Sequence: | 192731836 | Sequence: | 192731837 | Sequence: | 192731838 | Sequence: | 192731839 | Sequence: | 192731840 | Sequence: | 192731841 | Sequence: | 192731842 | Sequence: | 192731843 | Sequence: | 192731844 | Sequence: | 192731849 | Sequence: | 192731845 | Sequence: | 192731846 | Sequence: | 192731847 | Sequence: | 192731848 |
Mesh Term | Herpes Simplex | Mesh Term | Herpes Zoster | Mesh Term | Crohn Disease | Mesh Term | Intestinal Diseases | Mesh Term | Inflammatory Bowel Diseases | Mesh Term | Gastroenteritis | Mesh Term | Gastrointestinal Diseases | Mesh Term | Digestive System Diseases | Mesh Term | Herpesviridae Infections | Mesh Term | DNA Virus Infections | Mesh Term | Virus Diseases | Mesh Term | Varicella Zoster Virus Infection | Mesh Term | Infections | Mesh Term | Skin Diseases, Viral | Mesh Term | Skin Diseases, Infectious | Mesh Term | Skin Diseases |
Downcase Mesh Term | herpes simplex | Downcase Mesh Term | herpes zoster | Downcase Mesh Term | crohn disease | Downcase Mesh Term | intestinal diseases | Downcase Mesh Term | inflammatory bowel diseases | Downcase Mesh Term | gastroenteritis | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | herpesviridae infections | Downcase Mesh Term | dna virus infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | varicella zoster virus infection | Downcase Mesh Term | infections | Downcase Mesh Term | skin diseases, viral | Downcase Mesh Term | skin diseases, infectious | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48140363 | Sequence: | 48140364 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Wisconsin, Madison | Name | Boston Medical Center |
Design Group Interventions
Sequence: | 67892032 | Sequence: | 67892033 |
Design Group Id | 55382227 | Design Group Id | 55382228 |
Intervention Id | 52291549 | Intervention Id | 52291549 |
Eligibilities
Sequence: | 30653071 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patient is between the ages of 18-70 years, inclusive. Exclusion Criteria: Previous receipt of any HZ vaccine |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254257430 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30399927 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26571341 |
Intervention Id | 52291549 |
Name | Recombinant zoster vaccine |
Responsible Parties
Sequence: | 28766431 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798678
2018-12-26
https://zephyrnet.com/?p=NCT03798678
NCT03798678https://www.clinicaltrials.gov/study/NCT03798678?tab=tableNANANAThis phase I trial studies the best dose of CB-839 HCl when given together with carfilzomib and dexamethasone in treating patients with multiple myeloma that has come back or does not respond to previous treatment. CB-839 HCl and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving CB-839 HCl, carfilzomib, and dexamethasone may work better in treating patients with multiple myeloma.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-09 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-06-07 |
Start Month Year | December 26, 2018 |
Primary Completion Month Year | January 30, 2024 |
Verification Month Year | January 2023 |
Verification Date | 2023-01-31 |
Last Update Posted Date | 2023-06-07 |
Detailed Descriptions
Sequence: | 20821318 |
Description | PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of glutaminase inhibitor CB-839 hydrochloride (CB-839 HCl) in combination with carfilzomib and dexamethasone. SECONDARY OBJECTIVES: I. Evaluate the safety and tolerability of CB-839 HCl in combination with carfilzomib and dexamethasone. II. To determine the overall response rate (ORR) associated with the combination of CB-839 HCl with carfilzomib and dexamethasone. CORRELATIVE RESEARCH OBJECTIVES: I. Evaluate plasma pharmacokinetic (PK) profiles of CB-839 HCl and carfilzomib when used in combination. II. To perform molecular profiling assays on malignant and normal tissues, including, but not limited to, whole exome sequencing (WES), messenger ribonucleic acid (RNA) sequencing (RNAseq), circulating cell free (cf) deoxyribonucleic acid (DNA) analysis, flow cytometry assessments, immunohistochemical (IHC) staining, and metabolomics-based assessments in order to identify potential predictive and prognostic biomarkers, and identify resistance mechanisms using genomic DNA, RNA, flow cytometry, IHC, and metabolomics-based assessment platforms. III. To contribute genetic analysis data from de-identified biospecimens to Genomic Data Commons (GDC), a well annotated cancer molecular and clinical data repository, for current and future research. IV. To bank CD138+ multiple myeloma (MM) cells from the bone marrow, and blood (for cfDNA analysis) obtained from patients at the Experimental Therapeutics Clinical Trials Network (ETCTN) Biorepository at Nationwide Children's Hospital. OUTLINE: This is a dose escalation study of glutaminase inhibitor CB-839 hydrochloride. Patients receive glutaminase inhibitor CB-839 hydrochloride orally (PO) every 12 hours on days 1-28, dexamethasone PO on days 1, 2, 8, 9, 15, 16, and 23, and carfilzomib intravenously (IV) over 10 minutes on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then periodically for up to 1 year. |
Facilities
Sequence: | 201015882 | Sequence: | 201015883 | Sequence: | 201015884 | Sequence: | 201015885 | Sequence: | 201015886 |
Name | Yale University | Name | Moffitt Cancer Center | Name | Mayo Clinic in Rochester | Name | Rutgers Cancer Institute of New Jersey | Name | Ohio State University Comprehensive Cancer Center |
City | New Haven | City | Tampa | City | Rochester | City | New Brunswick | City | Columbus |
State | Connecticut | State | Florida | State | Minnesota | State | New Jersey | State | Ohio |
Zip | 06520 | Zip | 33612 | Zip | 55905 | Zip | 08903 | Zip | 43210 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States |
Browse Interventions
Sequence: | 96455012 | Sequence: | 96454997 | Sequence: | 96454998 | Sequence: | 96454999 | Sequence: | 96455000 | Sequence: | 96455001 | Sequence: | 96455002 | Sequence: | 96455003 | Sequence: | 96455004 | Sequence: | 96455005 | Sequence: | 96455006 | Sequence: | 96455007 | Sequence: | 96455008 | Sequence: | 96455009 | Sequence: | 96455010 | Sequence: | 96455011 | Sequence: | 96455013 | Sequence: | 96455014 | Sequence: | 96455015 |
Mesh Term | Protease Inhibitors | Mesh Term | Dexamethasone | Mesh Term | Dexamethasone acetate | Mesh Term | Ichthammol | Mesh Term | BB 1101 | Mesh Term | Anti-Inflammatory Agents | Mesh Term | Antiemetics | Mesh Term | Autonomic Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Gastrointestinal Agents | Mesh Term | Glucocorticoids | Mesh Term | Hormones | Mesh Term | Hormones, Hormone Substitutes, and Hormone Antagonists | Mesh Term | Antineoplastic Agents, Hormonal | Mesh Term | Antineoplastic Agents | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Dermatologic Agents |
Downcase Mesh Term | protease inhibitors | Downcase Mesh Term | dexamethasone | Downcase Mesh Term | dexamethasone acetate | Downcase Mesh Term | ichthammol | Downcase Mesh Term | bb 1101 | Downcase Mesh Term | anti-inflammatory agents | Downcase Mesh Term | antiemetics | Downcase Mesh Term | autonomic agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | gastrointestinal agents | Downcase Mesh Term | glucocorticoids | Downcase Mesh Term | hormones | Downcase Mesh Term | hormones, hormone substitutes, and hormone antagonists | Downcase Mesh Term | antineoplastic agents, hormonal | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | dermatologic agents |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52427050 | Sequence: | 52427051 |
Name | Recurrent Multiple Myeloma | Name | Refractory Multiple Myeloma |
Downcase Name | recurrent multiple myeloma | Downcase Name | refractory multiple myeloma |
Id Information
Sequence: | 40340431 | Sequence: | 40340432 | Sequence: | 40340433 | Sequence: | 40340434 | Sequence: | 40340435 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | NCI-2019-00111 | Id Value | NCI-2019-00111 | Id Value | 10219 | Id Value | 10219 | Id Value | UM1CA186686 |
Id Type | Registry Identifier | Id Type | Other Identifier | Id Type | Other Identifier | Id Type | U.S. NIH Grant/Contract | ||
Id Type Description | CTRP (Clinical Trial Reporting Program) | Id Type Description | Mayo Clinic Cancer Center LAO | Id Type Description | CTEP | ||||
Id Link | https://reporter.nih.gov/quickSearch/UM1CA186686 |
Countries
Sequence: | 42771624 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55877194 |
Group Type | Experimental |
Title | Treatment (CB-839 HCI, dexamethasone, carfilzomib) |
Description | Patients receive glutaminase inhibitor CB-839 Patients receive glutaminase inhibitor CB-839 hydrochloride PO every 12 hours on days 1-28, dexamethasone PO on days 1, 2, 8, 9, 15, 16, and 23, and carfilzomib IV over 10 minutes on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity |
Interventions
Sequence: | 52736356 | Sequence: | 52736357 | Sequence: | 52736358 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Carfilzomib | Name | Dexamethasone | Name | Telaglenastat Hydrochloride |
Description | Given IV | Description | Given PO | Description | Given PO |
Design Outcomes
Sequence: | 178340804 | Sequence: | 178340805 | Sequence: | 178340806 | Sequence: | 178340807 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other |
Measure | Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) | Measure | Incidence of adverse events | Measure | Overall response rate (ORR) | Measure | Pharmacokinetic (PK) profiles and pharmacodynamic effect |
Time Frame | Up to 28 days | Time Frame | Up to 30 days after study treatment | Time Frame | Up to 1 year | Time Frame | Days 1 and 15 of cycle 1 |
Description | MTD will be determined by dose limiting toxicity (DLT). MTD is defined as the dose level below the lowest dose that induces DLT in at least 2 patients (out of 6). The highest dose is defined as the RP2D. A standard cohort 3+3 design will be used. | Description | Incidence of adverse events will be graded according to Common Terminology Criteria for Adverse Events version 5.0. The number and severity of all AEs (overall and by dose-level) will be tabulated and summarized in this patient population. These data will be summarized with and without regard to the relationship to the treatment (i.e., ignoring the relationship data and after sub-setting the data to only events that are at least possibly related to study drug). | Description | The ORR will be defined as the percentage of patients that achieve at least a partial response (as their best response). Properties of the binomial distribution will be used in order to construct an exact 95% confidence interval around this proportion. | Description | PK and pharmacodynamic data will be examined in an exploratory manner. |
Browse Conditions
Sequence: | 194459587 | Sequence: | 194459588 | Sequence: | 194459589 | Sequence: | 194459590 | Sequence: | 194459591 | Sequence: | 194459592 | Sequence: | 194459593 | Sequence: | 194459594 | Sequence: | 194459595 | Sequence: | 194459596 | Sequence: | 194459597 | Sequence: | 194459598 | Sequence: | 194459599 | Sequence: | 194459600 |
Mesh Term | Multiple Myeloma | Mesh Term | Neoplasms, Plasma Cell | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Hemostatic Disorders | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Paraproteinemias | Mesh Term | Blood Protein Disorders | Mesh Term | Hematologic Diseases | Mesh Term | Hemorrhagic Disorders | Mesh Term | Lymphoproliferative Disorders | Mesh Term | Immunoproliferative Disorders | Mesh Term | Immune System Diseases |
Downcase Mesh Term | multiple myeloma | Downcase Mesh Term | neoplasms, plasma cell | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | hemostatic disorders | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | paraproteinemias | Downcase Mesh Term | blood protein disorders | Downcase Mesh Term | hematologic diseases | Downcase Mesh Term | hemorrhagic disorders | Downcase Mesh Term | lymphoproliferative disorders | Downcase Mesh Term | immunoproliferative disorders | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48556202 |
Agency Class | NIH |
Lead Or Collaborator | lead |
Name | National Cancer Institute (NCI) |
Overall Officials
Sequence: | 29418330 |
Role | Principal Investigator |
Name | Wilson I Gonsalves |
Affiliation | Mayo Clinic Cancer Center LAO |
Design Group Interventions
Sequence: | 68498718 | Sequence: | 68498719 | Sequence: | 68498720 |
Design Group Id | 55877194 | Design Group Id | 55877194 | Design Group Id | 55877194 |
Intervention Id | 52736356 | Intervention Id | 52736357 | Intervention Id | 52736358 |
Eligibilities
Sequence: | 30912118 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients must have relapsed and/or refractory myeloma and be experiencing disease relapse Patients must have measurable disease by International Myeloma Working Group (IMWG) criteria (any of the following): Serum M-protein >= 0.5 g/dL or for IgA myeloma, an elevated IgA level by quantitative IgA nephelometry Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only The effects of CB-839 HCl on the developing human fetus are unknown. For this reason and because carfilzomib caused embryo-fetal toxicity in pregnant rabbits at doses lower than the recommended dose, women of child-bearing potential and men must agree to use two effective methods of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of CB-839 HCl, carfilzomib, and dexamethasone administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of CB-839 HCl, carfilzomib, and dexamethasone administration Exclusion Criteria: Patients who are refractory or intolerant to carfilzomib (prior carfilzomib exposure accepted) Patients who have received recent prior chemotherapy with: Alkylators (e.g., melphalan, cyclophosphamide) and anthracyclines =< 14 days prior to registration, Any of the following: Pregnant women or women of reproductive ability who are unwilling to use two effective methods of contraception from the time of signing the informed consent form through 4 months after the last dose of study drug And men who are unwilling to use birth control while taking the drug and for 4 months after stopping treatment Pregnant women are excluded from this study because carfilzomib is a PI with the potential for abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with CB-839 HCl, carfilzomib, and dexamethasone, breastfeeding should be discontinued if the mother is treated with this drug combination Central nervous system (CNS) involvement Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other AEs On concurrent treatment with an HIV protease inhibitor Human immunodeficiency virus (HIV) protease inhibitors can affect the unfolded protein response in myeloma cells as well as the activity of PIs |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254174421 |
Number Of Facilities | 5 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30657818 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26798662 | Sequence: | 26798663 | Sequence: | 26798664 | Sequence: | 26798665 | Sequence: | 26798666 | Sequence: | 26798667 | Sequence: | 26798668 | Sequence: | 26798669 | Sequence: | 26798670 | Sequence: | 26798671 | Sequence: | 26798672 | Sequence: | 26798673 | Sequence: | 26798674 | Sequence: | 26798675 | Sequence: | 26798676 | Sequence: | 26798677 | Sequence: | 26798678 | Sequence: | 26798679 | Sequence: | 26798680 | Sequence: | 26798681 | Sequence: | 26798682 | Sequence: | 26798683 | Sequence: | 26798684 | Sequence: | 26798685 | Sequence: | 26798686 | Sequence: | 26798687 | Sequence: | 26798688 | Sequence: | 26798689 | Sequence: | 26798690 | Sequence: | 26798691 | Sequence: | 26798692 | Sequence: | 26798693 | Sequence: | 26798694 | Sequence: | 26798695 | Sequence: | 26798696 | Sequence: | 26798697 | Sequence: | 26798698 | Sequence: | 26798699 | Sequence: | 26798700 | Sequence: | 26798701 | Sequence: | 26798702 | Sequence: | 26798703 | Sequence: | 26798704 | Sequence: | 26798705 | Sequence: | 26798706 | Sequence: | 26798707 | Sequence: | 26798708 | Sequence: | 26798709 | Sequence: | 26798710 | Sequence: | 26798711 | Sequence: | 26798712 | Sequence: | 26798713 | Sequence: | 26798714 | Sequence: | 26798715 | Sequence: | 26798716 | Sequence: | 26798717 | Sequence: | 26798718 | Sequence: | 26798719 | Sequence: | 26798720 | Sequence: | 26798721 | Sequence: | 26798722 | Sequence: | 26798723 | Sequence: | 26798724 | Sequence: | 26798725 | Sequence: | 26798726 | Sequence: | 26798727 | Sequence: | 26798728 | Sequence: | 26798729 |
Intervention Id | 52736356 | Intervention Id | 52736356 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736357 | Intervention Id | 52736358 | Intervention Id | 52736358 |
Name | Kyprolis | Name | PR-171 | Name | Aacidexam | Name | Adexone | Name | Aknichthol Dexa | Name | Alba-Dex | Name | Alin | Name | Alin Depot | Name | Alin Oftalmico | Name | Amplidermis | Name | Anemul mono | Name | Auricularum | Name | Auxiloson | Name | Baycadron | Name | Baycuten | Name | Baycuten N | Name | Cortidexason | Name | Cortisumman | Name | Decacort | Name | Decadrol | Name | Decadron | Name | Decadron DP | Name | Decalix | Name | Decameth | Name | Decasone R.p. | Name | Dectancyl | Name | Dekacort | Name | Deltafluorene | Name | Deronil | Name | Desamethasone | Name | Desameton | Name | Dexa-Mamallet | Name | Dexa-Rhinosan | Name | Dexa-Scheroson | Name | Dexa-sine | Name | Dexacortal | Name | Dexacortin | Name | Dexafarma | Name | Dexafluorene | Name | Dexalocal | Name | Dexamecortin | Name | Dexameth | Name | Dexamethasone Intensol | Name | Dexamethasonum | Name | Dexamonozon | Name | Dexapos | Name | Dexinoral | Name | Dexone | Name | Dinormon | Name | Dxevo | Name | Fluorodelta | Name | Fortecortin | Name | Gammacorten | Name | Hemady | Name | Hexadecadrol | Name | Hexadrol | Name | Lokalison-F | Name | Loverine | Name | Methylfluorprednisolone | Name | Millicorten | Name | Mymethasone | Name | Orgadrone | Name | Spersadex | Name | TaperDex | Name | Visumetazone | Name | ZoDex | Name | CB-839 HCl | Name | Glutaminase Inhibitor CB-839 Hydrochloride |
Responsible Parties
Sequence: | 29024487 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798665
2018-07-06
https://zephyrnet.com/?p=NCT03798665
NCT03798665https://www.clinicaltrials.gov/study/NCT03798665?tab=tableXian Bang Tantbx-n9mB@126.com13458406996Prospective, multicenter, non-interventional registration studies were used in this project . Eight hundreds patients with solid tumors who met the inclusion criteria in six hospitals in Sichuan Province, Sichuan Province, were selected from the first chemotherapy cycle using PEG-rhG-CSF (can be any chemotherapy cycle of the patient), and each subsequent chemotherapy cycle was recorded. The use of PEG-rhG-CSF and related patient outcomes until the end of chemotherapy. Analyze the clinical practice of using PEG-rhG-CSF in the real world.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-08 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | July 6, 2018 |
Primary Completion Month Year | July 6, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Facilities
Sequence: | 200280564 |
Status | Recruiting |
Name | Affiliated Hospital of North Sichuan Medical College |
City | Nanchong |
State | Sichuan |
Country | China |
Facility Contacts
Sequence: | 28132853 |
Facility Id | 200280564 |
Contact Type | primary |
Name | Xian Bang Tan |
tbx-n9mB@126.com | |
Phone | 13458406996 |
Conditions
Sequence: | 52221498 |
Name | Neutropenia |
Downcase Name | neutropenia |
Id Information
Sequence: | 40195610 |
Id Source | org_study_id |
Id Value | CB-RWS |
Countries
Sequence: | 42609640 |
Name | China |
Removed | False |
Interventions
Sequence: | 52535312 |
Intervention Type | Drug |
Name | Pegfilgrastim(PEG-rhG-CSF) |
Description | From the first chemotherapy cycle using PEG-rhG-CSF (which can be any chemotherapy cycle of the patient), record the use of PEG-rhG-CSF in this cycle and each subsequent chemotherapy cycle, including dosage, administration time and dosing frequency |
Design Outcomes
Sequence: | 177561396 | Sequence: | 177561397 | Sequence: | 177561398 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Dosage of PEG-rhG-CSF in chemotherapy | Measure | Administration time of PEG-rhG-CSF in chemotherapy | Measure | dosing frequency of PEG-rhG-CSF in chemotherapy |
Time Frame | 1 YEAR | Time Frame | 1 YEAR | Time Frame | 1 YEAR |
Browse Conditions
Sequence: | 193678340 | Sequence: | 193678341 | Sequence: | 193678342 | Sequence: | 193678343 | Sequence: | 193678344 |
Mesh Term | Neutropenia | Mesh Term | Agranulocytosis | Mesh Term | Leukopenia | Mesh Term | Leukocyte Disorders | Mesh Term | Hematologic Diseases |
Downcase Mesh Term | neutropenia | Downcase Mesh Term | agranulocytosis | Downcase Mesh Term | leukopenia | Downcase Mesh Term | leukocyte disorders | Downcase Mesh Term | hematologic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366398 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Affiliated Hospital of North Sichuan Medical College |
Central Contacts
Sequence: | 12020585 |
Contact Type | primary |
Name | Xian Bang Tan |
Phone | 13458406996 |
tbx-n9mB@126.com | |
Role | Contact |
Eligibilities
Sequence: | 30794693 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Population | Age ≥ 18 years old; Diagnosed as a malignant solid tumor by histology and cytology, requiring chemotherapy patients; The first use of PEG-rhG-CSF during the chemotherapy cycle (not limited to the first chemotherapy cycle, can be any chemotherapy cycle of the patient); Subjects volunteered to participate in this clinical trial and signed informed consent. |
Criteria | Inclusion Criteria:
Age ≥ 18 years old; Exclusion Criteria: PEG-rhG-CSF was used in the current chemotherapy cycle; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004308 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Designs
Sequence: | 30540733 |
Observational Model | Other |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28907053 |
Responsible Party Type | Principal Investigator |
Name | DaiYuan Ma |
Title | Director of Cancer Center Affiliation: Affiliated Hospital of North Sichuan Medical College |
Affiliation | Affiliated Hospital of North Sichuan Medical College |
]]>
https://zephyrnet.com/NCT03798652
2019-03-03
https://zephyrnet.com/?p=NCT03798652
NCT03798652https://www.clinicaltrials.gov/study/NCT03798652?tab=tableRussell Franks, DrRussell.Franks@kcl.ac.ukNAThe study will investigate whether a new high resolution heart Magnetic Resonance Imaging scan, combining assessment of ischemia and viability by perfusion and Late Gadolinium Enhancement -Cardiac Magnetic Resonance is superior to Late Gadolinium Enhacement imaging alone in predicting functional recovery following revascularisation.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-08-19 |
Start Month Year | March 3, 2019 |
Primary Completion Month Year | December 31, 2021 |
Verification Month Year | November 2018 |
Verification Date | 2018-11-30 |
Last Update Posted Date | 2019-08-19 |
Detailed Descriptions
Sequence: | 20709976 |
Description | Coronary artery disease, where the heart's blood supply is restricted by narrowings or blockages, is the commonest cause of heart failure. This condition is called ischaemic cardiomyopathy. In some patients, treating these narrowings/ blockages with by-pass surgery or stents, known as "revascularisation", helps improve the pumping strength of the heart but it is currently difficult to predict which patients will benefit. The best test the investigators currently have to predict who will benefit from revascularisation is an Magnetic Resonance Imaging scan of the heart which looks for how much the heart has been scarred. Hearts with no scar usually improve after revascularisation and hearts with lots of scar usually do not. However, lots of patients fall into the middle and have moderate amounts of scar. The Magnetic Resonance Imaging scan isn't good at predicting if this group of patients will benefit from revascularisation. Revascularisation procedures, including heart by-passes, are not without risk and often require time in intensive care, several days in hospital and a long recovery period at home. If the investigators can develop a better test which is more accurate at predicting whether hearts with moderate scar will improve then they will be able to provide better care for patients by ensuring only those patients who will get benefit from revascularisation are put through the procedure.
This study will investigate whether a new high-resolution heart Magnetic Resonance Imaging scan, which looks at not only levels of scar but also the quality of blood supply, is more accurate than current MRI scans at predicting heart recovery after revascularisation in patients with moderate amounts of scar. |
Facilities
Sequence: | 199965045 |
Status | Recruiting |
Name | King's College London |
City | London |
Zip | SE1 7EH |
Country | United Kingdom |
Facility Contacts
Sequence: | 28086640 | Sequence: | 28086641 |
Facility Id | 199965045 | Facility Id | 199965045 |
Contact Type | primary | Contact Type | backup |
Name | Amedeo Chiribiri, Dr | Name | Russell Franks, Dr |
Amedeo.Chiribiri@kcl.ac.uk | russell.franks@kcl.ac.uk | ||
Phone | +44 (0)2071887188 | Phone | +44 (0)2071887188 |
Conditions
Sequence: | 52138971 | Sequence: | 52138972 | Sequence: | 52138973 |
Name | Cardiovascular Diseases | Name | Ischemic Cardiomyopathy | Name | Cardiac Ischemia |
Downcase Name | cardiovascular diseases | Downcase Name | ischemic cardiomyopathy | Downcase Name | cardiac ischemia |
Id Information
Sequence: | 40135034 |
Id Source | org_study_id |
Id Value | 247309 |
Countries
Sequence: | 42542668 |
Name | United Kingdom |
Removed | False |
Design Groups
Sequence: | 55559310 |
Title | Patients referred for CABG |
Description | Patients with known coronary artery disease referred for isolated surgical revascularisation, who will be invited to attend our facility for a research CMR scan, a research 3D transthoracic echocardiogram and a 6 minute walk test |
Interventions
Sequence: | 52454871 | Sequence: | 52454872 | Sequence: | 52454873 |
Intervention Type | Device | Intervention Type | Device | Intervention Type | Other |
Name | Research CMR scan | Name | Research 3D transthoracic echocardiogram | Name | 6-minute walk test |
Description | CMR scanning at a 3Tesla scanner at King's College London | Description | The scan is required to assess left ventricular systolic function | Description | Sub maximal exercise that provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. |
Keywords
Sequence: | 79822774 | Sequence: | 79822775 |
Name | Perfusion | Name | Viability |
Downcase Name | perfusion | Downcase Name | viability |
Design Outcomes
Sequence: | 177263533 | Sequence: | 177263534 | Sequence: | 177263535 | Sequence: | 177263536 | Sequence: | 177263537 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other |
Measure | Recovery of the regional systolic function | Measure | Recovery of overall Left Ventricular ejection fraction | Measure | Change in Left Ventricular end diastolic volume | Measure | Composite of all cause death hospitalisation for heart failure | Measure | 6- minute walk test |
Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months |
Description | Recovery will be defined as a reduction in average resting wall motion score equal or more than 1. The region of interest will be defined as the segments of myocardium subentended by the revascularised coronary stenosis.
Segments will be considered to have been revascularised if surgical by-pass to the diseased coronary artery subtending the segment is considered successful by the surgical team at the time of surgery. |
Browse Conditions
Sequence: | 193366388 | Sequence: | 193366389 | Sequence: | 193366390 | Sequence: | 193366391 | Sequence: | 193366392 | Sequence: | 193366393 | Sequence: | 193366394 | Sequence: | 193366395 | Sequence: | 193366396 | Sequence: | 193366397 | Sequence: | 193366398 |
Mesh Term | Cardiovascular Diseases | Mesh Term | Cardiomyopathies | Mesh Term | Myocardial Ischemia | Mesh Term | Coronary Artery Disease | Mesh Term | Ischemia | Mesh Term | Pathologic Processes | Mesh Term | Heart Diseases | Mesh Term | Vascular Diseases | Mesh Term | Coronary Disease | Mesh Term | Arteriosclerosis | Mesh Term | Arterial Occlusive Diseases |
Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | cardiomyopathies | Downcase Mesh Term | myocardial ischemia | Downcase Mesh Term | coronary artery disease | Downcase Mesh Term | ischemia | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | heart diseases | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | coronary disease | Downcase Mesh Term | arteriosclerosis | Downcase Mesh Term | arterial occlusive diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290681 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | King's College London |
Overall Officials
Sequence: | 29268522 |
Role | Principal Investigator |
Name | Amedeo Chiribiri, Dr |
Affiliation | King's College London |
Central Contacts
Sequence: | 12000481 | Sequence: | 12000482 |
Contact Type | primary | Contact Type | backup |
Name | Amedeo Chiribiri, Dr | Name | Russell Franks, Dr |
Phone | +44 (0)2071887188 | ||
Amedeo.Chiribiri@kcl.ac.uk | Russell.Franks@kcl.ac.uk | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68107407 | Sequence: | 68107408 | Sequence: | 68107409 |
Design Group Id | 55559310 | Design Group Id | 55559310 | Design Group Id | 55559310 |
Intervention Id | 52454871 | Intervention Id | 52454872 | Intervention Id | 52454873 |
Eligibilities
Sequence: | 30747704 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | The patient will all the above inclusion criteria and none of the exclusion criteria will be identified from:
Referrals for cardiac MRI scans at King's College London; |
Criteria | Inclusion Criteria:
Known coronary artery disease referred for isolated surgical revascularisation; Exclusion Criteria: Contraindications to CMR, adenosine and low-dose dobutamine; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121798 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Number Of Other Outcomes To Measure | 2 |
Designs
Sequence: | 30493987 |
Observational Model | Cohort |
Time Perspective | Other |
Responsible Parties
Sequence: | 28860267 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798639
2019-01-07
https://zephyrnet.com/?p=NCT03798639
NCT03798639https://www.clinicaltrials.gov/study/NCT03798639?tab=tableNANANAThis phase I trial studies the side effects and how well nivolumab works when given together with radiation therapy or ipilimumab as adjuvant therapy in treating patients with Merkel cell cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, gamma rays, neutrons, protons or other sources to kill tumor cells and shrink tumors. Giving nivolumab with radiation therapy or ipilimumab after surgery may kill any remaining tumor cells.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-04-21 |
Start Month Year | January 7, 2019 |
Primary Completion Month Year | December 31, 2023 |
Verification Month Year | April 2023 |
Verification Date | 2023-04-30 |
Last Update Posted Date | 2023-04-21 |
Detailed Descriptions
Sequence: | 20639468 |
Description | PRIMARY OBJECTIVES:
I. To assess the tolerability of two different experimental immunotherapy regimens in the adjuvant setting in patients with Merkel cell carcinoma (MCC). SECONDARY OBJECTIVES: I. To assess the safety and tolerability profile of each of the treatment using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. II. To assess the efficacy of each of the treatment arms according to recurrence-free survival (RFS) at one and half years, defined as the time between the date of randomization and the date of first progression (local, regional or distant metastasis) or death (whatever the cause), whichever occurs first. III. To assess the efficacy of each of the treatment arms according to overall survival (OS) at three years, defined from the time of randomization and the date of death, compared to historical registry control. EXPLORATORY OBJECTIVES: I. To explore potential biomarkers, next generation T cell receptor (TCR) sequencing will be performed to identify and longitudinally track individual T cell clones thus granting a comprehensive insight into immunological changes that occur within the tumor and peripheral blood throughout the course of the disease. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive nivolumab intravenously (IV) over 30 minutes at week 0. Treatments repeat every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Beginning week 2, patients also receive radiation therapy on Monday-Friday or 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes at week 0. Treatments repeat every 2 weeks for nivolumab and 6 weeks for ipilimumab for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year. |
Facilities
Sequence: | 199205021 |
Name | Ohio State University Comprehensive Cancer Center |
City | Columbus |
State | Ohio |
Zip | 43210 |
Country | United States |
Browse Interventions
Sequence: | 95645035 | Sequence: | 95645036 | Sequence: | 95645037 | Sequence: | 95645038 | Sequence: | 95645039 | Sequence: | 95645040 |
Mesh Term | Nivolumab | Mesh Term | Ipilimumab | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Antineoplastic Agents | Mesh Term | Immune Checkpoint Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | nivolumab | Downcase Mesh Term | ipilimumab | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | immune checkpoint inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51958098 | Sequence: | 51958099 | Sequence: | 51958100 |
Name | Merkel Cell Carcinoma | Name | Pathologic Stage IIIA Merkel Cell Carcinoma AJCC v8 | Name | Pathologic Stage IIIB Merkel Cell Carcinoma AJCC v8 |
Downcase Name | merkel cell carcinoma | Downcase Name | pathologic stage iiia merkel cell carcinoma ajcc v8 | Downcase Name | pathologic stage iiib merkel cell carcinoma ajcc v8 |
Id Information
Sequence: | 39993159 | Sequence: | 39993160 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | OSU-18231 | Id Value | NCI-2018-03329 |
Id Type | Registry Identifier | ||
Id Type Description | CTRP (Clinical Trial Reporting Program) | ||
Countries
Sequence: | 42384127 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55358680 | Sequence: | 55358681 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Arm I (nivolumab, radiation therapy) | Title | Arm II (nivolumab, ipilimumab) |
Description | Patients receive nivolumab IV over 30 minutes at week 0. Treatments repeat every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Beginning week 2, patients also receive radiation therapy on Monday-Friday or 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. | Description | Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes at week 0. Treatments repeat every 2 weeks for nivolumab and 6 weeks for ipilimumab for up to 1 year in the absence of disease progression or unacceptable toxicity. |
Interventions
Sequence: | 52270402 | Sequence: | 52270403 | Sequence: | 52270404 |
Intervention Type | Biological | Intervention Type | Biological | Intervention Type | Radiation |
Name | Ipilimumab | Name | Nivolumab | Name | Radiation Therapy |
Description | Given IV | Description | Given IV | Description | Receive radiation therapy |
Design Outcomes
Sequence: | 176623894 | Sequence: | 176623895 | Sequence: | 176623896 | Sequence: | 176623897 | Sequence: | 176623898 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other |
Measure | Percentage of patients completing 12 months of treatment | Measure | Recurrence-free survival (RFS) one and half years | Measure | Overall survival at three years | Measure | Incidence of adverse events (AEs) | Measure | T cell analysis |
Time Frame | Up to 12 months | Time Frame | Time between the date of randomization and the date of first progression (local, regional or distant metastasis) or death (whatever the cause), assessed up to one and half years. | Time Frame | Time from randomization to the date of death, assessed up to 3 years | Time Frame | Up to 3 years post treatment | Time Frame | Baseline up to 3 years post treatment |
Description | Will be estimated along with the 95% confidence interval for each arm based on the binomial distribution. | Description | Kaplan-Meier curves will be generated to summarize the secondary outcomes, RFS and overall survival (OS), for each arm; the differences between groups in terms of hazard ratio for OS/RFS will also be estimated. | Description | Kaplan-Meier curves will be generated to summarize the secondary outcomes, RFS and OS, for each arm; the differences between groups in terms of hazard ratio for OS/RFS will also be estimated. | Description | Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Side effects will be summarized by each treatment group. | Description | TT cell analysis will be performed using peripheral blood at regular time points during the study period |
Browse Conditions
Sequence: | 192642160 | Sequence: | 192642161 | Sequence: | 192642162 | Sequence: | 192642163 | Sequence: | 192642164 | Sequence: | 192642165 | Sequence: | 192642166 | Sequence: | 192642167 | Sequence: | 192642168 | Sequence: | 192642169 | Sequence: | 192642170 | Sequence: | 192642171 | Sequence: | 192642172 | Sequence: | 192642173 | Sequence: | 192642174 | Sequence: | 192642175 |
Mesh Term | Carcinoma, Merkel Cell | Mesh Term | Carcinoma | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Polyomavirus Infections | Mesh Term | DNA Virus Infections | Mesh Term | Virus Diseases | Mesh Term | Infections | Mesh Term | Tumor Virus Infections | Mesh Term | Carcinoma, Neuroendocrine | Mesh Term | Neuroendocrine Tumors | Mesh Term | Neuroectodermal Tumors | Mesh Term | Neoplasms, Germ Cell and Embryonal | Mesh Term | Adenocarcinoma | Mesh Term | Neoplasms, Nerve Tissue |
Downcase Mesh Term | carcinoma, merkel cell | Downcase Mesh Term | carcinoma | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | polyomavirus infections | Downcase Mesh Term | dna virus infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | infections | Downcase Mesh Term | tumor virus infections | Downcase Mesh Term | carcinoma, neuroendocrine | Downcase Mesh Term | neuroendocrine tumors | Downcase Mesh Term | neuroectodermal tumors | Downcase Mesh Term | neoplasms, germ cell and embryonal | Downcase Mesh Term | adenocarcinoma | Downcase Mesh Term | neoplasms, nerve tissue |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48120030 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Claire Verschraegen |
Overall Officials
Sequence: | 29163571 |
Role | Principal Investigator |
Name | Claire Verschraegen, MD |
Affiliation | Ohio State University Comprehensive Cancer Center |
Design Group Interventions
Sequence: | 67864119 | Sequence: | 67864120 | Sequence: | 67864121 | Sequence: | 67864122 |
Design Group Id | 55358681 | Design Group Id | 55358680 | Design Group Id | 55358681 | Design Group Id | 55358680 |
Intervention Id | 52270402 | Intervention Id | 52270403 | Intervention Id | 52270403 | Intervention Id | 52270404 |
Eligibilities
Sequence: | 30639974 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Be willing and able to understand and give written informed consent and comply with all study related procedures Have node negative disease and any of the following high risk features Tumor size >= 2 cm Serum creatinine =< 1.5 x upper limit of normal (ULN) OR Measured or calculated creatinine clearance >= 40 mL/min creatinine clearance (performed within 16 days of treatment initiation) (Glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) Creatinine clearance should be calculated per institutional standard Exclusion Criteria: Has known distant metastatic MCC Subjects with prior history of non-Merkel cell carcinoma malignancies are excluded except Adequately treated basal cell, squamous cell skin cancer, chronic lymphocytic leukemia (CLL) or other indolent malignancies not requiring therapy (ie. active surveillance) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254175841 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30386893 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26561913 | Sequence: | 26561914 | Sequence: | 26561915 | Sequence: | 26561916 | Sequence: | 26561917 | Sequence: | 26561918 | Sequence: | 26561919 | Sequence: | 26561920 | Sequence: | 26561921 | Sequence: | 26561922 | Sequence: | 26561923 | Sequence: | 26561924 | Sequence: | 26561925 | Sequence: | 26561926 | Sequence: | 26561927 | Sequence: | 26561928 | Sequence: | 26561929 | Sequence: | 26561930 | Sequence: | 26561931 |
Intervention Id | 52270402 | Intervention Id | 52270402 | Intervention Id | 52270402 | Intervention Id | 52270402 | Intervention Id | 52270402 | Intervention Id | 52270403 | Intervention Id | 52270403 | Intervention Id | 52270403 | Intervention Id | 52270403 | Intervention Id | 52270403 | Intervention Id | 52270404 | Intervention Id | 52270404 | Intervention Id | 52270404 | Intervention Id | 52270404 | Intervention Id | 52270404 | Intervention Id | 52270404 | Intervention Id | 52270404 | Intervention Id | 52270404 | Intervention Id | 52270404 |
Name | Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody | Name | BMS-734016 | Name | MDX-010 | Name | MDX-CTLA4 | Name | Yervoy | Name | BMS-936558 | Name | MDX-1106 | Name | NIVO | Name | ONO-4538 | Name | Opdivo | Name | Cancer Radiotherapy | Name | Irradiate | Name | Irradiated | Name | irradiation | Name | Radiation | Name | Radiotherapeutics | Name | RADIOTHERAPY | Name | RT | Name | Therapy, Radiation |
Links
Sequence: | 4369037 |
Url | http://cancer.osu.edu |
Description | The Jamesline |
Responsible Parties
Sequence: | 28753495 |
Responsible Party Type | Sponsor-Investigator |
Name | Claire Verschraegen |
Title | Principal Investigator |
Affiliation | Ohio State University Comprehensive Cancer Center |
]]>
https://zephyrnet.com/NCT03798626
2019-05-22
https://zephyrnet.com/?p=NCT03798626
NCT03798626https://www.clinicaltrials.gov/study/NCT03798626?tab=tableNANANAThis study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma, and the preliminary efficacy of gevokizumab in combination with the SOC anti-cancer therapy in subjects with mCRC and mGEC.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-08-08 |
Start Month Year | May 22, 2019 |
Primary Completion Month Year | March 1, 2023 |
Verification Month Year | August 2023 |
Verification Date | 2023-08-31 |
Last Update Posted Date | 2023-08-08 |
Facilities
Sequence: | 200019886 | Sequence: | 200019887 | Sequence: | 200019888 | Sequence: | 200019889 | Sequence: | 200019890 | Sequence: | 200019891 | Sequence: | 200019892 | Sequence: | 200019893 | Sequence: | 200019894 | Sequence: | 200019895 | Sequence: | 200019896 | Sequence: | 200019897 | Sequence: | 200019898 | Sequence: | 200019899 | Sequence: | 200019900 | Sequence: | 200019901 | Sequence: | 200019902 | Sequence: | 200019903 | Sequence: | 200019904 | Sequence: | 200019905 | Sequence: | 200019906 | Sequence: | 200019907 | Sequence: | 200019908 | Sequence: | 200019909 | Sequence: | 200019910 | Sequence: | 200019911 | Sequence: | 200019912 | Sequence: | 200019913 | Sequence: | 200019914 | Sequence: | 200019915 | Sequence: | 200019916 | Sequence: | 200019917 | Sequence: | 200019918 | Sequence: | 200019919 |
Name | UCLA Medical Center UCLA Oncology Clinic | Name | Washington University School Siteman Cancer Center | Name | Sarah Cannon Research Institute Drug Ship – 4 | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site | Name | Novartis Investigative Site |
City | Los Angeles | City | Saint Louis | City | Nashville | City | Melbourne | City | Edegem | City | Bruxelles | City | Leuven | City | Calgary | City | Toronto | City | Santiago | City | Brno | City | Dresden | City | Frankfurt | City | Ulm | City | Ramat Gan | City | Tel Aviv | City | Milano | City | Rozzano | City | Nagoya | City | Kashiwa | City | Osaka-city | City | Sunto Gun | City | Bunkyo-ku | City | Seoul | City | Singapore | City | Sevilla | City | Hospitalet de LLobregat | City | Valencia | City | Madrid | City | Madrid | City | Madrid | City | Tainan | City | London | City | Manchester |
State | California | State | Missouri | State | Tennessee | State | Victoria | State | Antwerpen | State | Alberta | State | Ontario | State | Czech Republic | State | MI | State | MI | State | Aichi | State | Chiba | State | Osaka | State | Shizuoka | State | Tokyo | State | Andalucia | State | Catalunya | State | Comunidad Valenciana | ||||||||||||||||||||||||||||||||
Zip | 90095 | Zip | 63110 | Zip | 37203 | Zip | 3000 | Zip | 2650 | Zip | 1000 | Zip | 3000 | Zip | T2N 4N2 | Zip | M5G 1Z6 | Zip | 8330074 | Zip | 656 53 | Zip | 01307 | Zip | 60488 | Zip | 89081 | Zip | 52621 | Zip | 6423906 | Zip | 20162 | Zip | 20089 | Zip | 464 8681 | Zip | 277 8577 | Zip | 541-8567 | Zip | 411 8777 | Zip | 113-8603 | Zip | 05505 | Zip | 119074 | Zip | 41013 | Zip | 08907 | Zip | 46010 | Zip | 28009 | Zip | 28034 | Zip | 28050 | Zip | 70403 | Zip | SW3 6JJ | Zip | M20 4BX |
Country | United States | Country | United States | Country | United States | Country | Australia | Country | Belgium | Country | Belgium | Country | Belgium | Country | Canada | Country | Canada | Country | Chile | Country | Czechia | Country | Germany | Country | Germany | Country | Germany | Country | Israel | Country | Israel | Country | Italy | Country | Italy | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Korea, Republic of | Country | Singapore | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Taiwan | Country | United Kingdom | Country | United Kingdom |
Browse Interventions
Sequence: | 96013570 | Sequence: | 96013571 | Sequence: | 96013572 | Sequence: | 96013573 | Sequence: | 96013574 | Sequence: | 96013575 | Sequence: | 96013576 | Sequence: | 96013577 | Sequence: | 96013578 | Sequence: | 96013579 | Sequence: | 96013580 | Sequence: | 96013581 | Sequence: | 96013582 | Sequence: | 96013583 | Sequence: | 96013584 | Sequence: | 96013585 | Sequence: | 96013586 | Sequence: | 96013587 | Sequence: | 96013588 | Sequence: | 96013589 | Sequence: | 96013590 | Sequence: | 96013591 | Sequence: | 96013592 | Sequence: | 96013593 | Sequence: | 96013594 | Sequence: | 96013595 | Sequence: | 96013596 | Sequence: | 96013597 | Sequence: | 96013598 | Sequence: | 96013599 | Sequence: | 96013600 | Sequence: | 96013601 |
Mesh Term | Leucovorin | Mesh Term | Paclitaxel | Mesh Term | Bevacizumab | Mesh Term | Fluorouracil | Mesh Term | Oxaliplatin | Mesh Term | Irinotecan | Mesh Term | Ramucirumab | Mesh Term | Levoleucovorin | Mesh Term | Antineoplastic Agents, Phytogenic | Mesh Term | Antineoplastic Agents | Mesh Term | Tubulin Modulators | Mesh Term | Antimitotic Agents | Mesh Term | Mitosis Modulators | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Angiogenesis Inhibitors | Mesh Term | Angiogenesis Modulating Agents | Mesh Term | Growth Substances | Mesh Term | Physiological Effects of Drugs | Mesh Term | Growth Inhibitors | Mesh Term | Antimetabolites | Mesh Term | Antimetabolites, Antineoplastic | Mesh Term | Immunosuppressive Agents | Mesh Term | Immunologic Factors | Mesh Term | Topoisomerase I Inhibitors | Mesh Term | Topoisomerase Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Antidotes | Mesh Term | Protective Agents | Mesh Term | Vitamin B Complex | Mesh Term | Vitamins | Mesh Term | Micronutrients |
Downcase Mesh Term | leucovorin | Downcase Mesh Term | paclitaxel | Downcase Mesh Term | bevacizumab | Downcase Mesh Term | fluorouracil | Downcase Mesh Term | oxaliplatin | Downcase Mesh Term | irinotecan | Downcase Mesh Term | ramucirumab | Downcase Mesh Term | levoleucovorin | Downcase Mesh Term | antineoplastic agents, phytogenic | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | tubulin modulators | Downcase Mesh Term | antimitotic agents | Downcase Mesh Term | mitosis modulators | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | angiogenesis inhibitors | Downcase Mesh Term | angiogenesis modulating agents | Downcase Mesh Term | growth substances | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | growth inhibitors | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | antimetabolites, antineoplastic | Downcase Mesh Term | immunosuppressive agents | Downcase Mesh Term | immunologic factors | Downcase Mesh Term | topoisomerase i inhibitors | Downcase Mesh Term | topoisomerase inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | antidotes | Downcase Mesh Term | protective agents | Downcase Mesh Term | vitamin b complex | Downcase Mesh Term | vitamins | Downcase Mesh Term | micronutrients |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52148477 | Sequence: | 52148478 | Sequence: | 52148479 |
Name | Colorectal Cancer | Name | Gastroesophageal Cancer | Name | Renal Cell Carcinoma |
Downcase Name | colorectal cancer | Downcase Name | gastroesophageal cancer | Downcase Name | renal cell carcinoma |
Id Information
Sequence: | 40142135 | Sequence: | 40142136 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | CVPM087A2101 | Id Value | 2018-003952-19 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42551316 | Sequence: | 42551317 | Sequence: | 42551318 | Sequence: | 42551319 | Sequence: | 42551320 | Sequence: | 42551321 | Sequence: | 42551322 | Sequence: | 42551323 | Sequence: | 42551324 | Sequence: | 42551325 | Sequence: | 42551326 | Sequence: | 42551327 | Sequence: | 42551328 | Sequence: | 42551329 | Sequence: | 42551330 | Sequence: | 42551331 | Sequence: | 42551332 | Sequence: | 42551333 |
Name | United States | Name | Australia | Name | Belgium | Name | Canada | Name | Chile | Name | Czechia | Name | Germany | Name | Israel | Name | Italy | Name | Japan | Name | Korea, Republic of | Name | Singapore | Name | Spain | Name | Taiwan | Name | United Kingdom | Name | Argentina | Name | Austria | Name | Hong Kong |
Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | True | Removed | True | Removed | True |
Design Groups
Sequence: | 55569215 | Sequence: | 55569212 | Sequence: | 55569213 | Sequence: | 55569214 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | Cohort D: 2nd or 3rd line renal cell carcinoma | Title | Cohort A: 1st line colorectal cancer | Title | Cohort B: 2nd line colorectal cancer | Title | Cohort C: 2nd line gastroesophageal cancer |
Description | Treatment for 2nd or 3rd line metastatic renal cell carcinoma (mRCC) with Gevokizumab, cabozantinib | Description | Treatment for 1st line metastatic colorectal cancer (mCRC) with Gevokizumab, modified FOLFOX6, bevacizumab | Description | Treatment for 2nd line mCRC with Gevokizumab, FOLFIRI, bevacizumab | Description | Treatment for 2nd line metastatic gastroesophageal cancer (mGEC) with Gevokizumab, paclitaxel, ramucirumab |
Interventions
Sequence: | 52464299 | Sequence: | 52464300 | Sequence: | 52464301 | Sequence: | 52464302 | Sequence: | 52464303 | Sequence: | 52464304 | Sequence: | 52464305 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Gevokizumab | Name | Bevacizumab | Name | Modified FOLFOX6 | Name | FOLFIRI | Name | Ramucirumab | Name | Paclitaxel | Name | Cabozantinib |
Description | 60 mg/mL concentration; administered intravenously (IV) | Description | 25 mg/mL concentration; administered IV | Description | Oxaliplatin [5 mg/mL concentration; administered IV], leucovorin [10 mg/mL concentration; administered IV] (or levoleucovorin [10 mg/mL concentration; administered IV]), and 5-fluorouracil [50 mg/mL concentration; administered IV] | Description | Irinotecan [20 mg/mL concentration; administered IV], leucovorin [10 mg/mL concentration; administered IV] (or levoleucovorin [10 mg/mL concentration; administered IV]), and 5-fluorouracil [50 mg/mL concentration; administered IV] | Description | 10 mg/mL concentration; administered IV | Description | 6 mg/mL concentration; administered IV | Description | 60 mg tablet; administered orally |
Keywords
Sequence: | 79835564 | Sequence: | 79835558 | Sequence: | 79835559 | Sequence: | 79835560 | Sequence: | 79835561 | Sequence: | 79835562 | Sequence: | 79835563 | Sequence: | 79835565 | Sequence: | 79835566 | Sequence: | 79835567 | Sequence: | 79835568 | Sequence: | 79835569 | Sequence: | 79835570 | Sequence: | 79835571 |
Name | FOLFIRI | Name | colorectal cancer | Name | gastroesophageal cancer | Name | renal cell carcinoma | Name | gevokizumab | Name | bevacizumab | Name | modified FOLFOX6 | Name | ramucirumab | Name | paclitaxel | Name | cabozantinib | Name | CRC | Name | GEC | Name | RCC | Name | VPM087 |
Downcase Name | folfiri | Downcase Name | colorectal cancer | Downcase Name | gastroesophageal cancer | Downcase Name | renal cell carcinoma | Downcase Name | gevokizumab | Downcase Name | bevacizumab | Downcase Name | modified folfox6 | Downcase Name | ramucirumab | Downcase Name | paclitaxel | Downcase Name | cabozantinib | Downcase Name | crc | Downcase Name | gec | Downcase Name | rcc | Downcase Name | vpm087 |
Design Outcomes
Sequence: | 177300759 | Sequence: | 177300760 | Sequence: | 177300761 | Sequence: | 177300762 | Sequence: | 177300763 | Sequence: | 177300764 | Sequence: | 177300765 | Sequence: | 177300766 | Sequence: | 177300767 | Sequence: | 177300768 | Sequence: | 177300769 | Sequence: | 177300770 | Sequence: | 177300771 | Sequence: | 177300772 | Sequence: | 177300773 | Sequence: | 177300774 | Sequence: | 177300775 | Sequence: | 177300776 | Sequence: | 177300777 | Sequence: | 177300778 | Sequence: | 177300779 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Part 1a (Dose finding): Change in high-sensitivity C-reactive protein (hs-CRP) after first dose of gevokizumab monotherapy | Measure | Part 1b (Safety run-in): Number of dose limiting toxicities (DLTs) [Cohort C and Cohort D] | Measure | Part 1b (Safety run-in): Number of DLTs [Cohort A and Cohort B] | Measure | Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort A subjects at RDE level] | Measure | Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort B subjects at RDE level] | Measure | Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort C subjects at RDE level] | Measure | Overall response rate (ORR) per investigator assessment using RECIST v1.1 | Measure | Duration of response (DOR) per investigator assessment using RECIST v1.1 | Measure | Disease Control Rate (DCR) per investigator assessment using RECIST v1.1 | Measure | Overall survival (OS) | Measure | PFS by baseline hs-CRP category using RECIST 1.1 [Cohort A and B at RDE level] | Measure | PFS for subjects from Part 1b at doses other than RDE level (Cohort A and Cohort B) | Measure | Serum concentration of gevokizumab, as monotherapy and in the combination regimens | Measure | Serum concentration of bevacizumab | Measure | Serum concentration of ramucirumab | Measure | Serum concentration of irinotecan | Measure | Serum concentration of paclitaxel | Measure | Serum concentration of cabozantinib | Measure | Number of patients with anti-drug antibodies for gevokizumab in the combination regimens | Measure | Number of patients with anti-drug antibodies for bevacizumab in the combination regimens | Measure | Number of patients with anti-drug antibodies for ramucirumab in the combination regimens |
Time Frame | Baseline, Day 15 | Time Frame | First 4 weeks of combination treatment | Time Frame | First 6 weeks of combination treatment | Time Frame | At 15 months | Time Frame | At 9 months | Time Frame | At 6 months | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 3 months | Time Frame | Up to 3 months | Time Frame | Up to 3 months | Time Frame | Up to 5 years | Time Frame | Up to 5 years | Time Frame | Up to 5 years |
Description | Log scale change of hs-CRP at Day 15 from baseline | Description | DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the beginning of treatment with gevokizumab in combination with the SOC anti-cancer therapies and meets any of the protocol specified criteria. | Description | DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the beginning of treatment with gevokizumab in combination with the SOC anti-cancer therapies and meets any of the protocol specified criteria. | Description | PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1. | Description | PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1. | Description | PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1. | Description | ORR is defined as the proportion of subjects with best overall response (BOR) of complete response (CR) or partial response (PR), according to RECIST 1.1 | Description | Duration of response is defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria | Description | DCR is defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD), according to RECIST 1.1. | Description | OS is defined as the time from date of first dose of study treatment to date of death due to any cause. | Description | PFS is defined as the time from the date of first dosing of study drug to the date of the first documented progression or death due to any cause. | Description | PFS is defined as the time from the date of first dosing of study drug to the date of the first documented progression or death due to any cause. | Description | To characterize the pharmacokinetics of gevokizumab therapy | Description | To characterize the pharmacokinetics of bevacizumab therapy | Description | To characterize the pharmacokinetics of ramucirumab therapy | Description | To characterize the pharmacokinetics of irinotecan therapy | Description | To characterize the pharmacokinetics of paclitaxel therapy | Description | To characterize the pharmacokinetics of cabozantinib therapy | Description | Incidence of immunogenicity for gevokizumab | Description | Incidence of immunogenicity for bevacizumab | Description | Incidence of immunogenicity for ramucirumab |
Browse Conditions
Sequence: | 193401960 | Sequence: | 193401961 | Sequence: | 193401962 | Sequence: | 193401963 | Sequence: | 193401964 | Sequence: | 193401965 | Sequence: | 193401966 | Sequence: | 193401967 | Sequence: | 193401968 | Sequence: | 193401969 | Sequence: | 193401970 | Sequence: | 193401971 | Sequence: | 193401972 | Sequence: | 193401973 | Sequence: | 193401974 | Sequence: | 193401975 | Sequence: | 193401976 | Sequence: | 193401977 | Sequence: | 193401978 | Sequence: | 193401979 | Sequence: | 193401980 | Sequence: | 193401981 | Sequence: | 193401982 | Sequence: | 193401983 | Sequence: | 193401984 |
Mesh Term | Carcinoma | Mesh Term | Colorectal Neoplasms | Mesh Term | Carcinoma, Renal Cell | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Intestinal Neoplasms | Mesh Term | Gastrointestinal Neoplasms | Mesh Term | Digestive System Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Digestive System Diseases | Mesh Term | Gastrointestinal Diseases | Mesh Term | Colonic Diseases | Mesh Term | Intestinal Diseases | Mesh Term | Rectal Diseases | Mesh Term | Adenocarcinoma | Mesh Term | Kidney Neoplasms | Mesh Term | Urologic Neoplasms | Mesh Term | Urogenital Neoplasms | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Kidney Diseases | Mesh Term | Urologic Diseases | Mesh Term | Male Urogenital Diseases |
Downcase Mesh Term | carcinoma | Downcase Mesh Term | colorectal neoplasms | Downcase Mesh Term | carcinoma, renal cell | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | intestinal neoplasms | Downcase Mesh Term | gastrointestinal neoplasms | Downcase Mesh Term | digestive system neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | colonic diseases | Downcase Mesh Term | intestinal diseases | Downcase Mesh Term | rectal diseases | Downcase Mesh Term | adenocarcinoma | Downcase Mesh Term | kidney neoplasms | Downcase Mesh Term | urologic neoplasms | Downcase Mesh Term | urogenital neoplasms | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | kidney diseases | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | male urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48298867 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Novartis Pharmaceuticals |
Overall Officials
Sequence: | 29273185 |
Role | Study Director |
Name | Novartis Pharmaceuticals |
Affiliation | Novartis Pharmaceuticals |
Design Group Interventions
Sequence: | 68120666 | Sequence: | 68120667 | Sequence: | 68120668 | Sequence: | 68120669 | Sequence: | 68120670 | Sequence: | 68120671 | Sequence: | 68120672 | Sequence: | 68120673 | Sequence: | 68120674 | Sequence: | 68120675 | Sequence: | 68120676 |
Design Group Id | 55569212 | Design Group Id | 55569213 | Design Group Id | 55569214 | Design Group Id | 55569215 | Design Group Id | 55569212 | Design Group Id | 55569213 | Design Group Id | 55569212 | Design Group Id | 55569213 | Design Group Id | 55569214 | Design Group Id | 55569214 | Design Group Id | 55569215 |
Intervention Id | 52464299 | Intervention Id | 52464299 | Intervention Id | 52464299 | Intervention Id | 52464299 | Intervention Id | 52464300 | Intervention Id | 52464300 | Intervention Id | 52464301 | Intervention Id | 52464302 | Intervention Id | 52464303 | Intervention Id | 52464304 | Intervention Id | 52464305 |
Eligibilities
Sequence: | 30752754 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Metastatic disease not amenable to potentially curative surgery and with available archival tumor tissue or fresh tumor tissue biopsy. For Cohort A: – First line metastatic colorectal cancer. For Cohort B: – Second line metastatic colorectal cancer that has progressed on prior chemotherapy administered for metastatic disease and which must include a fluoropyrimidine and oxaliplatin. For Cohort C: – Second line metastatic gastroesophageal cancer that has progressed on prior line of chemotherapy administered for metastatic disease, and which must include a platinum agent and fluoropyrimidine doublet. For Cohort D: – Second or third line metastatic renal cell carcinoma with a clear-cell component and has received one or two lines of treatment for metastatic disease that included an anti-angiogenic agent for at least 4 weeks with radiologic progression on that treatment. For subjects starting from Part 1a in Cohorts A and B: Serum hs-CRP at screening ≥ 10 mg/L. For subjects starting from Part 2 in Cohort C: – Serum hs-CRP at screening ≥ 10 mg/L. Exclusion Criteria: For All Cohorts: Currently receiving any of the prohibited medications or has contraindications as outlined in the protocol. For Cohort D: Concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5, and medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5. Other protocol-defined inclusion/exclusion criteria may apply |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254186897 |
Number Of Facilities | 34 |
Registered In Calendar Year | 2019 |
Actual Duration | 45 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 6 |
Number Of Secondary Outcomes To Measure | 15 |
Designs
Sequence: | 30499020 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26662278 | Sequence: | 26662279 | Sequence: | 26662280 |
Intervention Id | 52464299 | Intervention Id | 52464301 | Intervention Id | 52464302 |
Name | VPM087 | Name | oxaliplatin, leucovorin, 5-fluorouracil | Name | irinotecan, leucovorin, 5-fluorouracil |
Responsible Parties
Sequence: | 28865296 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798613
2018-12-21
https://zephyrnet.com/?p=NCT03798613
NCT03798613https://www.clinicaltrials.gov/study/NCT03798613?tab=tableNANANAThe objective of this study is to assess the accuracy of the Apple Watch 4 Series watch in generating an ECG that is suitable for determination of heart rhythm compared to rhythms monitored via telemetry. Secondary objective is to assess the accuracy of the Apple Watch 4 series watch in identifying atrial fibrillation when it is present.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-21 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-04-09 |
Start Month Year | December 21, 2018 |
Primary Completion Month Year | March 29, 2019 |
Verification Month Year | April 2019 |
Verification Date | 2019-04-30 |
Last Update Posted Date | 2019-04-09 |
Detailed Descriptions
Sequence: | 20735788 |
Description | The study will assess the accuracy of the Apple watch 4 series watch when worn by post-operative cardiac surgery patients after they have transferred from the ICU to the cardiac telemetry unit.
During testing each subject will wear: An Apple Watch 4 series watch for no more than 5 minutes. The location of the watch (left or right wrist) will be randomly assigned. Heart rate and rhythm will be assessed by obtaining tracings from the Apple Watch 4 series watch while at the same point in time obtaining tracings from a standard telemetry monitor. ECGs from the Apple Watch 4 will be collected by asking the patient to place his/ her finger on the digital crown of the Apple Watch 4 for 30 seconds. The rhythm displayed by the Apple Watch 4 will be viewed on the Apple health app (available on the iPhone 8) and will be saved for subsequent viewing and analysis. Each enrolled patient will have a minimum of three assessments of heart rhythm per day for at least two days, generating a minimum of six data points per patient. After conclusion of the study for each subject, the ECG's from the health app pertaining to that subject will be reviewed by a board certified cardiologist as will the telemetry tracings. In order to obtain tracings of new onset post-operative atrial fibrillation. 50% of the subjects enrolled will be in sinus rhythm and 50% will be in atrial fibrillation at the time of enrollment. |
Facilities
Sequence: | 200244328 |
Name | Cleveland Clinic |
City | Cleveland |
State | Ohio |
Zip | 44195 |
Country | United States |
Conditions
Sequence: | 52208145 | Sequence: | 52208146 |
Name | Heart Rate Fast | Name | Heart Rate Low |
Downcase Name | heart rate fast | Downcase Name | heart rate low |
Id Information
Sequence: | 40186173 |
Id Source | org_study_id |
Id Value | 18-1397 |
Countries
Sequence: | 42599667 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55634699 | Sequence: | 55634700 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | Apple Watch 4 Series Device | Title | Continuous Telemetry |
Description | Apple watch 4 series heart rate monitoring device | Description | Standard continuous telemetry monitoring device |
Interventions
Sequence: | 52522102 | Sequence: | 52522103 |
Intervention Type | Device | Intervention Type | Device |
Name | Apple Watch 4 Series Device | Name | Continuous Telemetry Monitor |
Description | tracings from the apple watch 4 series watch | Description | tracings from the continuous telemetry monitor |
Keywords
Sequence: | 79922995 | Sequence: | 79922996 | Sequence: | 79922997 | Sequence: | 79922998 |
Name | Post-op Atrial Fibrillation | Name | Heart Rhythm | Name | Accuracy | Name | Apple Watch |
Downcase Name | post-op atrial fibrillation | Downcase Name | heart rhythm | Downcase Name | accuracy | Downcase Name | apple watch |
Design Outcomes
Sequence: | 177511440 | Sequence: | 177511441 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Heart rate accuracy compared to telemetry | Measure | Heart rhythm accuracy compared to telemetry |
Time Frame | 5 minutes | Time Frame | 5 minutes |
Description | Apple Watch 4 Series heart rate monitor device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient. | Description | Apple Watch 4 Series heart rhythm device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient. |
Browse Conditions
Sequence: | 193627141 | Sequence: | 193627142 | Sequence: | 193627143 | Sequence: | 193627144 | Sequence: | 193627145 | Sequence: | 193627146 | Sequence: | 193627147 |
Mesh Term | Tachycardia | Mesh Term | Bradycardia | Mesh Term | Arrhythmias, Cardiac | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Cardiac Conduction System Disease | Mesh Term | Pathologic Processes |
Downcase Mesh Term | tachycardia | Downcase Mesh Term | bradycardia | Downcase Mesh Term | arrhythmias, cardiac | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | cardiac conduction system disease | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48353726 | Sequence: | 48353727 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | The Cleveland Clinic | Name | Case Western Reserve University |
Overall Officials
Sequence: | 29305997 |
Role | Principal Investigator |
Name | Marc Gillinov, MD |
Affiliation | The Cleveland Clinic |
Design Group Interventions
Sequence: | 68199224 | Sequence: | 68199225 |
Design Group Id | 55634699 | Design Group Id | 55634700 |
Intervention Id | 52522102 | Intervention Id | 52522103 |
Eligibilities
Sequence: | 30786889 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Age > 18 years Exclusion Criteria: Presence of a cardiac pacemaker |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989648 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 3 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30532959 |
Allocation | Non-Randomized |
Intervention Model | Factorial Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28899253 |
Responsible Party Type | Principal Investigator |
Name | Marc Gillinov, MD |
Title | Principal Investigator |
Affiliation | The Cleveland Clinic |
]]>
https://zephyrnet.com/NCT03798600
2016-01-01
https://zephyrnet.com/?p=NCT03798600
NCT03798600https://www.clinicaltrials.gov/study/NCT03798600?tab=tableNANANAPK of Caspofungin in ICU septic patients might be changed as compared to healthy volunteers due to sepsis-related pathophysiology.
Sub-optimal plasma and tissue concentrations might be achieved in these patients when drugs are administered at the same dosage/regimen suggested for healthy volunteers.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-17 |
Start Month Year | January 1, 2016 |
Primary Completion Month Year | December 31, 2017 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-17 |
Detailed Descriptions
Sequence: | 20721643 |
Description | Open non randomized, non controlled single center study on the pharmacokinetics of caspofungin in 20 consecutive ICU patients with severe sepsis or septic shock, requiring caspofungin therapy and PK-PD evaluation for the optimization of caspofungin therapy. The aim of this study is to describe the Caspofungin PK-PD alterations in a cohort of critically ill septic patients. |
Browse Interventions
Sequence: | 96050267 | Sequence: | 96050268 | Sequence: | 96050269 | Sequence: | 96050270 | Sequence: | 96050271 |
Mesh Term | Caspofungin | Mesh Term | Antifungal Agents | Mesh Term | Anti-Infective Agents | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | caspofungin | Downcase Mesh Term | antifungal agents | Downcase Mesh Term | anti-infective agents | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52171253 | Sequence: | 52171254 |
Name | Critical Illness | Name | Infection |
Downcase Name | critical illness | Downcase Name | infection |
Id Information
Sequence: | 40158647 |
Id Source | org_study_id |
Id Value | CEAVC, 32366/2015; OSS.15.114 |
Design Groups
Sequence: | 55593194 |
Title | Critically ill patients |
Description | 20 patients consecutively admitted in the ICU with severe sepsis or septic shock requiring caspofungin therapy will be considered for this observational study.
Inclusion Criteria: Adult ICU patients (>18 yrs) with severe sepsis or septic shock undergoing caspofungin therapy based on clinical judgement (empiric therapy) or microbiological result (targeted therapy). Exclusion criteria: Concomitant ciclosporin or rifampicin therapy. Pregnancy Continuous renal replacement therapy Severe Liver failure (Child Pugh score > 6) |
Interventions
Sequence: | 52485497 |
Intervention Type | Drug |
Name | Caspofungin |
Description | In accordance with routine clinical practice, Caspofungin will be given at the loading dose of 70 mg followed by 50 mg daily (for people < 80 kg body weight). No dose reduction will be performed in Child-Pugh score A or B. Duration of therapy will be performed in accordance with ESCMID guidelines and clinical conditions. |
Keywords
Sequence: | 79868564 | Sequence: | 79868565 | Sequence: | 79868566 |
Name | Caspofungin | Name | pharmacokinetic | Name | pharmacodynamic |
Downcase Name | caspofungin | Downcase Name | pharmacokinetic | Downcase Name | pharmacodynamic |
Design Outcomes
Sequence: | 177378907 | Sequence: | 177378908 | Sequence: | 177378909 | Sequence: | 177378910 | Sequence: | 177378911 | Sequence: | 177378912 | Sequence: | 177378913 | Sequence: | 177378914 | Sequence: | 177378915 | Sequence: | 177378916 | Sequence: | 177378917 | Sequence: | 177378918 | Sequence: | 177378919 | Sequence: | 177378920 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU). | Measure | Alterations of Cmax/MIC target – which guarantees the maximal exposure of Candida spp to caspofungin | Measure | Alterations of Cmax/MIC target – which guarantees the maximal exposure of Candida spp to caspofungin | Measure | Alterations of AUC/MIC target – which guarantees the maximal exposure of Candida spp to caspofungin | Measure | Alterations of AUC/MIC target – which guarantees the maximal exposure of Candida spp to caspofungin | Measure | Alterations of Caspofungin maximum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU). | Measure | Alterations of Caspofungin maximum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU). | Measure | Alterations of Caspofungin minimum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU). | Measure | Alterations of Caspofungin minimum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU). | Measure | Alterations of Caspofungin volume distribution in septic patients admitted to the Intensive Care Unit (ICU). | Measure | Alterations of Caspofungin volume distribution in septic patients admitted to the Intensive Care Unit (ICU). | Measure | Alterations of Caspofungin elimination half life in septic patients admitted to the Intensive Care Unit (ICU). | Measure | Alterations of Caspofungin elimination half life in septic patients admitted to the Intensive Care Unit (ICU). | Measure | Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU). |
Time Frame | first 24 hours after loading dose | Time Frame | first 24 hours after loading dose | Time Frame | at day 4 after loading dose | Time Frame | first 24 hours after loading dose | Time Frame | at day 4 after loading dose | Time Frame | first 24 hours after loading dose | Time Frame | at day 4 after loading dose | Time Frame | first 24 hours after loading dose | Time Frame | at day 4 after loading dose | Time Frame | first 24 hours after loading dose | Time Frame | at day 4 after loading dose | Time Frame | first 24 hours after loading dose | Time Frame | at day 4 after loading dose | Time Frame | at day 4 after loading dose |
Description | The caspofungin AUC will be described and compared with that reported in the literature for healthy volunteers. | Description | The Cmax/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication. | Description | The Cmax/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication. | Description | The AUC/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication. | Description | The AUC/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication. | Description | The caspofungin maximum serum concentrations will be described and compared with those reported in the literature for healthy volunteers. | Description | The caspofungin maximum serum concentrations will be described and compared with those reported in the literature for healthy volunteers. | Description | The caspofungin minimum serum concentrations will be described and compared with those reported in the literature for healthy volunteers. | Description | The caspofungin minimum serum concentrations will be described and compared with those reported in the literature for healthy volunteers. | Description | The caspofungin volume distribution will be described and compared with those reported in the literature for healthy volunteers. | Description | The caspofungin volume distribution will be described and compared with those reported in the literature for healthy volunteers. | Description | The caspofungin elimination half life will be described and compared with those reported in the literature for healthy volunteers. | Description | The caspofungin elimination half life will be described and compared with those reported in the literature for healthy volunteers. | Description | The caspofungin AUC will be described and compared with that reported in the literature for healthy volunteers. |
Browse Conditions
Sequence: | 193486791 | Sequence: | 193486792 | Sequence: | 193486793 |
Mesh Term | Critical Illness | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | critical illness | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319307 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Careggi Hospital |
Overall Officials
Sequence: | 29285358 |
Role | Principal Investigator |
Name | Gianluca Villa, MD |
Affiliation | Azienda Careggi |
Design Group Interventions
Sequence: | 68149151 |
Design Group Id | 55593194 |
Intervention Id | 52485497 |
Eligibilities
Sequence: | 30765362 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | 20 patients consecutively admitted in the ICU with severe sepsis or septic shock requiring caspofungin therapy will be considered for this observational study. |
Criteria | Inclusion Criteria:
Adult ICU patients (>18 yrs) Exclusion Criteria: Concomitant ciclosporin or rifampicin therapy. |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 253884472 |
Registered In Calendar Year | 2019 |
Actual Duration | 24 |
Were Results Reported | False |
Has Single Facility | False |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 13 |
Designs
Sequence: | 30511529 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28877823 |
Responsible Party Type | Principal Investigator |
Name | Gianluca Villa |
Title | Principal investigator |
Affiliation | Careggi Hospital |
Study References
Sequence: | 52063298 |
Pmid | 32202224 |
Reference Type | derived |
Citation | Adembri C, Villa G, Rosi E, Tofani L, Fallani S, De Gaudio AR, Novelli A. Caspofungin PK in critically ill patients after the first and fourth doses: suggestions for therapeutic drug monitoring? J Chemother. 2020 May;32(3):124-131. doi: 10.1080/1120009X.2020.1737783. Epub 2020 Mar 23. |
]]>
https://zephyrnet.com/NCT03798587
2020-01-31
https://zephyrnet.com/?p=NCT03798587
NCT03798587https://www.clinicaltrials.gov/study/NCT03798587?tab=tableElena Cittera, MScelena.cittera@grupposandonato.it+39 026621The aim of this project is to test a new powerful PNA-based SENP1 inhibitor, previously characterized in an in vitro model of OS cell lines.
The most effective PNA, conjugated with a cell-permeable CPP, which is able to inhibit OS cells viability and invasiveness in both normoxia and hypoxia through SENP1-mediated inhibition of HIF1α, ZEB1, and Akt, will be investigated for its ability to penetrate and silence SENP1 expression in ex vivo human OS tissues.
Primary aim:
To determine the ability of PNA-CPP to penetrate into an ex vivo tridimensional tissue of OS, derived from wasted biological material obtained during OS eradication surgery, and to exert its biological function of inhibiting SENP1 within the tissue.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-11-22 |
Start Month Year | January 2020 |
Primary Completion Month Year | December 2020 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-11-22 |
Detailed Descriptions
Sequence: | 20741167 |
Description | Background:
Osteosarcoma (OS) is the most common type of primary malignant bone tumor in children and adolescents. The overall survival rate is dramatically reduced by the development of metastases, often pulmonary. Solid malignant tumors, such as OS, often develop a hypoxic microenvironment, which contributes to tumor growth, metastasis, treatment failure, and patient mortality. Adaptation to hypoxia, as well as to other environmental conditions, is often associated with modifications in the post-transcriptional regulation of key effectors. Among these, SUMOylation is carried out by small ubiquitin-like modifier (SUMO) proteins and is dynamically reversed (deSUMOylation) by Sentrin/SUMO-specific proteases (SENPs). SENP1, the best characterized SENP, is upregulated in multiple tumors being involved in tumorigenesis and tumor progression. Through deSUMOylation, SENP1 acts as a molecular hub that stabilizes and activates key regulator factors, such as hypoxia-inducible factor 1α (HIF1α), zinc finger E-box binding homeobox 1 (ZEB1), and Akt, responsible for tumor cells adaptation to hypoxic microenvironment, induction of cell proliferation, invasion and migration, and inhibition of apoptosis, thus contributing to tumor progression and metastasis. HIF1α is the master transcriptional regulator for cellular adaptation and survival under hypoxic conditions, and contributes to enhance the cell metastatic potential. SENP1-mediated HIF1α deSUMOylation prevents HIF1α degradation by proteasome, thus activating the HIF1α signaling pathway. SENP1 is overexpressed in OS cells under hypoxic condition and siRNA-mediated silencing of SENP1 decreases tumor cell viability, promotes cell apoptosis, reduces invasiveness, and inhibits the epithelial-mesenchymal transition (EMT). ZEB1 is involved in tumorigenesis, progression, invasion and metastases in several tumors (e.g. glioblastoma, prostate, lung, liver, and colorectal). ZEB1 silencing in OS cells leads to a reduced caspase-3 activity, NF-κB and iNOS inhibition, overall reduced cell proliferation and increased apoptosis. SENP1 knockdown in hepatocellular carcinoma (HCC) cells decreases ZEB1 and inhibits EMT]. Akt hyper-activation is essential for the onset and progression of tumors, including OS. In astroglioma cells siRNA-mediated inhibition of SENP1 is associated to Akt hypophosphorylation accompanied by the inhibition of its downstream targets Bcl-xL and cyclinD1 and p21 upregulation, leading to cell-cycle arrest and increased apoptosis. Altogether, these studies suggest that SENP1 acts as a hub whose inhibition reflects on multiple targets some of which, i.e. HIF1α, ZEB1, Akt, are key factors in tumor progression and metastasis in both normoxia and hypoxia. While it is known the effect of SENP1 on HIF1α in OS, it is reasonable to assume that SENP1 might mediate ZEB1 downregulation and Akt inactivation also in OS. Thus, novel SENP1 inhibition strategies are potentially effective therapeutic approaches to block OS growth and metastasis. SENP1 inhibition can be achieved by gene silencing mediated by siRNAs. However, naked siRNAs are highly unstable and liposome-based delivery systems are poorly efficient and cytotoxic both in vitro and in vivo. A promising approach for inhibition of SENP1 expression is gene silencing mediated by peptide nucleic acids (PNA), nucleobase oligomers with the phosphate backbone replaced by a pseudopeptide backbone of repeated units of N-(2-aminoethyl) glycine. Because of their unnatural backbone, PNAs are definitively resistant to both nuclease and protease activities, form a more specific and stable binding with the complementary DNA or RNA, allowing an efficient and persistent silencing effect. Although PNA cell permeability is very poor, it can be effectively enhanced by their conjugation with cell-penetrating peptides (CPP). In the last years, PNA have emerged as really promising tools for cancer diagnosis and therapy, and, above all, as effective candidates for stable gene silencing in gene therapy. Rational and preliminary study: 3 different PNA sequences targeting different SENP1 mRNA regions will be designed and tested. PNAs will be conjugated to an octa-arginine (R8) CPP that efficiently mediate the intracellular delivery of PNAs. The uptake will be studied with a scrambled-sequence R8- and fluorescein (Fl)-conjugated PNA (scrPNA-R8-Fl). An in vitro characterization of the ability of the designed PNA-CPP to penetrate intracellular and to silence the target SENP1 will be performed in cell lines of OS. To study the PNA-R8 uptake in OS cells, different OS cell lines (SaOS-2, MG-63, U2OS) with different invasive potential and all expressing SENP1, and primary human osteoblasts (hOb) as negative control for SENP1 expression, will be used. Following incubation with scrPNA-R8-Fl at different concentrations the uptake will be determined at consecutive time-points by flow cytometry, while the cytoplasmic localization will be confirmed by fluorescence microscopy. A scrPNA-Fl not conjugated to R8 will function as a negative control, as it is not expected to enter the cell. Cytotoxicity of scrPNA-R8 will be assayed by Alamar Blue Cell Viability assay. The silencing effectiveness of the different anti-SENP1 PNA-R8 conjugates (senpPNA-R8) will be assayed in all cell lines in both normoxia and hypoxia (1% O2, 5% CO2, and 94% N2). The senpPNA-R8-mediated SENP1 silencing efficiency will be assessed by RT-qPCR and western-blot (WB). scrPNA-R8 will serve as negative control, while cells transfected with siRNA targeting SENP1 will serve as positive control. In this part the most efficient silencing senpPNA-R8 compound will be selected. The senpPNA-R8-mediated downregulation of HIF1α, and potentially of ZEB1 expression and Akt phosphorylation inhibitions, as consequence of SENP1 inhibition in OS cells, will be assayed by WB. Thus, reduced cell viability, migration and invasion, induction of apoptosis, and EMT inhibition will be assayed, and compared to the effects in hOb. Cell viability will be determined by Alamar Blue assay, whereas apoptosis will be assayed by flow cytometry by staining of Annexin V and with propidium iodide. The residual migration and invasion ability will be assessed by wound-healing assay and transwell invasion assay, respectively. Downregulation of vimentin and N-cadherin and upregulation of E-cadherin, EMT markers and of the downstream targets of ZEB1 (caspase-3, NF-κB) and Akt, (cyclinD1 and Bcl-xL) will be determined by WB. The in vitro characterization of the penetration and silencing ability of the designed PNA-CPP in OS cell lines is the preliminary step of the study. An ex vivo analysis of the ability of the PNA-CPP to penetrate into a 3D tissue and silence the target SENP in an OS tissue explant from patients will follow. Aims of the study: The aim of this project is to test a new powerful PNA-based SENP1 inhibitor, previously characterized in an in vitro model of OS cell lines. The most effective PNA, conjugated with a cell-permeable CPP, which is able to inhibit OS cells viability and invasiveness in both normoxia and hypoxia through SENP1-mediated inhibition of HIF1α, ZEB1, and Akt, will be investigated for its ability to penetrate and silence SENP1 expression in ex vivo human OS tissues. Primary aim: To determine the ability of PNA-CPP to penetrate into an ex vivo tridimensional tissue of OS, derived from wasted biological material obtained during OS eradication surgery, and to exert its biological function of inhibiting SENP1 within the tissue. Study design: For this study, wasted biological material derived from osteosarcoma eradication surgery will be collected which comprise only a small proportion of the removed tumor mass other than that used for histological and molecular diagnosis. 15 patients with primary OS will be recruited. The target group will comprise patients hospitalized at IRCCS Istituto Ortopedico Galeazzi who will be subjected to surgical eradication of primary OS. The study will be presented to patients with age ≥18 years that can be recruited also in the IRCCS Istituto Ortopedico Galeazzi BioBanca protocol (ethical committee approval n. 29/INT/2017) by the surgeon. These patients will sign two Informed Consents: one for the BioBanca and one for the PNA-OS study. Patients with age <18 years will be additionally recruited besides the IRCCS Istituto Ortopedico Galeazzi BioBanca. These patients will be considered eligible for the study if the legal tutor will sign the Informed Consents relative to the PNA-OS study. Also samples of OS already existing in the BioBanca as frozen samples preserved in liquid nitrogen at BioRep Service-Provider (BioRep S.r.l. Via Olgettina 60, 20132, Milano), will be used. Every reasonable effort will be done to call these patients to sign a specific informed consent relative to this study. Since several practical issues (e.g. unsuitableness or low amount of biological material) can occur, we envision the possibility to recruit additional patients until the achievement of 15 complete samples. The Study will start after approval of Ethical Committee and the estimated duration is 36 months, divided as following: Timing for enrolment: 24 month Experimental design: Ex vivo analysis of the PNA-R8 silencing ability in osteosarcoma samples. We will investigate whether senpPNA-R8 is able to penetrate into a tridimensional OS tissue and to exert its silencing effect. 15 OS samples will be collected either in the context of the IRCCS Galeazzi BioBanca (ethical committee approval n. 29/INT/2017) or from newly recruited patients, in collaboration with the C.C.O.O.R.R. equip. Only wasted biological material derived from surgery will be used without any additional harm to the patients other than the surgery itself and the study does not involve any diagnostic aim or genetic profiling of the samples collected. OS samples, already existing in the BioBanca as frozen samples preserved in liquid nitrogen at BioRep Service-Provider (BioRep S.r.l. Via Olgettina 60, 20132, Milano), will be used to determine the initial expression levels of SENP1 in OS by RT-qPCR. For this, samples will be homogenized, total RNA will be extracted and RT-qPCR will be performed assaying for SENP1 expression levels. The remaining samples out of 15, freshly collected, will be preserved in physiological solution until usage. The OS samples will be cut in 3 mm3 pieces, placed in a 24-multiwell culture plate, and cultivated ex vivo as organotypic OS cultures in both normoxia and hypoxia-induced microenvironment under orbital rotation [21-23]. Organotypic tumor tissue maintain the complexity of the original tissue with tumor cells being surrounded by their original microenvironment rather than artificial matrices and this system is particularly advantageous for ex vivo drug screening, for studying drug uptake and molecular processes. OS cultures will be treated with senpPNA-R8, and SENP1 expression in naïve and PNA-treated samples will be determined by RT-qPCR and immunohistochemistry in paraffin-embedded sections. The ability of the PNA-R8 to penetrate within the hypoxic core of the OS samples will be assessed: after incubation with scrPNA-R8-Fl, sections will be immediately frozen (-80°C), processed and analyzed by immunofluorescence. Samples will be analyzed and stored at Laboratorio di Biochimica Sperimentale e Biologia Molecolare at the Istituto Ortopedico Galeazzi for the whole duration of the study. At the end of the study every residual material will be destroyed. |
Facilities
Sequence: | 200280592 |
Name | IRCCS Istituto Ortopedico Galeazzi |
City | Milano |
Zip | 20161 |
Country | Italy |
Facility Contacts
Sequence: | 28132856 | Sequence: | 28132857 |
Facility Id | 200280592 | Facility Id | 200280592 |
Contact Type | primary | Contact Type | backup |
Name | Marta Sofia Gomarasca, PhD | Name | Elena Cittera, MSc |
marta.gomarasca@grupposandonato.it | elena.cittera@grupposandonato.it | ||
Phone | 0039022261 | Phone | 0039022261 |
Phone Extension | 4068 | Phone Extension | 4057 |
Conditions
Sequence: | 52221522 |
Name | Primary Osteosarcoma of Bone |
Downcase Name | primary osteosarcoma of bone |
Id Information
Sequence: | 40195625 |
Id Source | org_study_id |
Id Value | PNA-OS |
Countries
Sequence: | 42609655 |
Name | Italy |
Removed | False |
Design Groups
Sequence: | 55649813 |
Title | OS patients |
Description | Patients with age ≥18 years that were/can be recruited within the IRCCS Istituto Ortopedico Galeazzi BioBanca (ethical committee approval n. 29/INT/2017).
Patients with age <18 years: will be additionally recruited besides the IRCCS Istituto Ortopedico Galeazzi BioBanca. The target group corresponds to patients hospitalized at Istituto Ortopedico Galeazzi, undergoing surgical eradication of primary osteosarcoma. Patients will be considered eligible for enrollment in the study if able to sign the consent to the procedure after appropriate information from the reference surgeon or signed by parents or legal guardian after appropriate information from the reference surgeon (if age <18). Inclusion Criteria: Indication for primary OS eradication surgery Exclusion criteria: -Patients not able to sign the Informed Consent. |
Design Outcomes
Sequence: | 177561481 | Sequence: | 177561482 |
Outcome Type | primary | Outcome Type | primary |
Measure | Determination of SENP1 expression in OS samples | Measure | Ex vivo analysis of the PNA-R8 silencing ability in osteosarcoma samples. |
Time Frame | 8 months | Time Frame | 16 months |
Description | OS samples, already existing in the BioBanca as frozen samples preserved in liquid nitrogen at BioRep Service-Provider (BioRep S.r.l. Via Olgettina 60, 20132, Milano), will be used to determine the initial expression levels of SENP1 in OS by RT-qPCR. For this, samples will be homogenized, total RNA will be extracted and RT-qPCR will be performed assaying for SENP1 expression levels. | Description | Freshly collected OS samples will be preserved in physiological solution until usage. The OS samples will be cut in 3 mm3 pieces, placed in a 24-multiwell culture plate, and cultivated ex vivo as organotypic OS cultures in both normoxia and hypoxia-induced microenvironment under orbital rotation. OS cultures will be treated with senpPNA-R8, and SENP1 expression in naïve and PNA-treated samples will be determined by RT-qPCR and immunohistochemistry in paraffin-embedded sections. The ability of the PNA-R8 to penetrate within the hypoxic core of the OS samples will be assessed: after incubation with scrPNA-R8-Fl, sections will be immediately frozen (-80°C), processed and analyzed by immunofluorescence. |
Browse Conditions
Sequence: | 193678423 | Sequence: | 193678424 | Sequence: | 193678425 | Sequence: | 193678426 | Sequence: | 193678427 | Sequence: | 193678428 | Sequence: | 193678429 |
Mesh Term | Osteosarcoma | Mesh Term | Neoplasms | Mesh Term | Neoplasms, Bone Tissue | Mesh Term | Neoplasms, Connective Tissue | Mesh Term | Neoplasms, Connective and Soft Tissue | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Sarcoma |
Downcase Mesh Term | osteosarcoma | Downcase Mesh Term | neoplasms | Downcase Mesh Term | neoplasms, bone tissue | Downcase Mesh Term | neoplasms, connective tissue | Downcase Mesh Term | neoplasms, connective and soft tissue | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | sarcoma |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366424 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Istituto Ortopedico Galeazzi |
Central Contacts
Sequence: | 12020588 | Sequence: | 12020589 |
Contact Type | primary | Contact Type | backup |
Name | Marta Sofia Gomarasca, PhD | Name | Elena Cittera, MSc |
Phone | +39 026621 | Phone | +39 026621 |
marta.gomarasca@grupposandonato.it | elena.cittera@grupposandonato.it | ||
Phone Extension | 4068 | Phone Extension | 4057 |
Role | Contact | Role | Contact |
Eligibilities
Sequence: | 30794708 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | 15 patients with primary OS.
Patients with age ≥18 years that were/can be recruited within the IRCCS Istituto Ortopedico Galeazzi BioBanca (ethical committee approval n. 29/INT/2017). Patients with age <18 years: will be additionally recruited besides the IRCCS Istituto Ortopedico Galeazzi BioBanca. The target group corresponds to patients hospitalized at Istituto Ortopedico Galeazzi, undergoing surgical eradication of primary osteosarcoma. Patients with age ≥18 will be considered eligible for enrollment in the study if able to sign the consent to the procedure after appropriate information from the reference surgeon. Patients with age <18 will be considered eligible for enrollment in the study if able to provide the consent to the procedure (donation of waste material) signed by parents or legal guardian after appropriate information from the reference surgeon. |
Criteria | Inclusion Criteria:
Indication for primary OS eradication surgery Patients with age ≥18 years: were/can be recruited within the IRCCS Istituto Ortopedico Galeazzi BioBanca (ethical committee approval n. 29/INT/2017). Patients with age <18 years: will be additionally recruited besides the IRCCS Istituto Ortopedico Galeazzi BioBanca. Exclusion Criteria: Patients not able to sign the Informed Consent. |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254004324 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 2 |
Designs
Sequence: | 30540748 |
Observational Model | Cohort |
Time Perspective | Other |
Responsible Parties
Sequence: | 28907068 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52118201 | Sequence: | 52118202 | Sequence: | 52118203 | Sequence: | 52118204 | Sequence: | 52118205 | Sequence: | 52118206 | Sequence: | 52118207 | Sequence: | 52118208 | Sequence: | 52118209 | Sequence: | 52118210 | Sequence: | 52118211 | Sequence: | 52118212 | Sequence: | 52118213 | Sequence: | 52118214 | Sequence: | 52118215 | Sequence: | 52118216 | Sequence: | 52118217 | Sequence: | 52118218 | Sequence: | 52118219 | Sequence: | 52118220 | Sequence: | 52118221 | Sequence: | 52118222 |
Pmid | 27366153 | Pmid | 26424695 | Pmid | 23740838 | Pmid | 25444927 | Pmid | 22138131 | Pmid | 28258134 | Pmid | 26695141 | Pmid | 27693211 | Pmid | 18809331 | Pmid | 28796315 | Pmid | 22213004 | Pmid | 28387915 | Pmid | 23884910 | Pmid | 22455499 | Pmid | 28414202 | Pmid | 19812898 | Pmid | 29734750 | Pmid | 28670958 | Pmid | 28670477 | Pmid | 26860465 | Pmid | 27111283 | Pmid | 16603054 |
Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result |
Citation | Abarrategi A, Tornin J, Martinez-Cruzado L, Hamilton A, Martinez-Campos E, Rodrigo JP, Gonzalez MV, Baldini N, Garcia-Castro J, Rodriguez R. Osteosarcoma: Cells-of-Origin, Cancer Stem Cells, and Targeted Therapies. Stem Cells Int. 2016;2016:3631764. doi: 10.1155/2016/3631764. Epub 2016 Jun 5. | Citation | Cao J, Wang Y, Dong R, Lin G, Zhang N, Wang J, Lin N, Gu Y, Ding L, Ying M, He Q, Yang B. Hypoxia-Induced WSB1 Promotes the Metastatic Potential of Osteosarcoma Cells. Cancer Res. 2015 Nov 15;75(22):4839-51. doi: 10.1158/0008-5472.CAN-15-0711. Epub 2015 Sep 30. Erratum In: Cancer Res. 2020 Jun 1;80(11):2421. | Citation | Philip B, Ito K, Moreno-Sanchez R, Ralph SJ. HIF expression and the role of hypoxic microenvironments within primary tumours as protective sites driving cancer stem cell renewal and metastatic progression. Carcinogenesis. 2013 Aug;34(8):1699-707. doi: 10.1093/carcin/bgt209. Epub 2013 Jun 5. | Citation | Guan G, Zhang Y, Lu Y, Liu L, Shi D, Wen Y, Yang L, Ma Q, Liu T, Zhu X, Qiu X, Zhou Y. The HIF-1alpha/CXCR4 pathway supports hypoxia-induced metastasis of human osteosarcoma cells. Cancer Lett. 2015 Feb 1;357(1):254-264. doi: 10.1016/j.canlet.2014.11.034. Epub 2014 Nov 18. | Citation | Bettermann K, Benesch M, Weis S, Haybaeck J. SUMOylation in carcinogenesis. Cancer Lett. 2012 Mar 28;316(2):113-25. doi: 10.1016/j.canlet.2011.10.036. Epub 2011 Nov 2. | Citation | Cui CP, Wong CC, Kai AK, Ho DW, Lau EY, Tsui YM, Chan LK, Cheung TT, Chok KS, Chan ACY, Lo RC, Lee JM, Lee TK, Ng IOL. SENP1 promotes hypoxia-induced cancer stemness by HIF-1alpha deSUMOylation and SENP1/HIF-1alpha positive feedback loop. Gut. 2017 Dec;66(12):2149-2159. doi: 10.1136/gutjnl-2016-313264. Epub 2017 Mar 3. | Citation | Zhang W, Sun H, Shi X, Wang H, Cui C, Xiao F, Wu C, Guo X, Wang L. SENP1 regulates hepatocyte growth factor-induced migration and epithelial-mesenchymal transition of hepatocellular carcinoma. Tumour Biol. 2016 Jun;37(6):7741-8. doi: 10.1007/s13277-015-4406-y. Epub 2015 Dec 22. | Citation | Xia W, Tian H, Cai X, Kong H, Fu W, Xing W, Wang Y, Zou M, Hu Y, Xu D. Inhibition of SUMO-specific protease 1 induces apoptosis of astroglioma cells by regulating NF-kappaB/Akt pathways. Gene. 2016 Dec 31;595(2):175-179. doi: 10.1016/j.gene.2016.09.040. Epub 2016 Sep 28. | Citation | Yee Koh M, Spivak-Kroizman TR, Powis G. HIF-1 regulation: not so easy come, easy go. Trends Biochem Sci. 2008 Nov;33(11):526-34. doi: 10.1016/j.tibs.2008.08.002. Epub 2008 Sep 21. | Citation | Wang X, Liang X, Liang H, Wang B. SENP1/HIF-1alpha feedback loop modulates hypoxia-induced cell proliferation, invasion, and EMT in human osteosarcoma cells. J Cell Biochem. 2018 Feb;119(2):1819-1826. doi: 10.1002/jcb.26342. Epub 2017 Sep 27. | Citation | Shen A, Zhang Y, Yang H, Xu R, Huang G. Overexpression of ZEB1 relates to metastasis and invasion in osteosarcoma. J Surg Oncol. 2012 Jun 15;105(8):830-4. doi: 10.1002/jso.23012. Epub 2011 Dec 27. | Citation | Xu XM, Liu W, Cao ZH, Liu MX. Effects of ZEB1 on regulating osteosarcoma cells via NF-kappaB/iNOS. Eur Rev Med Pharmacol Sci. 2017 Mar;21(6):1184-1190. | Citation | Li R, Wei J, Jiang C, Liu D, Deng L, Zhang K, Wang P. Akt SUMOylation regulates cell proliferation and tumorigenesis. Cancer Res. 2013 Sep 15;73(18):5742-53. doi: 10.1158/0008-5472.CAN-13-0538. Epub 2013 Jul 24. | Citation | Hoyer J, Neundorf I. Peptide vectors for the nonviral delivery of nucleic acids. Acc Chem Res. 2012 Jul 17;45(7):1048-56. doi: 10.1021/ar2002304. Epub 2012 Mar 28. | Citation | Wu JC, Meng QC, Ren HM, Wang HT, Wu J, Wang Q. Recent advances in peptide nucleic acid for cancer bionanotechnology. Acta Pharmacol Sin. 2017 Jun;38(6):798-805. doi: 10.1038/aps.2017.33. Epub 2017 Apr 17. | Citation | Oh SY, Ju Y, Park H. A highly effective and long-lasting inhibition of miRNAs with PNA-based antisense oligonucleotides. Mol Cells. 2009 Oct 31;28(4):341-5. doi: 10.1007/s10059-009-0134-8. Epub 2009 Sep 30. | Citation | McClorey G, Banerjee S. Cell-Penetrating Peptides to Enhance Delivery of Oligonucleotide-Based Therapeutics. Biomedicines. 2018 May 5;6(2):51. doi: 10.3390/biomedicines6020051. | Citation | Song C, Liu W, Li J. USP17 is upregulated in osteosarcoma and promotes cell proliferation, metastasis, and epithelial-mesenchymal transition through stabilizing SMAD4. Tumour Biol. 2017 Jul;39(7):1010428317717138. doi: 10.1177/1010428317717138. | Citation | Meijer TG, Naipal KA, Jager A, van Gent DC. Ex vivo tumor culture systems for functional drug testing and therapy response prediction. Future Sci OA. 2017 Mar 27;3(2):FSO190. doi: 10.4155/fsoa-2017-0003. eCollection 2017 Jun. | Citation | Naipal KA, Verkaik NS, Sanchez H, van Deurzen CH, den Bakker MA, Hoeijmakers JH, Kanaar R, Vreeswijk MP, Jager A, van Gent DC. Tumor slice culture system to assess drug response of primary breast cancer. BMC Cancer. 2016 Feb 9;16:78. doi: 10.1186/s12885-016-2119-2. | Citation | Muff R, Botter SM, Husmann K, Tchinda J, Selvam P, Seeli-Maduz F, Fuchs B. Explant culture of sarcoma patients' tissue. Lab Invest. 2016 Jul;96(7):752-62. doi: 10.1038/labinvest.2016.49. Epub 2016 Apr 25. | Citation | van der Kuip H, Murdter TE, Sonnenberg M, McClellan M, Gutzeit S, Gerteis A, Simon W, Fritz P, Aulitzky WE. Short term culture of breast cancer tissues to study the activity of the anticancer drug taxol in an intact tumor environment. BMC Cancer. 2006 Apr 7;6:86. doi: 10.1186/1471-2407-6-86. |
]]>
https://zephyrnet.com/NCT03798574
2016-03-01
https://zephyrnet.com/?p=NCT03798574
NCT03798574https://www.clinicaltrials.gov/study/NCT03798574?tab=tableNANANASurvivors of invasive meningococcal disease (IMD) experience a range of mild to severe sequelae that impact upon their quality of life. The majority of studies to date have focused on the impact of IMD on childhood and very little is known about the impact of the disease on adolescents and young people.
The aim of this study is to assess the physical, neurocognitive, economic and societal impact of IMD on adolescents and young adult Australian survivors.
Hypothesis:
Adolescents and young adult survivors who are 2 to 10 years post IMD have significantly poorer outcomes including intellectual functioning and quality of life when compared to healthy controls.
IMD imposes a significant financial burden upon individuals, families and society.
Serogroup B disease is associated with an increased risk of sequelae when compared to non-B serogroup IMD.
Study design:
This a multi-centre, case-control mixed-methods study. Survivors of IMD (retrospective and prospective cases) and non-IMD healthy controls will be invited to participate in the study.
Retrospective IMD cases admitted in the previous 10 years will be identified through each of the participating hospitals (paediatric and adult hospitals). During the course of the study prospective recruitment of IMD cases will also occur at participating hospitals. Meningococcal foundations/groups will also be approached and asked to advertise and conduct a mail out to their members to inform them about the study.
Healthy controls will be prospectively recruited by “snowballing technique” whereby enrolled IMD cases will be asked to distribute a study information sheet to their healthy friends/acquaintances who are approximately the same age. Control participants may also be identified from databases at each participating site or through community advertising.
Enrolled cases will undergo a neurocognitive, psychological and physical examination 2 – 10 years post IMD admission. A subset of IMD cases will be invited to participate in a semi-structured interview. Controls will also undergo neurocognitive, psychological and physical examination.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-23 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-03-09 |
Start Month Year | March 1, 2016 |
Primary Completion Month Year | December 31, 2022 |
Verification Month Year | March 2023 |
Verification Date | 2023-03-31 |
Last Update Posted Date | 2023-03-09 |
Facilities
Sequence: | 200123960 | Sequence: | 200123961 | Sequence: | 200123962 | Sequence: | 200123963 |
Name | The Children's Hospital at Westmead | Name | Women's and Children's Hosptial | Name | Monash Children's Hospital, Melbourne | Name | Perth Children's Hospital |
City | Westmead | City | Adelaide | City | Clayton | City | Nedlands |
State | New South Wales | State | South Australia | State | Victoria | State | Western Australia |
Zip | 2145 | Zip | 5006 | Zip | 3168 | Zip | 6009 |
Country | Australia | Country | Australia | Country | Australia | Country | Australia |
Conditions
Sequence: | 52175909 | Sequence: | 52175910 | Sequence: | 52175911 |
Name | Meningococcal Infections | Name | Neisseria Meningitis Sepsis | Name | Neisseria Infection |
Downcase Name | meningococcal infections | Downcase Name | neisseria meningitis sepsis | Downcase Name | neisseria infection |
Id Information
Sequence: | 40161847 |
Id Source | org_study_id |
Id Value | HREC/14/WCHN/024 |
Countries
Sequence: | 42572549 |
Name | Australia |
Removed | False |
Design Groups
Sequence: | 55598336 | Sequence: | 55598337 |
Title | IMD Case | Title | Control |
Description | No intervention | Description | No intervention |
Design Outcomes
Sequence: | 177397492 | Sequence: | 177397493 | Sequence: | 177397494 | Sequence: | 177397495 | Sequence: | 177397496 | Sequence: | 177397497 | Sequence: | 177397498 | Sequence: | 177397499 | Sequence: | 177397500 | Sequence: | 177397501 | Sequence: | 177397502 | Sequence: | 177397503 | Sequence: | 177397504 | Sequence: | 177397505 | Sequence: | 177397506 | Sequence: | 177397507 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Difference in intellectual functioning between cases and controls | Measure | Difference in quality of life between cases and controls | Measure | Difference in academic achievement between cases and controls. | Measure | Difference in memory (verbal and visual) between cases and controls. | Measure | Difference in executive functioning between cases and controls. | Measure | Difference in executive functioning between cases and controls assessed through BRIEF self-report questionnaire | Measure | Difference in the frequency of psychiatric disorders between cases and controls. | Measure | Difference in psychological functioning between cases and controls. | Measure | Difference in behavioral ratings between cases and controls | Measure | Difference in health and disability functioning between cases and controls | Measure | Difference in hearing threshold levels between cases and controls | Measure | Difference in health status between cases and controls | Measure | To estimate the lifetime costs associated with survival following IMD | Measure | Explore adolescents and young people's experience of their hospital presentation, admission, and recovery from IMD | Measure | Carer's experience assessed through the Carer Experience Scale | Measure | Carer's experience assessed through ICEpop CAPability questionnaires |
Time Frame | Between 2 to 10 years post IMD admission | Time Frame | Between 2 to 10 years post IMD admission | Time Frame | Between 2 to 10 years post IMD admission | Time Frame | Between 2 to 10 years post IMD admission | Time Frame | Between 2 to 10 years post IMD admission | Time Frame | Between 2 to 10 years post IMD admission | Time Frame | Between 2 to 10 years post IMD admission | Time Frame | Between 2 to 10 years post IMD admission | Time Frame | Between 2 to 10 years post IMD admission | Time Frame | Between 2 to 10 years post IMD admission | Time Frame | Between 2 to 10 years post IMD admission | Time Frame | Between 2 to 10 years post IMD admission | Time Frame | From time of admission up to time of follow up (2 to 10 years post IMD admission) | Time Frame | Between 2 to 10 years post IMD admission | Time Frame | Between 2 to 10 years post IMD admission | Time Frame | Between 2 to 10 years post IMD admission |
Description | Measured by the Full Scale intelligence quotient (IQ) score obtained from the Wechsler Adult Intelligence Scale – Fourth Edition (WAIS-IV) | Description | Measured by the overall multi-attribute health utility score obtained from the Health Utilities Index Mark 3 (HUI3)-15Q self-report. | Description | Measured by Wechsler Individual Achievement Test – Second Edition (WIAT-II) | Description | Measured by Verbal Learning and Design Memory subtests from the Wide Range Assessment of Memory and Learning, Second Edition (WRAML2) | Description | Measured by Delis-Kaplan Executive Function System (D-KEFS) | Description | Assessed through BRIEF self-report questionnaire (parent and/or self-report) | Description | Assessed through Mini International Neuropsychiatric Interview (M.I.N.I 6.0) | Description | Assessed through self report questionnaire Depression Anxiety Stress Scales (DASS) (self-report) | Description | Measured by Conners Rating Scales (parent and/or self-report) | Description | Measured by the International Classification of Functioning, Disability and Health (ICF) tool. | Description | Measured by pure tone audiometry. | Description | The EQ-5D-5L will be completed to measure participant's health status and to calculate quality adjusted life years (QALYS) lost. | Description | IMD cases only: Lifetime dollar costs. | Description | A subset of IMD cases will participate in a semi-structured interview. | Description | For those IMD cases with a disability, the primary caregiver and other family members living in the same household will be invited to complete the Carer Experience Scale. | Description | For those IMD cases with a disability, the primary caregiver and other family members living in the same household will be invited to complete ICEpop CAPability questionnaire. |
Browse Conditions
Sequence: | 193504492 | Sequence: | 193504493 | Sequence: | 193504494 | Sequence: | 193504495 | Sequence: | 193504496 | Sequence: | 193504497 | Sequence: | 193504498 | Sequence: | 193504499 | Sequence: | 193504500 | Sequence: | 193504501 | Sequence: | 193504502 | Sequence: | 193504503 |
Mesh Term | Infections | Mesh Term | Communicable Diseases | Mesh Term | Meningococcal Infections | Mesh Term | Meningitis | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes | Mesh Term | Neuroinflammatory Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Neisseriaceae Infections | Mesh Term | Gram-Negative Bacterial Infections | Mesh Term | Bacterial Infections | Mesh Term | Bacterial Infections and Mycoses |
Downcase Mesh Term | infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | meningococcal infections | Downcase Mesh Term | meningitis | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | neuroinflammatory diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | neisseriaceae infections | Downcase Mesh Term | gram-negative bacterial infections | Downcase Mesh Term | bacterial infections | Downcase Mesh Term | bacterial infections and mycoses |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48323435 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Adelaide |
Overall Officials
Sequence: | 29287670 |
Role | Principal Investigator |
Name | Helen Marshall |
Affiliation | University of Adelaide |
Eligibilities
Sequence: | 30767977 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 15 Years |
Maximum Age | 24 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | Population sample from participating Australian hospitals in Adelaide, Melbourne, Perth, and Sydney. |
Criteria | Inclusion Criteria:
Patients aged 15 to 24 years 11 months at time of IMD admission Exclusion Criteria: Individuals who are not fluent with the English language. |
Adult | True |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253927719 |
Number Of Facilities | 4 |
Registered In Calendar Year | 2018 |
Actual Duration | 83 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 15 |
Maximum Age Num | 24 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 14 |
Designs
Sequence: | 30514137 |
Observational Model | Case-Control |
Time Perspective | Other |
Responsible Parties
Sequence: | 28880438 |
Responsible Party Type | Principal Investigator |
Name | Helen Marshall |
Title | Professor |
Affiliation | University of Adelaide |
Study References
Sequence: | 52068413 |
Pmid | 31888931 |
Reference Type | derived |
Citation | Marshall H, McMillan M, Wang B, Booy R, Afzali H, Buttery J, Blyth CC, Richmond P, Shaw D, Gordon D, Barton B. AMEND study protocol: a case-control study to assess the long-term impact of invasive meningococcal disease in Australian adolescents and young adults. BMJ Open. 2019 Dec 29;9(12):e032583. doi: 10.1136/bmjopen-2019-032583. |
]]>
https://zephyrnet.com/NCT03798561
2019-01-14
https://zephyrnet.com/?p=NCT03798561
NCT03798561https://www.clinicaltrials.gov/study/NCT03798561?tab=tableNANANAThis is an ascending dose escalation study to test the safety, tolerability and preliminary efficacy of ASN008 TG in first-in-human subjects
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-05-09 |
Start Month Year | January 14, 2019 |
Primary Completion Month Year | March 20, 2020 |
Verification Month Year | May 2020 |
Verification Date | 2020-05-31 |
Last Update Posted Date | 2023-05-09 |
Detailed Descriptions
Sequence: | 20777531 |
Description | This is a two part, randomized, blinded, vehicle-controlled study to determine a safe and tolerable dose of ASN008 TG. Part A will asses a single ascending dose of ASN008 TG in cohorts of healthy volunteers, while Part B will assess multiple ascending doses of TG, to be determined (TBD) based on Part A safety and tolerability, in patients with mild-to-moderate dermatitis. Results from Part A and B will characterize safety, tolerability and pharmacokinetics. Part B patients will be assessed for changes in pruritus based on a numerical rating scale (NRS) of pruritus at baseline and on Day 15. |
Facilities
Sequence: | 200571965 | Sequence: | 200571966 | Sequence: | 200571967 | Sequence: | 200571968 | Sequence: | 200571969 |
Name | Certified Research Associates | Name | Dermatology Consulting Services, PLLC | Name | Progressive Clinical Research | Name | Spaulding Research Clinic, Inc | Name | Innovaderm Recherches Inc |
City | Cortland | City | High Point | City | San Antonio | City | West Bend | City | Montréal |
State | New York | State | North Carolina | State | Texas | State | Wisconsin | State | Quebec |
Zip | 13045 | Zip | 27262 | Zip | 78213 | Zip | 53095 | Zip | H2K4L5 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | Canada |
Conditions
Sequence: | 52314340 | Sequence: | 52314341 | Sequence: | 52314342 |
Name | Dermatitis, Atopic | Name | Pruritus | Name | Dermatitis Eczema |
Downcase Name | dermatitis, atopic | Downcase Name | pruritus | Downcase Name | dermatitis eczema |
Id Information
Sequence: | 40261132 |
Id Source | org_study_id |
Id Value | ASN008-101 |
Countries
Sequence: | 42680531 | Sequence: | 42680532 |
Name | United States | Name | Canada |
Removed | False | Removed | False |
Design Groups
Sequence: | 55752712 | Sequence: | 55752713 | Sequence: | 55752714 | Sequence: | 55752715 | Sequence: | 55752716 | Sequence: | 55752717 | Sequence: | 55752718 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | 82 µg/cm2 ASN008 TG or Placebo | Title | 164 µg/cm2 ASN008 TG or Placebo | Title | 328 µg/cm2 ASN008 TG or Placebo | Title | 492 µg/cm2 ASN008 TG or Placebo | Title | ASN008 TG TBD Cohort 1 or Placebo | Title | ASN008 TG TBD Cohort 2 or Placebo | Title | ASN008 TG TBD Cohort 3 or Placebo |
Description | PART A: ASN008 TG 82 µg/cm2 single application in 7 days or Placebo TG (6 subjects ASN008: 2 subjects placebo) (6:2) | Description | PART A: ASN008 TG 164 µg/cm2 single application in 7 days or Placebo (6:2) | Description | Part A: ASN008 TG 328 µg/cm2 single application in 7 days or Placebo (6:2) | Description | Part A: ASN008 TG 492 µg/cm2 single application in 7 days or Placebo (6:2) | Description | Part B: ASN008 TG Cohort 1 daily application for 15 days or Placebo (9 subjects ASN008: 3 subjects Placebo) (9:3) | Description | Part B: ASN008 TG Cohort 2 daily application for 15 days or Placebo (9:3) | Description | Part B: Placebo TG Cohort 3 daily application for 15 days or Placebo (9:3) |
Interventions
Sequence: | 52625618 | Sequence: | 52625619 |
Intervention Type | Drug | Intervention Type | Drug |
Name | ASN008 TG | Name | Placebo TG |
Description | ASN008 TG | Description | Placebo TG |
Design Outcomes
Sequence: | 177907810 | Sequence: | 177907811 | Sequence: | 177907812 | Sequence: | 177907813 | Sequence: | 177907814 | Sequence: | 177907815 | Sequence: | 177907816 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Evaluate safety and tolerability of ASN008 topical gel to define a maximum tolerated dose (Part A and B) | Measure | Calculate area under the plasma concentration versus time curve (Part A and B) | Measure | Calculate the Pharmacokinetic Half-life (Part A and B) | Measure | Calculate the Pharmacokinetic maximum concentration (Part A and B) | Measure | Change from baseline in pruritus NRS in AD subjects (Part B) | Measure | Change from baseline in Eczema Area and Severity Score (EASI) in AD subjects (Part B) | Measure | Change from baseline in Investigator Global Assessment Score in AD subjects (Part B) |
Time Frame | Part A: 14 days; Part B: 22 days | Time Frame | 7 days and 16 days | Time Frame | 7 days and 16 days | Time Frame | 7 days and 16 days | Time Frame | 22 days | Time Frame | 22 days | Time Frame | 22 Days |
Description | Analyze incidence of treatment-emergent adverse events (TEAE) | Description | A plot of the concentration of ASN008 in plasma over time | Description | Derive maximum blood plasma concentration of Time required for ASN008 concentration to decrease by 50% | Description | Maximum concentration of ASN008 achieved after dosing | Description | Numeric Rating Scale ranging from 0 to 10; 0 indicates no itching; 10 indicates worst possible itching; Rating of pruritis based degree, duration, direction, disability, and distribution | Description | Measurement of area and severity of atopic dermatitis based on composite score 0 to 72 encompassing degree of erythema, induration, excoriation and lichenification; each scored from 0 to 3 with 0 indicating none and 3 indicating severe | Description | 5 point morphological assessment of overall disease severity scored from 0 to 4 with 0 indicating clear (no inflammation) and 4 indicating severe (marked erythema) |
Browse Conditions
Sequence: | 194031813 | Sequence: | 194031814 | Sequence: | 194031815 | Sequence: | 194031816 | Sequence: | 194031817 | Sequence: | 194031818 | Sequence: | 194031819 | Sequence: | 194031820 | Sequence: | 194031821 | Sequence: | 194031822 | Sequence: | 194031823 |
Mesh Term | Dermatitis, Atopic | Mesh Term | Dermatitis | Mesh Term | Pruritus | Mesh Term | Skin Diseases | Mesh Term | Skin Diseases, Eczematous | Mesh Term | Skin Manifestations | Mesh Term | Skin Diseases, Genetic | Mesh Term | Genetic Diseases, Inborn | Mesh Term | Hypersensitivity, Immediate | Mesh Term | Hypersensitivity | Mesh Term | Immune System Diseases |
Downcase Mesh Term | dermatitis, atopic | Downcase Mesh Term | dermatitis | Downcase Mesh Term | pruritus | Downcase Mesh Term | skin diseases | Downcase Mesh Term | skin diseases, eczematous | Downcase Mesh Term | skin manifestations | Downcase Mesh Term | skin diseases, genetic | Downcase Mesh Term | genetic diseases, inborn | Downcase Mesh Term | hypersensitivity, immediate | Downcase Mesh Term | hypersensitivity | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48453245 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Asana BioSciences |
Overall Officials
Sequence: | 29361673 |
Role | Study Director |
Name | Niranjan Rao, PhD |
Affiliation | Asana BioSciences |
Design Group Interventions
Sequence: | 68342282 | Sequence: | 68342283 | Sequence: | 68342284 | Sequence: | 68342285 | Sequence: | 68342286 | Sequence: | 68342287 | Sequence: | 68342288 | Sequence: | 68342289 | Sequence: | 68342290 | Sequence: | 68342291 | Sequence: | 68342292 | Sequence: | 68342293 | Sequence: | 68342294 | Sequence: | 68342295 |
Design Group Id | 55752713 | Design Group Id | 55752714 | Design Group Id | 55752715 | Design Group Id | 55752712 | Design Group Id | 55752716 | Design Group Id | 55752717 | Design Group Id | 55752718 | Design Group Id | 55752713 | Design Group Id | 55752714 | Design Group Id | 55752715 | Design Group Id | 55752712 | Design Group Id | 55752716 | Design Group Id | 55752717 | Design Group Id | 55752718 |
Intervention Id | 52625618 | Intervention Id | 52625618 | Intervention Id | 52625618 | Intervention Id | 52625618 | Intervention Id | 52625618 | Intervention Id | 52625618 | Intervention Id | 52625618 | Intervention Id | 52625619 | Intervention Id | 52625619 | Intervention Id | 52625619 | Intervention Id | 52625619 | Intervention Id | 52625619 | Intervention Id | 52625619 | Intervention Id | 52625619 |
Eligibilities
Sequence: | 30848297 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Part A – Healthy Volunteers: Written informed consent obtained prior to any required study-related procedure Part B- Subjects with AD: Written informed consent obtained prior to any required study-related procedure Exclusion Criteria: Both Part A and Part B: Pregnant or breast-feeding women Part A Only- Healthy Volunteers: -Used medications or skin emollients within 2 weeks prior to Day 1 unless approved by investigator and sponsor Part B Only – Subjects with AD: Has infected atopic dermatitis |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254230253 |
Number Of Facilities | 5 |
Registered In Calendar Year | 2019 |
Actual Duration | 14 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30594156 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Masking Description | Part A: Double blinded, with exception of unblinded dispensing pharmacist Part B: Double blinded |
Intervention Model Description | Phase 1, multicenter, double-blind, vehicle-controlled, randomized ascending doses trial. |
Subject Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28960629 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52217526 |
Pmid | 32616515 |
Reference Type | derived |
Citation | Ramachandran R, Thompson SK, Malkmus S, Mieda T, Lin JH, Gupta S, Yaksh TL. Topical Application of ASN008, a Permanently Charged Sodium Channel Blocker, Shows Robust Efficacy, a Rapid Onset, and Long Duration of Action in a Mouse Model of Pruritus. J Pharmacol Exp Ther. 2020 Sep;374(3):521-528. doi: 10.1124/jpet.120.265074. Epub 2020 Jul 2. |
]]>
https://zephyrnet.com/NCT03798548
2015-01-15
https://zephyrnet.com/?p=NCT03798548
NCT03798548https://www.clinicaltrials.gov/study/NCT03798548?tab=tableNANANAAdult patients scheduled to undergo TAVR were randomized to receive brief bedside cognitive behavioral therapy for depression/anxiety or treatment as usual.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | January 15, 2015 |
Primary Completion Month Year | March 31, 2017 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20716274 |
Description | Depression and anxiety are common symptoms in patients undergoing cardiac surgery and associated with increased cardiac morbidity and decreased functional status. Cognitive behavioral therapy (CBT) has been shown to be an effective intervention to treat these symptoms after cardiac surgery, but has not yet been studied in patients undergoing less invasive cardiac procedures such as Transcatheter Aortic Valve Replacement (TAVR). This study will examine the effect of CBT on symptoms of anxiety and depression in patients undergoing TAVR.
The CBT protocol was loosely structured on the Managing Depression and Anxiety using Education and Skills (MADES) protocol described in Dao and colleagues (2011). The current intervention was designed to address the needs of individuals who may develop anxiety or depression symptoms post-TAVR. The CBT intervention consisted of four 30 to 60-minute bedside treatment sessions with a trained clinician while the participant was hospitalized for TAVR. Main outcome measures were self-reported symptoms of depression and anxiety as measured by the Beck Depression Inventory-II and State Trait Anxiety Inventory Form Y1. Secondary outcomes included health related quality of life and hospital length of stay. |
Conditions
Sequence: | 52156415 |
Name | Depression, Anxiety |
Downcase Name | depression, anxiety |
Id Information
Sequence: | 40148173 |
Id Source | org_study_id |
Id Value | 32178 |
Design Groups
Sequence: | 55577845 | Sequence: | 55577846 |
Group Type | Experimental | Group Type | No Intervention |
Title | Brief Bedside CBT | Title | Treatment As Usual |
Interventions
Sequence: | 52471955 |
Intervention Type | Behavioral |
Name | Brief Bedside CBT |
Description | 4 sessions of CBT including psychoeducation about TAVR and how mood can impact recovery in cardiac patients, discussion of patients' expectations and any concerns. Teaching and practice of cognitive restructuring and behavioral goal setting techniques for a healthy recovery. |
Keywords
Sequence: | 79848006 | Sequence: | 79848007 | Sequence: | 79848008 |
Name | CBT | Name | Brief Therapy | Name | Bedside Intervention |
Downcase Name | cbt | Downcase Name | brief therapy | Downcase Name | bedside intervention |
Design Outcomes
Sequence: | 177327727 | Sequence: | 177327728 | Sequence: | 177327729 | Sequence: | 177327730 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change from Baseline Score on Beck Depression Inventory II (BDI-II) | Measure | Change from Baseline Score on State Trait Anxiety Inventory Form YI (STAI-YI) | Measure | Change from Baseline Score on Minnesota Living With Heart Failure Questionnaire (MLHFQ) | Measure | Change from Baseline Score on 12-Item Short Form Health Survey (SF12v2) |
Time Frame | An average of 3 days post TAVR Procedure, 1-Month Follow Up | Time Frame | An average of 3 days post TAVR Procedure, 1-Month Follow Up | Time Frame | 1-Month Follow Up | Time Frame | 1-Month Follow Up |
Description | 21-item self-report questionnaire with good reliability and validity in assessing symptoms of depression. Total score range 0-63 with higher scores indicating a worse outcome. Total BDI-II scores are interpreted as follows, 0-13: minimal, 14-19: mild, 20-28: moderate, 29-63: severe. In this study, a score of 14 or greater, and 20 or greater, were used define subpopulations with significant symptoms of depression on the BDI-II. | Description | 20-item self-report questionnaire with good internal consistency and construct validity in assessing symptoms of anxiety. Total score range 20-80 with higher scores indicating a worse outcome. The recommended cutoff score for clinically significant anxiety is 39 but a recent validity study of anxiety disorders in cardiac patients found ≥ 40 as an optimal cutoff score for screening the presence of an anxiety disorder. In this study, a score of 40 or greater, and 46 or greater, were used to define subpopulations with significant symptoms of anxiety on the STAI-Y1. | Description | 21-item self-report questionnaire designed to measure the effects of heart failure and treatments for heart failure on and individual's quality of life. Total score range 0-105. The total score is considered a measurement of heart failure severity as indicated by its adverse effect on the respondent's life over the past month. In this study, the MLHFQ total score was used as a continuous measure of heart failure related quality of life. Higher scores indicate a worse outcome. | Description | An abbreviated version of the 36-item Short Form Health Survey, which is a well-established measure assessing dimensions of mental and physical health. In this study, PCS and MCS summary scores were used as continuous measures of health-related quality of life. Scoring procedures involve computer-based scoring algorithms to calculate two summary scores, the physical component summary score (PCS) and mental component summary score (MCS), on a scale from 0 to 100 with a mean of 50 ± 10 that is normally distributed according to the adult U.S. population. Higher scores indicate a better outcome. |
Browse Conditions
Sequence: | 193431891 | Sequence: | 193431892 |
Mesh Term | Depression | Mesh Term | Behavioral Symptoms |
Downcase Mesh Term | depression | Downcase Mesh Term | behavioral symptoms |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306001 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Stanford University |
Design Group Interventions
Sequence: | 68130801 |
Design Group Id | 55577845 |
Intervention Id | 52471955 |
Eligibilities
Sequence: | 30757321 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Adults 18 years of age and older Exclusion Criteria: Current psychiatric instability (eg., suicidality, schizophrenia, bipolar disorder, active alcoholism or substance abuse) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254223917 |
Registered In Calendar Year | 2019 |
Actual Duration | 26 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30503546 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Double |
Intervention Model Description | Brief Bedside CBT versus Treatment As Usual |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Links
Sequence: | 4386994 |
Url | https://www.jtcvs.org/article/S0022-5223(11)00402-8/fulltext |
Description | Link to Dao et al 2011 |
Responsible Parties
Sequence: | 28869824 |
Responsible Party Type | Principal Investigator |
Name | William Fearon |
Title | Professor of Medicine |
Affiliation | Stanford University |
Study References
Sequence: | 52049382 |
Pmid | 21621227 |
Reference Type | background |
Citation | Dao TK, Youssef NA, Armsworth M, Wear E, Papathopoulos KN, Gopaldas R. Randomized controlled trial of brief cognitive behavioral intervention for depression and anxiety symptoms preoperatively in patients undergoing coronary artery bypass graft surgery. J Thorac Cardiovasc Surg. 2011 Sep;142(3):e109-15. doi: 10.1016/j.jtcvs.2011.02.046. Epub 2011 May 28. |
]]>
https://zephyrnet.com/NCT03798535
2018-12-19
https://zephyrnet.com/?p=NCT03798535
NCT03798535https://www.clinicaltrials.gov/study/NCT03798535?tab=tableNANANAThis is a non-interventional/observational cohort of NSCLC unresectable stage III patients treated with durvalumab.
The study will be carried out as a retrospective review of established medical records for a subset of unresectable stage III patients treated with durvalumab.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-21 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2023-05-30 |
Start Month Year | December 19, 2018 |
Primary Completion Month Year | December 20, 2023 |
Verification Month Year | May 2023 |
Verification Date | 2023-05-31 |
Last Update Posted Date | 2023-05-30 |
Detailed Descriptions
Sequence: | 20703091 |
Description | This is a non-interventional/observational study including NSCLC unresectable Stage III patients treated with durvalumab. Patient selection and retrospective data collection will be from participating countries: Australia, Belgium, Israel, Netherlands, Norway France, Germany, Italy, Switzerland, Spain
Chart abstractions will occur at specified intervals up to five years after the patient had the first dose of durvalumab. A target of four (maximum five) chart extractions is anticipated for each participant. Dates may be adjusted based on local market ethics processes or patient enrolment. First chart extraction will be used to determine which patients meet the inclusion/exclusion criteria for the study and will retrospectively collect all data from diagnosis of stage III unresectable NSCLC and the durvalumab start date (index date). |
Facilities
Sequence: | 199860344 | Sequence: | 199860345 | Sequence: | 199860346 | Sequence: | 199860347 | Sequence: | 199860348 | Sequence: | 199860349 | Sequence: | 199860350 | Sequence: | 199860351 | Sequence: | 199860352 | Sequence: | 199860353 | Sequence: | 199860354 | Sequence: | 199860355 | Sequence: | 199860356 | Sequence: | 199860357 | Sequence: | 199860358 | Sequence: | 199860359 | Sequence: | 199860360 | Sequence: | 199860361 | Sequence: | 199860362 | Sequence: | 199860363 | Sequence: | 199860364 | Sequence: | 199860365 | Sequence: | 199860366 | Sequence: | 199860367 | Sequence: | 199860368 | Sequence: | 199860369 | Sequence: | 199860370 | Sequence: | 199860371 | Sequence: | 199860372 | Sequence: | 199860373 | Sequence: | 199860374 | Sequence: | 199860375 | Sequence: | 199860376 | Sequence: | 199860377 | Sequence: | 199860378 | Sequence: | 199860379 | Sequence: | 199860380 | Sequence: | 199860381 | Sequence: | 199860382 | Sequence: | 199860383 | Sequence: | 199860384 | Sequence: | 199860385 | Sequence: | 199860386 | Sequence: | 199860387 | Sequence: | 199860388 | Sequence: | 199860389 | Sequence: | 199860390 | Sequence: | 199860391 | Sequence: | 199860392 | Sequence: | 199860393 | Sequence: | 199860394 | Sequence: | 199860395 | Sequence: | 199860396 | Sequence: | 199860397 | Sequence: | 199860398 | Sequence: | 199860399 | Sequence: | 199860400 | Sequence: | 199860401 | Sequence: | 199860402 | Sequence: | 199860403 | Sequence: | 199860404 | Sequence: | 199860405 | Sequence: | 199860406 | Sequence: | 199860407 | Sequence: | 199860408 | Sequence: | 199860409 | Sequence: | 199860410 | Sequence: | 199860411 | Sequence: | 199860412 | Sequence: | 199860413 | Sequence: | 199860414 | Sequence: | 199860415 | Sequence: | 199860416 | Sequence: | 199860417 | Sequence: | 199860418 | Sequence: | 199860419 | Sequence: | 199860420 | Sequence: | 199860421 | Sequence: | 199860422 | Sequence: | 199860423 | Sequence: | 199860424 | Sequence: | 199860425 | Sequence: | 199860426 | Sequence: | 199860427 | Sequence: | 199860428 | Sequence: | 199860429 | Sequence: | 199860430 | Sequence: | 199860431 | Sequence: | 199860432 | Sequence: | 199860433 | Sequence: | 199860434 | Sequence: | 199860435 | Sequence: | 199860436 | Sequence: | 199860437 | Sequence: | 199860438 | Sequence: | 199860439 | Sequence: | 199860440 | Sequence: | 199860441 | Sequence: | 199860442 | Sequence: | 199860443 | Sequence: | 199860444 | Sequence: | 199860445 | Sequence: | 199860446 | Sequence: | 199860447 | Sequence: | 199860448 | Sequence: | 199860449 | Sequence: | 199860450 | Sequence: | 199860451 | Sequence: | 199860452 | Sequence: | 199860453 | Sequence: | 199860454 | Sequence: | 199860455 | Sequence: | 199860456 | Sequence: | 199860457 | Sequence: | 199860458 | Sequence: | 199860459 | Sequence: | 199860460 | Sequence: | 199860461 | Sequence: | 199860462 | Sequence: | 199860463 | Sequence: | 199860464 | Sequence: | 199860465 | Sequence: | 199860466 | Sequence: | 199860467 | Sequence: | 199860468 | Sequence: | 199860469 | Sequence: | 199860470 | Sequence: | 199860471 | Sequence: | 199860472 | Sequence: | 199860473 | Sequence: | 199860474 | Sequence: | 199860475 | Sequence: | 199860476 | Sequence: | 199860477 | Sequence: | 199860478 | Sequence: | 199860479 | Sequence: | 199860480 | Sequence: | 199860481 | Sequence: | 199860482 | Sequence: | 199860483 | Sequence: | 199860484 | Sequence: | 199860485 | Sequence: | 199860486 | Sequence: | 199860487 | Sequence: | 199860488 | Sequence: | 199860489 | Sequence: | 199860490 | Sequence: | 199860491 | Sequence: | 199860492 | Sequence: | 199860493 | Sequence: | 199860494 | Sequence: | 199860495 | Sequence: | 199860496 | Sequence: | 199860497 | Sequence: | 199860498 | Sequence: | 199860499 | Sequence: | 199860500 | Sequence: | 199860501 | Sequence: | 199860502 | Sequence: | 199860503 | Sequence: | 199860504 | Sequence: | 199860505 | Sequence: | 199860506 | Sequence: | 199860507 | Sequence: | 199860508 | Sequence: | 199860509 | Sequence: | 199860510 | Sequence: | 199860511 | Sequence: | 199860512 | Sequence: | 199860513 | Sequence: | 199860514 | Sequence: | 199860515 | Sequence: | 199860516 | Sequence: | 199860517 | Sequence: | 199860518 | Sequence: | 199860519 | Sequence: | 199860520 | Sequence: | 199860521 | Sequence: | 199860522 | Sequence: | 199860523 | Sequence: | 199860524 | Sequence: | 199860525 | Sequence: | 199860526 | Sequence: | 199860527 | Sequence: | 199860528 | Sequence: | 199860529 | Sequence: | 199860530 | Sequence: | 199860531 | Sequence: | 199860532 | Sequence: | 199860533 | Sequence: | 199860534 | Sequence: | 199860535 | Sequence: | 199860536 | Sequence: | 199860537 | Sequence: | 199860538 | Sequence: | 199860539 | Sequence: | 199860540 | Sequence: | 199860541 | Sequence: | 199860542 | Sequence: | 199860543 | Sequence: | 199860544 | Sequence: | 199860545 | Sequence: | 199860546 | Sequence: | 199860547 | Sequence: | 199860548 | Sequence: | 199860549 | Sequence: | 199860550 | Sequence: | 199860551 | Sequence: | 199860552 | Sequence: | 199860553 | Sequence: | 199860554 | Sequence: | 199860555 | Sequence: | 199860556 | Sequence: | 199860557 | Sequence: | 199860558 | Sequence: | 199860559 | Sequence: | 199860560 | Sequence: | 199860561 | Sequence: | 199860562 | Sequence: | 199860563 | Sequence: | 199860564 | Sequence: | 199860565 | Sequence: | 199860566 | Sequence: | 199860567 | Sequence: | 199860568 | Sequence: | 199860569 | Sequence: | 199860570 | Sequence: | 199860571 | Sequence: | 199860572 | Sequence: | 199860573 | Sequence: | 199860574 | Sequence: | 199860575 | Sequence: | 199860576 | Sequence: | 199860577 | Sequence: | 199860578 | Sequence: | 199860579 | Sequence: | 199860580 | Sequence: | 199860581 | Sequence: | 199860582 | Sequence: | 199860583 | Sequence: | 199860584 | Sequence: | 199860585 | Sequence: | 199860586 | Sequence: | 199860587 | Sequence: | 199860588 | Sequence: | 199860589 | Sequence: | 199860590 | Sequence: | 199860591 | Sequence: | 199860592 | Sequence: | 199860593 | Sequence: | 199860594 | Sequence: | 199860595 | Sequence: | 199860596 | Sequence: | 199860597 |
Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | Research Site | Name | 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Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Belgium | Country | Belgium | Country | Belgium | Country | Belgium | Country | Belgium | Country | Belgium | Country | Belgium | Country | Belgium | Country | Belgium | Country | Belgium | Country | Belgium | Country | 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Germany | Country | Israel | Country | Israel | Country | Israel | Country | Israel | Country | Israel | Country | Israel | Country | Israel | Country | Israel | Country | Israel | Country | Israel | Country | Israel | Country | Israel | Country | Israel | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Netherlands | Country | Norway | Country | Norway | Country | Norway | Country | Norway | Country | Switzerland | Country | Switzerland | Country | Switzerland | Country | Switzerland | Country | Switzerland | Country | Switzerland | Country | Switzerland | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom | Country | United Kingdom |
Conditions
Sequence: | 52120158 |
Name | NSCLC |
Downcase Name | nsclc |
Id Information
Sequence: | 40119354 |
Id Source | org_study_id |
Id Value | D4194R00005 |
Countries
Sequence: | 42523597 | Sequence: | 42523598 | Sequence: | 42523599 | Sequence: | 42523600 | Sequence: | 42523601 | Sequence: | 42523602 | Sequence: | 42523603 | Sequence: | 42523604 | Sequence: | 42523605 | Sequence: | 42523606 |
Name | Australia | Name | Belgium | Name | France | Name | Germany | Name | Israel | Name | Italy | Name | Netherlands | Name | Norway | Name | Switzerland | Name | United Kingdom |
Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False |
Design Outcomes
Sequence: | 177201070 | Sequence: | 177201071 |
Outcome Type | primary | Outcome Type | primary |
Measure | To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating progression free survival (PFS) | Measure | To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating overall survival (OS) |
Time Frame | PFS is assessed as PFS rates at 12 months and 18 months, and as PFS median for a period of time of 5 years. From Index date (first dose of durvalumab) to progression or death whichever came first, assessed up to 5 years. | Time Frame | OS is assessed as OS rates at 2, 3 and 5 years, and as OS median for a period of time of 5 years. From Index date (first dose of durvalumab) to death or end of follow up, whichever came first, assessed during 5 years. |
Description | PFS defined as time from the index date (date of the first dose of durvalumab) to the date of investigator-determined disease progression or death (if no progression) or the end of follow-up | Description | OS following durvalumab regimen received from the index date to death or end of follow-up. |
Browse Conditions
Sequence: | 193288645 | Sequence: | 193288646 | Sequence: | 193288647 | Sequence: | 193288648 | Sequence: | 193288649 | Sequence: | 193288650 | Sequence: | 193288651 | Sequence: | 193288652 | Sequence: | 193288653 | Sequence: | 193288654 |
Mesh Term | Carcinoma, Non-Small-Cell Lung | Mesh Term | Carcinoma, Bronchogenic | Mesh Term | Bronchial Neoplasms | Mesh Term | Lung Neoplasms | Mesh Term | Respiratory Tract Neoplasms | Mesh Term | Thoracic Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases |
Downcase Mesh Term | carcinoma, non-small-cell lung | Downcase Mesh Term | carcinoma, bronchogenic | Downcase Mesh Term | bronchial neoplasms | Downcase Mesh Term | lung neoplasms | Downcase Mesh Term | respiratory tract neoplasms | Downcase Mesh Term | thoracic neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48273086 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | AstraZeneca |
Eligibilities
Sequence: | 30736638 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 130 Years |
Healthy Volunteers | No |
Population | Patient selection criteria: Patient selection and retrospective data collection will be from participating countries: Australia, Belgium, Israel, Netherlands, Norway France, Germany, Italy, Switzerland, Spain. Data will be collected from those patients who have received at least one dose of durvalumab between September 2017 through 21 DEC 2018. Patients may participate in other clinical trials during this follow-up period.
Patients must have completed a platinum-based chemotherapy concurrently or sequentially with radiation therapy without evidence of disease progression. There is no fixed maximum duration for durvalumab treatment and it continues until the physician determines that it is in the patient's best interest to stop therapy. |
Criteria | Inclusion Criteria:
Written informed consent or any locally required authorisation obtained from the patient prior to performing any protocol-related procedures Patients who die during the EAP are eligible to enter in the study when local laws allow for a consent waiver, if all other inclusion/exclusion criteria are met. Exclusion Criteria: -Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP). |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254020505 |
Number Of Facilities | 254 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 130 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Designs
Sequence: | 30482996 |
Observational Model | Cohort |
Time Perspective | Other |
Responsible Parties
Sequence: | 28849349 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798522
2019-02-01
https://zephyrnet.com/?p=NCT03798522
NCT03798522https://www.clinicaltrials.gov/study/NCT03798522?tab=tableNANANAbilateral continuous erector spinae plane blockade may represent a valuable alternatives to thoracіc epidurals analgaesіa in treatment of thoracic neuropathic pain.
There were 3 cases reported in 2017 suggested that the erector spinae plane block provides visceral abdominal analgesia in bariatric surgery and at end of the report they recommended further clinical investigation. The investigators hypothesіzed that performing the erector spinae plane (ESP) block at T7 would provide effective abdominal analgaesіa іn patients undergone laparoscopic bariatric surgery. The investigators aimed to compare the analgesic effect of erector spinae plane block and opioid based general anesthesia for laparoscopic bariatric surgeries.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-27 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-01-14 |
Start Month Year | February 1, 2019 |
Primary Completion Month Year | August 30, 2019 |
Verification Month Year | January 2020 |
Verification Date | 2020-01-31 |
Last Update Posted Date | 2020-01-14 |
Detailed Descriptions
Sequence: | 20721644 |
Description | The investigators hypothesized that, erector spinae plane block will provide good analgesia for patients undergoing laparoscopic bariatric surgery with less complication compared to opioid based general anesthesia. The visual analogue scale (VAS) will be explained clearly to all participants before conduction of anesthesia. All the drugs will be calculated according to the ideal body weight (IBW).A low-frequency (2-5 MHz) curved array ultrasound probe (Mindray®, China) will be used. In the 1st group: bilateral ultrasound-guided erector spinae plane block will be performed under complete aseptic conditions in the lateral position at T7 vertebrae and before induction of general anesthesia. An 8-cm echogenic 22-G block needle will be inserted in-plane. A total of 20 ml of local anesthetic solution (20 ml bupivacaine (Sunnypivacaine, Sunny pharmaceutical, Egypt) 0.25%) will then be injected into the erector spinae plane. This procedure will be repeated on the contralateral side taking care not to exceed the maximum recommended doses (2 mg/kg of IBW for bupivacaine). In the 2nd group: the investigator will give intravenous nalbuphine in a dose of 2mg /kg according to ideal body weight after induction of general anesthesia. All participants will be given 1 gram of intravenous paracetamol (15 mg/Kg), together with 4 mg ondansetron 10 min prior to the end of surgery for postoperative nausea and vomiting prophylaxis.
Intraoperatively, any increase in heart rate and/or arterial blood pressure 10 min after intubation by more than 20% of baseline values in response to surgical stimulus or thereafter throughout the whole operation will be managed by intravenous administration of fentanyl 0.5 µg/Kg. VAS score will be assessed 30 min after extubation and when the VAS score exceeded 4/10, rescue analgesia in the form of IV nalbuphine 5 mg will be administered. Another dose of rescue analgesia can be given in the post anesthesia care unit (PACU) if the VAS still more than 4 after 60 min of extubation. If still high, Ketorolac 60 mg will be given by intravenous infusion. |
Facilities
Sequence: | 200108200 |
Name | Hany Mohammed El-Hadi Shoukat Mohammed |
City | Giza |
Zip | 12211 |
Country | Egypt |
Browse Interventions
Sequence: | 96050272 | Sequence: | 96050273 | Sequence: | 96050274 | Sequence: | 96050275 | Sequence: | 96050276 | Sequence: | 96050277 | Sequence: | 96050278 | Sequence: | 96050279 |
Mesh Term | Nalbuphine | Mesh Term | Analgesics, Opioid | Mesh Term | Narcotics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Analgesics | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents |
Downcase Mesh Term | nalbuphine | Downcase Mesh Term | analgesics, opioid | Downcase Mesh Term | narcotics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | analgesics | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52171255 | Sequence: | 52171256 | Sequence: | 52171257 |
Name | Bariatric Surgery Candidate | Name | Morbid Obesity | Name | Visceral Pain |
Downcase Name | bariatric surgery candidate | Downcase Name | morbid obesity | Downcase Name | visceral pain |
Id Information
Sequence: | 40158648 |
Id Source | org_study_id |
Id Value | N-42-2018 |
Countries
Sequence: | 42568954 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55593195 | Sequence: | 55593196 |
Group Type | Experimental | Group Type | Active Comparator |
Title | erector spinae plane block group (ESPB) n=14 | Title | general anesthesia group (GA) n= 14 |
Description | Bilateral ultrasound guided erector spinae plane block will be performed in the lateral position at T7 vertebrae and before induction of GA. 20 ml of local anesthetic solution (20 ml bupivacaine (Sunnypivacaine, Sunny pharmaceutical, Egypt) 0.25%) will be injected in-plane into the ESP. This procedure will be repeated on the other side taking care not to exceed the maximum recommended doses (2 mg/kg of IBW for bupivacaine) and then GA will be conducted . | Description | these patients will receive iv nalbuphine in dose of 2mg /kg according to ideal body weight after induction of GA |
Interventions
Sequence: | 52485498 | Sequence: | 52485499 |
Intervention Type | Procedure | Intervention Type | Drug |
Name | bilateral ultrasound guided erector spinae plane block | Name | Nalbuphine |
Description | ESPB on both sides at T7 before GA | Description | in nalbuphine for analgesia after GA |
Keywords
Sequence: | 79868567 | Sequence: | 79868568 | Sequence: | 79868569 |
Name | ultrasound guided regional blocks | Name | laparoscopic surgery | Name | erector spinae plane block |
Downcase Name | ultrasound guided regional blocks | Downcase Name | laparoscopic surgery | Downcase Name | erector spinae plane block |
Design Outcomes
Sequence: | 177378921 | Sequence: | 177378922 | Sequence: | 177378923 | Sequence: | 177378924 | Sequence: | 177378925 | Sequence: | 177378926 | Sequence: | 177378927 | Sequence: | 177378928 | Sequence: | 177378929 | Sequence: | 177378930 | Sequence: | 177378931 | Sequence: | 177378932 | Sequence: | 177378933 | Sequence: | 177378934 | Sequence: | 177378935 | Sequence: | 177378936 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | The duration of analgesic effect in minutes | Measure | mean arterial blood pressure changes | Measure | Nalbuphine consumption | Measure | visual analogue scale (VAS) for assessment of postoperative pain | Measure | Block failure rate | Measure | Resumption of peristalsis | Measure | incidence of adverse effects | Measure | Incidence of shoulder pain | Measure | length of hospital stay | Measure | heart rate | Measure | Failure rate of the ESP block | Measure | demographic data | Measure | duration of surgery | Measure | weight | Measure | height | Measure | body mass index (BMI) |
Time Frame | defined as the time n minutes between finishing the block technique in ESPB group or after administration of nalbuphine in GA-group, and the request of first dose of postoperative analgesics) when VAS is more than 4 during the 1st 8 hours postoperatively | Time Frame | intraoperative and post extubation in the 1st hour | Time Frame | total dose given post operatively up to 1 hour postoperatively | Time Frame | at 30 minutes, 45 minutes and 60 minutes, 4 hours and 8 hours after surgery | Time Frame | in the first hour postoperatively | Time Frame | postoperatively up to 48 hours postoperatively | Time Frame | postoperative up to 48 hours | Time Frame | postoperativey up to 24 hours | Time Frame | postoperative up to 28 days postoperatively | Time Frame | intraoperatively and throughout one hour postextubation | Time Frame | in the first hour postoperatively | Time Frame | during 30 minutes preoperatively | Time Frame | from skin incision up to skin closure | Time Frame | during 30 minutes preoperatively | Time Frame | during 30 minutes preoperatively | Time Frame | uring 30 minutes preoperatively |
Description | The duration of analgesic effect is indicated by the 1st analgesic requisite after measurement of VAS | Description | mean arterial blood pressure will be assessed and measured in mmHg non invasively | Description | in mg | Description | in numbers, normal scale ranges from 0 to 10 with 0 means no pain and 10 means worst pain imaginable. if VAS score exceeded 4/10; this will be considered insufficient analgesia and participant will be given rescue analgesia | Description | patient required more than two 5mg doses of nalbuphine | Description | in hours | Description | postoperative nausea and vomiting, urinary retention, hematoma formation, local anesthetic toxicity and need of postoperative ICU or mechanical ventilation | Description | percent | Description | in days | Description | heart rate in beat per minute will be measured | Description | the block will be considered a failed block if the patient required more than two 5mg doses of nalbuphine | Description | age, sex, ASA class, co-morbidities | Description | in minutes | Description | kilograms | Description | meter | Description | weight in kilograms divided by square height in meter |
Browse Conditions
Sequence: | 193486794 | Sequence: | 193486795 | Sequence: | 193486796 | Sequence: | 193486797 | Sequence: | 193486798 | Sequence: | 193486799 | Sequence: | 193486800 | Sequence: | 193486801 | Sequence: | 193486802 | Sequence: | 193486803 |
Mesh Term | Obesity, Morbid | Mesh Term | Visceral Pain | Mesh Term | Obesity | Mesh Term | Overweight | Mesh Term | Overnutrition | Mesh Term | Nutrition Disorders | Mesh Term | Body Weight | Mesh Term | Nociceptive Pain | Mesh Term | Pain | Mesh Term | Neurologic Manifestations |
Downcase Mesh Term | obesity, morbid | Downcase Mesh Term | visceral pain | Downcase Mesh Term | obesity | Downcase Mesh Term | overweight | Downcase Mesh Term | overnutrition | Downcase Mesh Term | nutrition disorders | Downcase Mesh Term | body weight | Downcase Mesh Term | nociceptive pain | Downcase Mesh Term | pain | Downcase Mesh Term | neurologic manifestations |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319308 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Cairo University |
Design Group Interventions
Sequence: | 68149152 | Sequence: | 68149153 |
Design Group Id | 55593195 | Design Group Id | 55593196 |
Intervention Id | 52485498 | Intervention Id | 52485499 |
Eligibilities
Sequence: | 30765363 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Patient age >18 <60 Exclusion Criteria: Refusal of regional block |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253884488 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 7 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 10 |
Number Of Other Outcomes To Measure | 5 |
Designs
Sequence: | 30511530 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Single |
Intervention Model Description | erector spinae plane block group (ESPB) general anesthesia group (GA) |
Subject Masked | True |
Intervention Other Names
Sequence: | 26673744 | Sequence: | 26673745 |
Intervention Id | 52485498 | Intervention Id | 52485499 |
Name | ESPB | Name | GA |
Responsible Parties
Sequence: | 28877824 |
Responsible Party Type | Principal Investigator |
Name | Hany Mohammed El-Hadi Shoukat Mohammed |
Title | lecturer of anesthesia, pain management and surgical ICU |
Affiliation | Cairo University |
Ipd Information Types
Sequence: | 3334121 | Sequence: | 3334122 |
Name | Study Protocol | Name | Statistical Analysis Plan (SAP) |
]]>
https://zephyrnet.com/NCT03798509
2019-03-13
https://zephyrnet.com/?p=NCT03798509
NCT03798509https://www.clinicaltrials.gov/study/NCT03798509?tab=tableHongliang Fang, doctorfanghongliang@dashengbio.com021-58552006To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive B-cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-08-31 |
Start Month Year | March 13, 2019 |
Primary Completion Month Year | January 2022 |
Verification Month Year | August 2021 |
Verification Date | 2021-08-31 |
Last Update Posted Date | 2021-08-31 |
Detailed Descriptions
Sequence: | 20741170 |
Description | Participants with relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, electrocardiograph and blood draws. Participants receive chemotherapy prior to the infusion of CD19 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19 CAR+ T cells. Study procedures may be performed while hospitalized. |
Facilities
Sequence: | 200280595 |
Status | Recruiting |
Name | Shanghai General Hospital |
City | Shanghai |
State | Shanghai |
Zip | 200080 |
Country | China |
Facility Contacts
Sequence: | 28132858 |
Facility Id | 200280595 |
Contact Type | primary |
Name | Xianmin Song, Professor |
shongxm@139.com | |
Phone | 021-63240090 |
Phone Extension | 3173 |
Conditions
Sequence: | 52221525 | Sequence: | 52221526 |
Name | CD19-positive | Name | Acute Lymphoblastic Leukemia |
Downcase Name | cd19-positive | Downcase Name | acute lymphoblastic leukemia |
Id Information
Sequence: | 40195629 |
Id Source | org_study_id |
Id Value | HRAIN01-ALL01 |
Countries
Sequence: | 42609658 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55649818 |
Group Type | Experimental |
Title | Human CD19 targeted T Cells Injection |
Interventions
Sequence: | 52535341 |
Intervention Type | Drug |
Name | Human CD19 targeted T Cells Injection |
Description | Autologous genetically modified anti-CD19 CAR transduced T cells |
Keywords
Sequence: | 79941759 | Sequence: | 79941760 | Sequence: | 79941761 | Sequence: | 79941762 | Sequence: | 79941763 |
Name | CD19 | Name | CAR-T | Name | leukemia | Name | Relapsed /Refractory | Name | B-ALL |
Downcase Name | cd19 | Downcase Name | car-t | Downcase Name | leukemia | Downcase Name | relapsed /refractory | Downcase Name | b-all |
Design Outcomes
Sequence: | 177561495 | Sequence: | 177561496 | Sequence: | 177561497 | Sequence: | 177561498 | Sequence: | 177561499 | Sequence: | 177561500 | Sequence: | 177561501 | Sequence: | 177561502 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | DLT | Measure | Duration of CAR-positive T cells in circulation | Measure | The concentration of CD19-positive B cells in peripheral blood. | Measure | Overall response rate (ORR) after administration | Measure | Duration of remission (DOR) after administration | Measure | Progress Free Survival (PFS) after administration | Measure | Overall Survival (OS)after administration | Measure | The immunogenicity of Human CD19 targeted T Cells Injection. (the detection of human anti-mouse antibody) |
Time Frame | 28 days post infusion | Time Frame | 2 years post infusion | Time Frame | 2 years post infusion | Time Frame | 90 days post infusion | Time Frame | 2 years post infusion | Time Frame | 2 years post infusion | Time Frame | 2 years post infusion | Time Frame | 2 years post infusion |
Browse Conditions
Sequence: | 193678453 | Sequence: | 193678454 | Sequence: | 193678455 | Sequence: | 193678456 | Sequence: | 193678457 | Sequence: | 193678458 | Sequence: | 193678459 | Sequence: | 193678460 | Sequence: | 193678461 |
Mesh Term | Leukemia | Mesh Term | Precursor Cell Lymphoblastic Leukemia-Lymphoma | Mesh Term | Leukemia, Lymphoid | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Lymphoproliferative Disorders | Mesh Term | Lymphatic Diseases | Mesh Term | Immunoproliferative Disorders | Mesh Term | Immune System Diseases |
Downcase Mesh Term | leukemia | Downcase Mesh Term | precursor cell lymphoblastic leukemia-lymphoma | Downcase Mesh Term | leukemia, lymphoid | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lymphoproliferative disorders | Downcase Mesh Term | lymphatic diseases | Downcase Mesh Term | immunoproliferative disorders | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366429 | Sequence: | 48366430 |
Agency Class | INDUSTRY | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Hrain Biotechnology Co., Ltd. | Name | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
Central Contacts
Sequence: | 12020590 |
Contact Type | primary |
Name | Hongliang Fang, doctor |
Phone | 021-58552006 |
fanghongliang@dashengbio.com | |
Role | Contact |
Design Group Interventions
Sequence: | 68217409 |
Design Group Id | 55649818 |
Intervention Id | 52535341 |
Eligibilities
Sequence: | 30794711 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
18 to 70 Years Old, Male and female; Bone marrow examination clearly diagnosed as CD19 positive B-cell acute lymphoblastic leukemia and who met one of the following conditions: Those who failed to achieve CR after at least 2 courses of standard chemotherapy or had early relapse after complete remission (<12 months) or late relapse after complete remission (≥ 12 months) and failed to achieve CR after 1 course of standard chemotherapy; Liver, kidney and cardiopulmonary functions meet the following requirements: Creatinine is in the normal range; Exclusion Criteria: Graft-versus-host disease (GVHD), or need to use immunosuppressants; |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004327 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 7 |
Designs
Sequence: | 30540751 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28907071 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798496
2018-12-18
https://zephyrnet.com/?p=NCT03798496
NCT03798496https://www.clinicaltrials.gov/study/NCT03798496?tab=tableNANANAMost Galeazzi fractures can be treated adequately with open reduction and internal fixation (ORIF) of the radius alone, but some will remain unstable at the DRUJ and require repair of the TFCC.The purpose of this anatomical and biomechanical study was to define and measure DRUJ dislocation, displacement and instability associated with the sequential sectioning of the different bands in the interosseous membrane (IOM) and TFCC in the simulation of a Galeazzi fracture.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-19 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-07-13 |
Start Month Year | December 18, 2018 |
Primary Completion Month Year | January 31, 2021 |
Verification Month Year | July 2021 |
Verification Date | 2021-07-31 |
Last Update Posted Date | 2021-07-13 |
Detailed Descriptions
Sequence: | 20709980 |
Description | Instability of the DRUJ is a common clinical problem associated with Galeazzi fracture. Stability of the DRUJ is primarily provided by both the bony anatomy of the sigmoid notch of the radius and ulnar head and the soft tissues surrounding the joint. The interosseous membrane plays an important role in DRUJ stability but the TFCC is the major soft tissue stabilizer of the DRUJ. The Central Band works as a restraint on the radius from proximal migration in cooperation with the radial head and the TFCC and also works as a load transmitter between the radius and ulnar to redistribute load. Some investigators suggested that the distal membranous portion and DOB stabilizes the DRUJ when TFCC is disrupted. Watanabe et al. (2005) insisted on the importance of DOB, which constrained volar and dorsal instability of the radius at the DRUJ in all forearm rotation positions. The purpose of this anatomical and biomechanical study was to define and measure DRUJ dislocation in the simulation of a Galeazzi fracture. |
Facilities
Sequence: | 199965051 |
Name | Hospital de la Santa Creu i Sant Pau |
City | Barcelona |
Zip | 08025 |
Country | Spain |
Conditions
Sequence: | 52138979 |
Name | Galeazzi's Fracture |
Downcase Name | galeazzi's fracture |
Id Information
Sequence: | 40135041 |
Id Source | org_study_id |
Id Value | IIBSP-GAL-2018-75 |
Countries
Sequence: | 42542672 |
Name | Spain |
Removed | False |
Interventions
Sequence: | 52454878 |
Intervention Type | Procedure |
Name | Open reduction and internal fixation |
Description | Open reduction of the Galeazzi fracture dislocation with a plate. |
Design Outcomes
Sequence: | 177263571 | Sequence: | 177263572 |
Outcome Type | primary | Outcome Type | primary |
Measure | Displacement in distal radius fracture | Measure | Stability in the DRU joint |
Time Frame | 12 months | Time Frame | 12 months |
Description | The investigators will mesure the degree of displacement (mm) in a simulate distal radius fracture with a biomechanical device named Medmesin with a especific computer software that applies newtons (from 0 to 100N) in the radius in each especimen. | Description | Dislocation of the ulnar in the wrist. In the retrospective clinical reports the investigators evaluate the x-rays before and after the surgery and the radioulnar ratio in the CT scan (congruency method, Mino criteria and the epicenter method). |
Browse Conditions
Sequence: | 193366415 | Sequence: | 193366416 | Sequence: | 193366417 | Sequence: | 193366418 | Sequence: | 193366419 |
Mesh Term | Fractures, Bone | Mesh Term | Radius Fractures | Mesh Term | Wounds and Injuries | Mesh Term | Forearm Injuries | Mesh Term | Arm Injuries |
Downcase Mesh Term | fractures, bone | Downcase Mesh Term | radius fractures | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | forearm injuries | Downcase Mesh Term | arm injuries |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290688 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Overall Officials
Sequence: | 29268526 |
Role | Principal Investigator |
Name | Claudia Lamas, Ph D |
Affiliation | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Eligibilities
Sequence: | 30747708 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 85 Years |
Healthy Volunteers | No |
Population | Anatomical and biomechanical study: Twelve specimens from the Human Anatomy Department.
Clinical study: Review of reports (X-rays) about patients with Galeazzi fracture-dislocation treated with ORIF. |
Criteria | Inclusion Criteria:
Adults patients(18-85 years old) with Galeazzi fracture-dislocation treated with open reduction and internal fixation (ORIF). Exclusion Criteria: Children |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121821 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 25 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 85 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Designs
Sequence: | 30493991 |
Observational Model | Cohort |
Time Perspective | Other |
Intervention Other Names
Sequence: | 26655395 |
Intervention Id | 52454878 |
Name | DRUJ reduction with Kirschner wire |
Responsible Parties
Sequence: | 28860271 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52032712 | Sequence: | 52032713 | Sequence: | 52032714 | Sequence: | 52032715 | Sequence: | 52032716 | Sequence: | 52032717 | Sequence: | 52032718 | Sequence: | 52032719 | Sequence: | 52032720 | Sequence: | 52032721 |
Pmid | 25703865 | Pmid | 21872404 | Pmid | 24315636 | Pmid | 22721462 | Pmid | 19211201 | Pmid | 8463602 | Pmid | 24436838 | Pmid | 26518322 | Pmid | 28428910 | Pmid | 22100813 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Farr LD, Werner FW, McGrattan ML, Zwerling SR, Harley BJ. Anatomy and biomechanics of the forearm interosseous membrane. J Hand Surg Am. 2015 Jun;40(6):1145-51.e2. doi: 10.1016/j.jhsa.2014.12.025. Epub 2015 Feb 20. | Citation | Kitamura T, Moritomo H, Arimitsu S, Berglund LJ, Zhao KD, An KN, Rizzo M. The biomechanical effect of the distal interosseous membrane on distal radioulnar joint stability: a preliminary anatomic study. J Hand Surg Am. 2011 Oct;36(10):1626-30. doi: 10.1016/j.jhsa.2011.07.016. Epub 2011 Aug 26. | Citation | Loeffler BJ, Green JB, Zelouf DS. Forearm instability. J Hand Surg Am. 2014 Jan;39(1):156-67. doi: 10.1016/j.jhsa.2013.07.010. Epub 2013 Dec 6. | Citation | Moritomo H. The distal interosseous membrane: current concepts in wrist anatomy and biomechanics. J Hand Surg Am. 2012 Jul;37(7):1501-7. doi: 10.1016/j.jhsa.2012.04.037. | Citation | Noda K, Goto A, Murase T, Sugamoto K, Yoshikawa H, Moritomo H. Interosseous membrane of the forearm: an anatomical study of ligament attachment locations. J Hand Surg Am. 2009 Mar;34(3):415-22. doi: 10.1016/j.jhsa.2008.10.025. Epub 2009 Feb 11. | Citation | Petersen MS, Adams BD. Biomechanical evaluation of distal radioulnar reconstructions. J Hand Surg Am. 1993 Mar;18(2):328-34. doi: 10.1016/0363-5023(93)90370-I. | Citation | Riggenbach MD, Conrad BP, Wright TW, Dell PC. Distal oblique bundle reconstruction and distal radioulnar joint instability. J Wrist Surg. 2013 Nov;2(4):330-6. doi: 10.1055/s-0033-1358546. | Citation | Riggenbach MD, Wright TW, Dell PC. Reconstruction of the Distal Oblique Bundle of the Interosseous Membrane: A Technique to Restore Distal Radioulnar Joint Stability. J Hand Surg Am. 2015 Nov;40(11):2279-82. doi: 10.1016/j.jhsa.2015.08.019. | Citation | Werner FW, LeVasseur MR, Harley BJ, Anderson A. Role of the Interosseous Membrane in Preventing Distal Radioulnar Gapping. J Wrist Surg. 2017 May;6(2):97-101. doi: 10.1055/s-0036-1584545. Epub 2016 Jun 20. | Citation | Werner FW, Taormina JL, Sutton LG, Harley BJ. Structural properties of 6 forearm ligaments. J Hand Surg Am. 2011 Dec;36(12):1981-7. doi: 10.1016/j.jhsa.2011.09.026. Epub 2011 Nov 17. |
]]>
https://zephyrnet.com/NCT03798483
2019-01-24
https://zephyrnet.com/?p=NCT03798483
NCT03798483https://www.clinicaltrials.gov/study/NCT03798483?tab=tableNANANAThis study is a feasibility study. It will assess areas of uncertainty relating to the implementation of an individualised exercise programme for patients with a recent kneecap dislocation. This will help determine if a future larger study is feasible, and inform the design and conduct of future research that would aim to optimise outcomes after a kneecap dislocation.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-11 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2021-02-01 |
Start Month Year | January 24, 2019 |
Primary Completion Month Year | October 8, 2019 |
Verification Month Year | December 2018 |
Verification Date | 2018-12-31 |
Last Update Posted Date | 2021-02-01 |
Results First Posted Date | 2021-02-01 |
Detailed Descriptions
Sequence: | 20724609 |
Description | The investigators aim to recruit 15 adult participants with a recent, first-time or recurrent kneecap dislocation, from an acute hospital. Participants will receive up to 6 physiotherapy sessions over 3 months. The investigator's exercise programme aims to improve leg muscle strength and facilitate a return to the participant's usual activities. This may include activities such as hopping and changing direction which differentiates it from other programmes. Participants will be required to perform the exercise programme 3 times a week independently. Strategies to increase adherence to the exercise programme will also be used. This study is part of a Masters in Clinical Research funded by the National Institute for Health Research |
Facilities
Sequence: | 200141486 |
Name | John Radcliffe Hospital |
City | Oxford |
Zip | OX3 9DU |
Country | United Kingdom |
Conditions
Sequence: | 52178978 | Sequence: | 52178979 |
Name | Patella Dislocation | Name | Patella Dislocation Recurrent |
Downcase Name | patella dislocation | Downcase Name | patella dislocation recurrent |
Id Information
Sequence: | 40164322 | Sequence: | 40164323 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | MRes/18-19/04/2 | Id Value | 251913 |
Id Type | Other Identifier | ||
Id Type Description | Health Research Authority – IRAS ID | ||
Countries
Sequence: | 42575730 |
Name | United Kingdom |
Removed | False |
Design Groups
Sequence: | 55601887 |
Group Type | Experimental |
Title | Individualized exercise |
Description | Participants after a lateral kneecap dislocation will be enrolled into an individualized exercise intervention supervised by a physiotherapist |
Interventions
Sequence: | 52493164 |
Intervention Type | Other |
Name | Individualised exercise |
Description | The intervention will be comprised of up to 6, one-to-one physiotherapy sessions, over a maximum duration of 3 months. 1 or 2 extra sessions are allowed if deemed essential by the participant's physiotherapist. Less than 6 physiotherapy sessions can be agreed with the participant if they have achieved their goals. Throughout this time participants will be required to perform an exercise programme a minimum of 3 times per week. The exercise programme aims to increase leg muscle strength and facilitate a return to the participant's usual activities. It may include hopping and change of direction tasks if these are activities the participant would normally do. Behavioural change techniques to increase participant adherence to the exercise programme will also be used. |
Design Outcomes
Sequence: | 177410072 | Sequence: | 177410073 | Sequence: | 177410074 | Sequence: | 177410075 | Sequence: | 177410076 | Sequence: | 177410077 | Sequence: | 177410078 | Sequence: | 177410079 | Sequence: | 177410080 | Sequence: | 177410081 | Sequence: | 177410082 | Sequence: | 177410083 | Sequence: | 177410084 | Sequence: | 177410085 | Sequence: | 177410086 | Sequence: | 177410087 | Sequence: | 177410088 | Sequence: | 177410089 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Eligibility Rate | Measure | Recruitment Rate | Measure | Attrition | Measure | Acceptability [Participant Satisfaction]: Questionnaire | Measure | Adherence | Measure | Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] | Measure | Acceptability of Outcome Data Collection | Measure | Number of Treatment Related Adverse Events Experienced by Participants | Measure | Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria | Measure | Tegner Activity Scale Questionnaire | Measure | Lyhsolm Knee Scoring Scale Questionnaire | Measure | Quality of Life Using the EQ-5D-5L Questionnaire | Measure | Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy] | Measure | Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants] | Measure | Assess Delivery of the Intervention [Duration of Intervention] | Measure | Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] | Measure | Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] | Measure | Assess Delivery of the Intervention [Initial Injury Management] |
Time Frame | 15 weeks | Time Frame | 15 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | Through 12 weeks after first physiotherapy session | Time Frame | Baseline | Time Frame | 12 weeks | Time Frame | 12 Weeks | Time Frame | 12 weeks | Time Frame | From date of injury until date of the first physiotherapy session, assessed up to 6 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks |
Description | Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria | Description | Percentage of eligible participants who consented to participate in the study | Description | Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data | Description | Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. | Description | Percentage (0-100%) of scheduled physiotherapy sessions attended | Description | Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4) | Description | Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up | Description | The total number and type of treatment related adverse events experienced by participants will be recorded. This will be recorded from commencement of the intervention to 12 week follow-up. Treatment related adverse events will be recorded by physiotherapists at each physiotherapy session and by participant self report at 12 week follow up. | Description | Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction | Description | This measures activity on a scale from 0-10, with higher scores indicating higher activity. It will be administered as a patient completed questionnaire. | Description | It is scored from 0-100 with lower scores indicating higher pain and disability. It will be administered as a patient completed questionnaire. | Description | This assess quality of life using 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depress, each containing 5 options. These domains are combined to give a single score ranging from -0.594 to 1 for UK populations, with higher scores indicating higher quality of life. Participants rate their overall health on a visual analogue scale from 0 (worst health you can imagine) to 100 (the best help you can imagine). It will be administered as a patient completed questionnaire. | Description | Treatment logs will be analysed to record the duration (number of days) from injury to commencing the intervention | Description | Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants | Description | Treatment logs will be analysed to assess the duration (days) of the study intervention | Description | Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants | Description | Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants | Description | Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team |
Browse Conditions
Sequence: | 193516248 | Sequence: | 193516249 | Sequence: | 193516250 | Sequence: | 193516251 | Sequence: | 193516252 | Sequence: | 193516253 | Sequence: | 193516254 |
Mesh Term | Joint Dislocations | Mesh Term | Patellar Dislocation | Mesh Term | Joint Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Wounds and Injuries | Mesh Term | Knee Injuries | Mesh Term | Leg Injuries |
Downcase Mesh Term | joint dislocations | Downcase Mesh Term | patellar dislocation | Downcase Mesh Term | joint diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | knee injuries | Downcase Mesh Term | leg injuries |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48326279 | Sequence: | 48326280 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | City, University of London | Name | Oxford University Hospitals NHS Trust |
Overall Officials
Sequence: | 29289214 |
Role | Principal Investigator |
Name | Mark Haddad, PhD |
Affiliation | City, University of London |
Design Group Interventions
Sequence: | 68159982 |
Design Group Id | 55601887 |
Intervention Id | 52493164 |
Eligibilities
Sequence: | 30769727 |
Gender | All |
Minimum Age | 16 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
First time or recurrent lateral patella dislocation meeting the diagnostic criteria of 1) requiring reduction by paramedics or 2) diagnosed by a member of the trauma and orthopaedic team. Exclusion Criteria: Concurrent anterior cruciate ligament or posterior cruciate ligament injury confirmed by negative Lachman's and posterior drawer test or confirmed by Magnetic Resonance Imagery (MRI); medial collateral and lateral collateral ligament injury requiring application of a hinged knee brace or surgical repair; concomitant injury that would prohibit participation in the exercise intervention |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 253937151 |
Number Of Facilities | 1 |
Number Of Nsae Subjects | 2 |
Registered In Calendar Year | 2018 |
Actual Duration | 8 |
Were Results Reported | True |
Months To Report Results | 13 |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 16 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 6 |
Number Of Secondary Outcomes To Measure | 12 |
Designs
Sequence: | 30515881 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Drop Withdrawals
Sequence: | 28993726 |
Result Group Id | 56100821 |
Ctgov Group Code | FG000 |
Period | Overall Study |
Reason | Lost to Follow-up |
Count | 2 |
Milestones
Sequence: | 41014457 | Sequence: | 41014458 | Sequence: | 41014459 | Sequence: | 41014460 |
Result Group Id | 56100821 | Result Group Id | 56100821 | Result Group Id | 56100821 | Result Group Id | 56100821 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG000 | Ctgov Group Code | FG000 |
Title | STARTED | Title | Returned All Follow-up Outcome Data | Title | COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 15 | Count | 11 | Count | 13 | Count | 2 |
Milestone Description | Completed participants were participants that returned Lysholm Knee Scoring Scale data. 2 participants returned Lysholm Knee Scoring Scale outcome data only. | ||||||
Participant Flows
Sequence: | 3921906 |
Outcome Counts
Sequence: | 74016549 | Sequence: | 74016550 | Sequence: | 74016551 | Sequence: | 74016552 | Sequence: | 74016553 | Sequence: | 74016554 | Sequence: | 74016555 | Sequence: | 74016556 | Sequence: | 74016557 | Sequence: | 74016558 | Sequence: | 74016559 | Sequence: | 74016560 | Sequence: | 74016561 | Sequence: | 74016562 | Sequence: | 74016563 | Sequence: | 74016564 | Sequence: | 74016565 | Sequence: | 74016566 | Sequence: | 74016567 | Sequence: | 74016568 |
Outcome Id | 30811317 | Outcome Id | 30811318 | Outcome Id | 30811319 | Outcome Id | 30811320 | Outcome Id | 30811321 | Outcome Id | 30811321 | Outcome Id | 30811322 | Outcome Id | 30811323 | Outcome Id | 30811324 | Outcome Id | 30811325 | Outcome Id | 30811326 | Outcome Id | 30811327 | Outcome Id | 30811328 | Outcome Id | 30811329 | Outcome Id | 30811330 | Outcome Id | 30811331 | Outcome Id | 30811332 | Outcome Id | 30811333 | Outcome Id | 30811333 | Outcome Id | 30811334 |
Result Group Id | 56100822 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100824 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100824 | Result Group Id | 56100823 | Result Group Id | 56100825 | Result Group Id | 56100822 | Result Group Id | 56100824 | Result Group Id | 56100826 | Result Group Id | 56100824 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Scheduled physiotherapy sessions | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Prescribed leg resistance exercise | Units | Participants |
Count | 22 | Count | 15 | Count | 15 | Count | 11 | Count | 15 | Count | 66 | Count | 11 | Count | 15 | Count | 15 | Count | 15 | Count | 11 | Count | 13 | Count | 11 | Count | 15 | Count | 15 | Count | 15 | Count | 15 | Count | 15 | Count | 93 | Count | 15 |
Provided Documents
Sequence: | 2580332 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2018-12-17 |
Url | https://ClinicalTrials.gov/ProvidedDocs/83/NCT03798483/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27948259 | Sequence: | 27948260 | Sequence: | 27948261 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 |
Subjects At Risk | 15 | Subjects At Risk | 15 | Subjects At Risk | 15 |
Created At | 2023-08-09 01:49:36.032676 | Created At | 2023-08-09 01:49:36.032676 | Created At | 2023-08-09 01:49:36.032676 |
Updated At | 2023-08-09 01:49:36.032676 | Updated At | 2023-08-09 01:49:36.032676 | Updated At | 2023-08-09 01:49:36.032676 |
Reported Events
Sequence: | 528319399 | Sequence: | 528319400 |
Result Group Id | 56100827 | Result Group Id | 56100827 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 |
Time Frame | through 3 months after the first physiotherapy session | Time Frame | through 3 months after the first physiotherapy session |
Event Type | other | Event Type | other |
Subjects Affected | 1 | Subjects Affected | 1 |
Subjects At Risk | 15 | Subjects At Risk | 15 |
Event Count | 3 | Event Count | 1 |
Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders |
Adverse Event Term | Knee pain or swelling after completing prescribed exercise that last >1 week | Adverse Event Term | Recurrent patellar dislocation |
Frequency Threshold | 0 | Frequency Threshold | 0 |
Assessment | Systematic Assessment | Assessment | Non-systematic Assessment |
Responsible Parties
Sequence: | 28882189 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3852650 |
Pi Employee | No |
Result Contacts
Sequence: | 3852615 |
Organization | Oxford University hospital foundation trust |
Name | Colin Forde |
Phone | +441865221540 |
Colin.Forde@ouh.nhs.uk | |
Outcomes
Sequence: | 30811317 | Sequence: | 30811318 | Sequence: | 30811319 | Sequence: | 30811320 | Sequence: | 30811321 | Sequence: | 30811322 | Sequence: | 30811323 | Sequence: | 30811324 | Sequence: | 30811325 | Sequence: | 30811326 | Sequence: | 30811327 | Sequence: | 30811328 | Sequence: | 30811329 | Sequence: | 30811330 | Sequence: | 30811331 | Sequence: | 30811332 | Sequence: | 30811333 | Sequence: | 30811334 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Eligibility Rate | Title | Recruitment Rate | Title | Attrition | Title | Acceptability [Participant Satisfaction]: Questionnaire | Title | Adherence | Title | Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] | Title | Acceptability of Outcome Data Collection | Title | Number of Treatment Related Adverse Events Experienced by Participants | Title | Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria | Title | Tegner Activity Scale Questionnaire | Title | Lyhsolm Knee Scoring Scale Questionnaire | Title | Quality of Life Using the EQ-5D-5L Questionnaire | Title | Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy] | Title | Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants] | Title | Assess Delivery of the Intervention [Duration of Intervention] | Title | Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] | Title | Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] | Title | Assess Delivery of the Intervention [Initial Injury Management] |
Description | Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria | Description | Percentage of eligible participants who consented to participate in the study | Description | Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data | Description | Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. | Description | Percentage (0-100%) of scheduled physiotherapy sessions attended | Description | Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4) | Description | Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up | Description | The total number and type of treatment related adverse events experienced by participants will be recorded. This will be recorded from commencement of the intervention to 12 week follow-up. Treatment related adverse events will be recorded by physiotherapists at each physiotherapy session and by participant self report at 12 week follow up. | Description | Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction | Description | This measures activity on a scale from 0-10, with higher scores indicating higher activity. It will be administered as a patient completed questionnaire. | Description | It is scored from 0-100 with lower scores indicating higher pain and disability. It will be administered as a patient completed questionnaire. | Description | This assess quality of life using 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depress, each containing 5 options. These domains are combined to give a single score ranging from -0.594 to 1 for UK populations, with higher scores indicating higher quality of life. Participants rate their overall health on a visual analogue scale from 0 (worst health you can imagine) to 100 (the best help you can imagine). It will be administered as a patient completed questionnaire. | Description | Treatment logs will be analysed to record the duration (number of days) from injury to commencing the intervention | Description | Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants | Description | Treatment logs will be analysed to assess the duration (days) of the study intervention | Description | Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants | Description | Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants | Description | Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team |
Time Frame | 15 weeks | Time Frame | 15 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | Through 12 weeks after first physiotherapy session | Time Frame | Baseline | Time Frame | 12 weeks | Time Frame | 12 Weeks | Time Frame | 12 weeks | Time Frame | From date of injury until date of the first physiotherapy session, assessed up to 6 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | From date of review by trauma and orthopaedic team until date of the first physiotherapy session, assessed up to 6 weeks |
Population | These were patients with a clinically diagnosed lateral patellar dislocation who underwent an eligibility assessment | Population | 11/15 participants completed and returned data for this outcome | Population | 15 participants completed baseline patient-reported outcome measures and 11 participants completed all patient-reported outcome measures at 3-month follow-up and returned by post. Analysed data refers only to these participants.
Lysholm Knee Scoring Scale outcome data was obtained for 2 participants by phone at 3-month follow-up, so they are not included in analysed data |
Population | 15 participants were assessed for all the clinical findings below, except for the patella apprehension test which was only assessed in 13 participants. | ||||||||||||||||||||||||||||
Units | Participants | Units | Participants | Units | Participants | Units | units on a scale | Units | Scheduled physiotherapy sessions | Units | Participants | Units | percentage of questions | Units | Participants | Units | percentage | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | Days | Units | physiotherapy sessions | Units | Days | Units | participants | Units | Prescribed leg resistance exercise | Units | Participants |
Units Analyzed | Scheduled physiotherapy sessions | Units Analyzed | Prescribed leg resistance exercise | ||||||||||||||||||||||||||||||||
Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | ||||||||||||||||||||||
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Median | Param Type | Count of Units | Param Type | Count of Participants | Param Type | Number | Param Type | Count of Participants | Param Type | Number | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Number | Param Type | Count of Units | Param Type | Count of Participants |
Outcome Measurements
Sequence: | 235724878 | Sequence: | 235724901 | Sequence: | 235724910 | Sequence: | 235724879 | Sequence: | 235724880 | Sequence: | 235724881 | Sequence: | 235724882 | Sequence: | 235724883 | Sequence: | 235724884 | Sequence: | 235724885 | Sequence: | 235724886 | Sequence: | 235724887 | Sequence: | 235724888 | Sequence: | 235724889 | Sequence: | 235724890 | Sequence: | 235724891 | Sequence: | 235724892 | Sequence: | 235724893 | Sequence: | 235724894 | Sequence: | 235724895 | Sequence: | 235724896 | Sequence: | 235724897 | Sequence: | 235724898 | Sequence: | 235724899 | Sequence: | 235724900 | Sequence: | 235724902 | Sequence: | 235724903 | Sequence: | 235724904 | Sequence: | 235724905 | Sequence: | 235724906 | Sequence: | 235724907 | Sequence: | 235724908 | Sequence: | 235724909 | Sequence: | 235724911 | Sequence: | 235724912 | Sequence: | 235724913 | Sequence: | 235724914 | Sequence: | 235724915 | Sequence: | 235724916 | Sequence: | 235724917 | Sequence: | 235724918 | Sequence: | 235724919 | Sequence: | 235724920 | Sequence: | 235724921 | Sequence: | 235724922 | Sequence: | 235724923 | Sequence: | 235724924 | Sequence: | 235724925 | Sequence: | 235724926 | Sequence: | 235724927 | Sequence: | 235724928 | Sequence: | 235724929 | Sequence: | 235724930 | Sequence: | 235724931 | Sequence: | 235724932 | Sequence: | 235724933 |
Outcome Id | 30811317 | Outcome Id | 30811323 | Outcome Id | 30811327 | Outcome Id | 30811318 | Outcome Id | 30811319 | Outcome Id | 30811320 | Outcome Id | 30811320 | Outcome Id | 30811320 | Outcome Id | 30811320 | Outcome Id | 30811320 | Outcome Id | 30811320 | Outcome Id | 30811320 | Outcome Id | 30811320 | Outcome Id | 30811320 | Outcome Id | 30811320 | Outcome Id | 30811320 | Outcome Id | 30811321 | Outcome Id | 30811322 | Outcome Id | 30811322 | Outcome Id | 30811322 | Outcome Id | 30811323 | Outcome Id | 30811323 | Outcome Id | 30811323 | Outcome Id | 30811323 | Outcome Id | 30811323 | Outcome Id | 30811324 | Outcome Id | 30811324 | Outcome Id | 30811324 | Outcome Id | 30811325 | Outcome Id | 30811325 | Outcome Id | 30811325 | Outcome Id | 30811325 | Outcome Id | 30811326 | Outcome Id | 30811328 | Outcome Id | 30811328 | Outcome Id | 30811329 | Outcome Id | 30811330 | Outcome Id | 30811331 | Outcome Id | 30811332 | Outcome Id | 30811332 | Outcome Id | 30811332 | Outcome Id | 30811332 | Outcome Id | 30811332 | Outcome Id | 30811333 | Outcome Id | 30811333 | Outcome Id | 30811333 | Outcome Id | 30811334 | Outcome Id | 30811334 | Outcome Id | 30811334 | Outcome Id | 30811334 | Outcome Id | 30811334 | Outcome Id | 30811334 | Outcome Id | 30811334 | Outcome Id | 30811334 | Outcome Id | 30811334 | Outcome Id | 30811334 |
Result Group Id | 56100822 | Result Group Id | 56100823 | Result Group Id | 56100826 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100824 | Result Group Id | 56100824 | Result Group Id | 56100824 | Result Group Id | 56100824 | Result Group Id | 56100824 | Result Group Id | 56100824 | Result Group Id | 56100824 | Result Group Id | 56100824 | Result Group Id | 56100824 | Result Group Id | 56100824 | Result Group Id | 56100824 | Result Group Id | 56100823 | Result Group Id | 56100824 | Result Group Id | 56100824 | Result Group Id | 56100824 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100825 | Result Group Id | 56100825 | Result Group Id | 56100825 | Result Group Id | 56100822 | Result Group Id | 56100822 | Result Group Id | 56100822 | Result Group Id | 56100822 | Result Group Id | 56100824 | Result Group Id | 56100824 | Result Group Id | 56100824 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 | Result Group Id | 56100823 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 |
Classification | Follow-up EQ-5D-5L | Classification | How satisfied are you with the effect of your physiotherapy treatment? | Classification | How satisfied are you with your involvement in decision making about your physiotherapy treatment? | Classification | How satisfied were you with up to six physiotherapy sessions over three months after your injury? | Classification | How satisfied were you with the written information you were given describing the study? | Classification | How satisfied were you with the written information you were given about your injury? | Classification | How satisfied are you overall with the physiotherapy care you received after your injury? | Classification | How confident are you that you can return to all your normal activities? | Classification | How did doing your exercises fit into your weekly routine? | Classification | How confident are you that you were doing your exercises the way your physiotherapist showed you? | Classification | How confident are you that you understood how tiring the muscle strengthening exercises should feel? | Classification | How likely are you to continue your exercises now your physiotherapy is finished? | Classification | Baseline Lysholm Knee Scoring Scale | Classification | Baseline Tegner Activity Scale | Classification | Baseline EQ-5D-5L | Classification | Follow-up Lysholm Knee Scoring Scale | Classification | Follow-up Tegner Activity Scale | Classification | Medial patellofemoral ligament tenderness | Classification | convincing history of a lateral patellar dislocation | Classification | visible knee joint effusion or haemarthrosis | Classification | positive patella apprehension test, | Classification | Index score | Classification | Health on a Visual Analogue Scale | Classification | Knee flexibility exercise | Classification | Trunk and leg control exercise | Classification | Leg resistance exercise | Classification | Running exercise | Classification | Bespoke exercise | Classification | Prescribed sets between 1-3 | Classification | Prescribed repetitions between 8-12 | Classification | Prescribed frequency 3 or more per week | Classification | Lateral butress splint | Classification | Cricket pad splint | Classification | Hinged knee brace | Classification | Full weight-bearing | Classification | Two elbow crutches | Classification | No walking aids | Classification | Knee range of movement exercises | Classification | Non-weight bearing knee strengthening exercise | Classification | Gait practice, balance exercises | Classification | Weight-bearing knee strengthening, strengthening of unijured joints | ||||||||||||||||||||||||||||||
Category | 'Always' | Category | 'Often' | Category | 'Sometimes' | Category | knee pain or swelling after completing prescribed exercises that lasted >1 week | Category | Recurrent patella dislocation | Category | No treatment related adverse event | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Title | Eligibility Rate | Title | Acceptability of Outcome Data Collection | Title | Lyhsolm Knee Scoring Scale Questionnaire | Title | Recruitment Rate | Title | Attrition | Title | Acceptability [Participant Satisfaction]: Questionnaire | Title | Acceptability [Participant Satisfaction]: Questionnaire | Title | Acceptability [Participant Satisfaction]: Questionnaire | Title | Acceptability [Participant Satisfaction]: Questionnaire | Title | Acceptability [Participant Satisfaction]: Questionnaire | Title | Acceptability [Participant Satisfaction]: Questionnaire | Title | Acceptability [Participant Satisfaction]: Questionnaire | Title | Acceptability [Participant Satisfaction]: Questionnaire | Title | Acceptability [Participant Satisfaction]: Questionnaire | Title | Acceptability [Participant Satisfaction]: Questionnaire | Title | Acceptability [Participant Satisfaction]: Questionnaire | Title | Adherence | Title | Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] | Title | Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] | Title | Adherence [Participant-reported Adherence to Home Exercise Using a Likert Scale] | Title | Acceptability of Outcome Data Collection | Title | Acceptability of Outcome Data Collection | Title | Acceptability of Outcome Data Collection | Title | Acceptability of Outcome Data Collection | Title | Acceptability of Outcome Data Collection | Title | Number of Treatment Related Adverse Events Experienced by Participants | Title | Number of Treatment Related Adverse Events Experienced by Participants | Title | Number of Treatment Related Adverse Events Experienced by Participants | Title | Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria | Title | Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria | Title | Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria | Title | Presence/Absence of Common Lateral Patella Dislocation Diagnostic Criteria | Title | Tegner Activity Scale Questionnaire | Title | Quality of Life Using the EQ-5D-5L Questionnaire | Title | Quality of Life Using the EQ-5D-5L Questionnaire | Title | Assess Delivery of the Intervention [Duration From Injury to Commencing Physiotherapy] | Title | Assess Delivery of the Intervention [Number of Physiotherapy Sessions Received by Participants] | Title | Assess Delivery of the Intervention [Duration of Intervention] | Title | Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] | Title | Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] | Title | Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] | Title | Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] | Title | Assess Delivery of the Intervention [Types of Exercises Prescribed by Physiotherapists] | Title | Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] | Title | Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] | Title | Assess Delivery of the Intervention [Dose of Exercises Prescribed by Physiotherapists] | Title | Assess Delivery of the Intervention [Initial Injury Management] | Title | Assess Delivery of the Intervention [Initial Injury Management] | Title | Assess Delivery of the Intervention [Initial Injury Management] | Title | Assess Delivery of the Intervention [Initial Injury Management] | Title | Assess Delivery of the Intervention [Initial Injury Management] | Title | Assess Delivery of the Intervention [Initial Injury Management] | Title | Assess Delivery of the Intervention [Initial Injury Management] | Title | Assess Delivery of the Intervention [Initial Injury Management] | Title | Assess Delivery of the Intervention [Initial Injury Management] | Title | Assess Delivery of the Intervention [Initial Injury Management] |
Description | Percentage of patients with a diagnosed lateral patellar dislocation, screened for eligibility, who satisfied the eligibility criteria | Description | Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up | Description | It is scored from 0-100 with lower scores indicating higher pain and disability. It will be administered as a patient completed questionnaire. | Description | Percentage of eligible participants who consented to participate in the study | Description | Percentage (0-100%) of participants enrolled in the study who failed to provide any 12 week follow-up data | Description | Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. | Description | Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. | Description | Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. | Description | Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. | Description | Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. | Description | Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. | Description | Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. | Description | Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. | Description | Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. | Description | Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. | Description | Participant response to an internally designed patient questionnaire. This will measure several domains of of intervention acceptability: satisfaction with treatment, self-efficacy, burden of treatment, and intention to adhere. 6 questions will assess satisfaction with treatment, 3 questions will assess self-efficacy,1 question will assess burden of treatment and 1 question will assess intention to adhere. Each question will use a 5 point likert scale (0-4) with lower scores indicating higher satisfaction, self-efficacy, and intention to adhere. Each question will be reported individually. | Description | Percentage (0-100%) of scheduled physiotherapy sessions attended | Description | Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4) | Description | Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4) | Description | Participant response at follow-up to the question 'how often did you perform your exercises at least three times a week?' using a five-point Likert scale (0-4) anchored at 'always' (0) and 'never' (4) | Description | Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up | Description | Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up | Description | Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up | Description | Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up | Description | Percentage (0-100%) of questions completed in the following patient-reported outcome measures: Lysholm Knee Scoring Scale, Tegner Activity Scale, EQ-5D-5L, completed at baseline and returned at 3-month follow-up | Description | The total number and type of treatment related adverse events experienced by participants will be recorded. This will be recorded from commencement of the intervention to 12 week follow-up. Treatment related adverse events will be recorded by physiotherapists at each physiotherapy session and by participant self report at 12 week follow up. | Description | The total number and type of treatment related adverse events experienced by participants will be recorded. This will be recorded from commencement of the intervention to 12 week follow-up. Treatment related adverse events will be recorded by physiotherapists at each physiotherapy session and by participant self report at 12 week follow up. | Description | The total number and type of treatment related adverse events experienced by participants will be recorded. This will be recorded from commencement of the intervention to 12 week follow-up. Treatment related adverse events will be recorded by physiotherapists at each physiotherapy session and by participant self report at 12 week follow up. | Description | Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction | Description | Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction | Description | Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction | Description | Following diagnosis of a lateral patellar dislocation by an orthopaedic surgeon or physiotherapist, the clinician will be asked which of the following proposed assessment findings to include in the eligibility criteria for future studies, were present/absent during their clinical examination: positive patella apprehension test, visible knee joint effusion or haemarthrosis, medial patellofemoral ligament tenderness on palpation, and a convincing patient history of a visible deformity on the lateral aspect of the knee or a sensation of the patella 'popping' out of joint followed by spontaneous reduction | Description | This measures activity on a scale from 0-10, with higher scores indicating higher activity. It will be administered as a patient completed questionnaire. | Description | This assess quality of life using 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depress, each containing 5 options. These domains are combined to give a single score ranging from -0.594 to 1 for UK populations, with higher scores indicating higher quality of life. Participants rate their overall health on a visual analogue scale from 0 (worst health you can imagine) to 100 (the best help you can imagine). It will be administered as a patient completed questionnaire. | Description | This assess quality of life using 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depress, each containing 5 options. These domains are combined to give a single score ranging from -0.594 to 1 for UK populations, with higher scores indicating higher quality of life. Participants rate their overall health on a visual analogue scale from 0 (worst health you can imagine) to 100 (the best help you can imagine). It will be administered as a patient completed questionnaire. | Description | Treatment logs will be analysed to record the duration (number of days) from injury to commencing the intervention | Description | Treatment logs will be analysed to assess the number of physiotherapy sessions received by participants | Description | Treatment logs will be analysed to assess the duration (days) of the study intervention | Description | Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants | Description | Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants | Description | Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants | Description | Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants | Description | Treatment logs will be analysed to assess the types of exercise prescribed by physiotherapists to participants | Description | Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants | Description | Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants | Description | Treatment logs will be analysed to assess the dose of exercise prescribed by physiotherapists to participants | Description | Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team | Description | Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team | Description | Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team | Description | Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team | Description | Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team | Description | Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team | Description | Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team | Description | Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team | Description | Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team | Description | Treatment logs will be analysed to assess how participants are initially managed by trauma and orthopaedic team |
Units | Participants | Units | percentage of questions | Units | units on a scale | Units | Participants | Units | Participants | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | Scheduled physiotherapy sessions | Units | Participants | Units | Participants | Units | Participants | Units | percentage of questions | Units | percentage of questions | Units | percentage of questions | Units | percentage of questions | Units | percentage of questions | Units | Participants | Units | Participants | Units | Participants | Units | percentage | Units | percentage | Units | percentage | Units | percentage | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | Days | Units | physiotherapy sessions | Units | Days | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | Prescribed leg resistance exercise | Units | Prescribed leg resistance exercise | Units | Prescribed leg resistance exercise | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Count of Participants | Param Type | Number | Param Type | Median | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Count of Units | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Median | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Count of Units | Param Type | Count of Units | Param Type | Count of Units | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 15 | Param Value | 100 | Param Value | 90 | Param Value | 15 | Param Value | 2 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 56 | Param Value | 4 | Param Value | 5 | Param Value | 2 | Param Value | 100 | Param Value | 100 | Param Value | 100 | Param Value | 100 | Param Value | 100 | Param Value | 1 | Param Value | 1 | Param Value | 13 | Param Value | 100 | Param Value | 93.3 | Param Value | 66.7 | Param Value | 100 | Param Value | 6 | Param Value | 0.84 | Param Value | 90 | Param Value | 21 | Param Value | 3 | Param Value | 50 | Param Value | 13 | Param Value | 14 | Param Value | 15 | Param Value | 5 | Param Value | 5 | Param Value | 90 | Param Value | 89 | Param Value | 91 | Param Value | 12 | Param Value | 2 | Param Value | 1 | Param Value | 15 | Param Value | 7 | Param Value | 8 | Param Value | 7 | Param Value | 4 | Param Value | 2 | Param Value | 1 |
Param Value Num | 15.0 | Param Value Num | 100.0 | Param Value Num | 90.0 | Param Value Num | 15.0 | Param Value Num | 2.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 56.0 | Param Value Num | 4.0 | Param Value Num | 5.0 | Param Value Num | 2.0 | Param Value Num | 100.0 | Param Value Num | 100.0 | Param Value Num | 100.0 | Param Value Num | 100.0 | Param Value Num | 100.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 13.0 | Param Value Num | 100.0 | Param Value Num | 93.3 | Param Value Num | 66.7 | Param Value Num | 100.0 | Param Value Num | 6.0 | Param Value Num | 0.84 | Param Value Num | 90.0 | Param Value Num | 21.0 | Param Value Num | 3.0 | Param Value Num | 50.0 | Param Value Num | 13.0 | Param Value Num | 14.0 | Param Value Num | 15.0 | Param Value Num | 5.0 | Param Value Num | 5.0 | Param Value Num | 90.0 | Param Value Num | 89.0 | Param Value Num | 91.0 | Param Value Num | 12.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 15.0 | Param Value Num | 7.0 | Param Value Num | 8.0 | Param Value Num | 7.0 | Param Value Num | 4.0 | Param Value Num | 2.0 | Param Value Num | 1.0 |
Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Lower Limit | 76.5 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 0.0 | Dispersion Lower Limit | 3.0 | Dispersion Lower Limit | 0.8 | Dispersion Lower Limit | 85.0 | Dispersion Lower Limit | 15.0 | Dispersion Lower Limit | 3.0 | Dispersion Lower Limit | 37.0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Upper Limit | 95.0 | Dispersion Upper Limit | 0.0 | Dispersion Upper Limit | 0.0 | Dispersion Upper Limit | 0.0 | Dispersion Upper Limit | 0.0 | Dispersion Upper Limit | 1.0 | Dispersion Upper Limit | 0.0 | Dispersion Upper Limit | 1.0 | Dispersion Upper Limit | 2.0 | Dispersion Upper Limit | 1.0 | Dispersion Upper Limit | 1.0 | Dispersion Upper Limit | 1.0 | Dispersion Upper Limit | 7.0 | Dispersion Upper Limit | 1.0 | Dispersion Upper Limit | 95.0 | Dispersion Upper Limit | 27.0 | Dispersion Upper Limit | 5.0 | Dispersion Upper Limit | 79.0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Study References
Sequence: | 52071450 |
Pmid | 34749823 |
Reference Type | derived |
Citation | Forde C, Haddad M, Hirani SP, Keene DJ. Is an individually tailored programme of intense leg resistance and dynamic exercise acceptable to adults with an acute lateral patellar dislocation? A feasibility study. Pilot Feasibility Stud. 2021 Nov 8;7(1):197. doi: 10.1186/s40814-021-00932-x. |
Baseline Counts
Sequence: | 11385359 |
Result Group Id | 56100820 |
Ctgov Group Code | BG000 |
Units | Participants |
Scope | overall |
Count | 15 |
Result Groups
Sequence: | 56100820 | Sequence: | 56100821 | Sequence: | 56100822 | Sequence: | 56100823 | Sequence: | 56100824 | Sequence: | 56100825 | Sequence: | 56100826 | Sequence: | 56100827 |
Ctgov Group Code | BG000 | Ctgov Group Code | FG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | EG000 |
Result Type | Baseline | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event |
Title | Individualized Exercise | Title | Individualized Exercise | Title | Patients With a Diagnosed Lateral Patellar Dislocation | Title | Individualized Exercise | Title | Participants Who Completed and Returned Follow-up Outcome Data | Title | Individualized Exercise | Title | Patients Who Returned Lysholm Knee Scoring Scale Outcome Data | Title | Individualized Exercise |
Description | Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used. |
Description | Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used. |
Description | Patients with a clinically diagnosed lateral patellar dislocation | Description | Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used. |
Description | 11/15 participants completed and returned all follow-up data. The results represents outcome data from these eleven participants | Description | Participants after a lateral kneecap dislocation will be enrolled into an individualized exercise intervention supervised by a physiotherapist
Individualised exercise: The intervention will be comprised of up to 6, one-to-one physiotherapy sessions, over a maximum duration of 3 months. 1 or 2 extra sessions are allowed if deemed essential by the participant's physiotherapist. Less than 6 physiotherapy sessions can be agreed with the participant if they have achieved their goals. Throughout this time participants will be required to perform an exercise programme a minimum of 3 times per week. The exercise programme aims to increase leg muscle strength and facilitate a return to the participant's usual activities. It may include hopping and change of direction tasks if these are activities the participant would normally do. Behavioural change techniques to increase participant adherence to the exercise programme will also be used. |
Description | 13 participants returned Lysholm Knee Scoring Scale data, for 2 of these participants outcome data was obtained by phone | Description | Participants after a lateral kneecap dislocation were enrolled into an individualized exercise intervention supervised by a physiotherapist
Participants received up to six, one-to-one, face-to-face physiotherapy sessions, over a maximum duration of 3 months. Less than six physiotherapy sessions were used if participants achieved their goals, were self-managing effectively, and their physiotherapist agreed. Participants had to perform prescribed exercises a minimum of 3 times per week. Prescribed exercise aimed to restore leg muscle strength through intense leg strengthening exercises, and restore activity levels by prescribing dynamic exercises related to the activities participants wished to resume. Behavioural change techniques to increase participant adherence to the exercise programme were also used. |
Baseline Measurements
Sequence: | 125616098 | Sequence: | 125616099 | Sequence: | 125616100 | Sequence: | 125616101 | Sequence: | 125616102 | Sequence: | 125616103 | Sequence: | 125616104 | Sequence: | 125616105 | Sequence: | 125616106 | Sequence: | 125616107 | Sequence: | 125616108 | Sequence: | 125616109 | Sequence: | 125616110 | Sequence: | 125616111 | Sequence: | 125616112 | Sequence: | 125616113 | Sequence: | 125616114 | Sequence: | 125616115 | Sequence: | 125616116 | Sequence: | 125616117 | Sequence: | 125616118 | Sequence: | 125616119 | Sequence: | 125616120 | Sequence: | 125616121 | Sequence: | 125616122 | Sequence: | 125616123 | Sequence: | 125616124 |
Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 | Result Group Id | 56100820 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 | Ctgov Group Code | BG000 |
Classification | Ethnicity | Classification | Ethnicity | Classification | Ethnicity | Classification | United Kingdom | ||||||||||||||||||||||||||||||||||||||||||||||
Category | Female | Category | Male | Category | White British | Category | White Other | Category | Other | Category | Secondary education | Category | Higher professional or University education | Category | Employed | Category | Student | Category | 0 | Category | 1 | Category | 2 | Category | 3 | Category | 4 | Category | 5-6 | Category | 0 | Category | 1 | Category | 2 | Category | >10 | ||||||||||||||||
Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Region of Enrollment | Title | Height | Title | Weight | Title | Education | Title | Education | Title | Employment status | Title | Employment status | Title | Duration from injury to eligibility assessment | Title | Previous ipsilateral patellar dislocation | Title | Number of previous ipsilateral patellar dislocations | Title | Number of previous ipsilateral patellar dislocations | Title | Number of previous ipsilateral patellar dislocations | Title | Number of previous ipsilateral patellar dislocations | Title | Number of previous ipsilateral patellar dislocations | Title | Number of previous ipsilateral patellar dislocations | Title | Previous contralateral patellar dislocation | Title | Number of previous contralateral patellar dislocations (number of participants) | Title | Number of previous contralateral patellar dislocations (number of participants) | Title | Number of previous contralateral patellar dislocations (number of participants) | Title | Number of previous contralateral patellar dislocations (number of participants) | Title | Family history of patellar dislocation |
Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | meters | Units | Kilograms | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | days | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Median | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Median | Param Type | Median | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 22 | Param Value | 7 | Param Value | 8 | Param Value | 13 | Param Value | 1 | Param Value | 1 | Param Value | 15 | Param Value | 1.75 | Param Value | 69.9 | Param Value | 9 | Param Value | 6 | Param Value | 12 | Param Value | 3 | Param Value | 2 | Param Value | 5 | Param Value | 10 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 3 | Param Value | 12 | Param Value | 1 | Param Value | 1 | Param Value | 1 | Param Value | 1 |
Param Value Num | 22.0 | Param Value Num | 7.0 | Param Value Num | 8.0 | Param Value Num | 13.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 15.0 | Param Value Num | 1.75 | Param Value Num | 69.9 | Param Value Num | 9.0 | Param Value Num | 6.0 | Param Value Num | 12.0 | Param Value Num | 3.0 | Param Value Num | 2.0 | Param Value Num | 5.0 | Param Value Num | 10.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 12.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 1.0 |
Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | Dispersion Type | Inter-Quartile Range | ||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Lower Limit | 19.0 | Dispersion Lower Limit | 1.62 | Dispersion Lower Limit | 64.0 | Dispersion Lower Limit | 1.0 | ||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Upper Limit | 28.0 | Dispersion Upper Limit | 1.8 | Dispersion Upper Limit | 85.0 | Dispersion Upper Limit | 9.0 | ||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 | Number Analyzed | 15 |
]]>
https://zephyrnet.com/NCT03798470
2018-01-01
https://zephyrnet.com/?p=NCT03798470
NCT03798470https://www.clinicaltrials.gov/study/NCT03798470?tab=tableNANANAThe Emergency Department (ED) is an ideal location to identify patients in need of treatment for opioid addiction. A local non-profit community-based addiction recovery program, Faces and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance use disorders by identifying, training, credentialing and supervising individuals who have been in recovery for at least 2 years.
These peer recovery coaches become the primary workforce in this community-based model. FAVOR provides no-cost comprehensive services for addiction recovery. The investigators hypothesized that having FAVOR Recovery Coaches (FRC) evaluate patients during an ED visit for opioid overdose would result in a high degree of engagement from the patients and serve as an opportunity to begin treatment for addiction.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-24 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-02-19 |
Start Month Year | January 1, 2018 |
Primary Completion Month Year | December 31, 2018 |
Verification Month Year | February 2019 |
Verification Date | 2019-02-28 |
Last Update Posted Date | 2019-02-19 |
Detailed Descriptions
Sequence: | 20716275 |
Description | The Emergency Department (ED) is an ideal location to identify patients in need of treatment for opioid addiction. A local non-profit community-based addiction recovery program, Faces and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance use disorders by identifying, training, credentialing and supervising individuals who have been in recovery for at least 2 years.These peer recovery coaches become the primary workforce in this community-based model. FAVOR provides no-cost comprehensive services for addiction recovery. The investigators hypothesized that having FAVOR Recovery Coaches (FRC) evaluate patients during an ED visit for opioid overdose would result in a high degree of engagement from the patients and serve as an opportunity to begin treatment for addiction. |
Facilities
Sequence: | 200053181 |
Name | Greenville Health System |
City | Greenville |
State | South Carolina |
Zip | 29605 |
Country | United States |
Conditions
Sequence: | 52156416 | Sequence: | 52156417 | Sequence: | 52156418 |
Name | Opiate Abuse | Name | Opiate Overdose | Name | Opioid-use Disorder |
Downcase Name | opiate abuse | Downcase Name | opiate overdose | Downcase Name | opioid-use disorder |
Id Information
Sequence: | 40148174 |
Id Source | org_study_id |
Id Value | Pro00073004 |
Countries
Sequence: | 42557695 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55577847 |
Group Type | Experimental |
Title | Cohort |
Description | Intervention with FAVOR peer recovery coaching. Patients identified in the ED as opioid overdose and enrolled in the current study. |
Interventions
Sequence: | 52471956 |
Intervention Type | Behavioral |
Name | Peer Addiction Counseling |
Description | After identification, a 24/7 on-call FRC was paged and met with the patient in the ED. The patients were offered recovery services at the bedside by the FRC. The research team members offered voluntary participation and obtained informed consent to enrolling a longitudinal study looking into the success of his intervention. Patients did not need to participate to be eligible for counseling and resources from AVOR. The FRCs counselled and engaged the patient along with the family to offer a variety of services including active recovery coaching, group treatment modalities, family support services and transportation. After he initial encounter in the ED, the FAVOR team re-engaged the participant by phone or in person the next day and gradually increasing intervals thereafter. |
Keywords
Sequence: | 79848009 | Sequence: | 79848010 |
Name | opioid | Name | overdose |
Downcase Name | opioid | Downcase Name | overdose |
Design Outcomes
Sequence: | 177327731 | Sequence: | 177327732 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Percentage of patients with active involvement in recovery | Measure | All-cause Mortality |
Time Frame | One year | Time Frame | One year |
Description | Defined as: Patients who have had phone, email, or in-person contact with their FAVOR recovery coach after discharge from the Emergency Department. | Description | Number of participants with death from any cause within the study period. |
Browse Conditions
Sequence: | 193431893 | Sequence: | 193431894 | Sequence: | 193431895 | Sequence: | 193431896 | Sequence: | 193431897 | Sequence: | 193431898 | Sequence: | 193431899 |
Mesh Term | Opioid-Related Disorders | Mesh Term | Drug Overdose | Mesh Term | Opiate Overdose | Mesh Term | Narcotic-Related Disorders | Mesh Term | Substance-Related Disorders | Mesh Term | Chemically-Induced Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | opioid-related disorders | Downcase Mesh Term | drug overdose | Downcase Mesh Term | opiate overdose | Downcase Mesh Term | narcotic-related disorders | Downcase Mesh Term | substance-related disorders | Downcase Mesh Term | chemically-induced disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306002 | Sequence: | 48306003 | Sequence: | 48306004 |
Agency Class | OTHER | Agency Class | UNKNOWN | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Prisma Health-Upstate | Name | FAVOR (Faces and Voices of Recovery) OF GREENVILLE | Name | South Carolina Department of Alcohol and Other Drug Abuse Services |
Overall Officials
Sequence: | 29277901 |
Role | Principal Investigator |
Name | Christopher Carey, MD |
Affiliation | Greenville Health System Emergency Medicine |
Design Group Interventions
Sequence: | 68130802 |
Design Group Id | 55577847 |
Intervention Id | 52471956 |
Eligibilities
Sequence: | 30757322 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients presenting to the ED with opioid overdose or withdrawal Exclusion Criteria: Age <18 |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254223918 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 12 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30503547 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26665871 |
Intervention Id | 52471956 |
Name | FAVOR counseling |
Responsible Parties
Sequence: | 28869825 |
Responsible Party Type | Principal Investigator |
Name | Sarah Fabiano |
Title | Emergency Medicine Physician |
Affiliation | Prisma Health-Upstate |
]]>
https://zephyrnet.com/NCT03798457
2016-10-01
https://zephyrnet.com/?p=NCT03798457
NCT03798457https://www.clinicaltrials.gov/study/NCT03798457?tab=tableNANANAFADOI-ICECAP is a observational, prospective, multicenter study involving 20-25 nationwide Units of Internal Medicine. The study foresees the participation of 26 Internal Medicine Operative Units, and for each of them a prospective registration of data relative to at least 50 patients admitted with CAP (in total, at least 1300 evaluable subjects) is foreseen.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-28 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | October 1, 2016 |
Primary Completion Month Year | February 28, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20735810 |
Description | Phase 1 – Patients enrollment (October 2016 – February 2018) Each Investigator have recorded data concerning 50 patients. It will be collected general characteristics of patients, clinical parameters and conditions, diagnostic imaging and blood tests,
Phase 2 – Database review and validation (April 2018 – October 2018) The data collected will be analysed to process the endpoints. |
Conditions
Sequence: | 52208194 |
Name | Cardiovascular Events |
Downcase Name | cardiovascular events |
Id Information
Sequence: | 40186209 |
Id Source | org_study_id |
Id Value | FADOI.06.2015 |
Design Groups
Sequence: | 55634769 |
Title | Patients with CAP hospitalized in IM |
Description | Data of Patients with Community-acquired pneumonia (CAP) hospitalized in Internal Medicine Units will be collected for this study; no intervention is planned for this study |
Interventions
Sequence: | 52522161 |
Intervention Type | Other |
Name | No intervention |
Description | In this study there is no intervention |
Keywords
Sequence: | 79923080 |
Name | Community-acquired pneumonia (CAP) |
Downcase Name | community-acquired pneumonia (cap) |
Design Outcomes
Sequence: | 177511706 | Sequence: | 177511707 | Sequence: | 177511708 | Sequence: | 177511709 | Sequence: | 177511710 | Sequence: | 177511711 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Incidence of CV events | Measure | Mortality | Measure | Impact of acute CV events | Measure | Impact of CV events | Measure | Risk factor | Measure | Incidence of CV events in patients without history of heart failure, acute coronary syndrome, cerebrovascular disease, or clinically relevant arrhythmia |
Time Frame | 17 months | Time Frame | 18 months | Time Frame | 18 months | Time Frame | 18 months | Time Frame | 18 months | Time Frame | 18 months |
Description | To assess the cumulative incidence of well defined acute CV complications during hospitalization for CAP (index event). | Description | To evaluate the impact on 30-day mortality of acute CV events occurred during hospitalization | Description | To assess the impact of acute CV events occurred during hospitalization on the risk of hospital readmission within 30 days | Description | To assess the impact of CV events on the length of hospitalization | Description | To evaluate risk factors for the occurrence of acute CV events | Description | To evaluate the incidence of CV complications in the group of patients without history of heart failure, acute coronary syndrome, cerebrovascular disease, or clinically relevant arrhythmia |
Sponsors
Sequence: | 48353770 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Fadoi Foundation, Italy |
Overall Officials
Sequence: | 29306021 |
Role | Study Director |
Name | Gualberto Gussoni, MD |
Affiliation | Fadoi Foundation |
Design Group Interventions
Sequence: | 68199314 |
Design Group Id | 55634769 |
Intervention Id | 52522161 |
Eligibilities
Sequence: | 30786920 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Patients with Community-acquired pneumonia (CAP) hospitalized in Internal Medicine Units |
Criteria | Inclusion Criteria:
Age > 18 years Diagnosis of pneumonia defined by the presence on chest X-ray or CT-scan of lung of new infiltration associated with at least two of the following clinical features: fever > 37.8°C Exclusion Criteria: patients with Hospital-Acquired Pneumonia (HAP) (i.e. those patients with pneumonia acquired in hospital more than 48 hours after admission) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989695 |
Registered In Calendar Year | 2018 |
Actual Duration | 17 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30532990 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28899284 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52103133 |
Pmid | 33494707 |
Reference Type | derived |
Citation | Pieralli F, Vannucchi V, Nozzoli C, Augello G, Dentali F, De Marzi G, Uomo G, Risaliti F, Morbidoni L, Mazzone A, Santini C, Tirotta D, Corradi F, Gerloni R, Gnerre P, Gussoni G, Valerio A, Campanini M, Manfellotto D, Fontanella A; FADOI-ICECAP Study Group. Acute cardiovascular events in patients with community acquired pneumonia: results from the observational prospective FADOI-ICECAP study. BMC Infect Dis. 2021 Jan 25;21(1):116. doi: 10.1186/s12879-021-05781-w. Erratum In: BMC Infect Dis. 2021 Feb 19;21(1):195. |
]]>
https://zephyrnet.com/NCT03798444
2017-09-01
https://zephyrnet.com/?p=NCT03798444
NCT03798444https://www.clinicaltrials.gov/study/NCT03798444?tab=tableNANANAThis is an observational and cross-sectional study on the height loss, kyphosis indicators, bone mineral density and vertebral fractures in Chinese postmenopausal women
<![CDATA[
Studies
Study First Submitted Date | 2018-11-20 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | September 1, 2017 |
Primary Completion Month Year | September 30, 2017 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Detailed Descriptions
Sequence: | 20721648 |
Description | Postmenopausal women (N=255) aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017. Menopause was defined as the absence of menstrual cycles for at least one year. All subjects were noninstitutionalized and in good health.The criteria for exclusion were morphological abnormalities or skeletal distortions that prohibited either clinical measurements or morphometric assessments of skeletal radiographs All participants were interviewed using a standard questionnaire. Body weight and height were measured to the closest 0.1 kg and 0.5 cm, respectively, with subjects wearing light clothing and no shoes. Current height was measured using a wall-mounted stadiometer, with a horizontal plate pressed on the head, and hair flattened. All subjects provided basic information, including current age, age at the start of menopause, years since menopause (YSM), weight, and their tallest recalled height. The current measured height subtracted from the tallest recalled height was subjects' HHL.The RPD, which was the vertical distance between the lowest margin of the ribs and the superior surface of the iliac crest along the mid-axillary line, was measured twice by a physician who stood behind the subject. For the kyphosis assessment, subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The wall-occiput distance was defined as the horizontal distance between the wall and the back of the head. The distance between the prominence of the 7th cervical vertebra and the wall was defined as 7th cervical vertebra-wall distance (C7WD) , and wall-tragus-distance (WTD) was defined as the horizontal distance from the participant's tragus to the wall . All RPD and anthropometric indicators of kyphosis were measured in increments of 0.1 cm by two trained physicians.BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry. VFs were assessed using lateral spine imaging from T4 to L4 on X-ray. |
Facilities
Sequence: | 200108209 |
Name | The 2nd Xiangya Hospital, Central South University |
City | Changsha |
State | Hunan |
Zip | 410011 |
Country | China |
Conditions
Sequence: | 52171262 |
Name | Osteoporosis Fracture |
Downcase Name | osteoporosis fracture |
Id Information
Sequence: | 40158653 |
Id Source | org_study_id |
Id Value | CRong |
Countries
Sequence: | 42568958 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55593200 | Sequence: | 55593201 |
Title | Bone mineral denstiy | Title | Vertebral fractures |
Description | BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry in all subjects.Accroding to The World Health Organization, we defined osteoporosis as a T-score ≤-2.5,and the non osteoporosis as T-score>-2.5. | Description | VFs were assessed using lateral spine imaging from T4 to L4 on X-ray. A visual semi-quantitative method was used, with fractures defined as a vertebral height ratio <0.80 for the anterior/posterior or middle/posterior height ratio within a vertebra, or the posterior/posterior height ratio when compared to an adjacent vertebra. |
Interventions
Sequence: | 52485504 | Sequence: | 52485505 |
Intervention Type | Radiation | Intervention Type | Radiation |
Name | dual energy X-ray absorptiometry | Name | lateral spine imaging from T4 to L4 on X-ray |
Description | BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry. The lumbar spine, left femoral neck, or total hip of T-score ≤-2.5 as the osteoporosis | Description | VFs were assessed using lateral spine imaging from T4 to L4 on X-ray .A visual semi-quantitative method was used, with fractures defined as a vertebral Vertebral fractures should be diagnose if height ratio <0.80 for the anterior/posterior or middle/posterior height ratio within a vertebra, or the posterior/posterior height ratio when compared to an adjacent vertebra |
Keywords
Sequence: | 79868575 | Sequence: | 79868576 | Sequence: | 79868577 |
Name | Height loss, Kyphosis | Name | Osteoporosis, Vertebral fracture | Name | Postmenopausal women |
Downcase Name | height loss, kyphosis | Downcase Name | osteoporosis, vertebral fracture | Downcase Name | postmenopausal women |
Design Outcomes
Sequence: | 177378953 | Sequence: | 177378954 | Sequence: | 177378955 | Sequence: | 177378956 | Sequence: | 177378957 | Sequence: | 177378958 | Sequence: | 177378959 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Height | Measure | Weight | Measure | Rib to pelvis distance | Measure | Wall-occiput distance | Measure | 7th cervical vertebra-wall distance | Measure | Wall-tragus-distance | Measure | Historical height loss |
Time Frame | 4 weeks | Time Frame | 4 weeks | Time Frame | 4 weeks | Time Frame | 4 weeks | Time Frame | 4 weeks | Time Frame | 4 weeks | Time Frame | 4 weeks |
Description | Subjects wearing light clothing and no shoes. Current height was measured using a wall-mounted stadiometer, with a horizontal plate pressed on the head, and hair flattened. Height were measured to the closest 0.5 cm, | Description | Body weight was measured with subjects wearing light clothing and no shoes | Description | The rib to pelvis distance, which was the vertical distance between the lowest margin of the ribs and the superior surface of the iliac crest along the mid-axillary line, was measured twice by a physician who stood behind the subject. Measured in increments of 0.1 cm by two trained physicians. | Description | Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The wall-occiput distance was defined as the horizontal distance between the wall and the back of the head. Measured in increments of 0.1 cm by two trained physicians. | Description | Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The distance between the prominence of the 7th cervical vertebra and the wall was defined as 7th cervical vertebra-wall distance. Measured in increments of 0.1 cm by two trained physicians. | Description | Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown.Wall-tragus-distance was defined as the horizontal distance from the participant's tragus to the wall. Measured in increments of 0.1 cm by two trained physicians. | Description | The current measured height subtracted from the tallest recalled height was subjects' historical height loss |
Browse Conditions
Sequence: | 193486816 | Sequence: | 193486817 | Sequence: | 193486818 | Sequence: | 193486819 | Sequence: | 193486820 | Sequence: | 193486821 | Sequence: | 193486822 | Sequence: | 193486823 | Sequence: | 193486824 | Sequence: | 193486825 | Sequence: | 193486826 |
Mesh Term | Osteoporosis | Mesh Term | Fractures, Bone | Mesh Term | Spinal Fractures | Mesh Term | Osteoporotic Fractures | Mesh Term | Wounds and Injuries | Mesh Term | Bone Diseases, Metabolic | Mesh Term | Bone Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Metabolic Diseases | Mesh Term | Spinal Injuries | Mesh Term | Back Injuries |
Downcase Mesh Term | osteoporosis | Downcase Mesh Term | fractures, bone | Downcase Mesh Term | spinal fractures | Downcase Mesh Term | osteoporotic fractures | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | bone diseases, metabolic | Downcase Mesh Term | bone diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | spinal injuries | Downcase Mesh Term | back injuries |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319314 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Central South University |
Overall Officials
Sequence: | 29285363 |
Role | Principal Investigator |
Name | sheng zhifeng, MD |
Affiliation | Central south of university |
Design Group Interventions
Sequence: | 68149157 | Sequence: | 68149158 |
Design Group Id | 55593200 | Design Group Id | 55593201 |
Intervention Id | 52485504 | Intervention Id | 52485505 |
Eligibilities
Sequence: | 30765367 |
Sampling Method | Probability Sample |
Gender | Female |
Minimum Age | 50 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | Postmenopausal women aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017. |
Criteria | Inclusion Criteria:
Postmenopausal women aged ≥50 years (Menopause was defined as the absence of menstrual cycles for at least one year) Exclusion Criteria: Morphological abnormalities or skeletal distortions |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253884711 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 0 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 50 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 7 |
Designs
Sequence: | 30511534 |
Observational Model | Case-Control |
Time Perspective | Cross-Sectional |
Provided Documents
Sequence: | 2579104 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2016-03-28 |
Url | https://ClinicalTrials.gov/ProvidedDocs/44/NCT03798444/Prot_SAP_000.pdf |
Responsible Parties
Sequence: | 28877828 |
Responsible Party Type | Principal Investigator |
Name | ChenRong |
Title | Principal Investigator |
Affiliation | Central South University |
Study References
Sequence: | 52063341 | Sequence: | 52063342 | Sequence: | 52063343 | Sequence: | 52063344 | Sequence: | 52063345 | Sequence: | 52063346 |
Pmid | 24122280 | Pmid | 16143833 | Pmid | 12935830 | Pmid | 24627138 | Pmid | 29532182 | Pmid | 2108749 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Yoh K, Kuwabara A, Tanaka K. Detective value of historical height loss and current height/knee height ratio for prevalent vertebral fracture in Japanese postmenopausal women. J Bone Miner Metab. 2014 Sep;32(5):533-8. doi: 10.1007/s00774-013-0525-y. | Citation | Siminoski K, Warshawski RS, Jen H, Lee K. The accuracy of historical height loss for the detection of vertebral fractures in postmenopausal women. Osteoporos Int. 2006 Feb;17(2):290-6. doi: 10.1007/s00198-005-2017-y. Epub 2005 Sep 6. | Citation | Siminoski K, Warshawski RS, Jen H, Lee KC. Accuracy of physical examination using the rib-pelvis distance for detection of lumbar vertebral fractures. Am J Med. 2003 Aug 15;115(3):233-6. doi: 10.1016/s0002-9343(03)00299-7. No abstract available. | Citation | Mizukami S, Abe Y, Tsujimoto R, Arima K, Kanagae M, Chiba G, Aoyagi K. Accuracy of spinal curvature assessed by a computer-assisted device and anthropometric indicators in discriminating vertebral fractures among individuals with back pain. Osteoporos Int. 2014 Jun;25(6):1727-34. doi: 10.1007/s00198-014-2680-y. Epub 2014 Mar 14. | Citation | Suwannarat P, Amatachaya P, Sooknuan T, Tochaeng P, Kramkrathok K, Thaweewannakij T, Manimmanakorn N, Amatachaya S. Hyperkyphotic measures using distance from the wall: validity, reliability, and distance from the wall to indicate the risk for thoracic hyperkyphosis and vertebral fracture. Arch Osteoporos. 2018 Mar 12;13(1):25. doi: 10.1007/s11657-018-0433-9. | Citation | Ralston SH, Urquhart GD, Brzeski M, Sturrock RD. Prevalence of vertebral compression fractures due to osteoporosis in ankylosing spondylitis. BMJ. 1990 Mar 3;300(6724):563-5. doi: 10.1136/bmj.300.6724.563. |
]]>
https://zephyrnet.com/NCT03798431
2018-12-11
https://zephyrnet.com/?p=NCT03798431
NCT03798431https://www.clinicaltrials.gov/study/NCT03798431?tab=tableNANANAThe goal of this pilot study is to test the Mindful Recovery OBOT Care Continuum (M-ROCC) model in primary care office-based opioid treatment (OBOT). M-ROCC features integration of evidence-based mindfulness training with weekly group-based opioid treatment. Primary outcomes include (1) Feasibility measured by implementation of the curriculum into two CHA primary care sites and attendance at weekly sessions; (2) Acceptance via self-report and qualitative interviews. Secondary outcomes include anxiety reduction.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-10 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2020-11-13 |
Start Month Year | December 11, 2018 |
Primary Completion Month Year | February 3, 2020 |
Verification Month Year | November 2020 |
Verification Date | 2020-11-30 |
Last Update Posted Date | 2020-11-13 |
Detailed Descriptions
Sequence: | 20741188 |
Description | The primary objective of this study is to conduct a single-arm pilot study in order to refine a Mindfulness-Based Intervention for the Opioid Use Disorder (OUD) treatment in primary care, called the Mindful Recovery OUD Care Continuum (M-ROCC). Study investigators will conduct qualitative interviews, assess opioid use, preliminary pre/post measures for participants participating in the pilot study. Additional aims of the pilot study is manual refinement and pilot testing assessment batteries to prepare for a multi-site RCT.
The study will focus on demonstrating feasibility and acceptability of the M-ROCC continuum. |
Facilities
Sequence: | 200280615 |
Name | Cambridge Health Alliance |
City | Somerville |
State | Massachusetts |
Zip | 02143 |
Country | United States |
Conditions
Sequence: | 52221565 | Sequence: | 52221566 | Sequence: | 52221567 | Sequence: | 52221568 |
Name | Opioid-use Disorder | Name | Anxiety | Name | Depression | Name | Stress Related Disorder |
Downcase Name | opioid-use disorder | Downcase Name | anxiety | Downcase Name | depression | Downcase Name | stress related disorder |
Id Information
Sequence: | 40195652 | Sequence: | 40195653 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | CHA-IRB-1094/08/18 | Id Value | R21AT010125 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/R21AT010125 |
Countries
Sequence: | 42609676 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55649851 |
Group Type | Experimental |
Title | M-ROCC |
Description | Mindful Recovery OUD Care Continuum (M-ROCC) builds on other mindfulness interventions for addictive disorders, but is specifically designed with the clinical needs of OUD patients on buprenorphine and logistic needs of primary care OBOT clinicians in mind. It focuses on integration of mindfulness practice for living well through stress, anxiety, depression, pain and addiction recovery. M-ROCC curriculum has three primary components, including a low-dose mindfulness phase, an intensive mindfulness training phase and then ongoing mindful recovery support. |
Interventions
Sequence: | 52535370 |
Intervention Type | Behavioral |
Name | M-ROCC |
Description | LDM (Low-Dose Mindfulness): A 4-wk intro mindfulness program for OUD, 50 min/week including explicit training in use of mobile mindfulness apps, with rolling admission and ascending practice dose ladder. MTPC (Mindfulness Training for Primary Care): An eight-week intensive mindfulness group with ascending practice dose ladder and skill integration over 8 weeks & 120 minutes/wk. MCS (Mindfulness Maintenance Check-in Support): Ongoing weekly mindfulness group with check-in and reminders, leveraging mobile mindfulness apps and motivational counseling for grads of LDM for 50 mins/wk. After completion of the LDM group, participation in various levels is fluid based on patient motivation, choice, and readiness. |
Design Outcomes
Sequence: | 177561593 | Sequence: | 177561594 | Sequence: | 177561595 | Sequence: | 177561596 | Sequence: | 177561597 | Sequence: | 177561598 | Sequence: | 177561599 | Sequence: | 177561600 | Sequence: | 177561601 | Sequence: | 177561602 | Sequence: | 177561603 | Sequence: | 177561604 | Sequence: | 177561605 | Sequence: | 177561606 | Sequence: | 177561607 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Likelihood of recommending program to a friend | Measure | Number of weekly sessions attended | Measure | Anxiety PROMIS-SF 8a | Measure | Number of biochemically-confirmed illicit opioid abstinent weeks | Measure | PROMIS-SF 8a (PROMIS-ASF) Pain Interference | Measure | Number of biochemically-confirmed cocaine abstinent weeks | Measure | Brief Experiential Avoidance Questionnaire (BEAQ) | Measure | Patient Reported Outcomes Measurement Information System – Depression Short Form (PROMIS-DSF) | Measure | Five Facet Mindfulness Questionnaire (FFMQ) | Measure | Difficulties in Emotion Regulation (DERS) Scale | Measure | Perceived Stress Scale (PSS) Scale | Measure | Self-Compassion Scale-Short Form (SCS-SF) | Measure | Multidimensional Assessment of Interoceptive Awareness (MAIA) | Measure | Sustained Attention to Response Task (SART) | Measure | Hypothetical Delay Discounting Task (HDT) |
Time Frame | Week 24 | Time Frame | Week 24 | Time Frame | Week 24 | Time Frame | Week 24 | Time Frame | Week 24 | Time Frame | Week 24 | Time Frame | Week 24 | Time Frame | Week 24 | Time Frame | Week 24 | Time Frame | Week 24 | Time Frame | Week 24 | Time Frame | Week 24 | Time Frame | Week 24 | Time Frame | Week 24 | Time Frame | Week 24 |
Description | Percentage of participants who would recommend the program to a friend (score of 4 or 5 on a Likert scale (1-5)) | Description | Percentage of attendance out of 24 weekly group sessions during the 6 month study period. | Description | The Patient Reported Outcomes Measurement Information System – Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale used to assess patient-reported health status for anxiety. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Subjects are asked to rate their experience of the item in the past seven days on a 5-point scale from 1 (Never) to 5 (Always). With use of the PROMIS Assessment Center Scoring Service, a T score is generated from subject responses. A sample item includes "My worries overwhelmed me." | Description | Number of 2-week time periods with no self-reported illicit opioid use and biochemically-confirmed abstinence from illicit opioid use during a 24-week period. Urine toxicology will be administered every two weeks for 24 weeks and weekly self-report about illicit opioid use will be collected weekly. | Description | The PROMIS Pain Interference instruments measure the self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items probing sleep and enjoyment in life, though the item bank only contains one sleep item. The Pain Interference short form is universal rather than disease-specific. It assesses pain interference over the past seven days. each question has five response options ranging in value from one to five (for pediatrics and parent proxy it is 0 to 4). To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 6-item form, the lowest possible raw score is 6; the highest possible raw score is 30. A higher PROMIS T-score represents higher consequences of pain. | Description | Number of 2-week time periods with no self-reported cocaine use and biochemically-confirmed abstinence from cocaine use during a 24-week period. | Description | The Brief Experiential Avoidance Questionnaire (BEAQ) is a 15-item scale developed to assess a broad range of experiential avoidance (EA) content. Answers are based on a 6-point Likert scale. Total score is sum of individual items (range is 15 – 90). Higher score indicates higher levels of experiential avoidance. | Description | The Patient Reported Outcomes Measurement Information System – Depression Short Form 8a (PROMIS-DSF) is an 8-item scale used to assess patient-reported health status for depression. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point scale from 1 (Never) to 5 (Always). | Description | is a 39-item scale that examines five factors that represent aspects of the current empirical conception of mindfulness. These five facets include: "observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience." An example item is "I pay attention to how my emotions affect my thoughts and behavior." Subjects rate their degree of agreement with each of the items on a Likert-type scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true), with higher scores indicating higher experience of mindfulness. Total score is sum of all facets (range is 39 – 195). Subscales range from 7 – 40. | Description | The DERS is a 36-item self-report scale designed to assess emotional dysregulation. The scale assess 6 aspects of emotional dysregulation: non-acceptance of emotional responses ("When I'm upset, I become embarrassed for feeling that way"), difficulties engaging in goal directed behavior ("When I'm upset, I have difficulty thinking about anything else"), impulse control difficulties ("When I'm upset, I lose control over my behaviors"), lack of emotional awareness ("When I'm upset, I take time to figure out what I'm really feeling (reverse-scored)", limited access to emotion regulation strategies ("When I'm upset, it takes me a long time to feel better"), and lack of emotional clarity ("I have no idea how I am feeling"). Answers are selected from a 1-5 Likert scale. Total score is sum of each subscale. Subscales are scored by summing individual subscale items. Total score ranges from 36 to 180 and subscale scores range from 5 to 40. | Description | The PSS Scale uses 14 items to measure the degree to which situations in life are stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often). An example question is, "In the last month, how often have you felt difficulties were piling up so high that you could not overcome them?" Positively stated items are reverse scored before all scale items are summed to yield a total score. Total score ranges from 0 to 56. | Description | The short-form Self-Compassion Scale (SCS-SF) is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. The scale is scored on a 5 point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored. Total score is calculated by taking the mean of all scores and ranges from 1 to 5. | Description | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report scale designed to assess multiple aspects of interoception and interoceptive awareness. The 6 point Likert scale (ranging from 0-5) assesses 8 aspects of interoceptive awareness: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Subscales are averaged, and a higher total score represents a better outcome. Total average score can also be reported. Total and subscale scores range from 0 to 5. | Description | Participants complete a computerized test measuring sustained attention and response inhibition. They are asked to press a key in response to rapidly displayed integers (1-9) and withhold a response to a designated "no-go" integer. | Description | This is a brief delay discounting task performed on a computer that presents a series of 5 discrete choice questions between delayed larger reward and smaller sooner reward in dollars. |
Browse Conditions
Sequence: | 193678635 | Sequence: | 193678636 | Sequence: | 193678637 | Sequence: | 193678638 | Sequence: | 193678639 | Sequence: | 193678640 |
Mesh Term | Opioid-Related Disorders | Mesh Term | Anxiety Disorders | Mesh Term | Mental Disorders | Mesh Term | Narcotic-Related Disorders | Mesh Term | Substance-Related Disorders | Mesh Term | Chemically-Induced Disorders |
Downcase Mesh Term | opioid-related disorders | Downcase Mesh Term | anxiety disorders | Downcase Mesh Term | mental disorders | Downcase Mesh Term | narcotic-related disorders | Downcase Mesh Term | substance-related disorders | Downcase Mesh Term | chemically-induced disorders |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366459 | Sequence: | 48366460 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Cambridge Health Alliance | Name | National Center for Complementary and Integrative Health (NCCIH) |
Overall Officials
Sequence: | 29312934 |
Role | Principal Investigator |
Name | Zev Schuman-Olivier, MD |
Affiliation | Study Principal Investigator |
Design Group Interventions
Sequence: | 68217441 |
Design Group Id | 55649851 |
Intervention Id | 52535370 |
Eligibilities
Sequence: | 30794732 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
18 years or older Exclusion Criteria: Psychosis |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004354 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 13 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Number Of Other Outcomes To Measure | 10 |
Designs
Sequence: | 30540772 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | There will be no randomization for this pilot study. |
Provided Documents
Sequence: | 2584037 |
Document Type | Informed Consent Form |
Has Protocol | False |
Has Icf | True |
Has Sap | False |
Document Date | 2019-05-15 |
Url | https://ClinicalTrials.gov/ProvidedDocs/31/NCT03798431/ICF_000.pdf |
Responsible Parties
Sequence: | 28907092 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798418
2019-02-01
https://zephyrnet.com/?p=NCT03798418
NCT03798418https://www.clinicaltrials.gov/study/NCT03798418?tab=tableNANANAThe objective of this study is to investigate the effects of therapeutic exercise and nutrition intervention for sarcopenia and risk of falls in patients with major chronic diseases. The outcomes will be analyzed regarding muscle strength, quality, and volume, etc., balance and gait, bone density, body composition, fall and quality of life after the intervention.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-28 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-11-01 |
Start Month Year | February 1, 2019 |
Primary Completion Month Year | September 30, 2022 |
Verification Month Year | October 2022 |
Verification Date | 2022-10-31 |
Last Update Posted Date | 2022-11-01 |
Detailed Descriptions
Sequence: | 20709708 |
Description | The main common chronic diseases in the elderly such as stroke, osteoporosis, chronic kidney disease and cancer, have been regarded as the fall high-risk patients. These patients are considered to be at risk for sarcopenia due to decreased exercise, nutritional status, and other reasons. Sarcopenia can be diagnosed and intervened effectively to delay the vicious cycle of health. Past studies have pointed out that in addition to drug intervention, treatment for sarcopenia must be accompanied by appropriate exercise and nutritional intervention (such as protein supplements, vitamin D) in order to achieve the best prevention and treatment. |
Facilities
Sequence: | 199962368 |
Name | Changhua Christian Hospital |
City | Changhua |
Zip | 500 |
Country | Taiwan |
Conditions
Sequence: | 52138278 | Sequence: | 52138279 | Sequence: | 52138280 | Sequence: | 52138281 |
Name | Stroke | Name | Osteoporosis | Name | Chronic Kidney Diseases | Name | Cancer |
Downcase Name | stroke | Downcase Name | osteoporosis | Downcase Name | chronic kidney diseases | Downcase Name | cancer |
Id Information
Sequence: | 40134522 |
Id Source | org_study_id |
Id Value | CCH-170208 |
Countries
Sequence: | 42542162 |
Name | Taiwan |
Removed | False |
Design Groups
Sequence: | 55558584 | Sequence: | 55558585 |
Group Type | Active Comparator | Group Type | Experimental |
Title | exercise group | Title | exercise combine diet counseling group |
Description | elastic band strengthening exercise | Description | elastic band strengthening exercise combined diet counseling. |
Interventions
Sequence: | 52454245 | Sequence: | 52454246 |
Intervention Type | Behavioral | Intervention Type | Dietary Supplement |
Name | elastic band strengthening exercise | Name | diet counseling |
Description | 2-3days per week(150min per week) | Description | each patients in this group will receive4-5times diet counseling |
Keywords
Sequence: | 79821792 | Sequence: | 79821793 | Sequence: | 79821794 | Sequence: | 79821795 | Sequence: | 79821796 | Sequence: | 79821797 | Sequence: | 79821798 |
Name | Sarcopenia | Name | stroke | Name | osteoporosis | Name | chronic kidney disease | Name | cancer | Name | balance and gait | Name | fall |
Downcase Name | sarcopenia | Downcase Name | stroke | Downcase Name | osteoporosis | Downcase Name | chronic kidney disease | Downcase Name | cancer | Downcase Name | balance and gait | Downcase Name | fall |
Design Outcomes
Sequence: | 177261232 | Sequence: | 177261233 | Sequence: | 177261234 | Sequence: | 177261235 | Sequence: | 177261236 | Sequence: | 177261237 | Sequence: | 177261238 | Sequence: | 177261239 | Sequence: | 177261240 | Sequence: | 177261241 | Sequence: | 177261242 | Sequence: | 177261243 | Sequence: | 177261244 | Sequence: | 177261245 | Sequence: | 177261246 | Sequence: | 177261247 | Sequence: | 177261248 | Sequence: | 177261249 | Sequence: | 177261250 | Sequence: | 177261251 | Sequence: | 177261252 | Sequence: | 177261253 | Sequence: | 177261254 | Sequence: | 177261255 | Sequence: | 177261256 | Sequence: | 177261257 | Sequence: | 177261258 | Sequence: | 177261259 | Sequence: | 177261260 | Sequence: | 177261261 | Sequence: | 177261262 | Sequence: | 177261263 | Sequence: | 177261264 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change of walking speed | Measure | Change of grip force | Measure | Change of postural sway displacement | Measure | Change of postural sway velocity | Measure | Change of postural sway area | Measure | Change of step time | Measure | Change of stance time | Measure | Change of swing time | Measure | Change of single support time | Measure | Change of double support time | Measure | Change of step length | Measure | Change of stance length | Measure | Change of muscle thickness | Measure | Change of muscle fiber length | Measure | Change of muscle fiber orientation angle | Measure | Change of muscle cross section area | Measure | Change of physiological cost index (PCI) | Measure | Change of international Quality of Life Assessment Short Form -36 (SF-36) | Measure | Change of amplitude of Muscle activity | Measure | Change of concentration of CRP (C-Reactive Protein) | Measure | Change of concentration of ALB (Serum albumin) | Measure | Change of concentration of Glomerular Filtration Rate (GFR) | Measure | Change of concentration of Hemoglobin (Hb) | Measure | Change of concentration of Glucose SPOT | Measure | Change of concentration of Cholesterol | Measure | Change of concentration of Triglyceride | Measure | Change of concentration of Transferrin | Measure | Change of Berg balance test (BBS) | Measure | Change of Fugl-Meyer Assessment (FMA) | Measure | Change of Body Mass Index (BMI) | Measure | Change of Mini-mental state examination (MMSE) | Measure | Change of Modified Ashworth scale (MAS) | Measure | Change of Muscle tone |
Time Frame | baseline: before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | Time Frame: before intervention; follow-up: 3 months after intervention | Time Frame | Time Frame: before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention | Time Frame | before intervention; follow-up: 3 months after intervention |
Description | distance: 6m, patients can walk with foor orthosis and assistive devices | Description | Use a grip force meter (kg) to test both hands for test 3 times | Description | Use computerized dynography to measure the postural sway displacement (mm) | Description | Use computerized dynography to measure the postural sway velocity (mm/s) | Description | Use computerized dynography to measure the postural sway area (mm^2) | Description | Use computerized dynography to measure spatial gait parameter: step time (ms) | Description | Use computerized dynography to measure spatial gait parameter: stance time (ms) | Description | Use computerized dynography to measure spatial gait parameter: swing time (ms) | Description | Use computerized dynography to measure spatial gait parameter: single support time (ms) | Description | Use computerized dynography to measure spatial gait parameter: double support time (ms) | Description | Use computerized dynography to measure spatial gait parameter: step distance (mm) | Description | Use computerized dynography to measure spatial gait parameter: stance distance (mm) | Description | Use ultrasound to assess muscles morphological parameter: thickness (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius. | Description | Use ultrasound to assess muscles morphological parameter: fiber length (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius. | Description | Use ultrasound to assess muscles morphological parameter: fiber orientation angle (degrees). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius. | Description | Use ultrasound to assess muscles morphological parameter: cross-sectional area (mm^2).
Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius. |
Description | Heart rate (HR: beats/min) and walking speed (m/s) have been previously shown to be linearly related to oxygen uptake at sub-maximal exercise levels. Combination of these two parameters yields a single value in beats per meter, the physiological cost index (PCI). This is calculated as Working HR – Resting HR (beats/min) / Walking speed (m/s) | Description | including 8 health concepts: (1) physical functioning, (2) role limitations because of physical health problems; (3) bodily pain, (4) social functioning, (5) general mental health (psychological distress and psychological wellbeing), (6) role limitations because of emotional problems, (7) vitality (energy/fatigue), (8) general health perceptions.
Scoring: answers to each question are scored which are then summed and transformed to a 0 – 100 scale. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
Description | use electromyography to measure the muscles activity in microvolts (uv) included quadriceps, hamstrings, tibialis anterior, gastrocnemius during subject walking in self-selected speed in 6 meters. | Description | The concentration of CRP in the blood test. CRP is used mainly as a marker of inflammation. | Description | The concentration of ALB in the blood test. Albumin is the most important contributor to the maintenance of plasma colloid oncotic pressure; deficiency results in edema. | Description | The concentration of GFR in the blood test. The glomerular filtration rate is the best test to measure the patient's level of kidney function and determine the stage of kidney disease. It can calculate it from the results of the blood creatinine test. | Description | The concentration of Hb in the blood test. | Description | The concentration of Glucose SPOT in the blood test. TheSpot glucose measurement in epidermal interstitial fluid appears to be a promising alternative to capillary blood glucose estimation | Description | The concentration of Cholesterol in the blood test. | Description | The concentration of Triglyceride in the blood test. | Description | The concentration of Transferrin in the blood test. | Description | including 14 items which are scored on a 5 points scale (0-4). The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.
The item scores are summed, minimum score =0, maximum score = 56 |
Description | Items are scored on a 3-point ordinal scale (0 = cannot perform; 1 = performs partially; 2 = performs fully) Maximum Score = 226 points The 5 domains assessed include, Motor function (UE maximum score = 66; LE maximum score = 34), Sensory function (maximum score = 24), Balance (maximum score = 14), Joint range of motion (maximum score = 44), Joint pain (maximum score = 44) | Description | (body weight) kg/(height) m*(height)m | Description | It is an 11-question measure that tests five areas of cognitive function:
orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. |
Description | measures resistance during passive soft-tissue stretching, the score is ranged from 0-4 0: No increase in muscle tone
Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM |
Description | measure the muscle tone (kg/m) under muscle resting. Target muscles are quadricep, hamstring, anterior tibialis, gastrocnemius. |
Browse Conditions
Sequence: | 193363936 | Sequence: | 193363937 | Sequence: | 193363938 | Sequence: | 193363939 | Sequence: | 193363940 | Sequence: | 193363941 | Sequence: | 193363942 | Sequence: | 193363943 | Sequence: | 193363944 | Sequence: | 193363945 | Sequence: | 193363946 | Sequence: | 193363947 | Sequence: | 193363948 | Sequence: | 193363949 | Sequence: | 193363950 | Sequence: | 193363951 | Sequence: | 193363952 | Sequence: | 193363953 | Sequence: | 193363954 | Sequence: | 193363955 | Sequence: | 193363956 | Sequence: | 193363957 | Sequence: | 193363958 |
Mesh Term | Osteoporosis | Mesh Term | Sarcopenia | Mesh Term | Kidney Diseases | Mesh Term | Renal Insufficiency, Chronic | Mesh Term | Chronic Disease | Mesh Term | Nervous System Diseases | Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Male Urogenital Diseases | Mesh Term | Renal Insufficiency | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes | Mesh Term | Bone Diseases, Metabolic | Mesh Term | Bone Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Metabolic Diseases | Mesh Term | Muscular Atrophy | Mesh Term | Neuromuscular Manifestations | Mesh Term | Neurologic Manifestations | Mesh Term | Atrophy | Mesh Term | Pathological Conditions, Anatomical |
Downcase Mesh Term | osteoporosis | Downcase Mesh Term | sarcopenia | Downcase Mesh Term | kidney diseases | Downcase Mesh Term | renal insufficiency, chronic | Downcase Mesh Term | chronic disease | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | male urogenital diseases | Downcase Mesh Term | renal insufficiency | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | bone diseases, metabolic | Downcase Mesh Term | bone diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | muscular atrophy | Downcase Mesh Term | neuromuscular manifestations | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | atrophy | Downcase Mesh Term | pathological conditions, anatomical |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290031 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Changhua Christian Hospital |
Overall Officials
Sequence: | 29268078 |
Role | Study Director |
Name | Tasen Wei, Doctor |
Affiliation | Changhua Christian Hospital |
Design Group Interventions
Sequence: | 68106596 | Sequence: | 68106597 | Sequence: | 68106598 |
Design Group Id | 55558585 | Design Group Id | 55558584 | Design Group Id | 55558585 |
Intervention Id | 52454245 | Intervention Id | 52454245 | Intervention Id | 52454246 |
Eligibilities
Sequence: | 30747318 |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
55-85 years old Exclusion Criteria: lower limb Brunnstrom stage >5 |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254118833 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 44 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 19 |
Number Of Secondary Outcomes To Measure | 14 |
Designs
Sequence: | 30493603 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26655066 | Sequence: | 26655067 |
Intervention Id | 52454245 | Intervention Id | 52454246 |
Name | thera-band strengthening exercise | Name | nutrition counseling |
Responsible Parties
Sequence: | 28859884 |
Responsible Party Type | Principal Investigator |
Name | Ta-Sen Wei,MD |
Title | Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor |
Affiliation | Changhua Christian Hospital |
Study References
Sequence: | 52031717 | Sequence: | 52031718 | Sequence: | 52031719 | Sequence: | 52031720 | Sequence: | 52031721 | Sequence: | 52031722 | Sequence: | 52031723 |
Pmid | 24785098 | Pmid | 11518445 | Pmid | 11833018 | Pmid | 25852886 | Pmid | 17699348 | Pmid | 24415363 | Pmid | 19588334 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Biolo G, Cederholm T, Muscaritoli M. Muscle contractile and metabolic dysfunction is a common feature of sarcopenia of aging and chronic diseases: from sarcopenic obesity to cachexia. Clin Nutr. 2014 Oct;33(5):737-48. doi: 10.1016/j.clnu.2014.03.007. Epub 2014 Mar 29. | Citation | Stapleton T, Ashburn A, Stack E. A pilot study of attention deficits, balance control and falls in the subacute stage following stroke. Clin Rehabil. 2001 Aug;15(4):437-44. doi: 10.1191/026921501678310243. | Citation | Hyndman D, Ashburn A, Stack E. Fall events among people with stroke living in the community: circumstances of falls and characteristics of fallers. Arch Phys Med Rehabil. 2002 Feb;83(2):165-70. doi: 10.1053/apmr.2002.28030. | Citation | Kutner NG, Zhang R, Huang Y, Wasse H. Falls among hemodialysis patients: potential opportunities for prevention? Clin Kidney J. 2014 Jun;7(3):257-63. doi: 10.1093/ckj/sfu034. Epub 2014 Apr 15. | Citation | Cook WL, Tomlinson G, Donaldson M, Markowitz SN, Naglie G, Sobolev B, Jassal SV. Falls and fall-related injuries in older dialysis patients. Clin J Am Soc Nephrol. 2006 Nov;1(6):1197-204. doi: 10.2215/CJN.01650506. Epub 2006 Aug 30. | Citation | Couch ME, Dittus K, Toth MJ, Willis MS, Guttridge DC, George JR, Barnes CA, Gourin CG, Der-Torossian H. Cancer cachexia update in head and neck cancer: Definitions and diagnostic features. Head Neck. 2015 Apr;37(4):594-604. doi: 10.1002/hed.23599. Epub 2014 Mar 25. | Citation | Liu CJ, Latham NK. Progressive resistance strength training for improving physical function in older adults. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD002759. doi: 10.1002/14651858.CD002759.pub2. |
]]>
https://zephyrnet.com/NCT03798405
2019-01-01
https://zephyrnet.com/?p=NCT03798405
NCT03798405https://www.clinicaltrials.gov/study/NCT03798405?tab=tableNANANAThe investigators will compare two physician behaviors for managing pain in patients with IBD: proactive vs. reactive. Both the proactive and reactive behavior/strategies are standard of care at the institution in which the study will be performed. The PROACTIVE strategy is an IBD-specific analgesic orderset (built into our EMR and approved by the institution’s Pharmacy and Therapeutics committee), the REACTIVE strategy is a traditional “reactive” analgesic prescribing (prescribing medications only when patients have pain). The PROACTIVE IBD-specific analgesic orderset consists of medications which have evidence for use in IBD-related pain. This orderset is an educational guide, it does not force any order. The reactive prescribing habits could contain an array of pain medications depending on what the provider wants to prescribe.
Aims:
Aim 1: To assess whether there is a difference in pain scores or functional activity among hospitalized patients with IBD between reactive vs proactive physician behaviors.
Aim 2: To assess whether there is a difference in inpatient opioid-prescribing between reactive vs proactive physician behaviors.
Aim 3: To assess whether there is a difference in health care utilization, including length-of-stay and 30-day readmission, between reactive vs proactive physician behaviors.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-04 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2022-07-22 |
Start Month Year | January 1, 2019 |
Primary Completion Month Year | July 1, 2022 |
Verification Month Year | July 2022 |
Verification Date | 2022-07-31 |
Last Update Posted Date | 2022-07-22 |
Detailed Descriptions
Sequence: | 20637546 |
Description | Prospective, investigator-blinded, single-institution randomized-control trial . Consecutive adult patients with IBD (Crohn's disease or ulcerative colitis) admitted to the hospital will be screened for eligibility, and eligible patients will be approached and consented to participate. Subjects will be randomized to receive the P.A.I.N.-Sparing bundle or usual care. Patient randomization will be stratified by provider to avoid bias, using a web-based in-house system (RANDI3). Subjects will also be provided with a fitness tracker (Fitbit(R)) to measure functional status during their hospital stay. |
Facilities
Sequence: | 199189124 |
Name | Cedars-Sinai Medical Center |
City | Los Angeles |
State | California |
Zip | 90048 |
Country | United States |
Browse Interventions
Sequence: | 95637274 | Sequence: | 95637275 | Sequence: | 95637276 | Sequence: | 95637277 | Sequence: | 95637278 | Sequence: | 95637279 |
Mesh Term | Analgesics | Mesh Term | Narcotics | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Central Nervous System Depressants |
Downcase Mesh Term | analgesics | Downcase Mesh Term | narcotics | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | central nervous system depressants |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51953395 | Sequence: | 51953396 | Sequence: | 51953397 | Sequence: | 51953398 | Sequence: | 51953399 |
Name | Inflammatory Bowel Diseases | Name | Pain | Name | Opioid Use | Name | Crohn Disease | Name | Ulcerative Colitis |
Downcase Name | inflammatory bowel diseases | Downcase Name | pain | Downcase Name | opioid use | Downcase Name | crohn disease | Downcase Name | ulcerative colitis |
Id Information
Sequence: | 39989611 |
Id Source | org_study_id |
Id Value | Pro00050742 |
Countries
Sequence: | 42380516 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55353393 | Sequence: | 55353394 |
Group Type | Experimental | Group Type | No Intervention |
Title | Proactive | Title | Reactive (Control Group) |
Description | Proactive Analgesic Inpatient Narcotic-Sparing:
Pain management in patients in the proactive physician-behavior group will be based on the IBD Pain orderset in our EMR. This orderset is already in use and standard-of-care at Cedars. The orderset uses pain medications, which have evidence for use in IBD. The orderset is simply a guide to clinicians and does not force any doctor or patient to be in a "protocol". |
Description | Pain management in patients in the reactive group (control group) will follow traditional prescribing habits. As different providers vary in the way they treat pain, analgesic medication prescribing in the control group will be inherently variable in nature. The control group does not constitute a lack of treatment or placebo; rather, pain management in the control group will not be proactive as in the intervention group. |
Interventions
Sequence: | 52265628 |
Intervention Type | Behavioral |
Name | Proactive Analgesic Inpatient Narcotic-Sparing |
Description | Medications suggested to the physician with enhanced ease of ordering. |
Keywords
Sequence: | 79528858 | Sequence: | 79528859 | Sequence: | 79528860 |
Name | Pain | Name | Inflammatory Bowel Disease | Name | Opioids |
Downcase Name | pain | Downcase Name | inflammatory bowel disease | Downcase Name | opioids |
Design Outcomes
Sequence: | 176606148 | Sequence: | 176606149 | Sequence: | 176606150 | Sequence: | 176606151 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Patient-Reported Pain Scores | Measure | Healthcare Utilization | Measure | Functional Activity | Measure | Opioid-Consumption |
Time Frame | Difference in the average daily pain score from the first to the last day of hospitalization, typically 7 days. | Time Frame | From hospital admission until hospital discharge, typically 7 days. | Time Frame | From hospital admission until hospital discharge, typically 7 days. | Time Frame | From hospital admission until hospital discharge, typically 7 days. |
Description | Visual Analog Pain Numeric Rating Scale (Scale range 0 (no pain) to 10 (severe pain)) | Description | Hospital length of stay (in days) | Description | FitBit activity (number of steps per day) | Description | Milligram morphine-equivalents consumed per day |
Browse Conditions
Sequence: | 192623033 | Sequence: | 192623034 | Sequence: | 192623035 | Sequence: | 192623036 | Sequence: | 192623037 | Sequence: | 192623038 |
Mesh Term | Crohn Disease | Mesh Term | Intestinal Diseases | Mesh Term | Inflammatory Bowel Diseases | Mesh Term | Gastroenteritis | Mesh Term | Gastrointestinal Diseases | Mesh Term | Digestive System Diseases |
Downcase Mesh Term | crohn disease | Downcase Mesh Term | intestinal diseases | Downcase Mesh Term | inflammatory bowel diseases | Downcase Mesh Term | gastroenteritis | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | digestive system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48115546 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Cedars-Sinai Medical Center |
Overall Officials
Sequence: | 29160892 | Sequence: | 29160893 |
Role | Principal Investigator | Role | Study Director |
Name | Gil Y Melmed, MD, MS | Name | Sameer K Berry, MD, MBA |
Affiliation | Cedars-Sinai Medical Center | Affiliation | Cedars-Sinai Medical Center |
Design Group Interventions
Sequence: | 67857641 |
Design Group Id | 55353393 |
Intervention Id | 52265628 |
Eligibilities
Sequence: | 30637060 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Adults with confirmed IBD diagnosis Exclusion Criteria: Admitted for primary non-IBD complaint |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254132239 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 42 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30383994 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Health Services Research |
Time Perspective | |
Masking | Double |
Masking Description | The primary investigators will be blinded, as will the computer programmers who collect the data. |
Intervention Model Description | Consecutive patients with IBD admitted to the hospital will be screened, and eligible patients will be consented. Patients who have a pain score > 0 and require pain control will randomly receive the reactive traditional prescribing or the proactive standard-of-care orderset guideline – all patients will receive a FitBit exercise tracker. |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26560204 |
Intervention Id | 52265628 |
Name | P.A.I.N.-Sparing Bundle |
Responsible Parties
Sequence: | 28750728 |
Responsible Party Type | Principal Investigator |
Name | Gil Melmed |
Title | co-Director, Inflammatory Bowel Disease Center, Principal Investigator |
Affiliation | Cedars-Sinai Medical Center |
]]>
https://zephyrnet.com/NCT03798392
2019-02-28
https://zephyrnet.com/?p=NCT03798392
NCT03798392https://www.clinicaltrials.gov/study/NCT03798392?tab=tableAbeer Ahmed, MDabeer_ahmed@kasralainy.edu.eg01005244590Supraglottic airway devices (SGAs) are very commonly used during anesthesia but structural vulnerability to airway morbidity and issues about cuff pressure still concern anesthesiologists. There have been controversial results regarding optimal intra-cuff pressure in various types of cuffed supraglottic airways. When the supraglottic cuff pressure is more than the mucosal perfusion pressure, it is likely to either cause postoperative pharyngo-laryngeal symptoms like sore throat (dysphagia, dysphonia) or cause local mucosal trauma and nerve injuries. Supraglottic airway devices with non-inflatable cuff have advantages in omitting the cuff pressure monitoring and reducing potential pharyngo-laryngeal complications.
Self-pressurizing Air Q blocker is the latest version. It has a drain tube through which a suction tube is passed. There is an inflatable cuff at the end of this tube. On inflation, the cuff seals the esophageal opening into the stomach, preventing any regurgitation of stomach contents. Instead of the pilot balloon and inflating cuff, the air-Q SP with blocker has a communication orifice at the junction of the peri-glotic cuff and the airway tube. This communication between two spaces enables the cuff to dynamically regulate intra-cuff pressure depending on airway pressure. This distinguishing feature of the air-Q SP may result in reduced risk for airway morbidities related to cuff hyperinflation.
The Baska mask is a novel supraglottic airway device with a non-inflatable cuff, an oesophageal drainage inlet and side channels to facilitate aspiration of gastric contents, and an integrated bite-block. It was revealed that the baska mask is relatively easy to insert, provided a high-quality seal with the glotic aperture and the incidence of throat discomfort appeared low.
To our knowledge, and after searching in previous literature, no previous studies have compared the Air-Q SP with blocker with Baska mask; another supraglottic airway devices with non-inflatable cuff.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-10 |
Last Update Posted Date | 2019-01-10 |
Start Month Year | February 2019 |
Primary Completion Month Year | May 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-10 |
Facilities
Sequence: | 200053182 |
Status | Recruiting |
Name | Kasr Alainy Faculty of Medicine – Cairo university |
City | Cairo |
Zip | 00225 |
Country | Egypt |
Facility Contacts
Sequence: | 28097486 |
Facility Id | 200053182 |
Contact Type | primary |
Name | Abeer Ahmed, Assistant Professor |
Browse Interventions
Sequence: | 96027777 | Sequence: | 96027778 | Sequence: | 96027779 |
Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52156419 |
Name | Supraglottic Airway Devices |
Downcase Name | supraglottic airway devices |
Id Information
Sequence: | 40148175 |
Id Source | org_study_id |
Id Value | N-24- 2018 |
Countries
Sequence: | 42557696 |
Name | Egypt |
Removed | False |
Design Groups
Sequence: | 55577848 | Sequence: | 55577849 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | SP group | Title | Baska group |
Interventions
Sequence: | 52471957 | Sequence: | 52471958 |
Intervention Type | Device | Intervention Type | Device |
Name | Self-pressurizing Air Q blocker mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion | Name | Baska mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion |
Description | comparing the airway seal pressure 10 min after insertion of each devices . | Description | comparing the airway seal pressure 10 min after insertion of each devices . |
Design Outcomes
Sequence: | 177327733 |
Outcome Type | primary |
Measure | airway seal pressure 10 minutes after insertion |
Time Frame | 10 minutes after the device insertion. |
Sponsors
Sequence: | 48306005 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Cairo University |
Central Contacts
Sequence: | 12004730 |
Contact Type | primary |
Name | Abeer Ahmed, MD |
Phone | 01005244590 |
abeer_ahmed@kasralainy.edu.eg | |
Role | Contact |
Design Group Interventions
Sequence: | 68130803 | Sequence: | 68130804 |
Design Group Id | 55577848 | Design Group Id | 55577849 |
Intervention Id | 52471957 | Intervention Id | 52471958 |
Eligibilities
Sequence: | 30757323 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 50 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Female patients between the age group of 18 and 50 years, Exclusion Criteria: ASA III – V patients. |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254223928 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 50 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30503548 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Single |
Subject Masked | True |
Intervention Other Names
Sequence: | 26665872 | Sequence: | 26665873 |
Intervention Id | 52471957 | Intervention Id | 52471958 |
Name | airway management under general anesthesia | Name | airway management under general anesthesia |
Responsible Parties
Sequence: | 28869826 |
Responsible Party Type | Principal Investigator |
Name | Abeer Ahmed, MD |
Title | Assistant Professor of Anesthesia, SICU and pain management – kasr Aiainy Faculty of Medicine – Cairo University |
Affiliation | Cairo University |
]]>
https://zephyrnet.com/NCT03798379
2015-10-01
https://zephyrnet.com/?p=NCT03798379
NCT03798379https://www.clinicaltrials.gov/study/NCT03798379?tab=tableNANANATo evaluate the effect of lower extremity strengthening and balance exercises on balance, quality of life and neuropathic pain of the cancer patients receiving neurotoxic chemotherapy.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-04 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | October 1, 2015 |
Primary Completion Month Year | July 1, 2016 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Detailed Descriptions
Sequence: | 20735811 |
Description | Cancer-related mortality rates decreased considerably thanks to novel treatment methods and new agents over the last two decades. Although chemotherapy (CT) is an effective treatment type in reducing the size of the tumor and eliminating metastases, it may harm many different organs and systems due to short & long-term side effects. Peripheral neuropathy (PN) is regarded as a neurological and clinical side effect for cancer patients. PN may arise as a paraneoplastic symptom but more commonly occurs with neurotoxic CT agents. Short & long-term side effects that may damage sensory, motor, and autonomic neurons. This damage to the small-fiber sensory nerves causes a change in the sense of touch, pain, and warmth, while the damage to the large-fiber nerves causes a change in the sense of vibration and proprioception. Motor nerve damage affects voluntary movement, muscle tone, and coordination, and damage to the autonomic nervous system affects intestinal motility and blood pressure over smooth muscles. Despite the fact that studies on PN treatment have generally focused on pharmacological agents reducing pain or treating selected side effects, no agent that may be preventive for chemotherapy induced Peripheral Neuropathy (CIPN) due to neurotoxic chemotherapy has been recommended in the review of the American Society of Clinical Oncology.
Side effects due to CT such as anorexia, nausea, vomiting, mucositis, diarrhea, anemia or PN may lead to impairment in the quality of life of the patient and may significantly reduce the level of physical activity. Neurotoxic and ototoxic effects may cause ataxia, paresthesia and dysesthesia, leading to gait, and balance disorders. CIPN has been associated with balance disorder, loss of function and reduced quality of life in the literature. It may result in loss of balance, difficulty in ambulation, increase in the frequency of collapse and accordingly increase in injuries. Despite the fact that medical treatments used in CIPN are often helpful in the treatment of neuropathic pain, no effect has been observed on muscle strength, gait, and balance. It is believed that muscle strength and balance exercises, such as aerobic exercises, can provide mitochondria with oxygen and glucose by increasing blood supply, thereby contributing to energy production and reducing symptoms. Current data suggest that exercise is applicable, safe, and beneficial for this group of patients. Balance exercises at an early stage may prevent or delay the onset of sensory and motor symptoms. Although exercise is accepted as a supportive treatment, which should be addressed more seriously for a patient population with PN, there is not enough information in the literature on timing, frequency, and mode of administration of the treatment program that will be carried out in this specific group of patients. The aim of this study is to investigate the effects of therapeutic exercise program including concurrently initiated strengthening, balance and aerobic exercises on the symptoms, balance status and quality of life of the group of patients who have a limited physical activity, a risk of developing PN following the treatment, and will have a long-term bed rest and compare with the group of patients not receiving any exercise program in the same treatment period. |
Facilities
Sequence: | 200244562 |
Name | Marmara University Pendik Training and Research Hospital |
City | Istanbul |
Zip | 34000 |
Country | Turkey |
Conditions
Sequence: | 52208196 |
Name | Chemotherapy-induced Peripheral Neuropathy |
Downcase Name | chemotherapy-induced peripheral neuropathy |
Id Information
Sequence: | 40186212 |
Id Source | org_study_id |
Id Value | 09.2015.278 |
Countries
Sequence: | 42599716 |
Name | Turkey |
Removed | False |
Design Groups
Sequence: | 55634772 | Sequence: | 55634773 |
Group Type | Active Comparator | Group Type | No Intervention |
Title | Exercise group | Title | Control group |
Description | Eligible patients who were planned to receive neurotoxic chemotherapy | Description | Patients eligible for the study and received the 3rd cycle of chemotherapy |
Interventions
Sequence: | 52522168 |
Intervention Type | Other |
Name | Exercise |
Description | Strengthening, balance and aerobic exercises were explained to the patients examined before chemotherapy sessions and demonstrated by applying on the patient. |
Keywords
Sequence: | 79923089 | Sequence: | 79923090 | Sequence: | 79923091 | Sequence: | 79923092 |
Name | cancer | Name | chemotherapy | Name | peripheral neuropathy | Name | exercise |
Downcase Name | cancer | Downcase Name | chemotherapy | Downcase Name | peripheral neuropathy | Downcase Name | exercise |
Design Outcomes
Sequence: | 177511715 | Sequence: | 177511716 | Sequence: | 177511717 | Sequence: | 177511718 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Balance assessment | Measure | Berg balance scale | Measure | PainDETECT: questionnaire | Measure | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire |
Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months | Time Frame | 3 months |
Description | NeuroCom Balance Master® device (Natus Medical, San Carlos, California, USA) is a balance evaluation device measuring the position of the center of gravity, postural control along with static and dynamic stability. | Description | Berg balance scale used in the evaluation of balance based on performance is a 14-item measure in which patient is required to perform different activities.14 different activities are scored between 0 (worst) and 4 (best) according to the patient's performance. The maximum score is 56. A total score close to 56 indicates that the balance of patient is good. | Description | The presence of neuropathic pain was evaluated with the painDETECT questionnaire. The maximum score is 35 and a high score indicates the severity of neuropathic pain. When the PD-Q score is more than 13, it is indicated the presence of neuropathic pain component. | Description | It is a questionnaire developed by the European Organization for Research and Treatment of Cancer and used to assess the quality of life of cancer patients participating in clinical trials and includes a variety of components. Patients' higher points of functional scale and general health status scale and lower points of symptom scale scores indicate a high QoL. |
Browse Conditions
Sequence: | 193627337 | Sequence: | 193627338 | Sequence: | 193627339 |
Mesh Term | Peripheral Nervous System Diseases | Mesh Term | Neuromuscular Diseases | Mesh Term | Nervous System Diseases |
Downcase Mesh Term | peripheral nervous system diseases | Downcase Mesh Term | neuromuscular diseases | Downcase Mesh Term | nervous system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48353772 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Hitit University |
Design Group Interventions
Sequence: | 68199325 |
Design Group Id | 55634772 |
Intervention Id | 52522168 |
Eligibilities
Sequence: | 30786922 |
Gender | All |
Minimum Age | 20 Years |
Maximum Age | 75 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
the ability to understand the informed consent form, and the signing the informed consent form after being informed in detail, Exclusion Criteria: Previously diagnosed peripheral neuropathy (Diabetic peripheral neuropathy, entrapment neuropathies etc.) |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989697 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 9 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 20 |
Maximum Age Num | 75 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30532992 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | Single |
Masking Description | Non randomized, single blind, prospective |
Intervention Model Description | Parallel Assignment |
Subject Masked | True |
Responsible Parties
Sequence: | 28899286 |
Responsible Party Type | Principal Investigator |
Name | Yeliz Bahar Ozdemir |
Title | Principal investigator |
Affiliation | Hitit University |
Study References
Sequence: | 52103135 | Sequence: | 52103136 | Sequence: | 52103137 | Sequence: | 52103138 | Sequence: | 52103139 | Sequence: | 52103140 |
Pmid | 28963591 | Pmid | 24478323 | Pmid | 25261162 | Pmid | 27243828 | Pmid | 19417586 | Pmid | 29424607 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Zimmer P, Trebing S, Timmers-Trebing U, Schenk A, Paust R, Bloch W, Rudolph R, Streckmann F, Baumann FT. Eight-week, multimodal exercise counteracts a progress of chemotherapy-induced peripheral neuropathy and improves balance and strength in metastasized colorectal cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Feb;26(2):615-624. doi: 10.1007/s00520-017-3875-5. Epub 2017 Sep 30. | Citation | Streckmann F, Kneis S, Leifert JA, Baumann FT, Kleber M, Ihorst G, Herich L, Grussinger V, Gollhofer A, Bertz H. Exercise program improves therapy-related side-effects and quality of life in lymphoma patients undergoing therapy. Ann Oncol. 2014 Feb;25(2):493-9. doi: 10.1093/annonc/mdt568. | Citation | Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23. | Citation | Cammisuli S, Cavazzi E, Baldissarro E, Leandri M. Rehabilitation of balance disturbances due to chemotherapy-induced peripheral neuropathy: a pilot study. Eur J Phys Rehabil Med. 2016 Aug;52(4):479-88. Epub 2016 May 31. | Citation | Nurgalieva Z, Xia R, Liu CC, Burau K, Hardy D, Du XL. Risk of chemotherapy-induced peripheral neuropathy in large population-based cohorts of elderly patients with breast, ovarian, and lung cancer. Am J Ther. 2010 Mar-Apr;17(2):148-58. doi: 10.1097/MJT.0b013e3181a3e50b. | Citation | Hershman DL, Lacchetti C, Loprinzi CL. Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers: American Society of Clinical Oncology Clinical Practice Guideline Summary. J Oncol Pract. 2014 Nov;10(6):e421-e424. doi: 10.1200/JOP.2014.001776. No abstract available. |
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https://zephyrnet.com/NCT03798366
2019-01-14
https://zephyrnet.com/?p=NCT03798366
NCT03798366https://www.clinicaltrials.gov/study/NCT03798366?tab=tableNANANAThe main purpose of the study is to see if GLPG1690 helps (together with the standard of care treatment) in the treatment of the skin and other areas affected by systemic sclerosis.
Another aim is to find out how safe/well tolerated GLPG1690 will be and whether there are any side effects. The study will also look at other things, including whether the study drug affects disease progression and also if it changes any aspect of the quality of life.
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Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2021-05-04 |
Start Month Year | January 14, 2019 |
Primary Completion Month Year | May 21, 2020 |
Verification Month Year | April 2021 |
Verification Date | 2021-04-30 |
Last Update Posted Date | 2021-05-04 |
Results First Posted Date | 2021-05-04 |
Facilities
Sequence: | 200061805 | Sequence: | 200061806 | Sequence: | 200061807 | Sequence: | 200061808 | Sequence: | 200061809 | Sequence: | 200061810 | Sequence: | 200061811 | Sequence: | 200061812 | Sequence: | 200061813 | Sequence: | 200061814 | Sequence: | 200061815 | Sequence: | 200061816 | Sequence: | 200061817 | Sequence: | 200061818 | Sequence: | 200061819 | Sequence: | 200061820 | Sequence: | 200061821 | Sequence: | 200061822 |
Name | Pacific Arthritis Care Center | Name | UCLA Rheumatology | Name | RASF Clinical Research Center | Name | Massachusetts General Hospital | Name | University of Michigan | Name | Metroplex Clinical Research Center | Name | UT Physicians Center for Autoimmunity | Name | UZ Gent | Name | UZ Leuven | Name | Charité – Universitätsmedizin Berlin | Name | Universitätsklinikum Frankfurt | Name | Azienda Ospedaliero | Name | Ospedale San Raffaele S.r.l. – PPDS | Name | Hospital Universitario Vall d'Hebron – PPDS | Name | Hospital Universitario 12 de Octubre | Name | Hospital Nuestra Señora de Valme | Name | University Hospital Aintree | Name | Royal Free Hospital |
City | Los Angeles | City | Los Angeles | City | Boca Raton | City | Boston | City | Ann Arbor | City | Dallas | City | Houston | City | Gent | City | Leuven | City | Berlin | City | Frankfurt | City | Firenze | City | Milano | City | Barcelona | City | Madrid | City | Sevilla | City | Liverpool | City | London |
State | California | State | California | State | Florida | State | Massachusetts | State | Michigan | State | Texas | State | Texas | ||||||||||||||||||||||
Zip | 90045 | Zip | 90095 | Zip | 33486 | Zip | 02114 | Zip | 48109 | Zip | 75231 | Zip | 77030 | Zip | 9000 | Zip | 3000 | Zip | 10117 | Zip | 60590 | Zip | 50439 | Zip | 20132 | Zip | L9 7AL | Zip | NW32QG | ||||||
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | Belgium | Country | Belgium | Country | Germany | Country | Germany | Country | Italy | Country | Italy | Country | Spain | Country | Spain | Country | Spain | Country | United Kingdom | Country | United Kingdom |
Conditions
Sequence: | 52158829 |
Name | Systemic Sclerosis |
Downcase Name | systemic sclerosis |
Id Information
Sequence: | 40150021 | Sequence: | 40150022 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | GLPG1690-CL-204 | Id Value | 2018-001817-33 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42559608 | Sequence: | 42559609 | Sequence: | 42559610 | Sequence: | 42559611 | Sequence: | 42559612 | Sequence: | 42559613 |
Name | United States | Name | Belgium | Name | Germany | Name | Italy | Name | Spain | Name | United Kingdom |
Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False |
Design Groups
Sequence: | 55580709 | Sequence: | 55580710 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | GLPG1690 600 mg | Title | Placebo |
Description | Participants received GLPG1690 600 milligrams (mg), orally once daily for 24 weeks. | Description | Participants received GLPG1690 matching placebo, orally once daily for 24 weeks. |
Interventions
Sequence: | 52474400 | Sequence: | 52474401 |
Intervention Type | Drug | Intervention Type | Drug |
Name | GLPG1690 | Name | Placebo |
Description | Film-coated tablets of GLPG1690 for oral use. | Description | Film-coated tablets of GLPG1690 matching placebo for oral use. |
Design Outcomes
Sequence: | 177336088 | Sequence: | 177336089 | Sequence: | 177336090 | Sequence: | 177336091 | Sequence: | 177336092 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary |
Measure | Change From Baseline in mRSS at Week 4 | Measure | Change From Baseline in mRSS at Week 8 | Measure | Change From Baseline in mRSS at Week 16 | Measure | Change From Baseline in mRSS at Week 24 | Measure | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs |
Time Frame | Baseline, Week 4 | Time Frame | Baseline, Week 8 | Time Frame | Baseline, Week 16 | Time Frame | Baseline, Week 24 | Time Frame | Baseline up to end of the study (36 weeks) |
Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A treatment-emergent adverse event (TEAE) is any AE with an onset date on or after the start of stud drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of stud drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant. |
Browse Conditions
Sequence: | 193441369 | Sequence: | 193441370 | Sequence: | 193441371 | Sequence: | 193441372 | Sequence: | 193441373 | Sequence: | 193441374 |
Mesh Term | Scleroderma, Systemic | Mesh Term | Scleroderma, Diffuse | Mesh Term | Sclerosis | Mesh Term | Pathologic Processes | Mesh Term | Connective Tissue Diseases | Mesh Term | Skin Diseases |
Downcase Mesh Term | scleroderma, systemic | Downcase Mesh Term | scleroderma, diffuse | Downcase Mesh Term | sclerosis | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | connective tissue diseases | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48308403 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Galapagos NV |
Overall Officials
Sequence: | 29279265 |
Role | Study Director |
Name | Galapagos Study Director |
Affiliation | Galapagos NV |
Design Group Interventions
Sequence: | 68134096 | Sequence: | 68134097 |
Design Group Id | 55580709 | Design Group Id | 55580710 |
Intervention Id | 52474400 | Intervention Id | 52474401 |
Eligibilities
Sequence: | 30758779 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Able and willing to comply with the protocol requirements and to sign the informed consent form (ICF) as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations. Exclusion Criteria: Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254251149 |
Number Of Facilities | 18 |
Number Of Nsae Subjects | 146 |
Number Of Sae Subjects | 5 |
Registered In Calendar Year | 2019 |
Actual Duration | 16 |
Were Results Reported | True |
Months To Report Results | 10 |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 4 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30504996 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Quadruple |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Outcomes Assessor Masked | True |
Drop Withdrawals
Sequence: | 28983575 | Sequence: | 28983576 |
Result Group Id | 56087617 | Result Group Id | 56087618 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Period | Overall Study | Period | Overall Study |
Reason | Lost to Follow-up | Reason | Lost to Follow-up |
Count | 0 | Count | 1 |
Milestones
Sequence: | 41000861 | Sequence: | 41000862 | Sequence: | 41000863 | Sequence: | 41000864 | Sequence: | 41000865 | Sequence: | 41000866 |
Result Group Id | 56087617 | Result Group Id | 56087618 | Result Group Id | 56087617 | Result Group Id | 56087618 | Result Group Id | 56087617 | Result Group Id | 56087618 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 21 | Count | 12 | Count | 21 | Count | 11 | Count | 0 | Count | 1 |
Outcome Analyses
Sequence: | 16566219 | Sequence: | 16566220 | Sequence: | 16566221 | Sequence: | 16566222 |
Outcome Id | 30800457 | Outcome Id | 30800458 | Outcome Id | 30800459 | Outcome Id | 30800460 |
Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority | Non Inferiority Type | Superiority |
Param Type | Least square (LS) mean difference | Param Type | LS mean difference | Param Type | LS mean difference | Param Type | LS mean difference |
Param Value | -0.5 | Param Value | -0.7 | Param Value | -2.1 | Param Value | -2.8 |
Dispersion Type | Standard Error of the Mean | Dispersion Type | Standard Error of the Mean | Dispersion Type | Standard Error of the Mean | Dispersion Type | Standard Error of the Mean |
Dispersion Value | 1.29 | Dispersion Value | 1.31 | Dispersion Value | 1.35 | Dispersion Value | 1.36 |
P Value Modifier | P Value Modifier | P Value Modifier | P Value Modifier | ||||
P Value | 0.6757 | P Value | 0.6079 | P Value | 0.1298 | P Value | 0.0411 |
Ci N Sides | 2-Sided | Ci N Sides | 2-Sided | Ci N Sides | 2-Sided | Ci N Sides | 2-Sided |
Ci Percent | 95.0 | Ci Percent | 95.0 | Ci Percent | 95.0 | Ci Percent | 95.0 |
Ci Lower Limit | -3.1 | Ci Lower Limit | -3.3 | Ci Lower Limit | -4.8 | Ci Lower Limit | -5.6 |
Ci Upper Limit | 2.0 | Ci Upper Limit | 1.9 | Ci Upper Limit | 0.6 | Ci Upper Limit | -0.1 |
Method | Mixed Models Analysis | Method | Mixed Models Analysis | Method | Mixed Models Analysis | Method | Mixed Models Analysis |
Estimate Description | A negative difference indicates a greater improvement in the GLPG1690 treatment group. | Estimate Description | A negative difference indicates a greater improvement in the GLPG1690 treatment group. | Estimate Description | A negative difference indicates a greater improvement in the GLPG1690 treatment group. | Estimate Description | A negative difference indicates a greater improvement in the GLPG1690 treatment group. |
Groups Description | Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric. | Groups Description | Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric. | Groups Description | Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric. | Groups Description | Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric. |
Outcome Analysis Groups
Sequence: | 32128576 | Sequence: | 32128577 | Sequence: | 32128578 | Sequence: | 32128579 | Sequence: | 32128580 | Sequence: | 32128581 | Sequence: | 32128582 | Sequence: | 32128583 |
Outcome Analysis Id | 16566219 | Outcome Analysis Id | 16566219 | Outcome Analysis Id | 16566220 | Outcome Analysis Id | 16566220 | Outcome Analysis Id | 16566221 | Outcome Analysis Id | 16566221 | Outcome Analysis Id | 16566222 | Outcome Analysis Id | 16566222 |
Result Group Id | 56087619 | Result Group Id | 56087620 | Result Group Id | 56087619 | Result Group Id | 56087620 | Result Group Id | 56087619 | Result Group Id | 56087620 | Result Group Id | 56087619 | Result Group Id | 56087620 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Participant Flows
Sequence: | 3920805 |
Recruitment Details | Participants were enrolled at study sites in Belgium, the United States, United Kingdom, Spain, and Italy. The first participant was screened on 14 Jan 2019. The last study visit occurred on 22 Jun 2020. |
Pre Assignment Details | A total of 40 participants were screened, of whom 33 participants were randomized and treated. |
Outcome Counts
Sequence: | 73990087 | Sequence: | 73990088 | Sequence: | 73990089 | Sequence: | 73990090 | Sequence: | 73990091 | Sequence: | 73990092 | Sequence: | 73990093 | Sequence: | 73990094 | Sequence: | 73990095 | Sequence: | 73990096 |
Outcome Id | 30800457 | Outcome Id | 30800457 | Outcome Id | 30800458 | Outcome Id | 30800458 | Outcome Id | 30800459 | Outcome Id | 30800459 | Outcome Id | 30800460 | Outcome Id | 30800460 | Outcome Id | 30800461 | Outcome Id | 30800461 |
Result Group Id | 56087619 | Result Group Id | 56087620 | Result Group Id | 56087619 | Result Group Id | 56087620 | Result Group Id | 56087619 | Result Group Id | 56087620 | Result Group Id | 56087619 | Result Group Id | 56087620 | Result Group Id | 56087619 | Result Group Id | 56087620 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 21 | Count | 12 | Count | 21 | Count | 12 | Count | 21 | Count | 12 | Count | 21 | Count | 12 | Count | 21 | Count | 12 |
Provided Documents
Sequence: | 2578521 | Sequence: | 2578522 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2020-04-28 | Document Date | 2020-08-05 |
Url | https://ClinicalTrials.gov/ProvidedDocs/66/NCT03798366/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/66/NCT03798366/SAP_001.pdf |
Reported Event Totals
Sequence: | 27939424 | Sequence: | 27939425 | Sequence: | 27939426 | Sequence: | 27939427 | Sequence: | 27939428 | Sequence: | 27939429 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 2 | Subjects Affected | 20 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 11 | Subjects Affected | 0 |
Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 12 |
Created At | 2023-08-08 23:06:40.239151 | Created At | 2023-08-08 23:06:40.239151 | Created At | 2023-08-08 23:06:40.239151 | Created At | 2023-08-08 23:06:40.239151 | Created At | 2023-08-08 23:06:40.239151 | Created At | 2023-08-08 23:06:40.239151 |
Updated At | 2023-08-08 23:06:40.239151 | Updated At | 2023-08-08 23:06:40.239151 | Updated At | 2023-08-08 23:06:40.239151 | Updated At | 2023-08-08 23:06:40.239151 | Updated At | 2023-08-08 23:06:40.239151 | Updated At | 2023-08-08 23:06:40.239151 |
Reported Events
Sequence: | 528148955 | Sequence: | 528148956 | Sequence: | 528148957 | Sequence: | 528148958 | Sequence: | 528148959 | Sequence: | 528148960 | Sequence: | 528148961 | Sequence: | 528148962 | Sequence: | 528148963 | Sequence: | 528148964 | Sequence: | 528148965 | Sequence: | 528148966 | Sequence: | 528148967 | Sequence: | 528148968 | Sequence: | 528148969 | Sequence: | 528148970 | Sequence: | 528148971 | Sequence: | 528148972 | Sequence: | 528148973 | Sequence: | 528148974 | Sequence: | 528148975 | Sequence: | 528148976 | Sequence: | 528148977 | Sequence: | 528148978 | Sequence: | 528148979 | Sequence: | 528148980 | Sequence: | 528148981 | Sequence: | 528148933 | Sequence: | 528148934 | Sequence: | 528148935 | Sequence: | 528148936 | Sequence: | 528148937 | Sequence: | 528148938 | Sequence: | 528148939 | Sequence: | 528148940 | Sequence: | 528148941 | Sequence: | 528148942 | Sequence: | 528148943 | Sequence: | 528148944 | Sequence: | 528148945 | Sequence: | 528148946 | Sequence: | 528148947 | Sequence: | 528148948 | Sequence: | 528148949 | Sequence: | 528148950 | Sequence: | 528148951 | Sequence: | 528148952 | Sequence: | 528148953 | Sequence: | 528148954 | Sequence: | 528148982 | Sequence: | 528148983 | Sequence: | 528148984 | Sequence: | 528148985 | Sequence: | 528148986 | Sequence: | 528148987 | Sequence: | 528148988 | Sequence: | 528148989 | Sequence: | 528148990 | Sequence: | 528148991 | Sequence: | 528148992 | Sequence: | 528148993 | Sequence: | 528148994 | Sequence: | 528148995 | Sequence: | 528148996 | Sequence: | 528148997 | Sequence: | 528148998 | Sequence: | 528148999 | Sequence: | 528149000 | Sequence: | 528149001 | Sequence: | 528149002 | Sequence: | 528149003 | Sequence: | 528149004 | Sequence: | 528149005 | Sequence: | 528149006 | Sequence: | 528149007 | Sequence: | 528149008 | Sequence: | 528149009 | Sequence: | 528149010 | Sequence: | 528149011 | Sequence: | 528149012 | Sequence: | 528149013 | Sequence: | 528149014 | Sequence: | 528149015 | Sequence: | 528149016 | Sequence: | 528149017 | Sequence: | 528149018 | Sequence: | 528149019 | Sequence: | 528149020 | Sequence: | 528149021 | Sequence: | 528149022 | Sequence: | 528149023 | Sequence: | 528149024 | Sequence: | 528149025 | Sequence: | 528149026 | Sequence: | 528149027 | Sequence: | 528149028 | Sequence: | 528149029 | Sequence: | 528149030 | Sequence: | 528149031 | Sequence: | 528149032 | Sequence: | 528149033 | Sequence: | 528149034 | Sequence: | 528149035 | Sequence: | 528149036 | Sequence: | 528149037 | Sequence: | 528149038 | Sequence: | 528149039 | Sequence: | 528149040 | Sequence: | 528149041 | Sequence: | 528149042 | Sequence: | 528149043 | Sequence: | 528149044 | Sequence: | 528149045 | Sequence: | 528149046 | Sequence: | 528149047 | Sequence: | 528149048 | Sequence: | 528149049 | Sequence: | 528149050 | Sequence: | 528149051 | Sequence: | 528149052 | Sequence: | 528149053 | Sequence: | 528149054 | Sequence: | 528149055 | Sequence: | 528149056 | Sequence: | 528149057 | Sequence: | 528149058 | Sequence: | 528149059 | Sequence: | 528149060 | Sequence: | 528149061 | Sequence: | 528149062 | Sequence: | 528149063 | Sequence: | 528149064 | Sequence: | 528149065 | Sequence: | 528149066 | Sequence: | 528149067 | Sequence: | 528149068 | Sequence: | 528149069 | Sequence: | 528149070 | Sequence: | 528149071 | Sequence: | 528149072 | Sequence: | 528149073 | Sequence: | 528149074 | Sequence: | 528149075 | Sequence: | 528149076 | Sequence: | 528149077 | Sequence: | 528149078 | Sequence: | 528149079 | Sequence: | 528149080 | Sequence: | 528149081 | Sequence: | 528149082 | Sequence: | 528149083 | Sequence: | 528149084 | Sequence: | 528149085 | Sequence: | 528149086 | Sequence: | 528149087 | Sequence: | 528149088 | Sequence: | 528149089 | Sequence: | 528149090 | Sequence: | 528149091 | Sequence: | 528149092 | Sequence: | 528149093 | Sequence: | 528149094 | Sequence: | 528149095 | Sequence: | 528149096 | Sequence: | 528149097 | Sequence: | 528149098 | Sequence: | 528149099 | Sequence: | 528149100 | Sequence: | 528149101 | Sequence: | 528149102 | Sequence: | 528149103 | Sequence: | 528149104 | Sequence: | 528149105 | Sequence: | 528149106 | Sequence: | 528149107 | Sequence: | 528149108 | Sequence: | 528149109 | Sequence: | 528149110 | Sequence: | 528149111 | Sequence: | 528149112 | Sequence: | 528149113 | Sequence: | 528149114 | Sequence: | 528149115 | Sequence: | 528149116 | Sequence: | 528149117 | Sequence: | 528149118 | Sequence: | 528149119 | Sequence: | 528149120 | Sequence: | 528149121 | Sequence: | 528149122 | Sequence: | 528149123 | Sequence: | 528149124 | Sequence: | 528149125 | Sequence: | 528149126 | Sequence: | 528149127 | Sequence: | 528149128 | Sequence: | 528149129 | Sequence: | 528149130 | Sequence: | 528149131 | Sequence: | 528149132 |
Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 | Result Group Id | 56087621 | Result Group Id | 56087622 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) | Time Frame | Baseline up to end of the study (36 weeks) |
Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | serious | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other | Event Type | other |
Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 7 | Subjects Affected | 2 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 2 | Subjects Affected | 2 | Subjects Affected | 2 | Subjects Affected | 1 | Subjects Affected | 3 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 5 | Subjects Affected | 2 | Subjects Affected | 3 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 4 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 3 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 3 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 2 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 2 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 |
Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 | Subjects At Risk | 21 | Subjects At Risk | 12 |
Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. | Description | Participants in the safety analysis set were analyzed. |
Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Infections and infestations | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Gastrointestinal disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Nervous system disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Skin and subcutaneous tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Musculoskeletal and connective tissue disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Respiratory, thoracic and mediastinal disorders | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | Injury, poisoning and procedural complications | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | General disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Metabolism and nutrition disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Cardiac disorders | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Investigations | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Psychiatric disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Renal and urinary disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Vascular disorders | Organ System | Blood and lymphatic system disorders | Organ System | Blood and lymphatic system disorders | Organ System | Ear and labyrinth disorders | Organ System | Ear and labyrinth disorders | Organ System | Eye disorders | Organ System | Eye disorders |
Adverse Event Term | Conjunctivitis | Adverse Event Term | Conjunctivitis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis | Adverse Event Term | Gastroenteritis viral | Adverse Event Term | Gastroenteritis viral | Adverse Event Term | Herpes zoster | Adverse Event Term | Herpes zoster | Adverse Event Term | Hordeolum | Adverse Event Term | Hordeolum | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Nasopharyngitis | Adverse Event Term | Oral herpes | Adverse Event Term | Oral herpes | Adverse Event Term | Otitis media | Adverse Event Term | Otitis media | Adverse Event Term | Sinusitis | Adverse Event Term | Sinusitis | Adverse Event Term | Suspected COVID-19 | Adverse Event Term | Suspected COVID-19 | Adverse Event Term | Diarrhoea | Adverse Event Term | Diarrhoea | Adverse Event Term | Abdominal distension | Adverse Event Term | Abdominal distension | Adverse Event Term | Dyspepsia | Adverse Event Term | Dyspepsia | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Sepsis | Adverse Event Term | Sepsis | Adverse Event Term | Device related infection | Adverse Event Term | Device related infection | Adverse Event Term | Pharyngitis | Adverse Event Term | Pharyngitis | Adverse Event Term | Foreign body in gastrointestinal tract | Adverse Event Term | Foreign body in gastrointestinal tract | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Upper respiratory tract infection | Adverse Event Term | Rhinitis | Adverse Event Term | Rhinitis | Adverse Event Term | Urinary tract infection | Adverse Event Term | Urinary tract infection | Adverse Event Term | Cellulitis | Adverse Event Term | Cellulitis | Adverse Event Term | Influenza | Adverse Event Term | Influenza | Adverse Event Term | Pharyngitis | Adverse Event Term | Pharyngitis | Adverse Event Term | Bronchitis | Adverse Event Term | Bronchitis | Adverse Event Term | Gastrooesophageal reflux disease | Adverse Event Term | Oesophagitis | Adverse Event Term | Oesophagitis | Adverse Event Term | Abdominal pain | Adverse Event Term | Abdominal pain | Adverse Event Term | Aphthous ulcer | Adverse Event Term | Aphthous ulcer | Adverse Event Term | Constipation | Adverse Event Term | Constipation | Adverse Event Term | Eructation | Adverse Event Term | Eructation | Adverse Event Term | Gastric antral vascular ectasia | Adverse Event Term | Gastric antral vascular ectasia | Adverse Event Term | Gastrointestinal inflammation | Adverse Event Term | Gastrointestinal inflammation | Adverse Event Term | Gingival recession | Adverse Event Term | Gingival recession | Adverse Event Term | Nausea | Adverse Event Term | Nausea | Adverse Event Term | Headache | Adverse Event Term | Headache | Adverse Event Term | Dizziness | Adverse Event Term | Dizziness | Adverse Event Term | Dyskinesia | Adverse Event Term | Dyskinesia | Adverse Event Term | Memory impairment | Adverse Event Term | Memory impairment | Adverse Event Term | Migraine | Adverse Event Term | Migraine | Adverse Event Term | Skin lesion | Adverse Event Term | Skin lesion | Adverse Event Term | Digital pitting scar | Adverse Event Term | Digital pitting scar | Adverse Event Term | Hyperhidrosis | Adverse Event Term | Hyperhidrosis | Adverse Event Term | Skin ulcer | Adverse Event Term | Skin ulcer | Adverse Event Term | Acne | Adverse Event Term | Acne | Adverse Event Term | Hair growth abnormal | Adverse Event Term | Hair growth abnormal | Adverse Event Term | Hypertrichosis | Adverse Event Term | Hypertrichosis | Adverse Event Term | Night sweats | Adverse Event Term | Night sweats | Adverse Event Term | Rash | Adverse Event Term | Rash | Adverse Event Term | Rash erythematous | Adverse Event Term | Rash erythematous | Adverse Event Term | Rash macular | Adverse Event Term | Rash macular | Adverse Event Term | Arthralgia | Adverse Event Term | Arthralgia | Adverse Event Term | Back pain | Adverse Event Term | Back pain | Adverse Event Term | Bone disorder | Adverse Event Term | Bone disorder | Adverse Event Term | Fibromyalgia | Adverse Event Term | Fibromyalgia | Adverse Event Term | Muscular weakness | Adverse Event Term | Muscular weakness | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Musculoskeletal pain | Adverse Event Term | Myalgia | Adverse Event Term | Myalgia | Adverse Event Term | Osteolysis | Adverse Event Term | Osteolysis | Adverse Event Term | Pain in extremity | Adverse Event Term | Pain in extremity | Adverse Event Term | Scleroderma | Adverse Event Term | Scleroderma | Adverse Event Term | Synovitis | Adverse Event Term | Synovitis | Adverse Event Term | Tendonitis | Adverse Event Term | Tendonitis | Adverse Event Term | Tenosynovitis stenosans | Adverse Event Term | Tenosynovitis stenosans | Adverse Event Term | Cough | Adverse Event Term | Cough | Adverse Event Term | Rhinorrhoea | Adverse Event Term | Rhinorrhoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Dyspnoea | Adverse Event Term | Interstitial lung disease | Adverse Event Term | Interstitial lung disease | Adverse Event Term | Nasal congestion | Adverse Event Term | Nasal congestion | Adverse Event Term | Oropharyngeal pain | Adverse Event Term | Oropharyngeal pain | Adverse Event Term | Sinus congestion | Adverse Event Term | Sinus congestion | Adverse Event Term | Ligament sprain | Adverse Event Term | Ligament sprain | Adverse Event Term | Limb injury | Adverse Event Term | Limb injury | Adverse Event Term | Procedural pain | Adverse Event Term | Procedural pain | Adverse Event Term | Skin abrasion | Adverse Event Term | Skin abrasion | Adverse Event Term | Tendon injury | Adverse Event Term | Tendon injury | Adverse Event Term | Vascular injury | Adverse Event Term | Vascular injury | Adverse Event Term | Peripheral swelling | Adverse Event Term | Peripheral swelling | Adverse Event Term | Discomfort | Adverse Event Term | Discomfort | Adverse Event Term | Malaise | Adverse Event Term | Malaise | Adverse Event Term | Pyrexia | Adverse Event Term | Pyrexia | Adverse Event Term | Decreased appetite | Adverse Event Term | Decreased appetite | Adverse Event Term | Dyslipidaemia | Adverse Event Term | Dyslipidaemia | Adverse Event Term | Iron deficiency | Adverse Event Term | Iron deficiency | Adverse Event Term | Lactose intolerance | Adverse Event Term | Lactose intolerance | Adverse Event Term | Vitamin D deficiency | Adverse Event Term | Vitamin D deficiency | Adverse Event Term | Palpitations | Adverse Event Term | Palpitations | Adverse Event Term | Bundle branch block left | Adverse Event Term | Bundle branch block left | Adverse Event Term | Alanine aminotransferase increased | Adverse Event Term | Alanine aminotransferase increased | Adverse Event Term | Weight increased | Adverse Event Term | Weight increased | Adverse Event Term | Aspartate aminotransferase increased | Adverse Event Term | Aspartate aminotransferase increased | Adverse Event Term | Blood lactate dehydrogenase increased | Adverse Event Term | Blood lactate dehydrogenase increased | Adverse Event Term | Insomnia | Adverse Event Term | Insomnia | Adverse Event Term | Anger | Adverse Event Term | Anger | Adverse Event Term | Pollakiuria | Adverse Event Term | Pollakiuria | Adverse Event Term | Urinary incontinence | Adverse Event Term | Urinary incontinence | Adverse Event Term | Hot flush | Adverse Event Term | Hot flush | Adverse Event Term | Raynaud's phenomenon | Adverse Event Term | Raynaud's phenomenon | Adverse Event Term | Anaemia | Adverse Event Term | Anaemia | Adverse Event Term | Vertigo | Adverse Event Term | Vertigo | Adverse Event Term | Vision blurred | Adverse Event Term | Vision blurred |
Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 | Frequency Threshold | 0 |
Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 | Vocab | MedDRA 23.0 |
Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment |
Responsible Parties
Sequence: | 28871276 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3851549 |
Pi Employee | No |
Restriction Type | OTHER |
Other Details | The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately. |
Restrictive Agreement | The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately. |
Result Contacts
Sequence: | 3851514 |
Organization | Galapagos NV |
Name | Galapagos Medical Information |
Phone | +32 15 342 900 |
medicalinfo@glpg.com | |
Outcomes
Sequence: | 30800457 | Sequence: | 30800458 | Sequence: | 30800459 | Sequence: | 30800460 | Sequence: | 30800461 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary |
Title | Change From Baseline in mRSS at Week 4 | Title | Change From Baseline in mRSS at Week 8 | Title | Change From Baseline in mRSS at Week 16 | Title | Change From Baseline in mRSS at Week 24 | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs |
Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A treatment-emergent adverse event (TEAE) is any AE with an onset date on or after the start of stud drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of stud drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant. |
Time Frame | Baseline, Week 4 | Time Frame | Baseline, Week 8 | Time Frame | Baseline, Week 16 | Time Frame | Baseline, Week 24 | Time Frame | Baseline up to end of the study (36 weeks) |
Population | Participants in the FAS were analyzed. | Population | Participants in the FAS were analyzed. | Population | Participants in the FAS were analyzed. | Population | Participants in the FAS were analyzed. | Population | Safety analysis set consisted of all randomized participants who received at least 1 dose of investigational product. |
Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | Participants |
Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | ||
Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Count of Participants |
Outcome Measurements
Sequence: | 235627210 | Sequence: | 235627211 | Sequence: | 235627212 | Sequence: | 235627213 | Sequence: | 235627214 | Sequence: | 235627215 | Sequence: | 235627216 | Sequence: | 235627217 | Sequence: | 235627218 | Sequence: | 235627219 | Sequence: | 235627220 | Sequence: | 235627221 |
Outcome Id | 30800457 | Outcome Id | 30800457 | Outcome Id | 30800458 | Outcome Id | 30800458 | Outcome Id | 30800459 | Outcome Id | 30800459 | Outcome Id | 30800460 | Outcome Id | 30800460 | Outcome Id | 30800461 | Outcome Id | 30800461 | Outcome Id | 30800461 | Outcome Id | 30800461 |
Result Group Id | 56087619 | Result Group Id | 56087620 | Result Group Id | 56087619 | Result Group Id | 56087620 | Result Group Id | 56087619 | Result Group Id | 56087620 | Result Group Id | 56087619 | Result Group Id | 56087620 | Result Group Id | 56087619 | Result Group Id | 56087620 | Result Group Id | 56087619 | Result Group Id | 56087620 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Classification | TEAEs | Classification | TEAEs | Classification | Serious TEAEs | Classification | Serious TEAEs | ||||||||||||||||
Title | Change From Baseline in mRSS at Week 4 | Title | Change From Baseline in mRSS at Week 4 | Title | Change From Baseline in mRSS at Week 8 | Title | Change From Baseline in mRSS at Week 8 | Title | Change From Baseline in mRSS at Week 16 | Title | Change From Baseline in mRSS at Week 16 | Title | Change From Baseline in mRSS at Week 24 | Title | Change From Baseline in mRSS at Week 24 | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs |
Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A treatment-emergent adverse event (TEAE) is any AE with an onset date on or after the start of stud drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of stud drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant. | Description | An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A treatment-emergent adverse event (TEAE) is any AE with an onset date on or after the start of stud drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of stud drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant. | Description | An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A treatment-emergent adverse event (TEAE) is any AE with an onset date on or after the start of stud drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of stud drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant. | Description | An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A treatment-emergent adverse event (TEAE) is any AE with an onset date on or after the start of stud drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of stud drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant. |
Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | units on a scale | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Least Squares Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | -2.2 | Param Value | -1.6 | Param Value | -3.2 | Param Value | -2.5 | Param Value | -6.8 | Param Value | -4.8 | Param Value | -8.9 | Param Value | -6.0 | Param Value | 20 | Param Value | 11 | Param Value | 2 | Param Value | 1 |
Param Value Num | -2.2 | Param Value Num | -1.6 | Param Value Num | -3.2 | Param Value Num | -2.5 | Param Value Num | -6.8 | Param Value Num | -4.8 | Param Value Num | -8.9 | Param Value Num | -6.0 | Param Value Num | 20.0 | Param Value Num | 11.0 | Param Value Num | 2.0 | Param Value Num | 1.0 |
Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | Dispersion Type | Standard Error | ||||||||
Dispersion Value | 0.85 | Dispersion Value | 1.04 | Dispersion Value | 0.85 | Dispersion Value | 1.07 | Dispersion Value | 0.85 | Dispersion Value | 1.12 | Dispersion Value | 0.87 | Dispersion Value | 1.11 | ||||||||
Dispersion Value Num | 0.85 | Dispersion Value Num | 1.04 | Dispersion Value Num | 0.85 | Dispersion Value Num | 1.07 | Dispersion Value Num | 0.85 | Dispersion Value Num | 1.12 | Dispersion Value Num | 0.87 | Dispersion Value Num | 1.11 | ||||||||
Baseline Counts
Sequence: | 11381948 | Sequence: | 11381949 | Sequence: | 11381950 |
Result Group Id | 56087614 | Result Group Id | 56087615 | Result Group Id | 56087616 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 21 | Count | 12 | Count | 33 |
Result Groups
Sequence: | 56087614 | Sequence: | 56087615 | Sequence: | 56087616 | Sequence: | 56087617 | Sequence: | 56087618 | Sequence: | 56087619 | Sequence: | 56087620 | Sequence: | 56087621 | Sequence: | 56087622 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | GLPG1690 600 mg | Title | Placebo | Title | Total | Title | GLPG1690 600 mg | Title | Placebo | Title | GLPG1690 600 mg | Title | Placebo | Title | GLPG1690 600 mg | Title | Placebo |
Description | Participants received GLPG1690 600 mg, orally once daily for 24 weeks. | Description | Participants received GLPG1690 matching placebo, orally once daily for 24 weeks. | Description | Total of all reporting groups | Description | Participants received GLPG1690 600 milligrams (mg), orally once daily for 24 weeks. | Description | Participants received GLPG1690 matching placebo, orally once daily for 24 weeks. | Description | Participants received GLPG1690 600 mg, orally once daily for 24 weeks. | Description | Participants received GLPG1690 matching placebo, orally once daily for 24 weeks. | Description | Participants received GLPG1690 600 mg, orally once daily for 24 weeks. | Description | Participants received GLPG1690 matching placebo, orally once daily for 24 weeks. |
Baseline Measurements
Sequence: | 125567185 | Sequence: | 125567186 | Sequence: | 125567187 | Sequence: | 125567188 | Sequence: | 125567189 | Sequence: | 125567190 | Sequence: | 125567191 | Sequence: | 125567192 | Sequence: | 125567193 | Sequence: | 125567194 | Sequence: | 125567195 | Sequence: | 125567196 | Sequence: | 125567197 | Sequence: | 125567198 | Sequence: | 125567199 | Sequence: | 125567200 | Sequence: | 125567201 | Sequence: | 125567202 | Sequence: | 125567203 | Sequence: | 125567204 | Sequence: | 125567205 | Sequence: | 125567206 | Sequence: | 125567207 | Sequence: | 125567208 | Sequence: | 125567209 | Sequence: | 125567210 | Sequence: | 125567211 | Sequence: | 125567212 | Sequence: | 125567213 | Sequence: | 125567214 | Sequence: | 125567215 | Sequence: | 125567216 | Sequence: | 125567217 | Sequence: | 125567218 | Sequence: | 125567219 | Sequence: | 125567220 | Sequence: | 125567221 | Sequence: | 125567222 | Sequence: | 125567223 | Sequence: | 125567224 | Sequence: | 125567225 | Sequence: | 125567226 |
Result Group Id | 56087614 | Result Group Id | 56087615 | Result Group Id | 56087616 | Result Group Id | 56087614 | Result Group Id | 56087615 | Result Group Id | 56087616 | Result Group Id | 56087614 | Result Group Id | 56087615 | Result Group Id | 56087616 | Result Group Id | 56087614 | Result Group Id | 56087615 | Result Group Id | 56087616 | Result Group Id | 56087614 | Result Group Id | 56087615 | Result Group Id | 56087616 | Result Group Id | 56087614 | Result Group Id | 56087615 | Result Group Id | 56087616 | Result Group Id | 56087614 | Result Group Id | 56087615 | Result Group Id | 56087616 | Result Group Id | 56087614 | Result Group Id | 56087615 | Result Group Id | 56087616 | Result Group Id | 56087614 | Result Group Id | 56087615 | Result Group Id | 56087616 | Result Group Id | 56087614 | Result Group Id | 56087615 | Result Group Id | 56087616 | Result Group Id | 56087614 | Result Group Id | 56087615 | Result Group Id | 56087616 | Result Group Id | 56087614 | Result Group Id | 56087615 | Result Group Id | 56087616 | Result Group Id | 56087614 | Result Group Id | 56087615 | Result Group Id | 56087616 | Result Group Id | 56087614 | Result Group Id | 56087615 | Result Group Id | 56087616 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Not Hispanic or Latino | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | American Indian or Alaska Native | Category | Asian | Category | Asian | Category | Asian | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Native Hawaiian or Other Pacific Islander | Category | Black or African American | Category | Black or African American | Category | Black or African American | Category | White | Category | White | Category | White | Category | More than one race | Category | More than one race | Category | More than one race | Category | Unknown or Not Reported | Category | Unknown or Not Reported | Category | Unknown or Not Reported | ||||||||||||
Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Ethnicity (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Race (NIH/OMB) | Title | Modified Rodnan Skin Score (mRSS) | Title | Modified Rodnan Skin Score (mRSS) | Title | Modified Rodnan Skin Score (mRSS) |
Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | Description | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Units | years | Units | years | Units | years | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | units on a scale | Units | units on a scale | Units | units on a scale |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 50.4 | Param Value | 47.3 | Param Value | 49.3 | Param Value | 15 | Param Value | 8 | Param Value | 23 | Param Value | 6 | Param Value | 4 | Param Value | 10 | Param Value | 1 | Param Value | 1 | Param Value | 2 | Param Value | 20 | Param Value | 10 | Param Value | 30 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 21 | Param Value | 11 | Param Value | 32 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 27.0 | Param Value | 22.5 | Param Value | 25.3 |
Param Value Num | 50.4 | Param Value Num | 47.3 | Param Value Num | 49.3 | Param Value Num | 15.0 | Param Value Num | 8.0 | Param Value Num | 23.0 | Param Value Num | 6.0 | Param Value Num | 4.0 | Param Value Num | 10.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 2.0 | Param Value Num | 20.0 | Param Value Num | 10.0 | Param Value Num | 30.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 21.0 | Param Value Num | 11.0 | Param Value Num | 32.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 27.0 | Param Value Num | 22.5 | Param Value Num | 25.3 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 13.58 | Dispersion Value | 17.99 | Dispersion Value | 15.13 | Dispersion Value | 8.84 | Dispersion Value | 6.24 | Dispersion Value | 8.18 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 13.58 | Dispersion Value Num | 17.99 | Dispersion Value Num | 15.13 | Dispersion Value Num | 8.84 | Dispersion Value Num | 6.24 | Dispersion Value Num | 8.18 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 21 | Number Analyzed | 12 | Number Analyzed | 33 | Number Analyzed | 21 | Number Analyzed | 12 | Number Analyzed | 33 | Number Analyzed | 21 | Number Analyzed | 12 | Number Analyzed | 33 | Number Analyzed | 21 | Number Analyzed | 12 | Number Analyzed | 33 | Number Analyzed | 21 | Number Analyzed | 12 | Number Analyzed | 33 | Number Analyzed | 21 | Number Analyzed | 12 | Number Analyzed | 33 | Number Analyzed | 21 | Number Analyzed | 12 | Number Analyzed | 33 | Number Analyzed | 21 | Number Analyzed | 12 | Number Analyzed | 33 | Number Analyzed | 21 | Number Analyzed | 12 | Number Analyzed | 33 | Number Analyzed | 21 | Number Analyzed | 12 | Number Analyzed | 33 | Number Analyzed | 21 | Number Analyzed | 12 | Number Analyzed | 33 | Number Analyzed | 21 | Number Analyzed | 12 | Number Analyzed | 33 | Number Analyzed | 21 | Number Analyzed | 12 | Number Analyzed | 33 | Number Analyzed | 21 | Number Analyzed | 12 | Number Analyzed | 33 |
]]>
https://zephyrnet.com/NCT03798353
2019-05-13
https://zephyrnet.com/?p=NCT03798353
NCT03798353https://www.clinicaltrials.gov/study/NCT03798353?tab=tableNANANAMyocardial infarction causes necrosis of myocardial cells and reduces cardiac function. Today, there are treatments such as primary angioplasty and thrombolysis that are effective in limiting cell death after acute myocardial infarction. However, the post-infarct scar often conditions a global ventricular remodeling that can evolve clinically towards heart failure and in more advanced stages the only therapy that completely restores cardiac function is heart transplantation.
Mesenchymal stem cells are multipotent cells found from embryonic mesoderm and found in all tissues. In the field of cardiac regeneration, studies have shown a certain degree of benefit when treated with MSCs from different origins. Our approach is based on a decellularized matrix that carries the cells directly over myocardial infarction.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-21 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-12-02 |
Start Month Year | May 13, 2019 |
Primary Completion Month Year | September 27, 2022 |
Verification Month Year | December 2022 |
Verification Date | 2022-12-31 |
Last Update Posted Date | 2022-12-02 |
Detailed Descriptions
Sequence: | 20809621 |
Description | Myocardial infarction causes necrosis of myocardial cells and reduces cardiac function. Today there are treatments such as primary angioplasty and thrombolysis that are effective in limiting cell death after acute myocardial infarction. However, the post-infarct scar often conditions a global ventricular remodeling that can evolve clinically towards heart failure and, in more advanced stages, the only therapy that completely restores cardiac function is heart transplantation.
Experimental studies are evaluating new therapeutic approaches based on tissue engineering for myocardial regeneration. Cardiac tissue engineering attempts to create functional tissue constructs that can restore the structure and function of damaged myocardium. Mesenchymal stem cells (MSCs) are multipotent cells that develop from embryonic mesoderm and are found in all structural tissues of the body. In the field of cardiac regeneration, studies have shown a certain degree of benefit when treated with MSCs from different origins. The investigators approach is based on a decellularized matrix that carries the cells directly over myocardial infarction. Among the different types of MSC currently available, the investigators propose the use of those derived from the connective tissue surrounding the great vessels (2 arteries and one vein) of the umbilical cord called Wharton's gelatin (MSC, WJ) whose immunomodulatory properties are described extensively in the literature. These MSC, WJ cells have a PEI approved by the Spanish Agency for Medicines and Healthcare Products (AEMPS) (PEI 16-017) that guarantees an optimal manufacturing process for a clinical trial. |
Facilities
Sequence: | 200855707 |
Name | Hospital Universitari Germans Trias i Pujol |
City | Badalona |
State | Barcelona |
Zip | 08916 |
Country | Spain |
Conditions
Sequence: | 52395730 |
Name | Myocardial Infarction |
Downcase Name | myocardial infarction |
Id Information
Sequence: | 40318197 | Sequence: | 40318198 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | ICOR-2016-02 | Id Value | 2018-001964-49 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42741522 |
Name | Spain |
Removed | False |
Design Groups
Sequence: | 55842445 | Sequence: | 55842446 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Experimental group | Title | Control group |
Description | The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization.
In addition, the matrix-cell (PeriCord) construct will be placed on the ischemic area of the non-candidate revascularization area and will be fixed using surgical glue. PeriCord: Expanded and cryopreserved allogeneic umbilical cord Wharton´s jelly-derived adult mesenchymal stem cells colonized on human pericardial matrix . |
Description | The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization. No additional procedure will be performed. |
Interventions
Sequence: | 52705255 | Sequence: | 52705256 |
Intervention Type | Combination Product | Intervention Type | Procedure |
Name | PeriCord: Expanded and cryopreserved allogeneic umbilical cord Wharton´s jelly-derived adult mesenchymal stem cells colonized on human pericardial matrix. | Name | Surgery by sternotomy |
Description | A matrix-cell construct (PeriCord) will be placed on the ischemic area of the non-candidate revascularization area during a surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization. | Description | The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization. No additional procedure will be performed only the by-pass. |
Keywords
Sequence: | 80173548 | Sequence: | 80173549 | Sequence: | 80173550 | Sequence: | 80173551 | Sequence: | 80173552 | Sequence: | 80173553 |
Name | Cardiac repair | Name | Wharton jelly mesenchymal stem cells | Name | Chronic myocardial infarction | Name | Tissue engineering | Name | Cell therapy | Name | Clinical trial |
Downcase Name | cardiac repair | Downcase Name | wharton jelly mesenchymal stem cells | Downcase Name | chronic myocardial infarction | Downcase Name | tissue engineering | Downcase Name | cell therapy | Downcase Name | clinical trial |
Design Outcomes
Sequence: | 178209045 | Sequence: | 178209046 | Sequence: | 178209047 | Sequence: | 178209048 | Sequence: | 178209049 | Sequence: | 178209050 | Sequence: | 178209051 | Sequence: | 178209052 | Sequence: | 178209053 | Sequence: | 178209054 | Sequence: | 178209055 | Sequence: | 178209056 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other |
Measure | Rate of death or rehospitalization due to any cause and / or adverse reactions related to the procedure / product under investigation. | Measure | Rate of death or rehospitalization due to any cause and / or adverse reactions related to the procedure / product under investigation. | Measure | Death rate or rehospitalization due to cardiovascular causes | Measure | Rate of relevant arrhythmias in Holter of 24 hours | Measure | Relevant changes in N-terminal B-type natriuretic peptide (NT-proBNP) and High sensitivity troponin I (hsTnI) levels | Measure | Changes in the necrotic myocardial mass ratio | Measure | Changes of regional contractility | Measure | Changes in ejection fraction of the left ventricle | Measure | changes in left and right ventricular geometric remodeling | Measure | Changes in the score on the quality of life test Short Form 36 Healthy Survey (SF-36). | Measure | Changes in the score on the quality of life Kansas City Cardiomyopathy Questionnaire (KCCQ) test in cases of participants with heart failure will be used. | Measure | monocyte populations and cytokines and chemokines levels |
Time Frame | at 12 months of follow-up | Time Frame | At 1 week, 3 and 6 months | Time Frame | At 1 week, 3 , 6and 12 months | Time Frame | At 1 week, 3 and 12 months | Time Frame | At 1 week, 3 and 12 months | Time Frame | At 3 and 12 months | Time Frame | At 3 and 12 months | Time Frame | At 3 and 12 months | Time Frame | At 3 and 12 months | Time Frame | At 3 and 12 months | Time Frame | At 3 and 12 months | Time Frame | At screening, day 3 and day 5 |
Description | Safety measured with a combined endpoint of serious clinical events (death or rehospitalization due to any cause) and serious adverse reactions related to the investigational treatment. | Description | Safety measured with a combined endpoint of serious clinical events (death or rehospitalization due to any cause) and serious adverse reactions related to the investigational treatment | Description | Death rate or rehospitalization due to cardiovascular causes at week, 3, 6 and 12 months. | Description | Rate of relevant arrhythmias in Holter of 24 hours a week, 3 and 12 months. | Description | Relevant changes in NT-proBNP and hsTnI levels at week, 3 and 12 months. | Description | Changes in the necrotic myocardial mass ratio due to gadolinium retention at 3 and 12 months. | Description | change of regional contractility by nuclear magnetic resonance (NMR) at 3 and 12 months. | Description | Changes in ejection fraction of the left at 3 and 12 months | Description | changes in left and right ventricular geometric remodeling at 3 and 12 months | Description | Changes in the score on the quality of life test SF-36 will be used at 3 and 12 months. The mínimum value is 0 and the máximum value is 100. Higher scores mean a better outcome. | Description | Changes in the score on the quality of life test KCCQ in cases of participants with heart failure will be used at 3 and 12 months. The test is composed of 23 items. The options for the answers are Likert scales of 1 to 5, 6 or 7 points and the score of each of its dimensions has a theoretical range from 0 to 100, 100 being the best outcome. | Description | changes in the monocyte populations and cytokines and chemokines levels between the two groups in order to analyze if the PeriCord could improve these variables |
Browse Conditions
Sequence: | 194339368 | Sequence: | 194339369 | Sequence: | 194339370 | Sequence: | 194339371 | Sequence: | 194339372 | Sequence: | 194339373 | Sequence: | 194339374 | Sequence: | 194339375 | Sequence: | 194339376 |
Mesh Term | Myocardial Infarction | Mesh Term | Infarction | Mesh Term | Ischemia | Mesh Term | Pathologic Processes | Mesh Term | Necrosis | Mesh Term | Myocardial Ischemia | Mesh Term | Heart Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Vascular Diseases |
Downcase Mesh Term | myocardial infarction | Downcase Mesh Term | infarction | Downcase Mesh Term | ischemia | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | necrosis | Downcase Mesh Term | myocardial ischemia | Downcase Mesh Term | heart diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | vascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48528073 | Sequence: | 48528074 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Fundació Institut Germans Trias i Pujol | Name | Germans Trias i Pujol Hospital |
Overall Officials
Sequence: | 29402712 |
Role | Principal Investigator |
Name | Antoni Bayes-Genís, MD, PhD,FESC |
Affiliation | Institut del Cor, HUGTiP, IGTP |
Design Group Interventions
Sequence: | 68454189 | Sequence: | 68454190 |
Design Group Id | 55842445 | Design Group Id | 55842446 |
Intervention Id | 52705255 | Intervention Id | 52705256 |
Eligibilities
Sequence: | 30894786 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 99 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Myocardial infarction of ≥50% of transmurally due to MR Exclusion Criteria: Severe valvular disease with indication of surgical repair |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254139394 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 41 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 99 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 10 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30640526 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Masking Description | The randomization will be known exclusively by the cardiac surgery team and the study coordinator, and it will be blind to the patient and to the rest of the investigators team: clinical cardiologist who performs the follow-up, team that performs image tests, core lab that evaluates the imaging tests and the equipment that statistically analyzes the data. |
Intervention Model Description | – Experimental group: The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization.
In addition, the matrix-cell construct will be placed on the ischemic area of the non-candidate revascularization area and will be fixed using surgical glue. – Control group: The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization. No additional procedure will be performed. |
Subject Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 29007130 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798340
2016-03-24
https://zephyrnet.com/?p=NCT03798340
NCT03798340https://www.clinicaltrials.gov/study/NCT03798340?tab=tableNANANAThe investigator assumed that perturbed-event-induced vibrotactile cueing enable more precision arm movement adjustment, sensory function and dexterity improvement in the spastic arm. Thus the specific aim of the study was to develop a vibrotactile therapy system that can provide vibrotactile feedback through the pinch performance of the hand when countering mechanically induced perturbations and also analyzed training effects of the perturbation-based pinch task training system on the sensorimotor performance of the hands for stroke patients.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-30 |
Start Month Year | March 24, 2016 |
Primary Completion Month Year | October 4, 2016 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-30 |
Facilities
Sequence: | 199965052 |
Name | National Cheng-Kung University Hospital |
City | Tainan |
Zip | 704 |
Country | Taiwan |
Conditions
Sequence: | 52138980 |
Name | Stroke Rehabilitation |
Downcase Name | stroke rehabilitation |
Id Information
Sequence: | 40135042 |
Id Source | org_study_id |
Id Value | A-ER-104-206 |
Countries
Sequence: | 42542673 |
Name | Taiwan |
Removed | False |
Design Groups
Sequence: | 55559316 | Sequence: | 55559317 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Vibratory perturbed task-specific movement training | Title | Traditional task-oriented facilitation |
Description | Intervention: 10 minutes of traditional sensorimotor facilitation followed by 20 minutes of vibratory perturbed task-specific movement training | Description | Intervention:10 minutes of traditional sensorimotor training followed by 20 minutes of reach-to-grasp and hand release training. |
Interventions
Sequence: | 52454879 | Sequence: | 52454880 | Sequence: | 52454881 |
Intervention Type | Other | Intervention Type | Other | Intervention Type | Other |
Name | Vibratory perturbed task-specific movement training | Name | Traditional task-oriented facilitation | Name | Sensorimotor training |
Description | The perturbation-based pinch task training was conducted with the affected hand placed on the pinch device. The horizontal vibratory perturbation was generated for a total of 20 minutes by two recoil-type actuators with a frequency of 30 Hz and an amplitude of 2 mm, and intermittent exposure (10 s per 30 s). Each training session was divided into eight cycles with a training interval of 2 min per 2.5 min. | Description | Reach-to-grasp training and hand release training | Description | Targeted to goals that are relevant to the sensorimotor facilitation of the patient |
Keywords
Sequence: | 79822787 | Sequence: | 79822788 | Sequence: | 79822789 | Sequence: | 79822790 |
Name | stroke | Name | perturbation-based training | Name | task-specific motor training | Name | recovery of function |
Downcase Name | stroke | Downcase Name | perturbation-based training | Downcase Name | task-specific motor training | Downcase Name | recovery of function |
Design Outcomes
Sequence: | 177263573 | Sequence: | 177263574 | Sequence: | 177263575 | Sequence: | 177263576 | Sequence: | 177263577 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
Measure | Change in the result of Fugl-Meyer assessment for UE motor function | Measure | Change in the result of Modified Ashworth scale (MAS) | Measure | Change in the result of Box and blocks test | Measure | Change in the result of Semmes-Weinstein monofilament (SWM) test | Measure | Change in the result of Motor Activity Log |
Time Frame | baseline, endpoint (6 weeks) and follow up (18 weeks) | Time Frame | baseline, endpoint (6 weeks) and follow up (18 weeks) | Time Frame | baseline, endpoint (6 weeks) and follow up (18 weeks) | Time Frame | baseline, endpoint (6 weeks) and follow up (18 weeks) | Time Frame | baseline, endpoint (6 weeks) and follow up (18 weeks) |
Description | Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity. | Description | Muscle tone is defined by the resistance of a muscle being stretched.The tester graded the resistance felt, with a single score. The higher values represent a worse outcome. 0 point for no increase in muscle tone; 1 point for slight increase in muscle tone, manifested by a catch or by minimal resistance at the end of the range of motion (ROM) when the affected part is moved in flexion or extension; 1 + for slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2 point for more marked increase in muscle tone through most of the ROM, but affected parteasily moved, 3 point for considerable increase in muscle tone and passive movement difficult; 4 point for affected part rigid in flexion or extension. | Description | The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome. | Description | The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome. | Description | MAL is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale. |
Browse Conditions
Sequence: | 193366420 | Sequence: | 193366421 | Sequence: | 193366422 | Sequence: | 193366423 | Sequence: | 193366424 | Sequence: | 193366425 | Sequence: | 193366426 |
Mesh Term | Stroke | Mesh Term | Cerebrovascular Disorders | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases |
Downcase Mesh Term | stroke | Downcase Mesh Term | cerebrovascular disorders | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290689 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | National Cheng-Kung University Hospital |
Design Group Interventions
Sequence: | 68107414 | Sequence: | 68107415 | Sequence: | 68107416 | Sequence: | 68107417 |
Design Group Id | 55559316 | Design Group Id | 55559317 | Design Group Id | 55559317 | Design Group Id | 55559316 |
Intervention Id | 52454879 | Intervention Id | 52454880 | Intervention Id | 52454881 | Intervention Id | 52454881 |
Eligibilities
Sequence: | 30747709 |
Gender | All |
Minimum Age | 20 Years |
Maximum Age | 80 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Clinical diagnosis of unilateral cerebral infarction or hemorrhage Exclusion Criteria: Subject has a uncontrolled hypertension |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121824 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 6 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 20 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 5 |
Designs
Sequence: | 30493992 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28860272 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52032722 |
Pmid | 33278364 |
Reference Type | derived |
Citation | Hsu HY, Kuan TS, Tsai CL, Wu PT, Kuo YL, Su FC, Kuo LC. Effect of a Novel Perturbation-Based Pinch Task Training on Sensorimotor Performance of Upper Extremity for Patients With Chronic Stroke: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):811-818. doi: 10.1016/j.apmr.2020.11.004. Epub 2020 Dec 2. |
]]>
https://zephyrnet.com/NCT03798327
2018-11-01
https://zephyrnet.com/?p=NCT03798327
NCT03798327https://www.clinicaltrials.gov/study/NCT03798327?tab=tableNANANAThe proposed project is a randomized controlled trial of a new home-based palliative care program for adults with advanced dementia and their caregivers within the Mount Sinai Health System. Potential subjects will be identified from Mount Sinai records or referred by a Mount Sinai healthcare provider. Patients will only be approached after authorization by their Mount Sinai physician. Participants who consent to enrollment will be randomized to receive the intervention (home-based palliative care program) or usual care (with their nominated Mount Sinai physician). Patients will be enrolled in the study for 6 months.
Effectiveness of the intervention will be determined through assessment of patient and caregiver reported outcomes and abstraction of data from medical records and administrative claims. Impact on the following parameters will be measured: (i) Patient symptoms, quality of life, satisfaction with care, documentation of advanced directives, receipt of care consistent with preferences (ii) Caregiver burden, satisfaction with care, and depression (iii) Healthcare utilization and costs of care.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-08-01 |
Start Month Year | November 1, 2018 |
Primary Completion Month Year | April 29, 2022 |
Verification Month Year | July 2022 |
Verification Date | 2022-07-31 |
Last Update Posted Date | 2022-08-01 |
Detailed Descriptions
Sequence: | 20827258 |
Description | The objective of this randomized controlled trial is to study the impact of a new home based palliative care program on patients' symptoms, quality of life, satisfaction with care, completion of advance care planning documentation and receipt of care consistent with preferences. In addition, the study will examine the impact of this model of care on patient healthcare utilization, including hospitalization, emergency department utilization, and hospice use prior to death. The trial will also include patients' caregivers, in order to examine the impact of the intervention on caregiver burden and prevalence of depression.
Patients randomized to the intervention will be scheduled for an intake visit. This visit will be undertaken by the team's registered nurse and/or social worker, together with a community health worker, and other team members (advanced practice nurse, MD), depending on patients' needs. Visits will combine a combination of video-teleconferencing technology and in person visits. Following this visit, and in conjunction with the nurse practitioner and/or MD, a care plan will be developed to address areas of clinical need highlighted during the intake visit. Patients in the intervention arm will receive ongoing monitoring and input (telephone-based, video-based, and in-person) from members of the clinical team, dependent on their identified needs. Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of clinical need. Patients and caregivers will be provided with access to a 24 hour telephone line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours. These physicians will be able to provide advice to patients and caregivers. |
Facilities
Sequence: | 201087032 | Sequence: | 201087033 | Sequence: | 201087034 | Sequence: | 201087035 |
Name | Mount Sinai Beth Israel | Name | Mount Sinai West | Name | Mount Sinai St. Luke's | Name | Icahn School of Medicine at Mount Sinai |
City | New York | City | New York | City | New York | City | New York |
State | New York | State | New York | State | New York | State | New York |
Zip | 10003 | Zip | 10019 | Zip | 10025 | Zip | 10029 |
Country | United States | Country | United States | Country | United States | Country | United States |
Conditions
Sequence: | 52442604 |
Name | Dementia |
Downcase Name | dementia |
Id Information
Sequence: | 40352652 | Sequence: | 40352653 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | GCO 17-02787 | Id Value | R56AG067045-01 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/R56AG067045-01 |
Countries
Sequence: | 42786455 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55894594 | Sequence: | 55894595 |
Group Type | Experimental | Group Type | No Intervention |
Title | Home Palliative Care | Title | Control Arm |
Description | Randomized to Intervention Arm | Description | Usual Care – Patients will be cared for by the physician who treats their dementia and other illnesses. |
Interventions
Sequence: | 52752593 |
Intervention Type | Behavioral |
Name | Home Palliative Care |
Description | Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician. |
Keywords
Sequence: | 80236887 | Sequence: | 80236888 |
Name | Palliative Care | Name | Home-Based Care |
Downcase Name | palliative care | Downcase Name | home-based care |
Design Outcomes
Sequence: | 178400246 | Sequence: | 178400247 | Sequence: | 178400248 | Sequence: | 178400249 | Sequence: | 178400250 | Sequence: | 178400251 | Sequence: | 178400252 | Sequence: | 178400253 | Sequence: | 178400254 | Sequence: | 178400255 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Symptom Management at the End of Life for Dementia scale | Measure | Patient Quality of Life – Alzheimer's Disease scale | Measure | Number of Complete of Advance Directives | Measure | Preference Consistent Care | Measure | Caregiver Zaria Burden Inventory | Measure | Caregiver FAMCARE-10 | Measure | Caregiver PHQ-9 | Measure | Number of hospital admissions | Measure | Number of emergency department visits | Measure | Number of outpatient appointments |
Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months |
Description | This will be determined using a validated structured questionnaire administered to patient-subjects or caregiver via telephone interview or in person by the trained research coordinator
Scale: Symptom Management at the End of Life for Dementia – Likert scale, 9 items, each 0-5, (45 total possible score) higher is worse symptoms |
Description | This will be determined using a validated structured questionnaire administered to patient-subjects or caregiver via telephone interview or in person by the trained research coordinator.
Scale: Quality of Life – Alzheimer's Disease; Likert scale, 13 items, each 1-4, (52 total possible score) lower is worse quality of life |
Description | The Study Team will examine the patient's chart for completion of advanced directives
Scale: Study Team will examine the patient's chart for completion of advanced directives (yes/no). |
Description | The Study Team will examine if the care patients receive is concordant with the care they wanted to receive.
Scale: Simple chart review of whether care received matches stated preferences (yes/no) |
Description | Zarit Burden Inventory to determine caregiver burden by using a validated structured 22-item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. Each item is on a 5-point scale range from 0 (never) to 4 (always)
Scale: Zarit Burden Inventory – Likert scale 0-4,total score = 0-88, higher score is more burden |
Description | FAMCARE-10 to assess caregiver satisfaction by using a validated 10-item structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator.
Scale: FamCare; Likert scale, 0-3, higher is higher satisfaction |
Description | PHQ-9 to assess Caregiver Depression by using a validated structured 9 item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
Scale: Patient Health Questionnaire – 9; Likert scale, 0-3, total possible = 0-27; higher is worse depression [Time Frame: 6 months] |
Description | healthcare utilization | Description | healthcare utilization | Description | healthcare utilization |
Browse Conditions
Sequence: | 194522412 | Sequence: | 194522413 | Sequence: | 194522414 | Sequence: | 194522415 | Sequence: | 194522416 | Sequence: | 194522417 |
Mesh Term | Dementia | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Neurocognitive Disorders | Mesh Term | Mental Disorders |
Downcase Mesh Term | dementia | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | neurocognitive disorders | Downcase Mesh Term | mental disorders |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48570861 | Sequence: | 48570862 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Icahn School of Medicine at Mount Sinai | Name | National Institute on Aging (NIA) |
Overall Officials
Sequence: | 29426952 |
Role | Study Director |
Name | Nathan Goldstein, MD |
Affiliation | Icahn School of Medicine at Mount Sinai |
Design Group Interventions
Sequence: | 68521087 |
Design Group Id | 55894594 |
Intervention Id | 52752593 |
Eligibilities
Sequence: | 30920984 |
Gender | All |
Minimum Age | 65 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Presence of advanced dementia Exclusion Criteria: Subject has no usual physician within Mount Sinai |
Adult | False |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254190324 |
Number Of Facilities | 4 |
Registered In Calendar Year | 2019 |
Actual Duration | 42 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 65 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 9 |
Designs
Sequence: | 30666656 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Health Services Research |
Time Perspective | |
Masking | Single |
Masking Description | Single blind control |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 29033353 |
Responsible Party Type | Principal Investigator |
Name | Nathan Goldstein |
Title | Professor, Geriatrics and Palliative Medicine |
Affiliation | Icahn School of Medicine at Mount Sinai |
]]>
https://zephyrnet.com/NCT03798314
2019-01-30
https://zephyrnet.com/?p=NCT03798314
NCT03798314https://www.clinicaltrials.gov/study/NCT03798314?tab=tableNANANAThis phase I trials studies side effects and best dose of pomalidomide when given together with nivolumab in treating patients with primary central nervous system diffuse large B cell lymphoma or primary vitreoretinal diffuse large B cell lymphoma that has come back or that has not responded to treatment. Immunotherapy with monoclonal antibodies, such as pomalidomide and nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-01-06 |
Start Month Year | January 30, 2019 |
Primary Completion Month Year | December 30, 2020 |
Verification Month Year | September 2021 |
Verification Date | 2021-09-30 |
Last Update Posted Date | 2023-01-06 |
Detailed Descriptions
Sequence: | 20697134 |
Description | PRIMARY OBJECTIVES:
I. To establish the maximum tolerated dose (MTD) of pomalidomide which can be safely combined with the fixed dose schedule of nivolumab in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) and primary vitreoretinal lymphoma (PVRL). (Phase I) SECONDARY OBJECTIVES: I. To evaluate the overall response rate (ORR) and progression free survival (PFS) of nivolumab and pomalidomide combination in patients with relapsed/refractory PCNSL and PVRL. OUTLINE: This is dose-escalation study of pomalidomide. Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 and pomalidomide orally (PO) on days 1-14. Treatment repeats every 4 weeks until disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 weeks, then every 3 months for 4 years. |
Facilities
Sequence: | 199787881 | Sequence: | 199787882 |
Name | Mayo Clinic in Florida | Name | Mayo Clinic |
City | Jacksonville | City | Rochester |
State | Florida | State | Minnesota |
Zip | 32224-9980 | Zip | 55905 |
Country | United States | Country | United States |
Browse Interventions
Sequence: | 95919626 | Sequence: | 95919627 | Sequence: | 95919628 | Sequence: | 95919629 | Sequence: | 95919630 | Sequence: | 95919631 | Sequence: | 95919632 | Sequence: | 95919633 | Sequence: | 95919634 | Sequence: | 95919635 | Sequence: | 95919636 | Sequence: | 95919637 |
Mesh Term | Nivolumab | Mesh Term | Pomalidomide | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Antineoplastic Agents | Mesh Term | Immune Checkpoint Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Immunologic Factors | Mesh Term | Physiological Effects of Drugs | Mesh Term | Angiogenesis Inhibitors | Mesh Term | Angiogenesis Modulating Agents | Mesh Term | Growth Substances | Mesh Term | Growth Inhibitors |
Downcase Mesh Term | nivolumab | Downcase Mesh Term | pomalidomide | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | immune checkpoint inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | immunologic factors | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | angiogenesis inhibitors | Downcase Mesh Term | angiogenesis modulating agents | Downcase Mesh Term | growth substances | Downcase Mesh Term | growth inhibitors |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52104846 | Sequence: | 52104847 | Sequence: | 52104848 | Sequence: | 52104849 |
Name | Recurrent Nervous System Lymphoma | Name | Recurrent Primary Vitreoretinal DLBCL | Name | Refractory Nervous System Lymphoma | Name | Refractory Primary Vitreoretinal DLBCL |
Downcase Name | recurrent nervous system lymphoma | Downcase Name | recurrent primary vitreoretinal dlbcl | Downcase Name | refractory nervous system lymphoma | Downcase Name | refractory primary vitreoretinal dlbcl |
Id Information
Sequence: | 40106696 | Sequence: | 40106697 | Sequence: | 40106698 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | MC178A | Id Value | NCI-2018-03661 | Id Value | MC178A |
Id Type | Registry Identifier | Id Type | Other Identifier | ||
Id Type Description | CTRP (Clinical Trial Reporting Program) | Id Type Description | Mayo Clinic in Arizona | ||
Countries
Sequence: | 42509357 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55521251 |
Group Type | Experimental |
Title | Treatment (nivolumab and pomalidomide) |
Description | Patients receive nivolumab IV over 30 minutes on day 1 and pomalidomide PO on days 1-14. Treatment repeats every 4 weeks until disease progression or unacceptable toxicity. |
Interventions
Sequence: | 52418956 | Sequence: | 52418957 |
Intervention Type | Biological | Intervention Type | Drug |
Name | Nivolumab | Name | Pomalidomide |
Description | Given IV | Description | Given PO |
Design Outcomes
Sequence: | 177148513 | Sequence: | 177148514 | Sequence: | 177148515 | Sequence: | 177148516 | Sequence: | 177148517 | Sequence: | 177148518 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Maximum-tolerated dose (MTD) of pomalidomide | Measure | Incidence of adverse events | Measure | Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment | Measure | Overall response rate (ORR) | Measure | Progression-free survival (PFS) | Measure | Incidence of adverse events |
Time Frame | Up to 28 days | Time Frame | Up to 12 weeks following end of treatment. | Time Frame | Up to 12 weeks following end of treatment | Time Frame | Up to 4 years | Time Frame | From registration to progression or death due to primary central nervous system lymphoma (PCNSL) or primary vitreoretinal lymphoma (PVRL), assessed up to 4 years | Time Frame | Up to 12 weeks following treatment |
Description | The MTD in this study will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients). | Description | Will be evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number and severity of all adverse events will be tabulated and summarized in this patient population both overall and by dose level. The grade 3+ adverse events will also be described and summarized in a similar fashion. | Description | The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below. | Description | Will be estimated by the number of patients with an objective status of complete response (CR), unconfirmed complete response (CRu), or partial response (PR) divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true overall response rate will be calculated. | Description | Will be estimated using the method of Kaplan-Meier. | Description | Will be assessed by CTCAE version 5.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. |
Browse Conditions
Sequence: | 193226354 | Sequence: | 193226355 | Sequence: | 193226356 | Sequence: | 193226357 | Sequence: | 193226358 | Sequence: | 193226359 | Sequence: | 193226360 | Sequence: | 193226361 | Sequence: | 193226362 | Sequence: | 193226363 |
Mesh Term | Lymphoma | Mesh Term | Recurrence | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Lymphoproliferative Disorders | Mesh Term | Lymphatic Diseases | Mesh Term | Immunoproliferative Disorders | Mesh Term | Immune System Diseases | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | lymphoma | Downcase Mesh Term | recurrence | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lymphoproliferative disorders | Downcase Mesh Term | lymphatic diseases | Downcase Mesh Term | immunoproliferative disorders | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48258571 | Sequence: | 48258572 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Mayo Clinic | Name | National Cancer Institute (NCI) |
Overall Officials
Sequence: | 29247342 |
Role | Principal Investigator |
Name | Han Tun |
Affiliation | Mayo Clinic |
Design Group Interventions
Sequence: | 68060901 | Sequence: | 68060902 |
Design Group Id | 55521251 | Design Group Id | 55521251 |
Intervention Id | 52418956 | Intervention Id | 52418957 |
Eligibilities
Sequence: | 30727490 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patient must have one of the following: Relapsed or refractory primary central nervous system (CNS) diffuse large B cell lymphoma (PCNSDLBCL) with a brain lesion >= 1 cm, or with cerebrospinal fluid (CSF) relapse with positive CSF cytology, or with ocular relapse with positive ocular tissue biopsy NOTE: Tissue biopsy is not absolutely necessary for brain tumor unless clinical and radiologic findings strongly suggest other etiologies as per treating physician. Initial diagnosis must be made by tissue biopsy OR Relapsed/refractory primary vitreoretinal diffuse large B cell lymphoma (DLBCL) with a CNS lesion >= 1 cm, or with CSF relapse with positive CSF cytology, or with ocular relapse with positive ocular tissue biopsy. Relapsed PVRL must have progressed or failed at least one systemic regimen NOTE: Intraocular treatments are not regarded as systemic therapy Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/ml, =< 14 days prior to registration and within 24 hours of starting pomalidomide. In addition, must either commit to continue abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. WOCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a WOCBP even if they have had a vasectomy. In addition, women of childbearing potential (WOCBP) receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of nivolumab. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of nivolumab. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure A woman of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) Exclusion Criteria: Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown: Pregnant women Other active malignancy =< 3 years prior to registration EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix Use of corticosteroid in the absence of cerebral edema NOTE: If a corticosteroid is used, it should be used at the lowest dose possible for the shortest possible duration. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of treatment assignment are excluded Active hepatitis B or C with uncontrolled disease NOTE: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients. Hepatitis B core IgM antibody (HBcIgM Ab), Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV) Ab screen (Scrn) w/Reflex testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV infection Patient received radiation alone previously NOTE: Radiation therapy would not be regarded as a systemic therapy |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253979906 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2019 |
Actual Duration | 23 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30473917 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26635870 | Sequence: | 26635871 | Sequence: | 26635872 | Sequence: | 26635873 | Sequence: | 26635874 | Sequence: | 26635875 | Sequence: | 26635876 | Sequence: | 26635877 | Sequence: | 26635878 | Sequence: | 26635879 |
Intervention Id | 52418956 | Intervention Id | 52418956 | Intervention Id | 52418956 | Intervention Id | 52418956 | Intervention Id | 52418956 | Intervention Id | 52418957 | Intervention Id | 52418957 | Intervention Id | 52418957 | Intervention Id | 52418957 | Intervention Id | 52418957 |
Name | BMS-936558 | Name | MDX-1106 | Name | NIVO | Name | ONO-4538 | Name | Opdivo | Name | 4-Aminothalidomide | Name | Actimid | Name | CC-4047 | Name | Imnovid | Name | Pomalyst |
Responsible Parties
Sequence: | 28840337 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798301
2020-02-06
https://zephyrnet.com/?p=NCT03798301
NCT03798301https://www.clinicaltrials.gov/study/NCT03798301?tab=tableCancer Connectclinicaltrials@cancer.wisc.edu800-622-8922The present trial will consist of the treatment of 20 pediatric and adult Hematopoietic Stem Cell Transplantation (HSCT) recipients or immunocompromised participants diagnosed with opportunistic Cytomegalovirus (CMV) infections with virus-specific, antigen-selected T-cells. CMV-specific T-cells will be isolated from donor leukapheresis products using the CliniMACS® Prodigy. Prior studies on transfer of CMV specific T-cells have been shown to be safe and efficacious in the treatment of CMV infections.
The main trial objective is to evaluate the feasibility and safety of CMV-specific T-cell transfer in adult and pediatric participants suffering from CMV infections or reactivation following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic therapy).
Participants will be followed for one year.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-01-31 |
Start Month Year | February 6, 2020 |
Primary Completion Month Year | September 2025 |
Verification Month Year | January 2023 |
Verification Date | 2023-01-31 |
Last Update Posted Date | 2023-01-31 |
Facilities
Sequence: | 200615769 |
Status | Recruiting |
Name | University of Wisconsin Carbone Cancer Center |
City | Madison |
State | Wisconsin |
Zip | 53705 |
Country | United States |
Facility Contacts
Sequence: | 28187139 |
Facility Id | 200615769 |
Contact Type | primary |
Name | Jenny Weiland |
jlweiland@pediatrics.wisc.edu | |
Phone | 608-890-8070 |
Facility Investigators
Sequence: | 18380300 |
Facility Id | 200615769 |
Role | Principal Investigator |
Name | Kenneth DeSantes, MD |
Conditions
Sequence: | 52327634 | Sequence: | 52327635 | Sequence: | 52327636 | Sequence: | 52327637 |
Name | CMV Infection | Name | Cytomegalovirus Infections | Name | CMV Viremia | Name | Opportunistic Infections |
Downcase Name | cmv infection | Downcase Name | cytomegalovirus infections | Downcase Name | cmv viremia | Downcase Name | opportunistic infections |
Id Information
Sequence: | 40270580 | Sequence: | 40270581 | Sequence: | 40270582 | Sequence: | 40270583 | Sequence: | 40270584 | Sequence: | 40270585 |
Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id | Id Source | secondary_id | Id Source | secondary_id | Id Source | secondary_id |
Id Value | UW18073 | Id Value | 2018-1278 | Id Value | NCI-2019-00245 | Id Value | A536755 | Id Value | SMPHPEDIATRICSHEM-ONCOL | Id Value | Protocol Version: 7/15/2022 |
Id Type | Other Identifier | Id Type | Registry Identifier | Id Type | Other Identifier | Id Type | Other Identifier | Id Type | Other Identifier | ||
Id Type Description | Institutional Review Board | Id Type Description | NCI CTRP | Id Type Description | UW Madison | Id Type Description | UW Madison | Id Type Description | UW Madison | ||
Countries
Sequence: | 42690596 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55767382 |
Group Type | Experimental |
Title | Treatment Arm |
Description | Suspension of CMV-specific T-cells in 10 mL of 0.9% NaCl with 2% HSA. Single dose max. 25,000 T cells/kg body weight (BW) of the recipient delivered via IV bolus injection. |
Interventions
Sequence: | 52638665 |
Intervention Type | Biological |
Name | CMV-specific T-cells |
Description | Naturally occurring, allogeneic donor lymphocytes derived from a leukapheresis or a whole blood product, enriched for CMVspecific CD4+ and CD8+ T-cells |
Keywords
Sequence: | 80084263 | Sequence: | 80084264 | Sequence: | 80084265 | Sequence: | 80084266 |
Name | Immunocompromised | Name | Allogeneic Stem Cell Transplantation | Name | Hematopoietic stem cell transplantation (HSCT) | Name | T-cell |
Downcase Name | immunocompromised | Downcase Name | allogeneic stem cell transplantation | Downcase Name | hematopoietic stem cell transplantation (hsct) | Downcase Name | t-cell |
Design Outcomes
Sequence: | 177957408 | Sequence: | 177957409 | Sequence: | 177957410 | Sequence: | 177957411 | Sequence: | 177957412 | Sequence: | 177957413 | Sequence: | 177957414 | Sequence: | 177957415 | Sequence: | 177957416 | Sequence: | 177957417 | Sequence: | 177957418 | Sequence: | 177957419 | Sequence: | 177957420 | Sequence: | 177957421 | Sequence: | 177957422 | Sequence: | 177957423 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Feasibility: Number of Participants Who Drop-Out Before T-Cell Transfer | Measure | Feasibility: Number of Days from Participant Enrollment to Administration of CMV-VST | Measure | Feasibility: Successful production of CMV-VST from donors | Measure | Safety: Number of Subjects who experience infusion-related adverse events following CMV-VST infusion | Measure | Safety: Number of Subjects who experience newly occurring acute GVHD grade 1 | Measure | Safety: Number of subjects experiencing newly occurring acute GVHD grade ≥ 2 or experience aggravation of pre-existing acute GVHD | Measure | Safety: Number of subjects experiencing chronic GVHD | Measure | The number of severe infusion-related adverse events or severe non-hematological adverse events | Measure | Safety: Time to Occurrence of GVHD | Measure | Efficacy: Percentage of Participants with a ≥1 log decrease in CMV viral load | Measure | Efficacy: Time to ≥1 log change in viral load | Measure | Efficacy: Number of Participants with CMV Clearance | Measure | Efficacy: Time to CMV Clearance | Measure | Efficacy: Number of Participants with Reduction or Clearance of Clinical Symptoms | Measure | Efficacy: Number of CMV Reactivations Following Initial Viral Clearance | Measure | Efficacy: Overall Survival |
Time Frame | up to 21 days from enrollement | Time Frame | up to 21 days from enrollment | Time Frame | up to 21 weeks from enrollment | Time Frame | up to 4 hours after CMV-VST infusion | Time Frame | up to 12 weeks from CMV-VST infusion | Time Frame | up to 12 weeks from CMV-VST infusion | Time Frame | up to 12 weeks from CMV-VST infusion | Time Frame | up to 28 days from CMV-VST infusion | Time Frame | up to 12 weeks from CMV-VST infusion | Time Frame | up to 12 weeks from CMV-VST infusion | Time Frame | up to 12 weeks from CMV-VST infusion | Time Frame | up to 12 weeks from CMV-VST infusion | Time Frame | up to 12 weeks from CMV-VST infusion | Time Frame | up to 12 weeks from CMV-VST infusion | Time Frame | up to 52 weeks from CMV-VST infusion | Time Frame | up to 52 weeks |
Description | The feasibility of this intervention will in part be accomplished by measuring the number of dropped out participants before T-Cell Transfer. | Description | The feasibility of this intervention will in part be accomplished by measuring the amount of time from participant enrollment to administration of Cytomegalovirus-Viral Specific T-Cells (CMV-VST). | Description | The feasibility of this intervention will be assessed by quantifying the number of successful productions of Cytomegalovirus-Viral Specific T-Cells (CMV-VST) on an intent to treat basis. | Description | Incidence assessed by monitoring vital signs and specific adverse events | Description | Incidence of subjects who experience newly occurring acute GVHD grade 1 | Description | Incidence of newly occurring acute GVHD grade ≥ 2 or increase in grade of pre-existing acute GVHD | Description | Incidence of chronic GVHD | Description | Incidence of infusion-related adverse events ≥ grade 3 and non-hematological adverse events ≥ grade 4 after CMV-VST, which are not due to pre-existing infection or original malignancy or pre-existing condition | Description | Time to occurrence of acute GVHD of any grade or to occurrence of chronic GVHD will be evaluated using the Kaplan-Meier method to assess incidence and severity of acute or chronic GVHD from day of T-cell transfer. The first day of GVHD onset at a certain grade will be used to calculate a cumulative incidence curve for that GVHD grade, acute or chronic. Overall cumulative incidence curves will be computed along with the 95% confidence intervals until Week 12 after T-cell transfer with death considered as a competing risk. | Description | Evaluation of efficacy will in part be measured by percentage of participants with a ≥1 log decrease in CMV viral load at Week 12. | Description | Evaluation of efficacy will in part be measured by time to ≥1 log change in viral load in days. | Description | Evaluation of efficacy will in part be measured by the number of patients with CMV clearance, defined as negative Polymerase Chain Reaction (PCR) from Day 7 to Week 12 after T-cell transfer. | Description | Evaluation of efficacy will in part be measured by the time to CMV clearance (defined as negative PCR) from Day 0 to first day of two subsequent negative CMV PCR studies. | Description | Evaluation of efficacy will in part be measured by the number of participants with reduction or clearance of clinical symptoms of underlying CMV infection from Day 7 to Week 12 after T-cell transfer as compared to Day 0. | Description | Evaluation of efficacy will in part be measured by the number of CMV reactivations following initial viral clearance until Week 52. | Description | Evaluation of efficacy will in part be measured by the overall survival. Overall survival rate (OS): time from T-cell transfer (Day 0) to death or last follow-up throughout the study from Day 1 to Week 52. |
Browse Conditions
Sequence: | 194082368 | Sequence: | 194082369 | Sequence: | 194082370 | Sequence: | 194082371 | Sequence: | 194082372 | Sequence: | 194082373 | Sequence: | 194082374 | Sequence: | 194082375 | Sequence: | 194082376 | Sequence: | 194082377 | Sequence: | 194082378 | Sequence: | 194082379 | Sequence: | 194082380 |
Mesh Term | Infections | Mesh Term | Communicable Diseases | Mesh Term | Cytomegalovirus Infections | Mesh Term | Opportunistic Infections | Mesh Term | Viremia | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes | Mesh Term | Herpesviridae Infections | Mesh Term | DNA Virus Infections | Mesh Term | Virus Diseases | Mesh Term | Sepsis | Mesh Term | Systemic Inflammatory Response Syndrome | Mesh Term | Inflammation |
Downcase Mesh Term | infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | cytomegalovirus infections | Downcase Mesh Term | opportunistic infections | Downcase Mesh Term | viremia | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | herpesviridae infections | Downcase Mesh Term | dna virus infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | sepsis | Downcase Mesh Term | systemic inflammatory response syndrome | Downcase Mesh Term | inflammation |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48465786 | Sequence: | 48465787 |
Agency Class | OTHER | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Wisconsin, Madison | Name | University of Wisconsin Carbone Cancer Center (UWCCC) |
Overall Officials
Sequence: | 29368470 | Sequence: | 29368471 |
Role | Principal Investigator | Role | Study Director |
Name | Kenneth DeSantes, MD | Name | Jacques Galipeau, MD |
Affiliation | University of Wisconsin, Madison | Affiliation | University of Wisconsin, Madison |
Central Contacts
Sequence: | 12048021 |
Contact Type | primary |
Name | Cancer Connect |
Phone | 800-622-8922 |
clinicaltrials@cancer.wisc.edu | |
Role | Contact |
Design Group Interventions
Sequence: | 68360812 |
Design Group Id | 55767382 |
Intervention Id | 52638665 |
Eligibilities
Sequence: | 30855937 |
Gender | All |
Minimum Age | 1 Month |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Adult or pediatric patient suffering from CMV reactivation/infections following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic therapy). CMV reactivation/viremia defined as positive (>500 copies/ml) CMV qPCR and/or Patients must have ONE OF THE FOLLOWING CRITERIA: Absence of an improvement of viral load after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log, i.e. 10-fold), or Exclusion Criteria: Patient with acute GVHD > grade 2 or active moderate or severe chronic GVHD at time of T-cell transfer Donor Eligibility: The original donor will be the first choice as source of T cells. If the original donor is not available for donation (such as NMDP donor, cord blood unit, or related donor not available) of peripheral mononuclear cells or does not meet all donor eligibility criteria (including donor selection criteria based on University of Wisconsin – Madison Standard Operating Procedures for the selection of allogeneic donors), alternative related donors will be selected, with preference for those who have full HLA matching in 6/6 loci over those with partial HLA matching (≥ 3/6 HLA loci). All donors must be ≥ 18 years old, available, CMV IgG positive, eligible and capable of undergoing a single standard 2 blood volume leukapheresis. If original HSCT donor is not available, CMV IgG negative or ineligible, a CMV IgG positive fully matched or haploidentical family donor will be used. |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254312639 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 1 |
Minimum Age Unit | Month |
Number Of Primary Outcomes To Measure | 9 |
Number Of Secondary Outcomes To Measure | 7 |
Designs
Sequence: | 30601778 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | single-center, open-label, single-arm, pilot study |
Links
Sequence: | 4400263 |
Url | https://cancer.wisc.edu/ |
Description | University of Wisconsin Carbone Cancer Center |
Responsible Parties
Sequence: | 28968291 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798288
2019-03-08
https://zephyrnet.com/?p=NCT03798288
NCT03798288https://www.clinicaltrials.gov/study/NCT03798288?tab=tableNANANAThe intervention consists of a digital decision support system delivering a weekly plan of suggested activities that the participant can use to self-manage their low back pain (LBP) via an smartphone app.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-02-17 |
Start Month Year | March 8, 2019 |
Primary Completion Month Year | May 6, 2020 |
Verification Month Year | February 2023 |
Verification Date | 2023-02-28 |
Last Update Posted Date | 2023-02-17 |
Detailed Descriptions
Sequence: | 20702262 |
Description | The selfBACK intervention consists of the selfBACK system, that provides the participants with an individually tailored weekly plan of suggested activities to use in their self-management of low back pain.
The selfBACK system constitutes a data-driven decision support system that uses case-based reasoning to capture and reuse participant cases to suggest the most suitable self-management plan for participants. The system is an intelligent system delivering self-management plans tailored to individual participant characteristics. Information about participant characteristics is collected via a (baseline) questionnaire, weekly self-reports via the app on symptom progression etc., and a wristband that detect daily number of steps. The weekly plans are presented in an app to participants. The weekly plan includes three categories of content; information/education Outcomes are collected as baseline, 6 weeks, 3, 6, 9 months. |
Facilities
Sequence: | 199852480 | Sequence: | 199852481 |
Name | Physical Activity and Health at Work, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark | Name | Norwegian University of Science and Technology |
City | Odense | City | Trondheim |
Zip | 5230 | ||
Country | Denmark | Country | Norway |
Conditions
Sequence: | 52117974 |
Name | Low Back Pain |
Downcase Name | low back pain |
Id Information
Sequence: | 40117742 |
Id Source | org_study_id |
Id Value | 18/17955CDJ |
Countries
Sequence: | 42521789 | Sequence: | 42521790 |
Name | Denmark | Name | Norway |
Removed | False | Removed | False |
Design Groups
Sequence: | 55536107 | Sequence: | 55536108 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Usual care + selfBACK | Title | Usual care |
Description | The selfBACK system constitutes a data-driven decision support system that uses case-based reasoning to capture and reuse participant cases to suggest the most suitable self-management plan for participants. The system is an intelligent system delivering self-management plans tailored to individual participant characteristics. Information about participant characteristics is collected via a (baseline) questionnaire, weekly self-reports via the app on symptom progression etc., and a wristband that detect daily number of steps. The weekly plans are presented in an app to participants.
The weekly plan includes three categories of content; information/education |
Description | Any diagnostic or treatment-related pathway (e.g. receive information, advice or treatment) as instructed by their health care professional. Patients are allowed to seek care, treatment or help elsewhere as normal. |
Interventions
Sequence: | 52433102 | Sequence: | 52433103 |
Intervention Type | Behavioral | Intervention Type | Other |
Name | selfBACK | Name | Usual care |
Description | Participants will use the selfBACK system and app in addition to receiving usual care | Description | Participants will receive usual care |
Keywords
Sequence: | 79786498 | Sequence: | 79786499 | Sequence: | 79786500 |
Name | Digital Decision Support System | Name | App | Name | Self-management |
Downcase Name | digital decision support system | Downcase Name | app | Downcase Name | self-management |
Design Outcomes
Sequence: | 177192240 | Sequence: | 177192231 | Sequence: | 177192232 | Sequence: | 177192233 | Sequence: | 177192234 | Sequence: | 177192235 | Sequence: | 177192236 | Sequence: | 177192237 | Sequence: | 177192238 | Sequence: | 177192239 | Sequence: | 177192241 | Sequence: | 177192242 | Sequence: | 177192243 | Sequence: | 177192244 | Sequence: | 177192245 | Sequence: | 177192246 | Sequence: | 177192247 | Sequence: | 177192248 | Sequence: | 177192249 | Sequence: | 177192250 |
Outcome Type | other | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other | Outcome Type | other |
Measure | Activity limitation | Measure | Roland Morris Disability Questionnaire | Measure | Pain Self-Efficacy Questionnaire | Measure | The Fear Avoidance Belief Questionnaire | Measure | Pain intensity | Measure | Brief Illness Perception Questionnaire | Measure | Saltin-Grimby Physical Activity Level Scale | Measure | Patients Global Perceived Effect | Measure | Workability | Measure | Health-related Quality of Life | Measure | Sleep | Measure | Perceived Stress Scale | Measure | Patient Health Questionnaire-8 | Measure | Patient Specific Functional Scale | Measure | Pain duration and frequency | Measure | Virtual Care Climate Questionnaire | Measure | User ratings | Measure | Tailoring variables | Measure | Physical activity | Measure | Exercise volume |
Time Frame | change from baseline to 3 months | Time Frame | change from baseline to 3 months | Time Frame | change from baseline to 3 months | Time Frame | change from baseline to 3 months | Time Frame | change from baseline to 3 months | Time Frame | change from baseline to 3 months | Time Frame | change from baseline to 3 months | Time Frame | 3 months | Time Frame | change from baseline to 3 months | Time Frame | change from baseline to 3 months | Time Frame | change from baseline to 3 months | Time Frame | change from baseline to 3 months | Time Frame | change from baseline to 3 months | Time Frame | change from baseline to 3 months | Time Frame | change from baseline to 3 months | Time Frame | 4 months | Time Frame | 4 months | Time Frame | weekly for 9 months | Time Frame | weekly for 9 months | Time Frame | weekly for 9 months |
Description | Activity Limitation evaluates if LBP has limited work and leisure time activities. The questionnaire consists of two single items with response options "yes" and "no". | Description | The primary outcome is the Roland Morris Disability Questionnaire (RMDQ) assessing pain-related disability. The questionnaire includes 24 items asking participants to indicate if they experience functional impairments by answering "yes" or "no" to a series of descriptions of functional abilities with higher scores indicating higher level of disability. | Description | The questionnaire assesses the participant's level of confidence in carrying out specific activities despite their pain. The PSEQ is a 10-item questionnaire scored on an ordinal scale ranging from zero [completely disagree] to six [completely agree]. | Description | The FABQ is a 5-item questionnaire, where the participants score their beliefs about their LBP on an ordinal scale ranging from zero [completely disagree] to six [completely agree] | Description | Pain intensity measured as average and worst LBP within the past week. Measured on a 0 – 10 Numerical Rating Scale with 0 being no pain and 10 being worst pain imaginable. | Description | The questionnaire evaluates the participants' illness perception in an 8-item questionnaire. Items are scored on an ordinal scale ranging from zero [no problems] to 10 [worst severity]. | Description | Participants indicate their amount of time per week performing leisure activities with four levels of intensity ranging from sedentary to vigorous physically active | Description | A single item question for Patient's Global Perceived Effect will be asked at follow-up, where participants are asked to rate improvement or deterioration of their LBP compared to before the intervention | Description | Workability is measured by a single-item and rated on an 11-point NRS scale ranging from zero [completely unable to work] to 10 [work ability at its best]. | Description | The EuroQoL 5-dimension (EQ-5D) questionnaire is used to asses quality of life within each of the five dimension (i.e., mobility, self-care, activities, pain/discomfort and anxiety/depression). | Description | Sleep is assessed by self-report using four items concerning problems with falling asleep, waking up repeatedly, waking up too early, and feeling sleepy during the day. | Description | a 10-item questionnaire asking about frequency of thoughts and feelings related to perceived stress | Description | the questionnaire is an 8-item questionnaire used to evaluate the participants' depressive symptoms. Items are scored on a 4-point Likert scale scoring frequency of experiencing symptoms of depression. | Description | Participants rate their function on up to two self-selected activities, are asked to rate if they are unable to do or are having difficulty with the their ability to perform self-selected activities regarded as important by the participants themselves | Description | Pain duration measures patients' self-reported length of current pain episode. Pain medication measures the frequency of the non-prescription pain medication use for LBP. | Description | The Virtual Care Climate Questionnaire concerns patients' perceived support for autonomy in a virtual care setting. | Description | Three rating questions on overall rating, ease of use and recommendation to others scored on a 5-point system | Description | Participants in the intervention are on a weekly basis asked a set of tailoring questions. These are tracked over the intervention period. The tailoring questions include items on lob back pain (NRS for pain intensity), function, fear-avoidance, workability, sleep, pain self-efficacy, stress, symptoms of depression, and barriers for self-management.
Note. not all questions are asked on a weekly basis |
Description | The patients' weekly recommended step count goal, and the actual achieved step count per. day | Description | The patients report back their completed exercise volume as number of sets and repetitions for their suggested exercises, when they perform them |
Browse Conditions
Sequence: | 193280414 | Sequence: | 193280415 | Sequence: | 193280416 | Sequence: | 193280417 |
Mesh Term | Back Pain | Mesh Term | Low Back Pain | Mesh Term | Pain | Mesh Term | Neurologic Manifestations |
Downcase Mesh Term | back pain | Downcase Mesh Term | low back pain | Downcase Mesh Term | pain | Downcase Mesh Term | neurologic manifestations |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48271093 | Sequence: | 48271094 | Sequence: | 48271095 | Sequence: | 48271096 | Sequence: | 48271097 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER_GOV | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | University of Southern Denmark | Name | Norwegian University of Science and Technology | Name | National Research Centre for the Working Environment, Denmark | Name | University of Glasgow | Name | Robert Gordon University |
Overall Officials
Sequence: | 29255396 |
Role | Principal Investigator |
Name | Karen Søgaard, PhD |
Affiliation | University of Southern Denmark |
Design Group Interventions
Sequence: | 68079195 | Sequence: | 68079196 | Sequence: | 68079197 |
Design Group Id | 55536107 | Design Group Id | 55536108 | Design Group Id | 55536107 |
Intervention Id | 52433102 | Intervention Id | 52433103 | Intervention Id | 52433103 |
Eligibilities
Sequence: | 30735430 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Seeking care from primary health-care practice (general practitioners, physiotherapists, chiropractors) or a local outpatient spinecenter (DK) for non-specific LBP within the past 8 weeks Exclusion Criteria: Not interested, |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254014477 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2019 |
Actual Duration | 14 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Number Of Other Outcomes To Measure | 13 |
Designs
Sequence: | 30481790 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Masking Description | The analysis of the data will be performed blindly. |
Intervention Model Description | The study design is a multi-center randomised controlled trial with 2 parallel arms |
Investigator Masked | True |
Links
Sequence: | 4383456 |
Url | http://www.selfback.eu |
Description | project webpage |
Provided Documents
Sequence: | 2576398 | Sequence: | 2576399 |
Document Type | Study Protocol | Document Type | Statistical Analysis Plan |
Has Protocol | True | Has Protocol | False |
Has Icf | False | Has Icf | False |
Has Sap | False | Has Sap | True |
Document Date | 2019-02-20 | Document Date | 2023-02-08 |
Url | https://ClinicalTrials.gov/ProvidedDocs/88/NCT03798288/Prot_000.pdf | Url | https://ClinicalTrials.gov/ProvidedDocs/88/NCT03798288/SAP_002.pdf |
Responsible Parties
Sequence: | 28848140 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52012667 | Sequence: | 52012668 | Sequence: | 52012669 | Sequence: | 52012670 | Sequence: | 52012671 |
Pmid | 30030208 | Pmid | 35130898 | Pmid | 34338710 | Pmid | 33118959 | Pmid | 31793897 |
Reference Type | background | Reference Type | derived | Reference Type | derived | Reference Type | derived | Reference Type | derived |
Citation | Mork PJ, Bach K; selfBACK Consortium. A Decision Support System to Enhance Self-Management of Low Back Pain: Protocol for the selfBACK Project. JMIR Res Protoc. 2018 Jul 20;7(7):e167. doi: 10.2196/resprot.9379. Erratum In: JMIR Res Protoc. 2019 Jan 03;8(1):e12180. | Citation | Overas CK, Nilsen TIL, Nicholl BI, Rughani G, Wood K, Sogaard K, Mair FS, Hartvigsen J. Multimorbidity and co-occurring musculoskeletal pain do not modify the effect of the SELFBACK app on low back pain-related disability. BMC Med. 2022 Feb 8;20(1):53. doi: 10.1186/s12916-022-02237-z. | Citation | Sandal LF, Bach K, Overas CK, Svendsen MJ, Dalager T, Stejnicher Drongstrup Jensen J, Kongsvold A, Nordstoga AL, Bardal EM, Ashikhmin I, Wood K, Rasmussen CDN, Stochkendahl MJ, Nicholl BI, Wiratunga N, Cooper K, Hartvigsen J, Kjaer P, Sjogaard G, Nilsen TIL, Mair FS, Sogaard K, Mork PJ. Effectiveness of App-Delivered, Tailored Self-management Support for Adults With Lower Back Pain-Related Disability: A selfBACK Randomized Clinical Trial. JAMA Intern Med. 2021 Oct 1;181(10):1288-1296. doi: 10.1001/jamainternmed.2021.4097. | Citation | Rasmussen CDN, Svendsen MJ, Wood K, Nicholl BI, Mair FS, Sandal LF, Mork PJ, Sogaard K, Bach K, Stochkendahl MJ. App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation. JMIR Res Protoc. 2020 Oct 29;9(10):e20308. doi: 10.2196/20308. | Citation | Sandal LF, Stochkendahl MJ, Svendsen MJ, Wood K, Overas CK, Nordstoga AL, Villumsen M, Rasmussen CDN, Nicholl B, Cooper K, Kjaer P, Mair FS, Sjogaard G, Nilsen TIL, Hartvigsen J, Bach K, Mork PJ, Sogaard K. An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 3;8(12):e14720. doi: 10.2196/14720. |
]]>
https://zephyrnet.com/NCT03798275
2018-01-01
https://zephyrnet.com/?p=NCT03798275
NCT03798275https://www.clinicaltrials.gov/study/NCT03798275?tab=tableNANANACoffee, tea, and cocoa contain caffeine, a plant alkaloid. They are frequently consumed during pregnancy. We examined the effect of coffee consumption on fetal renal artery blood flow and amniotic fluid index (AFI) in the third trimester of pregnancy
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | January 1, 2018 |
Primary Completion Month Year | August 1, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Detailed Descriptions
Sequence: | 20741194 |
Description | This cross-sectional study occurred in a tertiary center with volunteer pregnant women who agreed to drink coffee. In healthy pregnant women with isolated borderline oligohydramnios, AFI and fetal renal artery blood flow indices were evaluated before and after coffee consumption. Sixty three patients for the borderline oligohydramnios group (the study group) were included in this study. These patients were compared with 63 healthy pregnant women who had normal amniotic fluid volume (the control group) |
Facilities
Sequence: | 200280620 |
Name | Yusuf Madendağ |
City | Kayseri̇ |
Zip | 38090 |
Country | Turkey |
Conditions
Sequence: | 52221576 | Sequence: | 52221577 |
Name | Coffee | Name | Pregnancy |
Downcase Name | coffee | Downcase Name | pregnancy |
Id Information
Sequence: | 40195661 |
Id Source | org_study_id |
Id Value | 2017/489 |
Countries
Sequence: | 42609681 |
Name | Turkey |
Removed | False |
Design Groups
Sequence: | 55649866 | Sequence: | 55649867 |
Group Type | Active Comparator | Group Type | No Intervention |
Title | the study group | Title | the control group |
Description | healthy pregnant women with borderline oligohydramnios who accept to drink a cup of coffee | Description | healthy pregnant women with normal amniotic volume |
Interventions
Sequence: | 52535386 |
Intervention Type | Dietary Supplement |
Name | coffee |
Description | 2 g Nescafe Clasico contains approximately 65 mg caffeine |
Keywords
Sequence: | 79941819 | Sequence: | 79941820 | Sequence: | 79941821 | Sequence: | 79941822 |
Name | amniotic fluid index | Name | caffeine | Name | coffee | Name | oligohydramnios |
Downcase Name | amniotic fluid index | Downcase Name | caffeine | Downcase Name | coffee | Downcase Name | oligohydramnios |
Design Outcomes
Sequence: | 177561649 | Sequence: | 177561650 |
Outcome Type | primary | Outcome Type | primary |
Measure | amniotic fluid index | Measure | fetal renal artery doppler indices |
Time Frame | two hours | Time Frame | two hours |
Sponsors
Sequence: | 48366472 |
Agency Class | OTHER_GOV |
Lead Or Collaborator | lead |
Name | Kayseri Education and Research Hospital |
Overall Officials
Sequence: | 29312940 |
Role | Principal Investigator |
Name | YUSUF MADENDAĞ |
Affiliation | Sağlık Bilimleri Üniversitesi Kayseri Şehir hastanesi |
Design Group Interventions
Sequence: | 68217463 |
Design Group Id | 55649866 |
Intervention Id | 52535386 |
Eligibilities
Sequence: | 30794739 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 35 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Pregnant women with a singleton, uncomplicated pregnancy between the 34th and 37th weeks of gestation were included in this study during routine antenatal examinations Exclusion Criteria: abnormal amniotic fluid volume (AFV), any intake of nutrient or fluid within the 4 hours previous to ultrasonographic examination [10], abnormal Doppler blood flow, hypertension, preeclampsia, chromosomal anomaly, intrauterine growth restriction, fetal anomaly, collagen vascular disease, ruptured fetal membranes, and multiple pregnancies. |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254004377 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 7 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 35 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Designs
Sequence: | 30540779 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Subject Masked | True |
Caregiver Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28907099 |
Responsible Party Type | Principal Investigator |
Name | Yusuf MADENDAG |
Title | obstetrics and gynecology |
Affiliation | Kayseri Education and Research Hospital |
]]>
https://zephyrnet.com/NCT03798262
2017-02-16
https://zephyrnet.com/?p=NCT03798262
NCT03798262https://www.clinicaltrials.gov/study/NCT03798262?tab=tableNANANAThe investigators will investigate the effects of acute and sub-acute administration of gluten on mood, intestinal permeability, gastrointestinal symptoms and gut peptide levels in healthy volunteers (HV).
<![CDATA[
Studies
Study First Submitted Date | 2018-10-11 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | February 16, 2017 |
Primary Completion Month Year | April 2, 2018 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Facilities
Sequence: | 199965058 | Sequence: | 199965059 |
Name | Jan Tack | Name | TARGID |
City | Leuven | City | Leuven |
Zip | 3000 | Zip | 3000 |
Country | Belgium | Country | Belgium |
Conditions
Sequence: | 52138988 |
Name | Healthy Volunteers, Gluten |
Downcase Name | healthy volunteers, gluten |
Id Information
Sequence: | 40135053 |
Id Source | org_study_id |
Id Value | S58915 |
Countries
Sequence: | 42542678 |
Name | Belgium |
Removed | False |
Design Groups
Sequence: | 55559324 | Sequence: | 55559325 |
Group Type | Active Comparator | Group Type | Placebo Comparator |
Title | Gluten | Title | Placebo |
Description | Patients receive 16 g of gluten acutely and afterwards 2 glutenfree muffins with 8 g of gluten for 5 days sub-acutely | Description | Patients receive 16 g of whey protein acutely and afterwards 2 glutenfree muffins for 5 days sub-acutely |
Interventions
Sequence: | 52454893 | Sequence: | 52454894 |
Intervention Type | Other | Intervention Type | Other |
Name | Gluten | Name | Placebo |
Description | Tereos | Description | Whey protein from Nestlé Healthy Science |
Design Outcomes
Sequence: | 177263589 | Sequence: | 177263590 | Sequence: | 177263591 | Sequence: | 177263592 | Sequence: | 177263593 | Sequence: | 177263594 | Sequence: | 177263595 | Sequence: | 177263596 | Sequence: | 177263597 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The effect of gluten acutely and sub-acutely on extraintestinal symptoms in HV measured on the Positive and Negative Affect Schedule | Measure | The effect of gluten acutely and sub-acutely on extraintestinal symptoms in HV measured on the Profile of Mood State. | Measure | The effect of gluten acutely and sub-acutely on gastrointestinal symptoms in HV measured on the visual analogue scale for gastrointestinal symptoms | Measure | The effect of gluten acutely and sub-acutely on intestinal permeability (using the lactulose mannitol ratio) | Measure | Effect of acute and sub-acute gluten administration on high sensitive reactive protein levels in blood samples | Measure | Effect of acute and sub-acute gluten administration on Lipopolysaccharide-Binding Protein levels in blood samples | Measure | Effect of acute and sub-acute gluten administration on Lipopolysaccharide levels in blood samples | Measure | Effect of acute and sub-acute gluten administration on gut microbiota composition (stool samples) | Measure | Effect of acute and sub-acute gluten administration on cortisol awakening response (saliva samples) |
Time Frame | At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 36), after test visit 4 (at day 41) | Time Frame | At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 21), after test visit 3 (at day 36), after test visit 4 (at day 41) | Time Frame | At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 21), after test visit 3 (at day 36), after test visit 4 (at day 41) | Time Frame | At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 36), after test visit 4 (at day 41) | Time Frame | During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) | Time Frame | During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) | Time Frame | During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) | Time Frame | After test visit 0 (day 0), day 13 and day 14, after test visit 1 (day 15), day 16, 17, 18, 19 and 20, two days before test visit 3 (day 34 and 35), day 36, 37, 38, 39, 40 | Time Frame | Day before test visit 1 (day 14), test visit 1 (day 15), test visit 2 (day 21), day before test visit 3 (day 35), test visit 3 (day 36) and test visit 4 (day 41) |
Description | Change from baseline. Scores can be 'very slightly or not at all', 'a little', 'moderately', 'quite a bit', 'extremely'. Measured at day 0, day 15, day 20, day 36 and day 41. | Description | Change from baseline. Scores are measured on the Visual Analogue Scale. The scale is ranged 0 – 10, in which 0 no occurrence of the symptom and 10 a lot occurrence of the symptom. Measured at day 0, day 15, day 20, day 36 and day 41. | Description | Scores are measured on the Visual Analogue Scale. With '0' no complaints and '10' a lot of complaints (change from baseline). | Description | Investigate change in intestinal permeability after gluten administration. In the urine we can measure the ratio lactulose/mannitol. This can be measured using High Performance Liquid Chromatography | Description | Change in high sensitive reactive protein levels measured at day 0, day 21 and day 41. | Description | Change in lipopolysaccharide-binding protein levels measured at day 0, day 21 and day 41. | Description | Change in lipopolysaccharide levels measured at day 0, day 21 and day 41. | Description | Change in gut microbiota composition (compared to day 0) with focus on: Bifidobacterium, Lactobacillus, Enterobacteriaceae, E. coli; measured in stool samples. Analyses will provide an overall view of the gut microbiota composition. | Description | Change in cortisol levels between gluten and placebo administration (saliva samples). Measured using an ELISA assay. |
Sponsors
Sequence: | 48290697 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Universitaire Ziekenhuizen KU Leuven |
Design Group Interventions
Sequence: | 68107433 | Sequence: | 68107434 |
Design Group Id | 55559324 | Design Group Id | 55559325 |
Intervention Id | 52454893 | Intervention Id | 52454894 |
Eligibilities
Sequence: | 30747713 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Body Mass Index (BMI) of 20 – 25 kg/m2 Exclusion Criteria: Medical Coeliac disease (excluded either by absence of the HLA-DQ2 and HLA-DQ8 haplotype or by a normal duodenal biopsy (Marsh 0) performed at endoscopy while on a gluten containing diet in individuals expressing the HLA-DQ2 (human leukocyte antigen) or HLA-DQ8 haplotype) |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254121841 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2018 |
Actual Duration | 13 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 7 |
Designs
Sequence: | 30493996 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | Single |
Intervention Model Description | single-blinded, randomised controlled, cross-over study |
Subject Masked | True |
Responsible Parties
Sequence: | 28860276 |
Responsible Party Type | Principal Investigator |
Name | Prof Dr Jan Tack |
Title | Principal Investigator |
Affiliation | Universitaire Ziekenhuizen KU Leuven |
]]>
https://zephyrnet.com/NCT03798249
2017-05-11
https://zephyrnet.com/?p=NCT03798249
NCT03798249https://www.clinicaltrials.gov/study/NCT03798249?tab=tableNANANAThe investigators will investigate the effects of acute and sub-acute administration of gluten on mood, intestinal permeability, gastrointestinal symptoms, gut microbiota and cortisol levels in NCGS patients.
<![CDATA[
Studies
Study First Submitted Date | 2018-10-11 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | May 11, 2017 |
Primary Completion Month Year | January 2022 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Facilities
Sequence: | 200159095 | Sequence: | 200159096 |
Status | Recruiting | Status | Recruiting |
Name | TARGID | Name | Jan Tack |
City | Leuven | City | Leuven |
State | Vlaams-Brabant | ||
Zip | 3000 | ||
Country | Belgium | Country | Belgium |
Facility Contacts
Sequence: | 28113712 | Sequence: | 28113713 |
Facility Id | 200159095 | Facility Id | 200159096 |
Contact Type | primary | Contact Type | primary |
Name | Annelies Geeraerts | Name | Jan Tack |
Annelies.Geeraerts@kuleuven.be | jan.tack@med.kuleuven.be | ||
Phone | 016377034 | Phone | 498797124 |
Conditions
Sequence: | 52185410 | Sequence: | 52185411 |
Name | NCGS | Name | Gluten |
Downcase Name | ncgs | Downcase Name | gluten |
Id Information
Sequence: | 40169012 |
Id Source | org_study_id |
Id Value | S60127 |
Countries
Sequence: | 42580614 |
Name | Belgium |
Removed | False |
Design Groups
Sequence: | 55609033 | Sequence: | 55609034 |
Group Type | Active Comparator | Group Type | Placebo Comparator |
Title | Gluten | Title | Placebo |
Description | Patients will receive acutely 16 g of gluten and 2 muffins glutenfree with 8 g of gluten, twice a day, during 5 days | Description | Patients will receive acutely 16 g of whey protein and 2 glutenfree muffins, twice a day, during 5 days |
Interventions
Sequence: | 52499351 | Sequence: | 52499352 |
Intervention Type | Other | Intervention Type | Other |
Name | Gluten | Name | Placebo |
Description | Tereos | Description | Nestlé Health Science |
Design Outcomes
Sequence: | 177431775 | Sequence: | 177431776 | Sequence: | 177431777 | Sequence: | 177431778 | Sequence: | 177431779 | Sequence: | 177431780 | Sequence: | 177431781 | Sequence: | 177431782 | Sequence: | 177431783 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Positive and Negative Affect Schedule | Measure | The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Profile of Mood State | Measure | The effect of gluten acutely and sub-acutely on gastrointestinal symptoms in NCGS patients measured on the visual analogue scale for gastrointestinal symptoms | Measure | Effect of acute and sub-acute gluten administration on intestinal permeability (lactulose mannitol ratio) | Measure | Effect of acute and sub-acute gluten administration on high sensitive reactive protein levels in bloodsample | Measure | Effect of acute and sub-acute gluten administration on Lipopolysaccharide-Binding Protein levels in bloodsample | Measure | Effect of acute and sub-acute gluten administration on lipopolysaccharide levels in bloodsample | Measure | Effect of acute and sub-acute gluten administration on gut microbiota composition | Measure | Effect of acute and sub-acute gluten administration on cortisol awakening response |
Time Frame | At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 35), after test visit 4 (at day 40) | Time Frame | At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 35), after test visit 4 (at day 40) | Time Frame | At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 35), after test visit 4 (at day 40) | Time Frame | At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 21), after test visit 3 (at day 36), after test visit 4 (at day 41) | Time Frame | During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) | Time Frame | During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) | Time Frame | During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) | Time Frame | After test visit 0 (day 0), day 13 and day 14, after test visit 1 (day 15), day 16, 17, 18, 19 and 20, two days before test visit 3 (day 34 and 35), day 36, 37, 38, 39, 40 | Time Frame | Day before test visit 1 (day 14), test visit 1 (day 15), test visit 2 (day 21), day before test visit 3 (day 35), test visit 3 (day 36) and test visit 4 (day 41) |
Description | Change from baseline. Scores can be 'very slightly or not at all', 'a little', 'moderately', 'quite a bit', 'extremely' | Description | Scores are measured on the Visual Analogue Scale. Change from baseline. The scale is ranged 0 – 10, in which 0 no occurrence of the symptom and 10 a lot occurrence of the symptom. Measured at day 0, day 15, day 21, day 36 and day 41. | Description | With '0' no complaints and '10' a lot of complaints (change from baseline). Measured on the Visual Analogue Scale. Measured at day 0, day 15, day 21, day 36 and day 41. | Description | Change in intestinal permeability after gluten administration. In the urine we can measure the ratio lactulose/mannitol. This can be measured using High Performance Liquid Chromatography at day 0, day 15, day 21, day 36 and day 41. | Description | Change in high sensitive reactive protein levels measured at day 0, day 21 and day 41 | Description | Change in lipopolysaccharide-binding protein levels measured at day 0, day 21 and day 41 | Description | Change in lipopolysaccharide levels measured at day 0, day 21 and day 41 | Description | Change in gut microbiota composition (compared to day 0) with focus on: Bifidobacterium, Lactobacillus, Enterobacteriaceae, E. coli (stool samples) | Description | Change in cortisol levels between gluten and placebo administration (saliva samples). Measured using an ELISA assay. |
Browse Conditions
Sequence: | 193539810 | Sequence: | 193539811 |
Mesh Term | Hypersensitivity | Mesh Term | Immune System Diseases |
Downcase Mesh Term | hypersensitivity | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332246 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Universitaire Ziekenhuizen KU Leuven |
Design Group Interventions
Sequence: | 68168081 | Sequence: | 68168082 |
Design Group Id | 55609033 | Design Group Id | 55609034 |
Intervention Id | 52499351 | Intervention Id | 52499352 |
Eligibilities
Sequence: | 30773531 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 60 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Non-coeliac gluten sensitivity patients Previous symptoms of IBS fulfilling Rome III criteria that self reportedly improved with a gluten-free diet Exclusion Criteria: Medical Coeliac disease Psychiatric disorders Eating disorders |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 253952546 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 60 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 7 |
Designs
Sequence: | 30519662 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Diagnostic |
Time Perspective | |
Masking | Single |
Intervention Model Description | single-blinded, randomised – controlled, crossover |
Subject Masked | True |
Responsible Parties
Sequence: | 28885963 |
Responsible Party Type | Principal Investigator |
Name | Prof Dr Jan Tack |
Title | Principal Investigator |
Affiliation | Universitaire Ziekenhuizen KU Leuven |
]]>
https://zephyrnet.com/NCT03798236
2018-12-10
https://zephyrnet.com/?p=NCT03798236
NCT03798236https://www.clinicaltrials.gov/study/NCT03798236?tab=tableNANANASingle center, randomized, double-blind, placebo-controlled clinical study to assess the safety and tolerability of PBF-1650 in order to obtain the Maximum Tolerated Dose (MTD).
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2020-06-30 |
Start Month Year | December 10, 2018 |
Primary Completion Month Year | March 30, 2019 |
Verification Month Year | June 2020 |
Verification Date | 2020-06-30 |
Last Update Posted Date | 2020-06-30 |
Detailed Descriptions
Sequence: | 20716280 |
Description | The clinical trial will be a dose escalation study without therapeutic benefit, in which PBF-1650 will be administered as single oral ascending- dose to healthy young male volunteers. Up to four different rising doses will be tested (40 mg, 80 mg, 120 and 240 mg) in groups/cohorts of 8 participants. Thus, four groups/cohorts will participate. For each dose level / group, the participants will be randomized to active or placebo with 2 participants being randomly assigned to placebo and 6 to the active drug. First, one volunteer will receive active drug (subgroup 1); after at least 48h of safety and tolerability assessment a second subgroup of 3 volunteers will receive 2 active drug and 1 placebo; after at least another 48h of safety and tolerability parameters assessment a third subgroup of 4 volunteers will receive 3 active drug and 1 placebo. After evaluation of safety parameters of corresponding dose level, the process will replicate one week afterwards in the following dosages.
The pharmacokinetics profile of PBF-1650 after single oral dose administration of the four dose levels will be also assessed. |
Facilities
Sequence: | 200053186 |
Name | Clinica Universidad de Navarra |
City | Pamplona |
State | Navarra |
Zip | 31007 |
Country | Spain |
Conditions
Sequence: | 52156426 |
Name | Psoriasis |
Downcase Name | psoriasis |
Id Information
Sequence: | 40148180 |
Id Source | org_study_id |
Id Value | PBF-1650CT-01 |
Countries
Sequence: | 42557700 |
Name | Spain |
Removed | False |
Design Groups
Sequence: | 55577860 | Sequence: | 55577861 | Sequence: | 55577862 | Sequence: | 55577863 | Sequence: | 55577864 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Placebo Comparator |
Title | PBF-1650 40mg | Title | PBF-1650 80mg | Title | PBF-1650 120mg | Title | PBF-1650 240mg | Title | Placebo |
Interventions
Sequence: | 52471963 | Sequence: | 52471964 |
Intervention Type | Drug | Intervention Type | Drug |
Name | PBF-1650 oral capsules | Name | Placebo oral capsule |
Description | Adenosine A3 receptor (AA3R) antagonist | Description | solid microcrystalline cellulose |
Keywords
Sequence: | 79848016 | Sequence: | 79848017 | Sequence: | 79848018 |
Name | Adenosine A3 receptor antagonist | Name | autoimmune diseases | Name | Immune modulator |
Downcase Name | adenosine a3 receptor antagonist | Downcase Name | autoimmune diseases | Downcase Name | immune modulator |
Design Outcomes
Sequence: | 177327742 |
Outcome Type | primary |
Measure | Number of Adverse events |
Time Frame | 7 Days |
Description | Adverse Events will be qualified according to the definitions and values stated in CTCAE V04 v4) |
Browse Conditions
Sequence: | 193431915 | Sequence: | 193431916 | Sequence: | 193431917 |
Mesh Term | Psoriasis | Mesh Term | Skin Diseases, Papulosquamous | Mesh Term | Skin Diseases |
Downcase Mesh Term | psoriasis | Downcase Mesh Term | skin diseases, papulosquamous | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306010 | Sequence: | 48306011 |
Agency Class | INDUSTRY | Agency Class | UNKNOWN |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Palobiofarma SL | Name | Clínica Universidad de Navarra |
Design Group Interventions
Sequence: | 68130811 | Sequence: | 68130812 | Sequence: | 68130813 | Sequence: | 68130814 | Sequence: | 68130815 |
Design Group Id | 55577862 | Design Group Id | 55577863 | Design Group Id | 55577860 | Design Group Id | 55577861 | Design Group Id | 55577864 |
Intervention Id | 52471963 | Intervention Id | 52471963 | Intervention Id | 52471963 | Intervention Id | 52471963 | Intervention Id | 52471964 |
Eligibilities
Sequence: | 30757328 |
Gender | Male |
Minimum Age | 18 Years |
Maximum Age | 45 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Healthy male subjects, 18-45 years (inclusive) of age at the time of enrollment. Exclusion Criteria: History of serious adverse reactions or hypersensitivity to any drug. |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254224849 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 3 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 45 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30503553 |
Allocation | Randomized |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Intervention Model Description | Single center, randomized, double-blind, placebo-controlled clinical study. |
Subject Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28869831 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798223
2019-01-10
https://zephyrnet.com/?p=NCT03798223
NCT03798223https://www.clinicaltrials.gov/study/NCT03798223?tab=tableNANANAA randomized controlled trial to evaluate which treatment protocol in selective laser trabeculoplasty that is most optimal in terms of efficacy and safety.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-03-07 |
Start Month Year | January 10, 2019 |
Primary Completion Month Year | May 31, 2025 |
Verification Month Year | January 2023 |
Verification Date | 2023-01-31 |
Last Update Posted Date | 2023-03-07 |
Detailed Descriptions
Sequence: | 20662749 |
Description | A randomized controlled trial in which individuals scheduled for SLT are randomized to one of four treatment protocols, which represent the most common variants of the treatment in clinical use.
Treatment is performed either at 360 degrees or 180 degrees and with a laser energy level either 0,1 millijoules (mJ) below the microbubble formation limit ("low" energy) or at a level that gives microbubbles at 50-75% of laser effects ("high" energy). This gives four treatment arms: 180/low, 180/high, 360/low and 360/high. Group allocation is masked for the patient and is coded in the records. The results for short and long term treatment effects are compared between the groups, as well as the complication rate and postoperative discomfort. |
Facilities
Sequence: | 199443235 | Sequence: | 199443236 | Sequence: | 199443237 | Sequence: | 199443238 |
Name | Ogonkliniken, Sodra Alvsborgs Sjukhus | Name | Ogonkliniken, Sahlgrenska Universitetssjukhuset | Name | Ogonkliniken, Skaraborgs Sjukhus | Name | Ogonkliniken NU-sjukvarden |
City | Boras | City | Molndal | City | Skovde | City | Uddevalla |
State | Vastra Gotaland | State | Vastra Gotaland | State | Vastra Gotaland | State | Vastra Gotaland |
Zip | 50182 | Zip | 43130 | Zip | 54142 | Zip | 45153 |
Country | Sweden | Country | Sweden | Country | Sweden | Country | Sweden |
Conditions
Sequence: | 52017646 | Sequence: | 52017647 | Sequence: | 52017648 |
Name | Glaucoma, Open-Angle | Name | Pseudoexfoliation Glaucoma | Name | Ocular Hypertension |
Downcase Name | glaucoma, open-angle | Downcase Name | pseudoexfoliation glaucoma | Downcase Name | ocular hypertension |
Id Information
Sequence: | 40038230 | Sequence: | 40038231 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | Optimal SLT | Id Value | 254861 |
Id Type | Other Identifier | ||
Id Type Description | FoU i VGR ID nr | ||
Countries
Sequence: | 42434532 |
Name | Sweden |
Removed | False |
Design Groups
Sequence: | 55424238 | Sequence: | 55424239 | Sequence: | 55424240 | Sequence: | 55424241 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | 180/low | Title | 180/high | Title | 360/low | Title | 360/high |
Description | SLT treatment in the lower half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted 0,1 mJ below the threshold of formation of micro bubbles. | Description | SLT treatment in the lower half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects. | Description | SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted 0,1 mJ below the threshold of formation of micro bubbles. | Description | SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects. |
Interventions
Sequence: | 52329996 |
Intervention Type | Procedure |
Name | SLT |
Description | A drop of Pilocarpine 4% is administered to the eye 20 minutes before SLT. Immediately before SLT a drop of Tetracaine hydrochloride 1% is administered. Selective laser trabeculoplasty is conducted through a Latina lens, in a fashion determined by randomization to a study arm (see description). |
Keywords
Sequence: | 79621519 |
Name | Selective Laser Trabeculoplasty |
Downcase Name | selective laser trabeculoplasty |
Design Outcomes
Sequence: | 176844688 | Sequence: | 176844689 | Sequence: | 176844690 | Sequence: | 176844691 | Sequence: | 176844692 | Sequence: | 176844693 | Sequence: | 176844694 | Sequence: | 176844695 | Sequence: | 176844696 | Sequence: | 176844697 | Sequence: | 176844698 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in intraocular pressure (IOP) | Measure | Achievement of 20% reduction in IOP | Measure | Survival (no additional intervention) | Measure | Survival (SLT allowed) | Measure | Pain perioperatively: on a scale | Measure | Pain postoperatively: on a scale | Measure | Light sensitivity postoperatively | Measure | Impairment of vision postoperatively | Measure | Redness postoperatively | Measure | Flare (inflammation measurement of the anterior chamber) | Measure | Adverse events |
Time Frame | Before SLT and thereafter regularly for 3 years | Time Frame | For 3 years | Time Frame | For 3 years | Time Frame | For 3 years | Time Frame | Immediately after treatment | Time Frame | During the first month | Time Frame | During the first month | Time Frame | During the first month | Time Frame | During the first month | Time Frame | Pre-operatively and then one day, one week and one month post-operatively. | Time Frame | 3 years (although adverse events, if any, are anticipated to emerge in the first post-operative days or weeks). |
Description | The IOP is measured with a Goldmann Applanation Tonometer (GAT) three times before SLT and then at regular intervals after the procedure. The reduction is registered and analyzed in absolute (mmHg) and relative (percent of the IOP before SLT) measures.
Measurement of IOP is planned 1, 3, 6 and 12 months post SLT, and thereafter every six months for 3 years after SLT. The study is conducted in a regular clinical setting and the above mentioned times might be delayed. If target pressure is not achieved, measurements will be planned at shorter intervals, according to a specified algorithm, due to safety reasons. |
Description | See Outcome 1. Analysis of differences between the study arms will also be conducted measuring the proportion of eyes achieving 20% reduction in IOP or more at different time points in each group. | Description | Kaplan-Meier survival analysis will be conducted, measuring the proportion of eyes that stay in the study groups but do not receive any further IOP-lowering intervention (medical, surgical or laser). | Description | See Outcome 3. Kaplan-Meier survival analysis is performed the same way, but additional SLT-treatment will not be judged as failure. | Description | The patient will grade perioperative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol. | Description | The patient will grade post-operative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol, also stating the duration of pain. | Description | The patient will grade post-operative sensitivity to light on an arbitrary scale between 0 (no difference) and 4 (very intense sensitivity to light) on a written protocol, also stating the duration of light sensitivity. | Description | The patient will grade post-operative impairment of vision on an arbitrary scale between 0 (no difference) and 4 (cannot see ones own hand) on a written protocol, also stating the duration of vision impairment. | Description | The patient will grade post-operative redness of the eye on an arbitrary scale between 0 (no difference) and 4 (very intense redness) on a written protocol, also stating the duration of redness. | Description | 15 participants from each treatment arm (60 in total, randomized in a separate block after informed consent) will undergo measurement with a Laser Flare Meter. | Description | The type and frequency of adverse events will be recorded and analyzed in each of the study arms. |
Browse Conditions
Sequence: | 192877654 | Sequence: | 192877655 | Sequence: | 192877656 | Sequence: | 192877657 | Sequence: | 192877658 | Sequence: | 192877659 | Sequence: | 192877660 |
Mesh Term | Glaucoma | Mesh Term | Ocular Hypertension | Mesh Term | Glaucoma, Open-Angle | Mesh Term | Exfoliation Syndrome | Mesh Term | Eye Diseases | Mesh Term | Iris Diseases | Mesh Term | Uveal Diseases |
Downcase Mesh Term | glaucoma | Downcase Mesh Term | ocular hypertension | Downcase Mesh Term | glaucoma, open-angle | Downcase Mesh Term | exfoliation syndrome | Downcase Mesh Term | eye diseases | Downcase Mesh Term | iris diseases | Downcase Mesh Term | uveal diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48176014 | Sequence: | 48176015 |
Agency Class | OTHER_GOV | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Vastra Gotaland Region | Name | Göteborg University |
Overall Officials
Sequence: | 29196897 | Sequence: | 29196898 |
Role | Study Chair | Role | Principal Investigator |
Name | Marcelo Ayala, MD, PhD | Name | Tobias Dahlgren, MD |
Affiliation | Vastra Gotaland Region | Affiliation | Vastra Gotaland Region |
Design Group Interventions
Sequence: | 67943650 | Sequence: | 67943651 | Sequence: | 67943652 | Sequence: | 67943653 |
Design Group Id | 55424239 | Design Group Id | 55424238 | Design Group Id | 55424241 | Design Group Id | 55424240 |
Intervention Id | 52329996 | Intervention Id | 52329996 | Intervention Id | 52329996 | Intervention Id | 52329996 |
Eligibilities
Sequence: | 30675398 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
diagnosis primary open-angle glaucoma, pseudo-exfoliative glaucoma or ocular hypertension. Exclusion Criteria: change of IOP-lowering medication during the last three months. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253866424 |
Number Of Facilities | 4 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 8 |
Designs
Sequence: | 30422156 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Masking Description | The treatment protocol is masked for the patient and for the nurses conducting measures of intraocular pressure during follow-up. |
Subject Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28788683 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798210
2017-01-01
https://zephyrnet.com/?p=NCT03798210
NCT03798210https://www.clinicaltrials.gov/study/NCT03798210?tab=tablePeter Benno, MD, PhDpeter.benno@endoskopienheten.se+46 70 579554Explorative investigation to study the effect of the endogenous bacterium Lactobacillus reuteri ATCC PTA 4659 as a nutrient additive against relapse in ulcerative colitis. Forty patients will be studied with a randomized parallel design over one year. Patients with established treatment against relapse of ulcerative colitis with mesalazine ≤4 grams will be requested to participate in the study, allocated to 20 patients with placebo and 20 with active treatment L. reuteri as an “add-on”. Inklusion: 18-80 years of age, ≥1 relapse with bleeding during previous 12 months with a disease activity Mayo Clinical Score ≤2, treatment with mesalazine ≤4,0 g daily. Exklusion: >80 years of age, no registered bleeding during recent 12 months, on-going steroid treatment, immunosuppressives, biologics or adhesion inhibitors, antibiotics or other clinical trial. behandling med probiotika. Disease monitoring will be done with:
Time to disease relapse with macroscopic bleeding and Mayo score ≥5, blood chemistry and CRP, lipopolysaccharides and gut permeability, fecal calprotectin, and short health scale at 4 weeks, 26 weeks and 52 weeks.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-14 |
Start Month Year | January 1, 2017 |
Primary Completion Month Year | January 31, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-14 |
Detailed Descriptions
Sequence: | 20721652 |
Description | Research question To study whether dietary supplementation with L. reuteri ATCC PTA 4659 (Lr4659) is safe and can reduce the relapse rate and have a positive effect in patients with ulcerative colitis (UC).
Lr4659 is a naturally occurring strain of human origin. It is a typical member of the L. reuteri species, with typical sugar fermentation patterns, reuterin production and growth characteristics. Identification using 16SrRNA gene analysis shows that it has 99% similarity with the type strain of L. reuteri thus confirming that it belongs to this well-known and well-studied species that is considered safe for human consumption. In vitro studies indicate that this strain has strong tolerance to acid environments, as do many other L. reuteri strains and that it has the unusual ability to interfere with TNFalpha mediated propagation of inflammatory responses in human macrophages. Treatment with the probiotic bacterium L. reuteri has been shown to prevent dextran sodium sulfate (DSS)-induced colitis in rats. During DSS-induced colitis, the number of bacteria in the inner firmly-adherent mucus layer increased and bacterial composition of the two layers no longer differed. However, L. reuteri decreased the bacterial translocation from the intestine to mesenteric lymph nodes during DSS treatment, which might be an important part of the mechanisms by which L. reuteri ameliorates DSS-induced colitis in rats. Study design This is a double-blind randomized clinical trial. Randomization will be done to either mesalazine plus Lr4659, or to mesalazine plus placebo for a continuous treatment until new bleeding episode or a maximum of 52 weeks. Forty patients with UC in remission, medicated with <4 g mesalazine and aged over 18 years will be recruited. After written consent to the study the subjects in whom the eligibility criteria are confirmed the subjects will be randomized to receive either 2 daily doses of Lr4659 (n=15) or the corresponding placebo. The total length of study treatment is 52 weeks. Concomitant treatment During the period of the study, the subjects will refrain from ingestion of any kind of probiotic or bacterial preparation. The objective is to determine whether dietary supplementation with Lr4659 is able to: Prolong time in remission and Time from last bleeding episode until re-bleeding, Time from start of study treatment until re-bleeding, Reduce Mayo score reduction by at least 50%, Reduce f-calprotectin, Reduce recovered sucralose in the sucralose gut permeability test, Reduce zonulin expression from gut mucosa, Impact microflora composition Study Product and Dosage Lr4659, consisting of L. reuteri ATCC PTA 4659 will be delivered at a dose of 5×108 colony forming units (CFU) as a powder in capsules. One dose is to be taken in the morning and one in the evening yielding a total daily dose of 1×109 CFU/day. Placebo capsules are identical to Lr4659 except for the active ingredient. The study products will be taken daily throughout the entire 52-week study-period. Inclusion criteria for study: UC confirmed by biopsy, Mayo full score < 2, Total or left-sided UC, Stable diagnose of UC >1 year, History of more than 1 yearly recurrence, Current remission period exceeding 2 months, 18-80 years of age, Baseline 5-ASA ≤4g daily, Mentally fit to participate, Informed consent obtained Exclusion criteria: Crohn's disease, Ulcerative proctitis, Infective colitis, Liver disease, Current use of probiotics, Current medication acetylsalicylic acid (ASA), non-steroidal antiinflammatory drugs (NSAID), corticosteroids, anticoagulants, serotonin-selective re-uptake inhibitors (SSRI), serotonin-noradrenaline re-uptake inhibitors (SNRI), azathioprine (AZA), 6-mercaptopurin (6-MP), thioguanin (TG), anti-TNF-alpha biologicals, Participation in other clinical trials Analyses Evaluation of the clinical Mayo score will be done by ocular inspection and immediate recording in the CRF. C-reactive protein (CRP) will be locally analysed according to clinical routine by Department of clinical chemistry, Uppsala University Hospital. Fecal calprotectin will be analysed according to local routines (Bühlmann, Schönenbuch, Switzerland) by Department of clinical chemistry, Uppsala University Hospital). "Gut" permeability focuses on colonic permeability as studied with recovery of different sugar components in the urine. 24-hour urine will be analysed by an in-house high performance liquid chromatography (HPLC) method by GastroLab, Uppsala University Hospital. Fecal microbiology, alfa-diversity, beta-diversity Expected findings: Prolonged interval to next flare of UC with rectal bleeding. Reduced calprotectin and CRP levels. |
Facilities
Sequence: | 200108214 |
Status | Recruiting |
Name | Uppsala University |
City | Uppsala |
Zip | 75185 |
Country | Sweden |
Facility Contacts
Sequence: | 28106424 | Sequence: | 28106425 |
Facility Id | 200108214 | Facility Id | 200108214 |
Contact Type | primary | Contact Type | backup |
Name | Per M Hellström, Prof | Name | Peter Benno, MD, PhD |
per.hellstrom@medsci.uu.se | peter.benno@endoskopienheten.se | ||
Phone | +46 70 3727423 | Phone | +46 70 5795554 |
Conditions
Sequence: | 52171269 |
Name | Ulcerative Colitis Flare |
Downcase Name | ulcerative colitis flare |
Id Information
Sequence: | 40158659 |
Id Source | org_study_id |
Id Value | ATCC PTA 4659 |
Countries
Sequence: | 42568963 |
Name | Sweden |
Removed | False |
Design Groups
Sequence: | 55593208 | Sequence: | 55593209 |
Group Type | Placebo Comparator | Group Type | Experimental |
Title | Placebo | Title | Lactobacillus reuter's |
Description | Look and taste-alike placebo tablets in white plastic vials. | Description | Lactobacillus reuteri tablets in white plastic vials. |
Interventions
Sequence: | 52485512 | Sequence: | 52485513 |
Intervention Type | Dietary Supplement | Intervention Type | Dietary Supplement |
Name | Lactobacillus reuteri | Name | Placebo |
Description | Study group split in two arms for experimental treatment with Lactobacillus reuteri or placebo. | Description | Placebo |
Keywords
Sequence: | 79868590 | Sequence: | 79868591 | Sequence: | 79868592 | Sequence: | 79868593 |
Name | ulcerative colitis | Name | prevention | Name | microbiota | Name | Lactobacillus |
Downcase Name | ulcerative colitis | Downcase Name | prevention | Downcase Name | microbiota | Downcase Name | lactobacillus |
Design Outcomes
Sequence: | 177378982 | Sequence: | 177378983 | Sequence: | 177378984 | Sequence: | 177378985 | Sequence: | 177378986 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other | Outcome Type | other |
Measure | Rectal bleeding with Mayo score ≥5 | Measure | Increased fecal calprotectin | Measure | Increased CRP | Measure | Serum Zonulin | Measure | Gut permeability |
Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months |
Description | Rectal bleeding as sign of increased inflammatory activity as determined by the Mayor Clinic Score for evaluation of disease activity in ulcerative colitis | Description | Gut inflammatory biomarker | Description | General inflammatory biomarker | Description | Gut permeability biomarker | Description | Recovery of sugar molecules in urine as marker of increased permeability |
Browse Conditions
Sequence: | 193486859 | Sequence: | 193486860 | Sequence: | 193486861 | Sequence: | 193486862 | Sequence: | 193486863 | Sequence: | 193486864 | Sequence: | 193486865 | Sequence: | 193486866 | Sequence: | 193486867 | Sequence: | 193486868 |
Mesh Term | Colitis | Mesh Term | Colitis, Ulcerative | Mesh Term | Ulcer | Mesh Term | Gastroenteritis | Mesh Term | Gastrointestinal Diseases | Mesh Term | Digestive System Diseases | Mesh Term | Colonic Diseases | Mesh Term | Intestinal Diseases | Mesh Term | Pathologic Processes | Mesh Term | Inflammatory Bowel Diseases |
Downcase Mesh Term | colitis | Downcase Mesh Term | colitis, ulcerative | Downcase Mesh Term | ulcer | Downcase Mesh Term | gastroenteritis | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | colonic diseases | Downcase Mesh Term | intestinal diseases | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | inflammatory bowel diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319321 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Uppsala University |
Overall Officials
Sequence: | 29285368 |
Role | Principal Investigator |
Name | Per M Hellström, Prof |
Affiliation | Uppsala University |
Central Contacts
Sequence: | 12008884 | Sequence: | 12008885 |
Contact Type | primary | Contact Type | backup |
Name | Per M Hellström, Prof | Name | Peter Benno, MD, PhD |
Phone | +46 70 3727423 | Phone | +46 70 579554 |
per.hellstrom@medsci.uu.se | peter.benno@endoskopienheten.se | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68149165 | Sequence: | 68149166 |
Design Group Id | 55593209 | Design Group Id | 55593208 |
Intervention Id | 52485512 | Intervention Id | 52485513 |
Eligibilities
Sequence: | 30765372 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 80 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Diagnosis of UC confirmed by biopsy Exclusion Criteria: Crohn's disease |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253884848 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Number Of Other Outcomes To Measure | 2 |
Designs
Sequence: | 30511538 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | Triple |
Masking Description | Pre-masked randomized tablet vials with Lactobacillus reuteri, or corresponding placebo |
Intervention Model Description | Lactobacillus reuteri versus placebo on prevention of flare in ulcerative colitis/proctosgmoiditis |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28877833 |
Responsible Party Type | Principal Investigator |
Name | Per Hellström |
Title | Prof, MD, PhD |
Affiliation | Uppsala University |
]]>
https://zephyrnet.com/NCT03798197
2019-01-30
https://zephyrnet.com/?p=NCT03798197
NCT03798197https://www.clinicaltrials.gov/study/NCT03798197?tab=tableNANANAAssessment of the effect of a high fat meal on the quantity in blood of a female sex hormone called estetrol (E4).
The study also aims at determining how subject tolerate the study drug and how safe it is for them.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-05-07 |
Start Month Year | January 30, 2019 |
Primary Completion Month Year | April 6, 2019 |
Verification Month Year | May 2019 |
Verification Date | 2019-05-31 |
Last Update Posted Date | 2019-05-07 |
Facilities
Sequence: | 200280653 |
Name | MC Comac Medical Ltd. |
City | Sofia |
Country | Bulgaria |
Conditions
Sequence: | 52221608 |
Name | Food-effect |
Downcase Name | food-effect |
Id Information
Sequence: | 40195680 | Sequence: | 40195681 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | MIT-Do001-C101 | Id Value | 2018-003761-34 |
Id Type | EudraCT Number | ||
Countries
Sequence: | 42609695 |
Name | Bulgaria |
Removed | False |
Design Groups
Sequence: | 55649890 | Sequence: | 55649891 |
Group Type | Active Comparator | Group Type | Experimental |
Title | 30 mg estetrol (E4) without food (fasted) | Title | 30 mg estetrol (E4) with food (fed) |
Description | Treatment A (reference): One 30 mg E4 tablet administered orally following an overnight fast of at least 10 hours. | Description | Treatment B (test): One 30 mg E4 tablet administered orally 30 min after the start of an FDA prescribed high-fat breakfast preceded by at least a 10 hours overnight fast. |
Interventions
Sequence: | 52535421 |
Intervention Type | Drug |
Name | 30 mg estetrol (E4) |
Description | All subjects received both Treatment A and Treatment B either at the first treatment period (Period 1) or at the second treatment period (Period 2). Approximately half of the subjects was randomized to receive either Treatment A followed by Treatment B (sequence AB), or Treatment B followed by Treatment A (sequence BA). |
Keywords
Sequence: | 79941864 | Sequence: | 79941865 |
Name | Estetrol | Name | Menopausal hormone therapy |
Downcase Name | estetrol | Downcase Name | menopausal hormone therapy |
Design Outcomes
Sequence: | 177561776 | Sequence: | 177561777 | Sequence: | 177561778 | Sequence: | 177561779 | Sequence: | 177561780 | Sequence: | 177561781 | Sequence: | 177561782 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Maximum concentration (Cmax) of Estetrol in plasma | Measure | Area under the curve (AUC) from time zero to the last determinable concentration of Estetrol | Measure | AUC0-inf of Estetrol | Measure | Time of Cmax (Tmax) | Measure | Terminal phase rate constant (ke) | Measure | Terminal half-life (t1/2) | Measure | Number of subjects with adverse events as measure of safety and tolerability |
Time Frame | Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose | Time Frame | Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose | Time Frame | Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose | Time Frame | Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose | Time Frame | Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose | Time Frame | Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose | Time Frame | From Day 28 prior screening to end of study (Day 4 of Period 2) |
Description | PK sampling | Description | PK sampling | Description | PK sampling | Description | PK sampling | Description | PK sampling | Description | PK sampling |
Sponsors
Sequence: | 48366492 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Donesta Bioscience |
Overall Officials
Sequence: | 29312953 |
Role | Principal Investigator |
Name | Dobrin Svinarov, MD |
Affiliation | MC Comac Medical Ltd. |
Design Group Interventions
Sequence: | 68217502 | Sequence: | 68217503 |
Design Group Id | 55649891 | Design Group Id | 55649890 |
Intervention Id | 52535421 | Intervention Id | 52535421 |
Eligibilities
Sequence: | 30794756 |
Gender | Female |
Minimum Age | 40 Years |
Maximum Age | 65 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Overtly healthy postmenopausal females as determined by medical history, physical examination including breast examination, gynecological examination, cervical smear (Pap smear) if subject has cervix, vital signs, and laboratory tests performed within 28 days before first study drug intake. Exclusion Criteria: For non-hysterectomized women: uterine disease or medical condition including: Bi-layer endometrial thickness >5mm as determined by TVUS; Use of : Any prescription drugs within 28 days prior to the first study dose administration. Donation or loss of ≥ 450 mL blood within 1 month prior to initial study drug administration. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004400 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 2 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 40 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30540796 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26696967 |
Intervention Id | 52535421 |
Name | 30 mg E4 tablet |
Responsible Parties
Sequence: | 28907116 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798184
2018-11-19
https://zephyrnet.com/?p=NCT03798184
NCT03798184https://www.clinicaltrials.gov/study/NCT03798184?tab=tableNANANAComposite restoration of non-carious cervical lesions has always been a challenge for the clinician, considering that the most frequent cause of failure is retention loss.
Adhesion of composite restoration may be obtained by following four different etching techniques: total-etch in three steps, total-etch in two steps, self-etch in two steps, and self-etch in one step. Nowadays the tendency is to simplify the adhesive classic protocols. With the introduction of universal adhesives such as Prime&Bond Active (Dentsply Sirona) it is possible to obtain a total-etch pattern (enamel and dentine) without the classic etching technique with orthophosphoric acid.
On the other hand, there has been an increase in the awareness of the importance of remaining dental tissue preservation, avoiding preparation of a cavity. This is why it is now preferable to use bioactive glass in order to increase micromechanical retention on the dental surface, instead of the classical approach of preparing the surface with burs.
To date, there are no studies evaluating the clinical performance of the universal adhesive Prime&Bond Active on direct resin composite restoration of non-carious cervical lesions neither in a selective-etch mode (enamel etching) or a self-etch mode (no etching) or using sandblasting with bioactive glass. Therefore, the main objective of the study is to evaluate the retention rate of composite restorations using Prime&Bond Active and a previous sandblasted surface with bioglass in a three-year follow-up, as well as the presence of marginal discoloration, marginal integrity and marginal caries.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-18 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | November 19, 2018 |
Primary Completion Month Year | November 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Detailed Descriptions
Sequence: | 20709987 |
Description | The protocol to be followed in the study is as follows:
Obtention of a written informed consent of all participants. Randomly assigning each non-carious cervical lesion to one of the four experimental groups: 5.1. Selective enamel etching and surface roughening with bioglass 5.2. Selective enamel etching without surface roughening. 5.3. Self-etch and surface roughening with bioglass. 5.4. Self-etch without surface roughening. In experimental groups which need surface roughening (group 5.1 and 5.3), sandblasting with bioactive glass will be used in enamel. In experimental groups with selective enamel etch (5.1 and 5.2), 37 % orthophosphoric acid is applied for 15 seconds in enamel, followed by profuse washing with air/water spray for ten seconds and dried using air for 10 seconds without desiccating dentin. In groups 5.3 and 5.4 this step is omitted. Application of universal adhesive Prime&Bond Active on enamel and dentin for 20 seconds. Subsequently, evaporation of the solvent is realized by applying air for 5 seconds and then light curing for 20 seconds. The primary objective is to evaluate the retention of the restoration. The secondary objectives are to evaluate marginal discoloration, marginal integrity and marginal caries. |
Facilities
Sequence: | 199965067 |
Name | University of Valencia |
City | Valencia |
Country | Spain |
Conditions
Sequence: | 52138996 | Sequence: | 52138997 | Sequence: | 52138998 | Sequence: | 52138999 | Sequence: | 52139000 | Sequence: | 52139001 |
Name | Self-etch | Name | Selective-etch | Name | Bioactive Glass | Name | Direct Resin Composite Restoration | Name | Non-carious Cervical Lesion | Name | Universal Adhesive |
Downcase Name | self-etch | Downcase Name | selective-etch | Downcase Name | bioactive glass | Downcase Name | direct resin composite restoration | Downcase Name | non-carious cervical lesion | Downcase Name | universal adhesive |
Id Information
Sequence: | 40135060 |
Id Source | org_study_id |
Id Value | 2/2018 |
Countries
Sequence: | 42542684 |
Name | Spain |
Removed | False |
Design Groups
Sequence: | 55559338 | Sequence: | 55559339 | Sequence: | 55559340 | Sequence: | 55559341 |
Group Type | Experimental | Group Type | Active Comparator | Group Type | Experimental | Group Type | Active Comparator |
Title | Selective-etch with bioglass surface roughening | Title | Selective-etch without bioglass surface roughening | Title | Self-etch with bioglass surface roughening | Title | Self-etch without bioglass surface roughening |
Interventions
Sequence: | 52454906 |
Intervention Type | Procedure |
Name | Non-carious cervical lesion restoration |
Description | Restoration of non-carious cervical lesions with Prime&Bond Active in self-etch or selective-etch mode with or without bioglass |
Keywords
Sequence: | 79822811 | Sequence: | 79822812 | Sequence: | 79822813 | Sequence: | 79822814 |
Name | Prime&Bond Active | Name | Bioactive glass | Name | non-carious cervical lesion | Name | direct resin composite |
Downcase Name | prime&bond active | Downcase Name | bioactive glass | Downcase Name | non-carious cervical lesion | Downcase Name | direct resin composite |
Design Outcomes
Sequence: | 177263626 | Sequence: | 177263627 | Sequence: | 177263628 | Sequence: | 177263629 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Retention rate | Measure | Marginal discoloration | Measure | Marginal integrity | Measure | Marginal caries |
Time Frame | Three years | Time Frame | Three years | Time Frame | Three years | Time Frame | Three years |
Description | Presence of resin composite restorations of non-carious cervical lesions at the three-year follow-up examination. | Description | Presence of marginal staining between the restoration and tooth will be evaluated following USPHS criteria (Modified United States Public Health Service) | Description | The quality of the interface between restoration and tooth will be evaluated following USPHS criteria (Modified United States Public Health Service) | Description | The presence of clinical diagnosis of caries will be evaluated following USPHS criteria (Modified United States Public Health Service) |
Browse Conditions
Sequence: | 193366504 | Sequence: | 193366505 | Sequence: | 193366506 | Sequence: | 193366507 | Sequence: | 193366508 | Sequence: | 193366509 | Sequence: | 193366510 |
Mesh Term | Uterine Cervical Diseases | Mesh Term | Uterine Diseases | Mesh Term | Genital Diseases, Female | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Genital Diseases |
Downcase Mesh Term | uterine cervical diseases | Downcase Mesh Term | uterine diseases | Downcase Mesh Term | genital diseases, female | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | genital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290704 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Valencia |
Design Group Interventions
Sequence: | 68107448 | Sequence: | 68107449 | Sequence: | 68107450 | Sequence: | 68107451 |
Design Group Id | 55559338 | Design Group Id | 55559339 | Design Group Id | 55559340 | Design Group Id | 55559341 |
Intervention Id | 52454906 | Intervention Id | 52454906 | Intervention Id | 52454906 | Intervention Id | 52454906 |
Eligibilities
Sequence: | 30747720 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Patients ≥ 18 years without systemic disease. Exclusion Criteria: Presence of rampant caries or advanced periodontal disease. Teeth with pulpal and/or periapical pathology, and endodontically treated teeth are excluded from the study. Teeth with previous pulp capping or previous class V restorations will also be excluded. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121848 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30494003 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28860283 |
Responsible Party Type | Principal Investigator |
Name | Cristina Pasarín Linares |
Title | Teaching Assistant |
Affiliation | University of Valencia |
]]>
https://zephyrnet.com/NCT03798171
2018-05-15
https://zephyrnet.com/?p=NCT03798171
NCT03798171https://www.clinicaltrials.gov/study/NCT03798171?tab=tableNANANAIn peritoneal dialysis patients, the presence of the catheter presents a risk of infection – exit site infection, tunnel infection or peritonitis. In our dialysis unit, we noticed a rise in exit-site infection associated with organisms derived from contaminated water. Therefore we decided to change the exit-site care in our unit.
This is a prospective observational single center study, that compares exit-site infection rated in peritoneal dialysis patients before and after our policy change for exit-site care.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | May 15, 2018 |
Primary Completion Month Year | May 15, 2021 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Detailed Descriptions
Sequence: | 20727156 |
Description | Peritoneal dialysis is a method for renal replacement therapy that uses the peritoneal membrane for exchange of fluids and dissolved substance . A catheter is surgically inserted with one end in the abdomen and the other protruding from the skin, in order to allow fluid exchange.
The presence of the catheter presents a risk of infection – exit site infection, tunnel infection or peritonitis – a cause of morbidity and treatment failure. Infection prevention is based, among other measures, on aseptic handeling of catheter exit-site. In our dialysis unit, we noticed a rise in pseudomonas exit-site infection and other organisms associated with contaminated water. Therefore we decided to change the exit-site care in our unit. Similar to central catheters handeling, we decided to cover the catheter exit-site during water exposure, and to change the prophylactic exit-site antibiotic regimen. This is a prospective observational single center study. All peritoneal dialysis patients in our institue will be counseled about change in exit-site care. For prevention of water exposure the patients will use stoma bags around the catheter during showers. After the shower, the exit-site is cleaned with a chlorhexidine based solution, an antibiotic cream is applied (Mupirocin) and dressed with a clean gauze. The patients will be followed for 3 years for adverse events. The number of infectious episodes will be recorded and compared to historical data (January 2015-December 2017). |
Facilities
Sequence: | 200159116 |
Status | Recruiting |
Name | Tel Aviv Sourasky Medical Canter |
City | Tel Aviv |
Country | Israel |
Facility Contacts
Sequence: | 28113716 |
Facility Id | 200159116 |
Contact Type | primary |
Name | Orit Kliuk Ben Bassat, MD |
oritkl@tlvmc.gov.il | |
Phone | 97236973270 |
Conditions
Sequence: | 52185425 |
Name | Peritoneal Dialysis Catheter Infection |
Downcase Name | peritoneal dialysis catheter infection |
Id Information
Sequence: | 40169032 |
Id Source | org_study_id |
Id Value | 0077-18-TLV |
Countries
Sequence: | 42580626 |
Name | Israel |
Removed | False |
Keywords
Sequence: | 79888628 | Sequence: | 79888629 | Sequence: | 79888630 | Sequence: | 79888631 |
Name | peritoneal dialysis | Name | exit site | Name | infection | Name | peritonitis |
Downcase Name | peritoneal dialysis | Downcase Name | exit site | Downcase Name | infection | Downcase Name | peritonitis |
Design Outcomes
Sequence: | 177431855 | Sequence: | 177431856 |
Outcome Type | primary | Outcome Type | secondary |
Measure | exit-site infection rate | Measure | peritonitis rate |
Time Frame | 36 months | Time Frame | 36 months |
Description | number of exit-site infection during 3 years of follow up, compared to historical data | Description | number of peritonitis episodes during 3 years of follow up, compared to historical data |
Browse Conditions
Sequence: | 193539859 | Sequence: | 193539860 | Sequence: | 193539861 | Sequence: | 193539862 |
Mesh Term | Infections | Mesh Term | Communicable Diseases | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
Downcase Mesh Term | infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48332269 |
Agency Class | OTHER_GOV |
Lead Or Collaborator | lead |
Name | Tel-Aviv Sourasky Medical Center |
Eligibilities
Sequence: | 30773543 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 99 Years |
Healthy Volunteers | No |
Population | peritoneal dialysis patients in Tel Aviv Sourasky medical center |
Criteria | Inclusion Criteria:
peritoneal dialysis patients capable to sign an informed consent or have an official guardian Exclusion Criteria: patient's refusal |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253952566 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 99 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30519674 |
Observational Model | Case-Only |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28885975 |
Responsible Party Type | Principal Investigator |
Name | michal roll |
Title | Department of nephrology |
Affiliation | Tel-Aviv Sourasky Medical Center |
]]>
https://zephyrnet.com/NCT03798158
2019-04-11
https://zephyrnet.com/?p=NCT03798158
NCT03798158https://www.clinicaltrials.gov/study/NCT03798158?tab=tableNANANAThe investigators aim to make an overview of persistent dyspnea at the end of an hospitalization for a respiratory disease using an actual tool, the Multidisciplinary Dyspnea Profile questionnaire.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-21 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2021-07-23 |
Start Month Year | April 11, 2019 |
Primary Completion Month Year | April 30, 2025 |
Verification Month Year | July 2021 |
Verification Date | 2021-07-31 |
Last Update Posted Date | 2021-07-23 |
Facilities
Sequence: | 200053207 |
Status | Recruiting |
Name | ADOREPS |
City | Paris |
Zip | 75013 |
Country | France |
Facility Contacts
Sequence: | 28097502 |
Facility Id | 200053207 |
Contact Type | primary |
Name | Capucine MORELOT, MD,PhD |
capucine.morelot@aphp.fr | |
Phone | 01 42 16 77 71 |
Phone Extension | 0033 |
Conditions
Sequence: | 52156443 | Sequence: | 52156444 |
Name | Dyspnea | Name | Pulmonary Disease |
Downcase Name | dyspnea | Downcase Name | pulmonary disease |
Id Information
Sequence: | 40148189 |
Id Source | org_study_id |
Id Value | 2018-A02757-48 |
Countries
Sequence: | 42557706 |
Name | France |
Removed | False |
Interventions
Sequence: | 52471972 |
Intervention Type | Other |
Name | Multidisciplinary Dyspnea Profile questionnaire |
Description | Multidisciplinary Dyspnea Profile questionnaire at the beginning and the end of an hospitalization |
Design Outcomes
Sequence: | 177327803 | Sequence: | 177327804 | Sequence: | 177327805 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Prevalence of persistent dyspnea in the end of an hospitalization for a a respiratory disease | Measure | Characterization of persistent dyspnea using MDP | Measure | Outcome of patients with persistent dyspnea after hospitalization |
Time Frame | An average of one week, until the end of the hospitalization | Time Frame | An average of one week, until the end of the hospitalization | Time Frame | 6 months |
Description | 6 months mortality, incidence of rehospitalization |
Browse Conditions
Sequence: | 193431946 | Sequence: | 193431947 | Sequence: | 193431948 | Sequence: | 193431949 |
Mesh Term | Dyspnea | Mesh Term | Respiratory Tract Diseases | Mesh Term | Respiration Disorders | Mesh Term | Signs and Symptoms, Respiratory |
Downcase Mesh Term | dyspnea | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | respiration disorders | Downcase Mesh Term | signs and symptoms, respiratory |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306027 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil |
Eligibilities
Sequence: | 30757334 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Every consecutive patient admitted to hospitalization for a respiratory cause having a significant dyspnea |
Criteria | Inclusion Criteria:
Age over 18 years old Exclusion Criteria: cognitive impairment |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254226515 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30503559 |
Observational Model | Other |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28869837 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798145
2021-12-31
https://zephyrnet.com/?p=NCT03798145
NCT03798145https://www.clinicaltrials.gov/study/NCT03798145?tab=tableNANANAGlaucoma is a leading cause of blindness worldwide. It is caused by persistently elevated intraocular pressure causing progressive visual field loss. While a number of conventional medical and surgical therapies exist, a significant number of patients fail to respond resulting in persistently elevated intraocular pressure and eventual blindness. While outflow from the eye primarily occurs through the front of the eye, there is an often overlooked pathway to remove fluid that is beneath the retina. Surgical removal of retina to create paths for outflow (surgical retinotomy) in areas damaged by glaucoma can provide access to this alternative outflow pathway thereby reducing intraocular pressure and halting the vision loss.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2020-07-17 |
Start Month Year | December 2021 |
Primary Completion Month Year | December 2024 |
Verification Month Year | July 2020 |
Verification Date | 2020-07-31 |
Last Update Posted Date | 2020-07-17 |
Detailed Descriptions
Sequence: | 20735826 |
Description | The goal of this study is to demonstrate that focal surgical retinotomies (holes in the retina) can result in predictable and lasting reduction in intraocular pressure while eliminating the risks associated with surgical retinectomy (broad areas of retinal removal).
In the late 1990s and early 2000s, Joussen et al pioneered a technique to lower intraocular pressure in patients with advanced untreatable glaucoma. All patients had intraocular pressures on average above 40 that were unresponsive to any available treatments. Forty-four patients underwent broad areas of retinal removal (retinectomy). All patients exhibited dramatic reductions in intraocular pressure which were maintained for 5 years (Joussen 2003). Unfortunately, the technique carried significant risks. 1) a subset of patients had excessively low intraocular pressure reductions. 2) a subset of patients had secondary proliferative vitreoretinopathy (a scarring response) that resulting in retinal deatchment. Despite its incredible effectiveness, these risks made clinicians hesitant to adopt the technique. Additionally, glaucoma specialists are unable to perform the technical procedures required creating a chasm between diagnosing physician (glaucoma specialist) and the treating physician (retina specialist). Finally, surgical microtools tools at the time were still in their infancy. The current proposal attempts to make critical modifications to the technique used by Joussen et al. (2003). First and foremost, we plan to use surgical retinotomies (holes in the retina) in lieu of a broad surgical retinectomy (broad peripheral retinal removal). This is a critical difference. Removal of the peripheral retina to the ora serrata carries significant risk of postoperative proliferative vitreoretinopathy. This is largely due to residual vitreous which cannot be removed from the far peripheral retina. This residual vitreous contracts in the postoperative period causing elevation of the retinectomy edges allowing for retinal detachment. Surgical retinotomies (holes in the retina), that do not involve the vitreous base are commonly used in retina surgery and do not carry anywhere close to the risk of retinal detachment that surgical retinectomy carries. As an example, the majority of retinal detachments are repaired by draining fluid through an iatrogenic surgical retinotomy (a hole created by the surgeon in the retina). These holes are created in the posterior retina and yet are virtually always undetectable by the patient. (Of note, a peripheral retinotomy is even harder to detect). More recently, there has been an upsurge of free-flap autologous retinal transplantation for macular holes (Grewal 2016) and macular degeneration (Parolini 2018). In these surgical procedures, an area of peripheral retina is removed and transplanted to the macula. The site of removal leaves a hole in the retina. In these studies the rate of redetachment in patients in whom a retinotomy was created is no higher than that of other standard retina surgeries. It is therefore clear that creation of retinal holes (retinotomy) is far different in terms of long-term risks than broad retinal removal to the ora serrata (retinectomy). Additionally, this increase in retina transplantation has been made possible by the microsurgical surgical tools that are now available. However, in the case of both the retinal detachment repair and autologous transplantation, the retinotomy size is not sufficient to induce intraocular pressure lowering effects. We therefore seek to build upon the original work from Joussen et al (2003) which showed that retina removal can have dramatic intraocular pressure lowering effects, but seek to use surgical retinotomies (holes in the retina) to achieve this retinal removal thereby avoiding his surgical complications while capitalizing on the long-term efficacy. By varying the size and number of surgical retinotomy, we will be able to provide a normogram for effective prediction of intraocular pressure lowering effects. By effectively predicting the magnitude of this surgical procedure, ophthalmologists will have a predictable and reliable method for treating glaucoma. Furthermore, because a surgical retinotomy does not close, it is predicted to provide a life-long effect. |
Conditions
Sequence: | 52208226 |
Name | Glaucoma |
Downcase Name | glaucoma |
Id Information
Sequence: | 40186236 |
Id Source | org_study_id |
Id Value | 49075 |
Design Groups
Sequence: | 55634813 |
Group Type | Experimental |
Title | Surgical Retinotomy |
Description | Surgical retinotomy will be constructed in the area of the scotoma. |
Interventions
Sequence: | 52522205 |
Intervention Type | Procedure |
Name | Surgical Retinotomy |
Description | Surgical removal of small areas of retinal to increase outflow through the posterior drainage pathway. |
Design Outcomes
Sequence: | 177511815 | Sequence: | 177511816 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Intraocular Pressure | Measure | Visual Field Progression |
Time Frame | 2 years | Time Frame | 2 years |
Description | Percentage Reduction in Intraocular Pressure | Description | Visual Field Progression on HVF 24-2 or Goldmann Visual Field |
Browse Conditions
Sequence: | 193627459 | Sequence: | 193627460 | Sequence: | 193627461 |
Mesh Term | Glaucoma | Mesh Term | Ocular Hypertension | Mesh Term | Eye Diseases |
Downcase Mesh Term | glaucoma | Downcase Mesh Term | ocular hypertension | Downcase Mesh Term | eye diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48353803 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Stanford University |
Design Group Interventions
Sequence: | 68199367 |
Design Group Id | 55634813 |
Intervention Id | 52522205 |
Eligibilities
Sequence: | 30786942 |
Gender | All |
Minimum Age | 50 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Glaucoma with reproducible and progressive peripheral field loss Elevated Intraocular pressure despite topical medications and filtering surgery (trabeculectomy, tube shunts) Pseudophakia (prior cataract surgery) Greater than 50 years old Exclusion Criteria: Uveitic Glaucoma Foveal threatening visual field loss (field loss within 5 degrees of fixation) (i.e. advanced glaucoma) Active ophthalmic infection Monocular (functional vision in only one eye) Rapidly progressive glaucoma (as assessed by more than -1.00 MD drop over three months of visual field testing) Non-native English Speakers |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253989727 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 50 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30533012 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28899306 |
Responsible Party Type | Principal Investigator |
Name | Ira Schachar |
Title | Principal Investigator |
Affiliation | Stanford University |
Study References
Sequence: | 52103207 | Sequence: | 52103208 | Sequence: | 52103209 | Sequence: | 52103210 | Sequence: | 52103211 |
Pmid | 26720054 | Pmid | 12928275 | Pmid | 29210941 | Pmid | 21336153 | Pmid | 29578892 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Grewal DS, Mahmoud TH. Autologous Neurosensory Retinal Free Flap for Closure of Refractory Myopic Macular Holes. JAMA Ophthalmol. 2016 Feb;134(2):229-30. doi: 10.1001/jamaophthalmol.2015.5237. No abstract available. | Citation | Joussen AM, Walter P, Jonescu-Cuypers CP, Koizumi K, Poulaki V, Bartz-Schmidt KU, Krieglstein GK, Kirchhof B. Retinectomy for treatment of intractable glaucoma: long term results. Br J Ophthalmol. 2003 Sep;87(9):1094-102. doi: 10.1136/bjo.87.9.1094. | Citation | Parolini B, Grewal DS, Pinackatt SJ, Baldi A, Di Salvatore A, Besozzi G, Finzi A, Cardillo D, Mahmoud TH. COMBINED AUTOLOGOUS TRANSPLANTATION OF NEUROSENSORY RETINA, RETINAL PIGMENT EPITHELIUM, AND CHOROID FREE GRAFTS. Retina. 2018 Sep;38 Suppl 1(Suppl 1):S12-S22. doi: 10.1097/IAE.0000000000001914. | Citation | Ramli N, Htoon HM, Ho CL, Aung T, Perera S. Risk factors for hypotony after transscleral diode cyclophotocoagulation. J Glaucoma. 2012 Mar;21(3):169-73. doi: 10.1097/IJG.0b013e318207091a. | Citation | Jain K, Dubey S, Pegu J. Comparison of Efficacy and Complications of Cyclophotocoagulation and Second Glaucoma Drainage Device After Initial Glaucoma Drainage Device Failure. J Glaucoma. 2018 Aug;27(8):e140. doi: 10.1097/IJG.0000000000000955. No abstract available. |
]]>
https://zephyrnet.com/NCT03798132
2019-01-01
https://zephyrnet.com/?p=NCT03798132
NCT03798132https://www.clinicaltrials.gov/study/NCT03798132?tab=tableNANANApathologically proved ovarian cancer patients that underwent contrast enhanced abdomino-pelvic CT and diagnostic laparoscopy before cytoreductive surgery (CRS) will be included in the study. Calculation of PCI (peritoneal cancer index) using Sugarbaker’s method, peritoneal carcinomatosis extent will be categorized into low, moderate and large. Agreement in general and in each category between CT, laparoscopy, surgery and pathology will be assessed using kappa agreement.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | January 1, 2019 |
Primary Completion Month Year | June 11, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-09 |
Detailed Descriptions
Sequence: | 20721656 |
Description | we will search medical records of primary ovarian cancer patients underwent CT abdomen, laparoscopy followed by cytoreductive surgery to calculate peritoneal carcinomatosis extent by each modality.
Regional PCI was calculated in each of the 13 anatomical abdominopelvic regions, then total PCI by summation of the lesion size score, it ranged from 0 to 39. Categorization of peritoneal carcinomatosis was classified into 3 categories low if PCI < 10, moderate if 10-20, and large if >20. |
Facilities
Sequence: | 200108479 |
Status | Recruiting |
Name | South Egypt Cancer Institute |
City | Assiut |
Zip | 11517 |
Country | Egypt |
Facility Contacts
Sequence: | 28106429 |
Facility Id | 200108479 |
Contact Type | primary |
Name | Shimaa Ahmed, Lecturer |
shimaaabdalla@aun.edu.eg | |
Phone | 01007653325 |
Conditions
Sequence: | 52171278 |
Name | Peritoneal Carcinomatosis |
Downcase Name | peritoneal carcinomatosis |
Id Information
Sequence: | 40158666 |
Id Source | org_study_id |
Id Value | SouthECI |
Countries
Sequence: | 42568969 |
Name | Egypt |
Removed | False |
Interventions
Sequence: | 52485523 |
Intervention Type | Diagnostic Test |
Name | laparoscopy |
Description | evaluation of peritoneal carcinomatosis by laparoscopy |
Keywords
Sequence: | 79868608 |
Name | Ovarian Neoplasms, Laparoscopy, Cytoreduction Surgical Procedures. |
Downcase Name | ovarian neoplasms, laparoscopy, cytoreduction surgical procedures. |
Design Outcomes
Sequence: | 177379007 | Sequence: | 177379008 |
Outcome Type | primary | Outcome Type | secondary |
Measure | peritoneal carcinomatosis | Measure | surgical decision making. |
Time Frame | one year | Time Frame | one year |
Description | Agreement in general and in each category between CT, laparoscopy, surgery and pathology was assessed using kappa agreement. | Description | correlation of peritoneal carcinomatosis categorization with surgical decision |
Browse Conditions
Sequence: | 193486903 | Sequence: | 193486904 | Sequence: | 193486905 | Sequence: | 193486906 | Sequence: | 193486907 | Sequence: | 193486908 | Sequence: | 193486909 | Sequence: | 193486910 | Sequence: | 193486911 | Sequence: | 193486912 |
Mesh Term | Carcinoma | Mesh Term | Peritoneal Neoplasms | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Abdominal Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Digestive System Neoplasms | Mesh Term | Digestive System Diseases | Mesh Term | Peritoneal Diseases |
Downcase Mesh Term | carcinoma | Downcase Mesh Term | peritoneal neoplasms | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | abdominal neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | digestive system neoplasms | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | peritoneal diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319330 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Shimaa Abdalla Ahmed |
Eligibilities
Sequence: | 30765378 |
Sampling Method | Non-Probability Sample |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | 100 Years |
Healthy Volunteers | No |
Population | pathologically proved ovarian cancer patients recived cytoreductive surgery and underwent preoperative CT and diagnostic laparoscopy |
Criteria | Inclusion Criteria:pathologically proved ovarian cancer patients underwent contrast enhanced abdominopelvic CT and diagnostic laparoscopy before cytoreductive surgery –
Exclusion Criteria:recurrent ovarian cancer – |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253884890 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 100 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30511544 |
Observational Model | Cohort |
Time Perspective | Retrospective |
Responsible Parties
Sequence: | 28877839 |
Responsible Party Type | Sponsor-Investigator |
Name | Shimaa Abdalla Ahmed |
Title | lecturer of radiodiagnosis |
Affiliation | South Egypt Cancer Institute |
Study References
Sequence: | 52063424 |
Pmid | 18801470 |
Reference Type | background |
Citation | Fagotti A, Ferrandina G, Fanfani F, Garganese G, Vizzielli G, Carone V, Salerno MG, Scambia G. Prospective validation of a laparoscopic predictive model for optimal cytoreduction in advanced ovarian carcinoma. Am J Obstet Gynecol. 2008 Dec;199(6):642.e1-6. doi: 10.1016/j.ajog.2008.06.052. Epub 2008 Sep 17. |
]]>
https://zephyrnet.com/NCT03798119
2019-02-25
https://zephyrnet.com/?p=NCT03798119
NCT03798119https://www.clinicaltrials.gov/study/NCT03798119?tab=tableMing-Lung Yu, Prof.fish6069@gmail.com+88673121101A total of 80 adult chronic hepatitis B patients with advanced liver fibrosis (including fibrosis stage 3 and cirrhosis), who are currently on nucleot(s)ide analogs (except tenofovir alafenamide) therapy with detectable HBV DNA after 52 weeks of therapy will switch prior NUCs to TAF 25 mg/day for 96 weeks
<![CDATA[
Studies
Study First Submitted Date | 2018-12-24 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-04-26 |
Start Month Year | February 25, 2019 |
Primary Completion Month Year | August 31, 2020 |
Verification Month Year | December 2018 |
Verification Date | 2018-12-31 |
Last Update Posted Date | 2019-04-26 |
Detailed Descriptions
Sequence: | 20741208 |
Description | Study Overview
Dosage regimen: Patients of CHB with advanced fibrosis and partial virological response to NUCs will be considered eligible for the present study. The enrollment will be up to the physician's discretion. The drug will be administered 1 pill (25 mg) per day orally, per manufacturers' instructions, and can be taken with food. Compliance: Enrolled patients must be monitored according to the protocol, GCP, and clinical practice guidelines. Study population: Approximately 80 adult CHB patients with advanced fibrosis (including fibrosis stage 3 and cirrhosis), who are currently on NUCs (except TAF) therapy with detectable HBV DNA after 52 weeks of therapy will switch prior NUCs to TAF 25 mg/day for 96 weeks. For patients of fibrosis stage 3, the numbers of enrolled patients will be no more than 40% of total enrolled patients. Study Objectives Primary objective: • To describe the improvement of rate of viral suppression with TAF in patients of partial virological response with previous anti-HBV NUCs. Secondary objective To describe the persistence or improvement of rate of ALT normalization (local and AASLD criteria) with TAF in patients of partial virological response with previous anti-HBV NUCs. Study Procedures: Pre-Screening: Patients who are currently under HBV NUC, except TAF therapy, with liver fibrosis stage 3 or 4 at the initiation of NUC, and with detectable HBV DNA after week 52 of therapy will be considered eligible in this prospective interventional cohort study. If the patient is deemed eligible to participate, the site will evaluate the potential patient using the inclusion/exclusion criteria and fill out the CRF for the screening visit. The local coordinator will transmit the pre-screening data to the central coordinator prior to the actual screening/baseline visit. If the patient is deemed eligible by the Primary Investigator, the patient will be given a study ID and allowed to enter the study. Screening/Baseline: Written and informed consent will be obtained prior to any study protocol-related procedures or data abstraction. If the patient has been pre-screened approved and all lab data are available, the participant will begin the study TAF treatment on the screening/baseline visit. The screening/baseline visit consists of obtaining written and informed consent, reviewing the inclusion/exclusion criteria, confirming medical history, completing a physical examination with vital signs and body weight, reviewing any concomitant medications and study drug dispensing. HCV, HDV, and HIV antibody test will be performed after written informed consent is obtained. The samples of HDV antibody test will be collected at local site and sent to KMUH, tested by central lab. Baseline resistance testing will also be performed by direct sequencing. Procedures: laboratory tests including CBC (complete blood count) panel, Serum Bilirubin (total/direct), AST, ALT, GGT, Albumin, BUN, Creatinine, Na, K, Phosphate, Prothrombin time (INR), and Urine routine/creatinine/phosphate will be done every visit. Pregnant test (only for women of child-bearing potential), Child-Pugh score, and FIB-4 score should also be done every visit. AFP (alpha-fetoprotein), and Abdominal ultrasound should also be done every 3 to 6 months for HCC surveillance. HBV serological markers including HBeAg/HBeAb, HBV DNA quantification (by central lab.) will be done every visit and HBsAg quantification (by central lab.) every 6 months. Bone Density Scan (DEXA) will be done at week 24, 48, and 96. Fibroscan/CAP will be performed at week 48, and 96 to determine regression of fibrosis. Blood will be drawn at the site at which the participant was recruited, and processed by a lab technician in the clinical laboratory at that respective site, except HDV antibody test and HBsAg/HBV DNA quantification which will be performed by the central lab. at KMUH. Treatment Visits: Treatment will consist of TAF 25 mg daily with food for 96 weeks. Treatment visits will occur at week 4, 12, 24, 36, 48, 72, and 96 as per routine clinical care, except for those who developed virological breakthrough, SAE, or others judged by the investigators. At every visit, the patient must bring all study drugs (including empty bottles), so that the study coordinator can count compliance using the number of remaining pills. This schedule of clinic visits and laboratory tests are routine and standard practice for investigators in their treatment of similar patients with CHB. Patients will be encouraged to adhere to these recommendations. Results of these laboratory tests and clinical evaluations will be recorded as well as any additional evaluations that are done as part of the patient's clinical care that is pertinent to the objective of the study. Discontinuation criteria: The study can be terminated at any time for any reasons by Primary Investigator. Though there is no formal treatment stopping rules in this study, patients might be asked to stop if there are any adverse events that the investigator feels make it the patient's best interest to stop treatment. Withdrawal of Subjects Withdrawal Criteria: Failure to follow study instructions or protocol violation that in the judgment of the investigator Adverse Events and Toxicity Management Assessment of safety: Safety assessments will include monitoring of laboratory results, vital signs, treatment-emergent adverse events, serious adverse events, etc. Safety assessments will be performed at every clinic visit as part of clinical care and during follow-up visits. If, in Primary Investigator's judgment, a clinical significant worsening from baseline is observed in any laboratory or other test parameters, physical exam finding, or vital sign, a corresponding clinical adverse event should be recorded. If a specific medical diagnosis has been made, that diagnosis or syndrome should be recorded as the adverse event, whenever possible. However, a complete description of the signs, symptoms, and investigations which led to the diagnosis should be provided. For example, if clinically significant elevations of liver function tests are known to be secondary to hepatitis, "hepatitis" and not "elevated liver function tests" should be recorded. If the cause is not known, the abnormal test or finding should be recorded as an adverse event, using appropriate medical terminology (e/g/ thrombocytopenia, peripheral edema). Maintenance of Safety Information: Safety information will be maintained in a clinical database/repository in a retrievable format. At a minimum, at the end of the treatment phase (="last patient off treatment") as well as the end of the follow-up phase (="last patient out") of the study, Primary Investigator shall provide all adverse events, both serious and non-serious, in report format. Statistics Data management and analysis will be performed at Kaohsiung Medical University Hospital. Sample size to be used in the analysis: We calculated that a sample size of 80 patients with a 10% dropout rate would provide 85% power to show increased to 30% of virologic response (HBV DNA <LLOQ) rate after 52 weeks of TAF therapy, compared to 15% of continuing prior NUC therapy with a type I error rate of 0.05 for the one-tailed analyses of the primary endpoint. Statistical methods to be employed: Descriptive and comparative statistics will be performed for all demographic and clinical variables that are outcome endpoints for this pilot study. Level of significance: A 95% confidence interval will be used. Termination of trial: Termination of the trial will be upon completion of follow-up of all 80 subjects enrolled and/or up to the discretion of the primary investigator. Procedure for missing, unused, spurious data: Data that is missing, unused or spurious data will all be treated as missing data. This data will be marked as an empty field. Deviation from the original statistical plan: Any deviation from the original statistical plan will be up to the discretion of the primary investigator. Selection of subjects to be included in analyses: All eligible subjects that have not been withdrawn from the study will be included in analyses. Interim analysis An interim analysis will be performed at Week 24 after all the 80 patients enrolled. |
Facilities
Sequence: | 200280666 |
Status | Recruiting |
Name | Kaohsiung Medical University Hospital |
City | Kaohsiung |
Zip | 807 |
Country | Taiwan |
Facility Contacts
Sequence: | 28132875 |
Facility Id | 200280666 |
Contact Type | primary |
Name | Ming-Lung Yu, DR |
fish6069@gmail.com | |
Phone | +88673121101 |
Phone Extension | 7475 |
Browse Interventions
Sequence: | 96133248 | Sequence: | 96133249 | Sequence: | 96133250 | Sequence: | 96133251 | Sequence: | 96133252 | Sequence: | 96133253 | Sequence: | 96133254 | Sequence: | 96133255 | Sequence: | 96133256 |
Mesh Term | Tenofovir | Mesh Term | Antiviral Agents | Mesh Term | Anti-Infective Agents | Mesh Term | Reverse Transcriptase Inhibitors | Mesh Term | Nucleic Acid Synthesis Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Anti-HIV Agents | Mesh Term | Anti-Retroviral Agents |
Downcase Mesh Term | tenofovir | Downcase Mesh Term | antiviral agents | Downcase Mesh Term | anti-infective agents | Downcase Mesh Term | reverse transcriptase inhibitors | Downcase Mesh Term | nucleic acid synthesis inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | anti-hiv agents | Downcase Mesh Term | anti-retroviral agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52221615 | Sequence: | 52221616 |
Name | Hepatitis B | Name | Fibrosis and Cirrhosis of Liver |
Downcase Name | hepatitis b | Downcase Name | fibrosis and cirrhosis of liver |
Id Information
Sequence: | 40195688 |
Id Source | org_study_id |
Id Value | KMUHIRB-F(II)-20180111 |
Countries
Sequence: | 42609699 |
Name | Taiwan |
Removed | False |
Design Groups
Sequence: | 55649898 |
Group Type | Experimental |
Title | Switch to TAF |
Description | Subjects who meet the inclusion and exclusion criteria will switch prior NUCs to TAF 25 mg/day for 96 weeks |
Interventions
Sequence: | 52535430 |
Intervention Type | Drug |
Name | Tenofovir Alafenamide |
Description | Subjects in this group will switch prior nucleot(s)ide analogs to Tenofovir Alafenamide 25 mg/day for 96 weeks |
Keywords
Sequence: | 79941882 | Sequence: | 79941883 | Sequence: | 79941884 | Sequence: | 79941885 | Sequence: | 79941886 |
Name | Hepatitis B | Name | advanced fibrosis | Name | Cirrhosis | Name | Switch | Name | Tenofovir alafenamide |
Downcase Name | hepatitis b | Downcase Name | advanced fibrosis | Downcase Name | cirrhosis | Downcase Name | switch | Downcase Name | tenofovir alafenamide |
Design Outcomes
Sequence: | 177561821 | Sequence: | 177561822 | Sequence: | 177561823 | Sequence: | 177561824 | Sequence: | 177561825 | Sequence: | 177561826 | Sequence: | 177561827 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Rate of virological response | Measure | Rate of virological response | Measure | Rate of ALT normalization | Measure | Changes of serum creatinine | Measure | Changes of calculated creatinine clearance (Cockcroft-Gault) | Measure | Changes in bone mineral density | Measure | Changes in liver fibrosis |
Time Frame | at 48 weeks of TAF therapy. | Time Frame | at 96 weeks of treatment | Time Frame | at week 48 and 96 | Time Frame | at week 48 and 96 | Time Frame | at week 48 and 96 | Time Frame | at week 48 and 96 | Time Frame | at week 48 and 96 |
Description | HBV DNA <LLOQ | Description | HBV DNA <LLOQ | Description | by local (<40 U/L), and AASLD (male ≤35, female ≤25 U/L) criteria | Description | determined by Fibroscan |
Browse Conditions
Sequence: | 193678811 | Sequence: | 193678812 | Sequence: | 193678813 | Sequence: | 193678814 | Sequence: | 193678815 | Sequence: | 193678816 | Sequence: | 193678817 | Sequence: | 193678818 | Sequence: | 193678819 | Sequence: | 193678820 | Sequence: | 193678821 | Sequence: | 193678822 | Sequence: | 193678823 | Sequence: | 193678824 | Sequence: | 193678825 | Sequence: | 193678826 | Sequence: | 193678827 | Sequence: | 193678828 |
Mesh Term | Hepatitis A | Mesh Term | Hepatitis B | Mesh Term | Hepatitis | Mesh Term | Liver Cirrhosis | Mesh Term | Fibrosis | Mesh Term | Liver Diseases | Mesh Term | Digestive System Diseases | Mesh Term | Hepatitis, Viral, Human | Mesh Term | Virus Diseases | Mesh Term | Infections | Mesh Term | Enterovirus Infections | Mesh Term | Picornaviridae Infections | Mesh Term | RNA Virus Infections | Mesh Term | Pathologic Processes | Mesh Term | Blood-Borne Infections | Mesh Term | Communicable Diseases | Mesh Term | Hepadnaviridae Infections | Mesh Term | DNA Virus Infections |
Downcase Mesh Term | hepatitis a | Downcase Mesh Term | hepatitis b | Downcase Mesh Term | hepatitis | Downcase Mesh Term | liver cirrhosis | Downcase Mesh Term | fibrosis | Downcase Mesh Term | liver diseases | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | hepatitis, viral, human | Downcase Mesh Term | virus diseases | Downcase Mesh Term | infections | Downcase Mesh Term | enterovirus infections | Downcase Mesh Term | picornaviridae infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | blood-borne infections | Downcase Mesh Term | communicable diseases | Downcase Mesh Term | hepadnaviridae infections | Downcase Mesh Term | dna virus infections |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366508 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Kaohsiung Medical University Chung-Ho Memorial Hospital |
Overall Officials
Sequence: | 29312957 |
Role | Principal Investigator |
Name | Ming-Lung Yu, Prof. |
Affiliation | Kaohsiung Medical University |
Central Contacts
Sequence: | 12020615 |
Contact Type | primary |
Name | Ming-Lung Yu, Prof. |
Phone | +88673121101 |
fish6069@gmail.com | |
Phone Extension | 7475 |
Role | Contact |
Design Group Interventions
Sequence: | 68217513 |
Design Group Id | 55649898 |
Intervention Id | 52535430 |
Eligibilities
Sequence: | 30794761 |
Gender | All |
Minimum Age | 20 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Male or female, age ≥20 years Exclusion Criteria: Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004405 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 20 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30540801 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28907121 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798106
2019-04-10
https://zephyrnet.com/?p=NCT03798106
NCT03798106https://www.clinicaltrials.gov/study/NCT03798106?tab=tableNANANAPazopanib is an angiogenesis inhibitor targeting VEGFR-1, -2, and -3; PDGFR-α and -β; and the receptor c-Kit, and is indicated for the treatment of subjects with advanced renal cell carcinoma (RCC) and advanced STS. For this orphan tumor, STS, PD-L1 targeting may be a promising strategy and favorable toxicity may warrant further combination.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-06-12 |
Start Month Year | April 10, 2019 |
Primary Completion Month Year | August 10, 2022 |
Verification Month Year | June 2023 |
Verification Date | 2023-06-30 |
Last Update Posted Date | 2023-06-12 |
Detailed Descriptions
Sequence: | 20806775 |
Description | Pazopanib is an angiogenesis inhibitor targeting VEGFR-1, -2, and -3; PDGFR-α and -β; and the receptor c-Kit, and is indicated for the treatment of subjects with advanced renal cell carcinoma (RCC) and advanced STS. Pro-angiogenic factors suppress various immune functions whereas antiangiogenic agents have potential to modulate the tumor microenvironment and improve immunotherapy. An analysis of patients with RCC treated with pazopanib demonstrated that elevated expression of PD-L1 correlates with shorter PFS. Investigator also identified 43% of PD-L1 expression in STS and PD-L1 expression had worse overall survival (5-year survival rate: 48% in PD-L1 positive vs. 68% in PD-L1 negative, p=0.015). In detail, PD-L1 expression was reported 52.6% in synovial sarcoma, 37.6% in rhabdomyosarcoma, and 100% in epithelioid sarcoma. For this orphan tumor, STS, PD-L1 targeting may be a promising strategy and favorable toxicity may warrant further combination. |
Facilities
Sequence: | 200819705 |
Name | Severance Hospital, Yonsei University Health System |
City | Seoul |
Zip | 03722 |
Country | Korea, Republic of |
Browse Interventions
Sequence: | 96390469 | Sequence: | 96390470 | Sequence: | 96390471 |
Mesh Term | Durvalumab | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Antineoplastic Agents |
Downcase Mesh Term | durvalumab | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | antineoplastic agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52388085 |
Name | Sarcoma |
Downcase Name | sarcoma |
Id Information
Sequence: | 40312974 |
Id Source | org_study_id |
Id Value | 4-2018-0743 |
Countries
Sequence: | 42736004 |
Name | Korea, Republic of |
Removed | False |
Design Groups
Sequence: | 55834560 |
Group Type | Experimental |
Title | durvalumab+pazopanib |
Description | Durvalumab 1500mg IV 1hr q3weeks Pazopanib 800mg QD PO q3wwks |
Interventions
Sequence: | 52698065 |
Intervention Type | Drug |
Name | Durvalumab, pazopanib |
Description | Durvalumab 1500mg IV 1hr q3weeks Pazopanib 800mg QD PO q3wwks |
Design Outcomes
Sequence: | 178180389 |
Outcome Type | primary |
Measure | Objective Response Rate |
Time Frame | 12 weeks |
Description | antitumor efficacy of durvalumab and pazopanib |
Browse Conditions
Sequence: | 194310797 | Sequence: | 194310798 | Sequence: | 194310799 | Sequence: | 194310800 |
Mesh Term | Sarcoma | Mesh Term | Neoplasms, Connective and Soft Tissue | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms |
Downcase Mesh Term | sarcoma | Downcase Mesh Term | neoplasms, connective and soft tissue | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48521352 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Yonsei University |
Design Group Interventions
Sequence: | 68444001 |
Design Group Id | 55834560 |
Intervention Id | 52698065 |
Eligibilities
Sequence: | 30890752 |
Gender | All |
Minimum Age | 19 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Histologically confirmed STS progression to 1 or 2 prior chemotherapy Exclusion Criteria: More than 4 prior cytotoxic regimens |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254131700 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 40 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 19 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30636501 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29003104 |
Responsible Party Type | Principal Investigator |
Name | Hyo Song Kim |
Title | professor |
Affiliation | Yonsei University |
]]>
https://zephyrnet.com/NCT03798093
2019-01-07
https://zephyrnet.com/?p=NCT03798093
NCT03798093https://www.clinicaltrials.gov/study/NCT03798093?tab=tableNANANANon-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing data collection. As part of the data collection, an optional echocardiogram will be performed if the parent consents.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-02-27 |
Start Month Year | January 7, 2019 |
Primary Completion Month Year | June 1, 2021 |
Verification Month Year | February 2023 |
Verification Date | 2023-02-28 |
Last Update Posted Date | 2023-02-27 |
Detailed Descriptions
Sequence: | 20788508 |
Description | Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing data collection. As part of the data collection, an optional echocardiogram will be performed if the parent consents. The consent will have a check box to indicate if they consent to the additional test.
Echocardiographic measurements will be performed on all infants at 12 hours +/-3 hours of age by our research sonographers who are blinded to infant randomization. Measurements will be taken according to a standard operating procedure to assess systemic blood flow, by superior vena cava (SVC) flow (ml/kg/min), right ventricular output (ml/kg/min), left ventricular output (LVO) (ml/kg/min), measures of left and right venitricular tissue Doppler and strain imaging. These measurements will be performed off line at a later time. Data will be entered into REDCap. If any structural abnormalities are found, the attending pediatrician will be notified of the abnormal echocardiogram. The consent will clearly state that this echo is not for diagnostic purposes. Any additional studies including an official complete echocardiogram and or cardiology consultation will be left to the discretion of the attending pediatrician, as he/she deems necessary |
Facilities
Sequence: | 200667511 |
Name | Sharp Mary Birch Hospital for Women and Newborns |
City | San Diego |
State | California |
Zip | 92123 |
Country | United States |
Conditions
Sequence: | 52342248 |
Name | Birth Asphyxia |
Downcase Name | birth asphyxia |
Id Information
Sequence: | 40281123 |
Id Source | org_study_id |
Id Value | MINVI Echo Study |
Countries
Sequence: | 42701844 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55783959 | Sequence: | 55783960 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | Umbilical Cord Milking | Title | Early Cord Clamping |
Description | The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk the entire length of umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for ECC as we have demonstrated in our previous trials. | Description | This will occur by clamping the umbilical cord as soon as possible. Since both ECC and UCM will occur after a brief assessment, it is important to note that the cord clamping time will be longer than in previously conducted preterm trials (average 20 seconds) which performed the intervention on all subjects regardless of whether or not they were vigorous. In all cases, the cord clamping time will be documented to ensure consistency. |
Interventions
Sequence: | 52653186 | Sequence: | 52653187 |
Intervention Type | Procedure | Intervention Type | Procedure |
Name | Umbilical Cord Milking | Name | Early Cord Clamping |
Description | At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds. | Description | The umbilical cord is clamped within 30 seconds of delivery. |
Keywords
Sequence: | 80104921 | Sequence: | 80104922 | Sequence: | 80104923 |
Name | Umbilical Cord Milking | Name | Immediate Cord Clamping | Name | Resuscitation |
Downcase Name | umbilical cord milking | Downcase Name | immediate cord clamping | Downcase Name | resuscitation |
Design Outcomes
Sequence: | 178011080 | Sequence: | 178011081 | Sequence: | 178011082 | Sequence: | 178011083 | Sequence: | 178011084 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Cardiac Output | Measure | Right Ventricular Output | Measure | SVC Flow | Measure | Peak Systolic Strain and Strain rate | Measure | Peak Systolic Tissue Doppler |
Time Frame | 12 +/- 6 hours of life | Time Frame | 12 +/- 6 hours of life | Time Frame | 12 +/- 6 hours of life | Time Frame | 12 +/- 6 hours of life | Time Frame | 12 +/- 6 hours of life |
Description | Cardiac Output measured by Left Ventricular Output | Description | Obtained from the modified short axis view of Cardiac Ultrasound | Description | SVC flow (Diameter obtained from the infaclavicular view (hybrid view), Doppler from the subcostal view) | Description | Measures of Left and Right Ventricular Strain and Strain rate | Description | Measure of left and right ventricular peak systolic Tissue Doppler velocity |
Browse Conditions
Sequence: | 194138399 | Sequence: | 194138400 | Sequence: | 194138401 | Sequence: | 194138402 | Sequence: | 194138403 | Sequence: | 194138404 |
Mesh Term | Asphyxia Neonatorum | Mesh Term | Asphyxia | Mesh Term | Death | Mesh Term | Pathologic Processes | Mesh Term | Wounds and Injuries | Mesh Term | Infant, Newborn, Diseases |
Downcase Mesh Term | asphyxia neonatorum | Downcase Mesh Term | asphyxia | Downcase Mesh Term | death | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | infant, newborn, diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48479096 | Sequence: | 48479097 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Sharp HealthCare | Name | Sharp Mary Birch Hospital for Women & Newborns |
Overall Officials
Sequence: | 29376217 |
Role | Principal Investigator |
Name | Anup Katheria, MD |
Affiliation | Sharp Mary Birch Hospital for Women & Newborns |
Design Group Interventions
Sequence: | 68381678 | Sequence: | 68381679 |
Design Group Id | 55783959 | Design Group Id | 55783960 |
Intervention Id | 52653186 | Intervention Id | 52653187 |
Eligibilities
Sequence: | 30864432 |
Gender | All |
Minimum Age | 35 Weeks |
Maximum Age | 42 Weeks |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Non-vigorous newborns born between 35-42 weeks gestation Exclusion Criteria: Known major congenital or chromosomal anomalies of newborn Known cardiac defects other than small ASD, VSD and PDA Complete placental abruption/cutting through the placenta at time of delivery Monochorionic multiples Cord Avulsion Presence of non-reducible nuchal cord Perinatal providers unaware of the protocol |
Adult | False |
Child | True |
Older Adult | False |
Calculated Values
Sequence: | 253949548 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 29 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 35 |
Maximum Age Num | 42 |
Minimum Age Unit | Weeks |
Maximum Age Unit | Weeks |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30610250 |
Allocation | Randomized |
Intervention Model | Crossover Assignment |
Observational Model | |
Primary Purpose | Diagnostic |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | Cluster Randomized Crossover |
Responsible Parties
Sequence: | 28976783 |
Responsible Party Type | Principal Investigator |
Name | Anup Katheria, M.D. |
Title | Director, Neonatal Research Institute |
Affiliation | Sharp HealthCare |
]]>
https://zephyrnet.com/NCT03798080
2019-02-19
https://zephyrnet.com/?p=NCT03798080
NCT03798080https://www.clinicaltrials.gov/study/NCT03798080?tab=tableNANANAPrimary Objective:
To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) to insulin glargine on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) who are not sufficiently controlled with basal insulin.
Secondary Objectives:
To assess the effects of iGlarLixi in comparison with insulin glargine
To assess the safety in each treatment group
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-07-19 |
Start Month Year | February 19, 2019 |
Primary Completion Month Year | December 1, 2020 |
Verification Month Year | April 2022 |
Verification Date | 2022-04-30 |
Last Update Posted Date | 2022-07-19 |
Detailed Descriptions
Sequence: | 20770281 |
Description | The maximum study duration per patient will be approximately 33 weeks: an up to 2-week screening period (it can be exceptionally extended up to one additional week), a 30-week, open label randomized treatment period comparing iGlarLixi to insulin glargine (± metformin for both treatments), and a 3-day post-treatment safety follow-up period. |
Facilities
Sequence: | 200512446 | Sequence: | 200512447 | Sequence: | 200512448 | Sequence: | 200512449 | Sequence: | 200512450 | Sequence: | 200512451 | Sequence: | 200512452 | Sequence: | 200512453 | Sequence: | 200512454 | Sequence: | 200512455 | Sequence: | 200512456 | Sequence: | 200512457 | Sequence: | 200512458 | Sequence: | 200512459 | Sequence: | 200512460 | Sequence: | 200512461 | Sequence: | 200512462 | Sequence: | 200512463 | Sequence: | 200512464 | Sequence: | 200512465 | Sequence: | 200512466 | Sequence: | 200512467 | Sequence: | 200512468 | Sequence: | 200512469 | Sequence: | 200512470 | Sequence: | 200512471 | Sequence: | 200512472 | Sequence: | 200512473 | Sequence: | 200512474 | Sequence: | 200512475 | Sequence: | 200512476 | Sequence: | 200512477 | Sequence: | 200512478 | Sequence: | 200512479 | Sequence: | 200512480 | Sequence: | 200512481 | Sequence: | 200512482 | Sequence: | 200512483 | Sequence: | 200512484 | Sequence: | 200512485 | Sequence: | 200512486 | Sequence: | 200512487 | Sequence: | 200512488 | Sequence: | 200512489 | Sequence: | 200512490 |
Name | Investigational Site Number 1560044 | Name | Investigational Site Number 1560001 | Name | Investigational Site Number 1560039 | Name | Investigational Site Number 1560005 | Name | Investigational Site Number 1560054 | Name | Investigational Site Number 1560015 | Name | Investigational Site Number 1560010 | Name | Investigational Site Number 1560030 | Name | Investigational Site Number 1560025 | Name | Investigational Site Number 1560016 | Name | Investigational Site Number 1560053 | Name | Investigational Site Number 1560045 | Name | Investigational Site Number 1560021 | Name | Investigational Site Number 1560018 | Name | Investigational Site Number 1560019 | Name | Investigational Site Number 1560041 | Name | Investigational Site Number 1560040 | Name | Investigational Site Number 1560007 | Name | Investigational Site Number 1560026 | Name | Investigational Site Number 1560042 | Name | Investigational Site Number 1560003 | Name | Investigational Site Number 1560032 | Name | Investigational Site Number 1560033 | Name | Investigational Site Number 1560028 | Name | Investigational Site Number 1560013 | Name | Investigational Site Number 1560017 | Name | Investigational Site Number 1560035 | Name | Investigational Site Number 1560038 | Name | Investigational Site Number 1560046 | Name | Investigational Site Number 1560008 | Name | Investigational Site Number 1560037 | Name | Investigational Site Number 1560031 | Name | Investigational Site Number 1560011 | Name | Investigational Site Number 1560002 | Name | Investigational Site Number 1560027 | Name | Investigational Site Number 1560047 | Name | Investigational Site Number 1560012 | Name | Investigational Site Number 1560006 | Name | Investigational Site Number 1560049 | Name | Investigational Site Number 1560020 | Name | Investigational Site Number 1560050 | Name | Investigational Site Number 1560036 | Name | Investigational Site Number 1560023 | Name | Investigational Site Number 1560022 | Name | Investigational Site Number 1560052 |
City | Baotou | City | Beijing | City | Beijing | City | Changchun | City | Changchun | City | Changsha | City | Chenzhou | City | Chongqing | City | Fuzhou | City | Guangzhou | City | Guangzhou | City | Guangzhou | City | Hefei | City | Hohhot | City | Huanggang | City | Jiaxing | City | Jinan | City | Jinan | City | Jinzhou | City | Kaifeng | City | Kunming | City | Lanzhou | City | Luoyang | City | Nanjing | City | Nanjing | City | Nanjing | City | Nanjing | City | Nanjing | City | Nantong | City | Pingxiang | City | Qingdao | City | Qinhuangdao | City | Shanghai | City | Shanghai | City | Shanghai | City | Shanghai | City | Shenyang | City | Tianjin | City | Urumqi | City | Xining | City | Xining | City | Xuzhou | City | Yangzhou | City | Zhuzhou | City | Zigong |
Zip | 014010 | Zip | 100034 | Zip | 102218 | Zip | 130033 | Zip | 130041 | Zip | 410013 | Zip | 400010 | Zip | 354200 | Zip | 510080 | Zip | 510080 | Zip | 510515 | Zip | 230022 | Zip | 010017 | Zip | 250000 | Zip | 250013 | Zip | 121000 | Zip | 475000 | Zip | 650032 | Zip | 730000 | Zip | 210008 | Zip | 210011 | Zip | 210029 | Zip | 226001 | Zip | 337055 | Zip | 266003 | Zip | 200240 | Zip | 201700 | Zip | 110004 | Zip | 300121 | Zip | 830000 | Zip | 810007 | Zip | 810016 | Zip | 225001 | Zip | 412007 | Zip | 643002 | ||||||||||||||||||||
Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China |
Browse Interventions
Sequence: | 96249052 | Sequence: | 96249053 | Sequence: | 96249054 | Sequence: | 96249055 | Sequence: | 96249056 | Sequence: | 96249057 | Sequence: | 96249058 |
Mesh Term | Insulin | Mesh Term | Insulin, Globin Zinc | Mesh Term | Metformin | Mesh Term | Insulin Glargine | Mesh Term | Lixisenatide | Mesh Term | Hypoglycemic Agents | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | insulin | Downcase Mesh Term | insulin, globin zinc | Downcase Mesh Term | metformin | Downcase Mesh Term | insulin glargine | Downcase Mesh Term | lixisenatide | Downcase Mesh Term | hypoglycemic agents | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52296014 |
Name | Type 2 Diabetes Mellitus |
Downcase Name | type 2 diabetes mellitus |
Id Information
Sequence: | 40248542 | Sequence: | 40248543 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | EFC14944 | Id Value | U1111-1190-7781 |
Id Type | Other Identifier | ||
Id Type Description | UTN | ||
Countries
Sequence: | 42666848 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55732672 | Sequence: | 55732673 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Soliqua (insulin glargine/lixisenatide) | Title | Lantus (insulin glargine) |
Description | iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning with or without metformin for 30 weeks | Description | Insulin glargine will be self-administered subcutaneously once daily at any time of the day with or without metformin for 30 weeks |
Interventions
Sequence: | 52607832 | Sequence: | 52607833 | Sequence: | 52607834 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Insulin glargine/Lixisenatide (HOE901/AVE0010) | Name | Insulin glargine (HOE901) | Name | Metformin |
Description | Pharmaceutical form: solution
Route of administration: subcutaneous |
Description | Pharmaceutical form: solution
Route of administration: subcutaneous |
Description | Pharmaceutical form: tablet
Route of administration: oral |
Design Outcomes
Sequence: | 177838273 | Sequence: | 177838261 | Sequence: | 177838262 | Sequence: | 177838263 | Sequence: | 177838264 | Sequence: | 177838265 | Sequence: | 177838266 | Sequence: | 177838267 | Sequence: | 177838268 | Sequence: | 177838269 | Sequence: | 177838270 | Sequence: | 177838271 | Sequence: | 177838272 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Immunogenicity (antibody variables) | Measure | Change in HbA1c | Measure | Patients with HbA1c <7.0% | Measure | Patients with HbA1c ≤ 6.5% | Measure | Change in postprandial plasma glucose (PPG) | Measure | Change in self-monitored plasma glucose (SMPG) profile | Measure | Patients with HbA1c <7.0% with no body weight gain | Measure | Change in body weight | Measure | Patients with HbA1c <7.0% with no body weight gain and no documented symptomatic hypoglycemia | Measure | Patients requiring rescue therapy | Measure | Change in fasting plasma glucose (FPG) | Measure | Confirmed hypoglycemia | Measure | Adverse events (AEs) |
Time Frame | From Baseline to Week 30 | Time Frame | From Baseline to Week 30 | Time Frame | At Week 30 | Time Frame | At Week 30 | Time Frame | From Baseline to Week 30 | Time Frame | From Baseline to Week 30 | Time Frame | At Week 30 | Time Frame | From Baseline to Week 30 | Time Frame | At Week 30 | Time Frame | From Baseline to Week 30 | Time Frame | From Baseline to Week 30 | Time Frame | From Baseline to Week 30 | Time Frame | From Baseline to Week 30 |
Description | Anti-lixisenatide antibodies (in iGlarLixi group) and anti-insulin antibodies from baseline to Week 30 | Description | Change in glycated hemoglobin (HbA1c) from baseline to Week 30 | Description | Percentage of patients reaching HbA1c <7% at Week 30 | Description | Percentage of patients reaching HbA1c ≤ 6.5% at Week 30 | Description | Absolute change in 2-hour blood glucose excursion and PPG during meal test from baseline to Week 30 | Description | Absolute change in 7-point SMPG profiles from baseline to Week 30 (each time point and average daily value) | Description | Percentage of patients reaching HbA1c <7% with no body weight gain at Week 30 | Description | Absolute change in body weight from baseline to Week 30 | Description | Percentage of patients reaching HbA1c <7% with no body weight gain at Week 30 and no documented (plasma glucose [PG] ≤70 mg/dL [3.9mmol/L]) symptomatic hypoglycemia during the 30-week randomized treatment period | Description | Percentage of patients requiring rescue therapy during the 30-week randomized treatment period | Description | Absolute change in FPG from baseline to Week 30 | Description | Severe hypoglycemia and episodes of hypoglycemia documented with PG ≤ 70 mg/dL (3.9mmol/L) regardless of symptoms | Description | Number of AEs, Serious AEs, AEs of Special Interest, and AEs requiring specific monitoring from baseline to Week 30 |
Browse Conditions
Sequence: | 193963989 | Sequence: | 193963990 | Sequence: | 193963991 | Sequence: | 193963992 | Sequence: | 193963993 |
Mesh Term | Diabetes Mellitus | Mesh Term | Diabetes Mellitus, Type 2 | Mesh Term | Glucose Metabolism Disorders | Mesh Term | Metabolic Diseases | Mesh Term | Endocrine System Diseases |
Downcase Mesh Term | diabetes mellitus | Downcase Mesh Term | diabetes mellitus, type 2 | Downcase Mesh Term | glucose metabolism disorders | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | endocrine system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48436341 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Sanofi |
Overall Officials
Sequence: | 29352619 |
Role | Study Director |
Name | Clinical Sciences & Operations |
Affiliation | Sanofi |
Design Group Interventions
Sequence: | 68317383 | Sequence: | 68317384 | Sequence: | 68317385 | Sequence: | 68317386 |
Design Group Id | 55732672 | Design Group Id | 55732673 | Design Group Id | 55732673 | Design Group Id | 55732672 |
Intervention Id | 52607832 | Intervention Id | 52607833 | Intervention Id | 52607834 | Intervention Id | 52607834 |
Eligibilities
Sequence: | 30837933 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion criteria :
Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year and treated with basal insulin for at least 6 months before screening visit (V1). Exclusion criteria: Age <18 years at screening visit (V1). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254149857 |
Number Of Facilities | 45 |
Registered In Calendar Year | 2019 |
Actual Duration | 21 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 12 |
Designs
Sequence: | 30583832 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26729453 | Sequence: | 26729454 | Sequence: | 26729455 |
Intervention Id | 52607832 | Intervention Id | 52607832 | Intervention Id | 52607833 |
Name | Soliqua | Name | iGlarLixi | Name | Lantus |
Responsible Parties
Sequence: | 28950249 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52196531 |
Pmid | 35762489 |
Reference Type | background |
Citation | Yuan X, Guo X, Zhang J, Dong X, Lu Y, Pang W, Gu S, Niemoeller E, Ping L, Nian G, Souhami E; LixiLan-L-CN investigators. Improved glycaemic control and weight benefit with iGlarLixi versus insulin glargine 100 U/mL in Chinese people with type 2 diabetes advancing their therapy from basal insulin plus oral antihyperglycaemic drugs: Results from the LixiLan-L-CN randomized controlled trial. Diabetes Obes Metab. 2022 Nov;24(11):2182-2191. doi: 10.1111/dom.14803. Epub 2022 Jul 25. |
]]>
https://zephyrnet.com/NCT03798067
2019-01-02
https://zephyrnet.com/?p=NCT03798067
NCT03798067https://www.clinicaltrials.gov/study/NCT03798067?tab=tableHui Zhang504099077@qq.com+8615996938739Acute kidney injury (AKI) is a common complication of cardiac surgery, which seriously affects the postoperative complication rate and mortality of patients.Acute kidney injury occurs in 5-30% of patients after cardiac surgery, but severe acute kidney injury requiring dialysis is relatively rare.At present, the diagnosis of AKI is based on serum creatinine (Scr) or urine volume. However, the changes of serum creatinine value have hysteresis, and the increase of serum creatinine level lags behind kidney injury for 48 ~ 72 h.Some drugs can also affect creatinine levels.Urine volume is also affected by many factors.Due to the lack of sensitivity and specificity of SCr, it is very important to find and adopt new early AKI markers.Kidney is an important metabolic organ of human body. Different from cerebrovascular system, kidney lacks automatic regulation ability and is easily affected by perfusion flow.Previous experiments have shown that placing a multi-plane esophageal probe into the human stomach through the esophagus can monitor the changes of left renal blood flow before, during and after cardiovascular surgery extracorporeal circulation, and has good repeatability, which may become an effective means to monitor renal blood flow during cardiovascular surgery.
In conclusion, this study intends to use esophageal ultrasound as a means to monitor renal blood flow, observe the changes of intraoperative renal hemodynamic indexes, and use KDIGO ( Kidney Disease:Improving Global Outcomes)as the standard of renal injury to explore the correlation between intraoperative hemodynamic changes and postoperative AKI, providing a new perspective for the pathophysiological study of AKI after cardiopulmonary bypass.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-01 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | January 2, 2019 |
Primary Completion Month Year | August 30, 2019 |
Verification Month Year | December 2018 |
Verification Date | 2018-12-31 |
Last Update Posted Date | 2019-01-09 |
Detailed Descriptions
Sequence: | 20780445 |
Description | The mechanism of acute kidney injury after CPB has not been fully elucidated, and current studies suggest that the main mechanisms are as follows:
(1) endogenous/exogenous nephrotoxic substances;(2) metabolic factors: mainly reflected in the preoperative status of patients, such as obesity, low body weight, etc.;(3) hemodynamic factors: hemodynamic instability is an important mechanism for further renal injury process such as ischemia reperfusion, which is mainly reflected in: a.preoperative and postoperative hypotension: cardiogenic shock caused by cardiac insufficiency and low cardiac displacement;Non-cardiogenic shock (vasoactive drugs/allergies/postoperative bleeding);b. hemodynamic instability of intraoperative intervention: deep anesthesia, intraoperative blood loss, CPB-related intraoperative low perfusion (long CPB time, low circulation flow, low mean arterial pressure in CPB), embolic release (atherosclerotic emboli/air emboli), aorta and distal arteriotomy;(4) neurohumoral system factors: hormones such as epinephrine, norepinephrine, renin and thyroxine change to varying degrees during cardiac surgery and CPB, thus affecting the body state and systemic blood vessels;(5) inflammation and oxidative stress. Kidney is an important metabolic organ of human body. Different from cerebrovascular system, kidney lacks automatic regulation ability and is easily affected by perfusion flow.For patients at high risk of postoperative acute kidney injury, appropriate intraoperative perfusion may reduce the incidence of postoperative acute kidney injury. Esophageal ultrasound was used as a means of monitoring renal blood flow to observe the changes in intraoperative renal hemodynamic indexes. Meanwhile, KDIGO was used as the standard for renal injury. AKI was divided into two groups according to whether postoperative AKI occurred, and the correlation between intraoperative hemodynamic changes and postoperative AKI in the two groups was discussed.It provides new ideas for the early diagnosis of postoperative acute kidney injury. |
Conditions
Sequence: | 52321624 |
Name | Postoperative Acute Kidney Injury |
Downcase Name | postoperative acute kidney injury |
Id Information
Sequence: | 40266290 |
Id Source | org_study_id |
Id Value | XYFY-2018-0008 |
Design Outcomes
Sequence: | 177935236 | Sequence: | 177935237 | Sequence: | 177935238 | Sequence: | 177935239 | Sequence: | 177935240 | Sequence: | 177935241 | Sequence: | 177935242 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | AUC(RI) | Measure | AUC(PI) | Measure | Changes in biomarkers | Measure | Length of ICU stay | Measure | Length of hospital stay | Measure | Use of renal replacement therapy | Measure | Survival rate |
Time Frame | RI monitored 30 minutes after cardiopulmonary bypass termination | Time Frame | PI monitored 30 minutes after cardiopulmonary bypass termination | Time Frame | Before surgery and at 4 hours, 12 hours, and 24 hours after surgery | Time Frame | an average of 2 days | Time Frame | an average of 10 days | Time Frame | Until 3 months after discharge | Time Frame | At 1, 7 and 30 days after discharge |
Description | ROC curve(receiver operating characteristic curve)will be drawn according to the incidence of renal resistance index (RI) monitored by TEE and the incidence of postoperative AKI in patients, and AUC value(Area Under Curve) will be statistically analyzed. | Description | ROC curve will be drawn according to the incidence of renal pulsatility index (PI) monitored by TEE and the incidence of postoperative AKI in patients, and AUC value will be statistically analyzed. | Description | Analysis of insulin-like growth factor-binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases-2 (TIMP-2) concentrations (both induction factors for G1 cell cycle arrest are associated with acute kidney injury and are predicted as biomarkers). | Description | All patients are routinely transferred to ICU after surgery | Description | All patients are routinely transferred to ICU after surgery | Description | The use of postoperative renal replacement therapy depends on the diagnosis and treatment of ICU staff. | Description | Record the survival rate after hospital discharged. |
Browse Conditions
Sequence: | 194059651 | Sequence: | 194059652 | Sequence: | 194059653 | Sequence: | 194059654 | Sequence: | 194059655 | Sequence: | 194059656 | Sequence: | 194059657 | Sequence: | 194059658 | Sequence: | 194059659 |
Mesh Term | Acute Kidney Injury | Mesh Term | Wounds and Injuries | Mesh Term | Renal Insufficiency | Mesh Term | Kidney Diseases | Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Male Urogenital Diseases |
Downcase Mesh Term | acute kidney injury | Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | renal insufficiency | Downcase Mesh Term | kidney diseases | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | male urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48460219 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Xuzhou Medical University |
Overall Officials
Sequence: | 29365449 |
Role | Study Director |
Name | Jin Dong Liu, M.S |
Affiliation | The Affiliated Hospital of Xuzhou Medical University |
Central Contacts
Sequence: | 12046243 | Sequence: | 12046244 |
Contact Type | primary | Contact Type | backup |
Name | Jin Dong Liu, M.S | Name | Hui Zhang |
Phone | +86-13951355136 | Phone | +8615996938739 |
liujindong1818@163.com | 504099077@qq.com | ||
Role | Contact | Role | Contact |
Eligibilities
Sequence: | 30852468 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Population | 60 patients undergoing elective cardiac surgery in the Affiliated Hospital of Xuzhou Medical University. |
Criteria | Inclusion Criteria:
Aged between 18 and 70; Exclusion Criteria: Acute myocardial infarction surgery within 7 days |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254272364 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30598320 |
Observational Model | Cohort |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28964810 |
Responsible Party Type | Principal Investigator |
Name | Jin Dong Liu |
Title | Principal Investigator |
Affiliation | Xuzhou Medical University |
Study References
Sequence: | 52226154 | Sequence: | 52226155 | Sequence: | 52226156 | Sequence: | 52226157 |
Pmid | 22163121 | Pmid | 28869251 | Pmid | 30471559 | Pmid | 26995003 |
Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result |
Citation | Weisse AB. Cardiac surgery: a century of progress. Tex Heart Inst J. 2011;38(5):486-90. | Citation | Wang Y, Bellomo R. Cardiac surgery-associated acute kidney injury: risk factors, pathophysiology and treatment. Nat Rev Nephrol. 2017 Nov;13(11):697-711. doi: 10.1038/nrneph.2017.119. Epub 2017 Sep 4. | Citation | Bellos I, Pergialiotis V, Kontzoglou K. Renal resistive index as predictor of acute kidney injury after major surgery: A systematic review and meta-analysis. J Crit Care. 2019 Apr;50:36-43. doi: 10.1016/j.jcrc.2018.11.001. Epub 2018 Nov 15. | Citation | Regolisti G, Maggiore U, Cademartiri C, Belli L, Gherli T, Cabassi A, Morabito S, Castellano G, Gesualdo L, Fiaccadori E. Renal resistive index by transesophageal and transparietal echo-doppler imaging for the prediction of acute kidney injury in patients undergoing major heart surgery. J Nephrol. 2017 Apr;30(2):243-253. doi: 10.1007/s40620-016-0289-2. Epub 2016 Mar 19. |
]]>
https://zephyrnet.com/NCT03798054
2019-02-15
https://zephyrnet.com/?p=NCT03798054
NCT03798054https://www.clinicaltrials.gov/study/NCT03798054?tab=tableNANANAPrimary Objectives:
The co-primary objective of this study is:
To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) versus lixisenatide on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change.
To demonstrate the non-inferiority of iGlarLixi versus insulin glargine on glycemic control as assessed by HbA1c change.
Secondary Objectives:
To assess the effects of iGlarLixi in comparison with insulin glargine alone and lixisenatide alone.
To assess the safety in each treatment group.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-07-19 |
Start Month Year | February 15, 2019 |
Primary Completion Month Year | March 1, 2021 |
Verification Month Year | April 2022 |
Verification Date | 2022-04-30 |
Last Update Posted Date | 2022-07-19 |
Detailed Descriptions
Sequence: | 20832666 |
Description | The maximum study duration per patient will be approximately 31 weeks: an up-to 6-week screening and run-in period (with an up-to 2-week screening phase and a 4-week run-in phase), followed by a 24-week randomized treatment period and a 3-day post-treatment safety follow up period. |
Facilities
Sequence: | 201122093 | Sequence: | 201122094 | Sequence: | 201122095 | Sequence: | 201122096 | Sequence: | 201122097 | Sequence: | 201122098 | Sequence: | 201122099 | Sequence: | 201122100 | Sequence: | 201122101 | Sequence: | 201122102 | Sequence: | 201122103 | Sequence: | 201122104 | Sequence: | 201122105 | Sequence: | 201122106 | Sequence: | 201122107 | Sequence: | 201122108 | Sequence: | 201122109 | Sequence: | 201122110 | Sequence: | 201122111 | Sequence: | 201122112 | Sequence: | 201122113 | Sequence: | 201122114 | Sequence: | 201122115 | Sequence: | 201122116 | Sequence: | 201122117 | Sequence: | 201122118 | Sequence: | 201122119 | Sequence: | 201122120 | Sequence: | 201122121 | Sequence: | 201122122 | Sequence: | 201122123 | Sequence: | 201122124 | Sequence: | 201122125 | Sequence: | 201122126 | Sequence: | 201122127 | Sequence: | 201122128 | Sequence: | 201122129 | Sequence: | 201122130 | Sequence: | 201122131 | Sequence: | 201122132 | Sequence: | 201122133 | Sequence: | 201122134 | Sequence: | 201122135 | Sequence: | 201122136 | Sequence: | 201122137 | Sequence: | 201122138 | Sequence: | 201122139 | Sequence: | 201122140 | Sequence: | 201122141 | Sequence: | 201122142 | Sequence: | 201122143 | Sequence: | 201122144 | Sequence: | 201122145 | Sequence: | 201122146 | Sequence: | 201122147 | Sequence: | 201122148 | Sequence: | 201122149 | Sequence: | 201122150 | Sequence: | 201122151 | Sequence: | 201122152 | Sequence: | 201122153 | Sequence: | 201122154 | Sequence: | 201122155 | Sequence: | 201122156 | Sequence: | 201122157 | Sequence: | 201122158 | Sequence: | 201122159 | Sequence: | 201122160 | Sequence: | 201122161 | Sequence: | 201122162 | Sequence: | 201122163 | Sequence: | 201122164 | Sequence: | 201122165 | Sequence: | 201122166 | Sequence: | 201122167 | Sequence: | 201122168 | Sequence: | 201122169 | Sequence: | 201122170 | Sequence: | 201122171 |
Name | Investigational Site Number 1560001 | Name | Investigational Site Number 1560006 | Name | Investigational Site Number 1560049 | Name | Investigational Site Number 1560039 | Name | Investigational Site Number 1560009 | Name | Investigational Site Number 1560027 | Name | Investigational Site Number 1560016 | Name | Investigational Site Number 1560053 | Name | Investigational Site Number 1560056 | Name | Investigational Site Number 1560010 | Name | Investigational Site Number 1560037 | Name | Investigational Site Number 1560050 | Name | Investigational Site Number 1560044 | Name | Investigational Site Number 1560033 | Name | Investigational Site Number 1560028 | Name | Investigational Site Number 1560012 | Name | Investigational Site Number 1560023 | Name | Investigational Site Number 1560035 | Name | Investigational Site Number 1560036 | Name | Investigational Site Number 1560011 | Name | Investigational Site Number 1560024 | Name | Investigational Site Number 1560047 | Name | Investigational Site Number 3440001 | Name | Investigational Site Number 1560025 | Name | Investigational Site Number 1560026 | Name | Investigational Site Number 1560048 | Name | Investigational Site Number 1560034 | Name | Investigational Site Number 1560005 | Name | Investigational Site Number 1560052 | Name | Investigational Site Number 1560031 | Name | Investigational Site Number 1560022 | Name | Investigational Site Number 1560014 | Name | Investigational Site Number 1560043 | Name | Investigational Site Number 1560041 | Name | Investigational Site Number 1560032 | Name | Investigational Site Number 1560038 | Name | Investigational Site Number 1560013 | Name | Investigational Site Number 1560007 | Name | Investigational Site Number 1560004 | Name | Investigational Site Number 1560029 | Name | Investigational Site Number 1560003 | Name | Investigational Site Number 1560054 | Name | Investigational Site Number 1560019 | Name | Investigational Site Number 1560059 | Name | Investigational Site Number 1560021 | Name | Investigational Site Number 1560017 | Name | Investigational Site Number 1560058 | Name | Investigational Site Number 1560018 | Name | Investigational Site Number 1560008 | Name | Investigational Site Number 1560055 | Name | Investigational Site Number 1560051 | Name | Investigational Site Number 1560030 | Name | Investigational Site Number 1560040 | Name | Investigational Site Number 1560060 | Name | Investigational Site Number 1560046 | Name | Investigational Site Number 1560045 | Name | Investigational Site Number 1560002 | Name | Investigational Site Number 1560015 | Name | Investigational Site Number 1560057 | Name | Investigational Site Number 4100009 | Name | Investigational Site Number 4100012 | Name | Investigational Site Number 4100010 | Name | Investigational Site Number 4100004 | Name | Investigational Site Number 4100003 | Name | Investigational Site Number 4100016 | Name | Investigational Site Number 4100011 | Name | Investigational Site Number 4100013 | Name | Investigational Site Number 4100001 | Name | Investigational Site Number 4100002 | Name | Investigational Site Number 4100005 | Name | Investigational Site Number 4580001 | Name | Investigational Site Number 4580005 | Name | Investigational Site Number 4580003 | Name | Investigational Site Number 4580006 | Name | Investigational Site Number 4580002 | Name | Investigational Site Number 4580004 | Name | Investigational Site Number 1580003 | Name | Investigational Site Number 1580005 | Name | Investigational Site Number 1580004 |
City | Beijing | City | Beijing | City | Beijing | City | Cangzhou | City | Changchun | City | Changchun | City | Changsha | City | Chengdu | City | Chengdu | City | Chenzhou | City | Chongqing | City | Chongqing | City | Dongguan | City | Guangzhou | City | Guangzhou | City | Handan | City | Hangzhou | City | Harbin | City | Harbin | City | Hengshui | City | Hohhot | City | Hohhot | City | Hong Kong | City | Huang Shi | City | Huanggang | City | Huizhou | City | Huzhou | City | Jinan | City | Jinhua | City | Jinzhou | City | Nanjing | City | Nanjing | City | Nanjing | City | Nanning | City | Qingdao | City | Qinhuangdao | City | Shanghai | City | Shanghai | City | Shanghai | City | Shanghai | City | Shenyang | City | Shenzhen | City | Suzhou | City | Suzhou | City | Tianjin | City | Tianjin | City | Urumqi | City | Wuhan | City | Xi'An | City | Xi'An | City | Xingtai | City | Xining | City | Yanji | City | Yueyang | City | Yueyang | City | Zhengzhou | City | Zhenjiang | City | Zhuzhou | City | Zigong | City | Ansan-Si | City | Busan | City | Guri-Si, Gyeonggi-Do | City | Gwangju | City | Seongnam-Si | City | Seoul | City | Seoul | City | Seoul | City | Seoul | City | Seoul | City | Wonju | City | Kelantan | City | Kuala Lumpur | City | Kuala Lumpur | City | Kuching | City | Putrajaya | City | Seremban | City | Taichung | City | Tainan Hsien | City | Taipei |
Zip | 1000029 | Zip | 101200 | Zip | 102218 | Zip | 061000 | Zip | 130033 | Zip | 130041 | Zip | 410013 | Zip | 610081 | Zip | 611130 | Zip | 400010 | Zip | 400013 | Zip | 510120 | Zip | 056002 | Zip | 150001 | Zip | 150001 | Zip | 053000 | Zip | 010017 | Zip | 010050 | Zip | 516001 | Zip | 250013 | Zip | 321000 | Zip | 121000 | Zip | 210029 | Zip | 530021 | Zip | 266042 | Zip | 200072 | Zip | 200240 | Zip | 201700 | Zip | 110022 | Zip | 518000 | Zip | 215006 | Zip | 300052 | Zip | 300121 | Zip | 830000 | Zip | 430014 | Zip | 710061 | Zip | 054031 | Zip | 810007 | Zip | 133000 | Zip | 414000 | Zip | 212001 | Zip | 412007 | Zip | 643002 | Zip | 15355 | Zip | 49241 | Zip | 11923 | Zip | 61469 | Zip | 13620 | Zip | 01832 | Zip | 03181 | Zip | 03722 | Zip | 05278 | Zip | 08308 | Zip | 26426 | Zip | 16150 | Zip | 56000 | Zip | 59100 | Zip | 93586 | Zip | 70300 | Zip | 407 | Zip | 710 | Zip | 11031 | ||||||||||||||||||||||||||||||||||
Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | China | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Malaysia | Country | Malaysia | Country | Malaysia | Country | Malaysia | Country | Malaysia | Country | Malaysia | Country | Taiwan | Country | Taiwan | Country | Taiwan |
Browse Interventions
Sequence: | 96509963 | Sequence: | 96509964 | Sequence: | 96509965 | Sequence: | 96509966 | Sequence: | 96509967 | Sequence: | 96509968 | Sequence: | 96509969 | Sequence: | 96509970 | Sequence: | 96509971 |
Mesh Term | Insulin | Mesh Term | Insulin, Globin Zinc | Mesh Term | Metformin | Mesh Term | Insulin Glargine | Mesh Term | Lixisenatide | Mesh Term | Sodium-Glucose Transporter 2 Inhibitors | Mesh Term | Hypoglycemic Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Molecular Mechanisms of Pharmacological Action |
Downcase Mesh Term | insulin | Downcase Mesh Term | insulin, globin zinc | Downcase Mesh Term | metformin | Downcase Mesh Term | insulin glargine | Downcase Mesh Term | lixisenatide | Downcase Mesh Term | sodium-glucose transporter 2 inhibitors | Downcase Mesh Term | hypoglycemic agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | molecular mechanisms of pharmacological action |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52455860 |
Name | Type 2 Diabetes Mellitus |
Downcase Name | type 2 diabetes mellitus |
Id Information
Sequence: | 40362363 | Sequence: | 40362364 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | EFC14943 | Id Value | U1111-1190-7669 |
Id Type | Other Identifier | ||
Id Type Description | UTN | ||
Countries
Sequence: | 42796426 | Sequence: | 42796427 | Sequence: | 42796428 | Sequence: | 42796429 | Sequence: | 42796430 |
Name | China | Name | Korea, Republic of | Name | Malaysia | Name | Taiwan | Name | Hong Kong |
Removed | False | Removed | False | Removed | False | Removed | False | Removed | True |
Design Groups
Sequence: | 55909723 | Sequence: | 55909724 | Sequence: | 55909725 |
Group Type | Experimental | Group Type | Active Comparator | Group Type | Active Comparator |
Title | Soliqua (insulin glargine/lixisenatide) | Title | Lantus (insulin glargine) | Title | Lyxumia (lixisenatide) |
Description | iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning on top of metformin for 24 weeks. | Description | Insulin glargine will be self-administered subcutaneously once daily at any time of the day on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period. | Description | Lixisenatide will be self-administered subcutaneously once daily according to the locally approved label on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period. |
Interventions
Sequence: | 52766015 | Sequence: | 52766016 | Sequence: | 52766017 | Sequence: | 52766018 | Sequence: | 52766019 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Insulin glargine/Lixisenatide (HOE901/AVE0010) | Name | Insulin glargine (HOE901) | Name | Lixisenatide (AVE0010) | Name | Metformin | Name | SGLT2 inhibitor |
Description | Pharmaceutical form: solution
Route of administration: subcutaneous |
Description | Pharmaceutical form: solution
Route of administration: subcutaneous |
Description | Pharmaceutical form: solution
Route of administration: subcutaneous |
Description | Pharmaceutical form: tablet
Route of administration: oral |
Description | Pharmaceutical form:tablet
Route of administration: oral |
Design Outcomes
Sequence: | 178449122 | Sequence: | 178449123 | Sequence: | 178449124 | Sequence: | 178449125 | Sequence: | 178449126 | Sequence: | 178449127 | Sequence: | 178449128 | Sequence: | 178449129 | Sequence: | 178449130 | Sequence: | 178449131 | Sequence: | 178449132 | Sequence: | 178449133 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in HbA1c | Measure | Change in postprandial plasma glucose (PPG) | Measure | Change in fasting plasma glucose (FPG) | Measure | Change in self-monitored plasma glucose (SMPG) profile | Measure | Patients with HbA1c <7.0% | Measure | Patients with HbA1c ≤ 6.5% | Measure | Change in body weight | Measure | Patients with HbA1c <7.0% with no body weight gain | Measure | Patients with HbA1c <7.0% with no body weight gain and no documented symptomatic hypoglycemia | Measure | Confirmed hypoglycemia | Measure | Adverse events (AEs) | Measure | Immunogenicity (antibody variables) |
Time Frame | From Baseline to Week 24 | Time Frame | From Baseline to Week 24 | Time Frame | From Baseline to Week 24 | Time Frame | From Baseline to Week 24 | Time Frame | At Week 24 | Time Frame | At Week 24 | Time Frame | From Baseline to Week 24 | Time Frame | At Week 24 | Time Frame | At Week 24 | Time Frame | From Baseline to Week 24 | Time Frame | From Baseline to Week 24 | Time Frame | From Baseline to Week 24 |
Description | Change in glycated hemoglobin (HbA1c) from baseline to Week 24 | Description | Absolute change in 2-hour blood glucose excursion and PPG during meal test from baseline to Week 24 (for all patients in iGlarLixi or insulin glargine group and patients who receive morning injection in the lixisenatide group) | Description | Absolute change in FPG from baseline to Week 24 | Description | Absolute change in 7-point SMPG profiles from baseline to Week 24 (each time point and average daily value) | Description | Percentage of patients reaching HbA1c <7% at Week 24 | Description | Percentage of patients reaching HbA1c ≤ 6.5% at Week 24 | Description | Absolute change in body weight from baseline to Week 24 | Description | Percentage of patients reaching HbA1c <7% with no body weight gain at Week 24 | Description | Percentage of patients reaching HbA1c <7% with no body weight gain at Week 24 and no documented (plasma glucose [PG] ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia during the 24 week treatment period | Description | Including severe hypoglycemia and episodes of hypoglycemia documented with PG ≤70 mg/dL (3.9 mmol/L) regardless of symptoms from baseline to Week 24 | Description | Number of AEs, serious AEs, AEs of Special Interest, and AEs requiring specific monitoring from baseline to Week 24 | Description | Anti-lixisenatide antibodies and anti-insulin antibodies (depending on the treatment group) from baseline to Week 24 |
Browse Conditions
Sequence: | 194573865 | Sequence: | 194573866 | Sequence: | 194573867 | Sequence: | 194573868 | Sequence: | 194573869 |
Mesh Term | Diabetes Mellitus | Mesh Term | Diabetes Mellitus, Type 2 | Mesh Term | Glucose Metabolism Disorders | Mesh Term | Metabolic Diseases | Mesh Term | Endocrine System Diseases |
Downcase Mesh Term | diabetes mellitus | Downcase Mesh Term | diabetes mellitus, type 2 | Downcase Mesh Term | glucose metabolism disorders | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | endocrine system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48583822 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Sanofi |
Overall Officials
Sequence: | 29434316 |
Role | Study Director |
Name | Clinical Sciences & Operations |
Affiliation | Sanofi |
Design Group Interventions
Sequence: | 68539472 | Sequence: | 68539473 | Sequence: | 68539474 | Sequence: | 68539475 | Sequence: | 68539476 | Sequence: | 68539477 | Sequence: | 68539478 | Sequence: | 68539479 | Sequence: | 68539480 |
Design Group Id | 55909723 | Design Group Id | 55909724 | Design Group Id | 55909725 | Design Group Id | 55909724 | Design Group Id | 55909725 | Design Group Id | 55909723 | Design Group Id | 55909724 | Design Group Id | 55909725 | Design Group Id | 55909723 |
Intervention Id | 52766015 | Intervention Id | 52766016 | Intervention Id | 52766017 | Intervention Id | 52766018 | Intervention Id | 52766018 | Intervention Id | 52766018 | Intervention Id | 52766019 | Intervention Id | 52766019 | Intervention Id | 52766019 |
Eligibilities
Sequence: | 30928773 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion criteria :
Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit (V1), treated for at least 3 months prior to the screening visit (V1) with metformin alone or metformin and a second oral antidiabetic treatment that can be a sulfonylurea (SU), a glinide, an alpha-glucosidase inhibitor (alpha-GI), a dipeptidyl peptidase-4 (DPP-4) inhibitor or a sodium-glucose co transporter 2 (SGLT-2) inhibitor and who are not adequately controlled with this treatment. Exclusion criteria: Age < legal age of majority at the screening visit (V1). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254207105 |
Number Of Facilities | 79 |
Registered In Calendar Year | 2019 |
Actual Duration | 24 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 11 |
Designs
Sequence: | 30674428 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26815508 | Sequence: | 26815509 | Sequence: | 26815510 | Sequence: | 26815511 |
Intervention Id | 52766015 | Intervention Id | 52766015 | Intervention Id | 52766016 | Intervention Id | 52766017 |
Name | Soliqua | Name | iGlarLixi | Name | Lantus | Name | Lyxumia |
Responsible Parties
Sequence: | 29041154 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52365475 |
Pmid | 35441412 |
Reference Type | background |
Citation | Yang W, Dong X, Li Q, Cheng Z, Yuan G, Liu M, Xiao J, Gu S, Niemoeller E, Chen L, Ping L, Souhami E; LixiLan-O-AP trial investigators. Efficacy and safety benefits of iGlarLixi versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with suboptimally controlled type 2 diabetes on oral agents: The LixiLan-O-AP randomized controlled trial. Diabetes Obes Metab. 2022 Aug;24(8):1522-1533. doi: 10.1111/dom.14722. Epub 2022 May 12. |
]]>
https://zephyrnet.com/NCT03798041
2019-02-01
https://zephyrnet.com/?p=NCT03798041
NCT03798041https://www.clinicaltrials.gov/study/NCT03798041?tab=tableNANANAWound healing after surgery is a complex procedure. Liquefaction of the fat and necrosis of inactivated tissue, as well as blood clots are always accumulated mostly within 24 hours after surgery. As such, early debridement within 24 hours after surgery might improve the healing of the wounds. This study is designed to compare the impact of early debridement of the wound versus regular dressing (24 hours later) on the wound healing. 100 patients will be included in this study, and divided into 2 groups randomly. Then, the healing of the wound, stitch removal time, incidence of incision complications will be compared between the two groups.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-01 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2021-12-09 |
Start Month Year | February 1, 2019 |
Primary Completion Month Year | March 16, 2021 |
Verification Month Year | March 2021 |
Verification Date | 2021-03-31 |
Last Update Posted Date | 2021-12-09 |
Facilities
Sequence: | 200755284 |
Name | The First Affiliated Hospital of Xi'an Jiaotong University |
City | Xi'an |
State | Shaanxi |
Zip | 710061 |
Country | China |
Conditions
Sequence: | 52358776 |
Name | Surgical Wound |
Downcase Name | surgical wound |
Id Information
Sequence: | 40292936 |
Id Source | org_study_id |
Id Value | XJTU1AFCRC2017SJ-007-1 |
Countries
Sequence: | 42716029 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55801750 | Sequence: | 55801751 |
Group Type | Experimental | Group Type | No Intervention |
Title | Debridement group | Title | Control group |
Description | The subjects in this group will be debrided within 24 hours after surgery. | Description | The subjects in this group will experience wound dressing change regularly 24 hours after surgery. |
Interventions
Sequence: | 52669676 |
Intervention Type | Behavioral |
Name | Debridement Within 24 Hours After Surgery |
Description | Debrided within 24 hours after surgery |
Keywords
Sequence: | 80126473 | Sequence: | 80126474 |
Name | Surgical Wound | Name | Suture, Complication |
Downcase Name | surgical wound | Downcase Name | suture, complication |
Design Outcomes
Sequence: | 178071550 | Sequence: | 178071551 |
Outcome Type | primary | Outcome Type | secondary |
Measure | healing time, d (day) | Measure | incidence of incision complications |
Time Frame | From date of surgery to the date of stitches off (up to 1 month) | Time Frame | From the date of surgery to stitches off (up to 1 month) |
Description | since the ending of surgery to stitches off. | Description | The incision complications include infection, dehiscence, fat liquefaction, etc. |
Browse Conditions
Sequence: | 194200534 | Sequence: | 194200535 |
Mesh Term | Wounds and Injuries | Mesh Term | Surgical Wound |
Downcase Mesh Term | wounds and injuries | Downcase Mesh Term | surgical wound |
Mesh Type | mesh-list | Mesh Type | mesh-list |
Sponsors
Sequence: | 48493783 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | First Affiliated Hospital Xi'an Jiaotong University |
Overall Officials
Sequence: | 29384517 |
Role | Principal Investigator |
Name | Xu-Feng Zhang, MD, PhD |
Affiliation | First Affiliated Hospital Xi'an Jiaotong University |
Design Group Interventions
Sequence: | 68405039 |
Design Group Id | 55801750 |
Intervention Id | 52669676 |
Eligibilities
Sequence: | 30873493 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
the patient with major abdominal incision. Exclusion Criteria: Pregnant woman |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254046623 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 25 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30619287 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28985814 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798028
2017-12-26
https://zephyrnet.com/?p=NCT03798028
NCT03798028https://www.clinicaltrials.gov/study/NCT03798028?tab=tablePing Zhu, Doctorzhuping@fmmu.edu.cn86-29-84773951This study evaluates the safety and therapeutic effects of single-dose human umbilical cord blood mesenchymal stem cells (UC-MSCs) on the adult patients with moderate/severe Rheumatoid Arthritis accompany with anemia or/and Interstitial pulmonary disease. Half of participants will receive UC-MSCs and keep the present medication,while the other half will receive a placebo and keep the present medication.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-09 |
Start Month Year | December 26, 2017 |
Primary Completion Month Year | December 31, 2019 |
Verification Month Year | December 2018 |
Verification Date | 2018-12-31 |
Last Update Posted Date | 2019-01-09 |
Facilities
Sequence: | 199965068 |
Status | Recruiting |
Name | Xijing Hospital |
City | Xi'an |
State | Shaanxi |
Zip | 710032 |
Country | China |
Facility Contacts
Sequence: | 28086648 |
Facility Id | 199965068 |
Contact Type | primary |
Name | Ping Zhu |
zhuping@fmmu.edu.cn | |
Phone | 862984773951 |
Phone Extension | 862984773951 |
Conditions
Sequence: | 52139002 |
Name | Rheumatoid Arthritis |
Downcase Name | rheumatoid arthritis |
Id Information
Sequence: | 40135061 |
Id Source | org_study_id |
Id Value | 2014ZX09508002 |
Countries
Sequence: | 42542685 |
Name | China |
Removed | False |
Design Groups
Sequence: | 55559342 | Sequence: | 55559343 |
Group Type | Experimental | Group Type | No Intervention |
Title | UC-MSCs treatment | Title | no UC-MSCs treatment |
Description | the participants will receive the single-dose UC-MSCs (1×10^6 cells/kg ) in combined with the present treatment. | Description | the participants will receive the placebo in combined with the present treatment. |
Interventions
Sequence: | 52454907 |
Intervention Type | Biological |
Name | UC-MSCs |
Description | The UC-MSCs will be administrated by intravenous injection at the dose of 1×10^6 cells/kg. |
Keywords
Sequence: | 79822815 | Sequence: | 79822816 |
Name | anemia | Name | Interstitial pulmonary disease |
Downcase Name | anemia | Downcase Name | interstitial pulmonary disease |
Design Outcomes
Sequence: | 177263630 | Sequence: | 177263631 | Sequence: | 177263632 | Sequence: | 177263633 | Sequence: | 177263634 | Sequence: | 177263635 | Sequence: | 177263636 | Sequence: | 177263637 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Improvement rate of blood routine hemoglobin (HGB) compared to baseline. | Measure | Improvement rate of forced vital capacity (FVC) and/or carbon monoxide diffusing capacity (DLCO) compared to baseline. | Measure | The remission rates of American College of Rheumatology (ACR) 20, ACR 50 and ACR 70. | Measure | White blood cell count and platelet count improved compared to the baseline. | Measure | Improvement rate of blood routine hemoglobin (HGB) compared to baseline. | Measure | Improvement rate of forced vital capacity (FVC) and/or carbon monoxide | Measure | Image improvement of lung on high resolution CT. | Measure | Improvement of 6-minute walking distance compared to baseline. |
Time Frame | 24 weeks | Time Frame | 24 weeks | Time Frame | 12 weeks and 24 weeks | Time Frame | 12 weeks and 24 weeks | Time Frame | 12 weeks | Time Frame | 12 weeks | Time Frame | 24 weeks | Time Frame | 12 weeks and 24 weeks |
Description | The HGB increases by 10g compared to the baseline is considered improvement. | Description | FVC increases by 0.5% and DLCO increases by 10% compared to baseline are considered improvement. | Description | The patients achieves 20%, 50%, or 70% remission according to American College of Rheumatology (ACR) criteria. | Description | White blood cell count increases to the 3.5×10^9/L and platelet count increases to 80×10^ 9. | Description | The HGB increases by 10 g compared to the baseline is considered improvement. | Description | FVC increases by 0.5% and DLCO increases by 10% compared to baseline | Description | The area change of image of lung. |
Browse Conditions
Sequence: | 193366511 | Sequence: | 193366512 | Sequence: | 193366513 | Sequence: | 193366514 | Sequence: | 193366515 | Sequence: | 193366516 | Sequence: | 193366517 | Sequence: | 193366518 |
Mesh Term | Arthritis | Mesh Term | Arthritis, Rheumatoid | Mesh Term | Joint Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Rheumatic Diseases | Mesh Term | Connective Tissue Diseases | Mesh Term | Autoimmune Diseases | Mesh Term | Immune System Diseases |
Downcase Mesh Term | arthritis | Downcase Mesh Term | arthritis, rheumatoid | Downcase Mesh Term | joint diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | rheumatic diseases | Downcase Mesh Term | connective tissue diseases | Downcase Mesh Term | autoimmune diseases | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48290705 | Sequence: | 48290706 | Sequence: | 48290707 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Xijing Hospital | Name | Changhai Hospital | Name | Southwest Hospital, China |
Central Contacts
Sequence: | 12000487 |
Contact Type | primary |
Name | Ping Zhu, Doctor |
Phone | 86-29-84773951 |
zhuping@fmmu.edu.cn | |
Role | Contact |
Design Group Interventions
Sequence: | 68107452 |
Design Group Id | 55559342 |
Intervention Id | 52454907 |
Eligibilities
Sequence: | 30747721 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Fulfill 2010 ACR/ the European League Against Rheumatism (EULAR) classification criteria or the 1987 ACR classification criteria. Exclusion Criteria: Participants who received glucocorticoid therapy by intra-articular injection within 1 week. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254121849 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30494004 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Subject Masked | True |
Intervention Other Names
Sequence: | 26655414 |
Intervention Id | 52454907 |
Name | placebo |
Responsible Parties
Sequence: | 28860284 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798015
2009-02-28
https://zephyrnet.com/?p=NCT03798015
NCT03798015https://www.clinicaltrials.gov/study/NCT03798015?tab=tableNANANAReconstructive mitral valve surgery is increasingly done by minimal- invasive anterolateral thoracotomy technique in contrast to surgical approach by sternotomy. The minimal invasive approach is favourable regarding surgical trauma, length of hospital stay and amount of blood loss.
This study is to investigate the neurological outcome after minimal- invasive mitral valve surgery compared to open mitral valve surgery by sternotomy.
Pre-, intra- and postsurgical data from mitral valve surgery derived from the Basel mitral valve registry (collected from 2009 until now) will be analyzed.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-04-20 |
Start Month Year | February 2009 |
Primary Completion Month Year | December 2021 |
Verification Month Year | April 2022 |
Verification Date | 2022-04-30 |
Last Update Posted Date | 2022-04-20 |
Facilities
Sequence: | 199426922 |
Name | Herzchirurgie University Hospital Basel |
City | Basel |
Zip | 4031 |
Country | Switzerland |
Conditions
Sequence: | 52012341 |
Name | Mitral Valve Reconstruction |
Downcase Name | mitral valve reconstruction |
Id Information
Sequence: | 40034264 |
Id Source | org_study_id |
Id Value | 2018-02143; ch18Grapow3 |
Countries
Sequence: | 42430370 |
Name | Switzerland |
Removed | False |
Design Groups
Sequence: | 55418113 |
Title | mitral valve surgery |
Description | outcome of mitral valve surgery (stroke yes or no) |
Interventions
Sequence: | 52324665 |
Intervention Type | Other |
Name | mitral valve surgery |
Description | assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery |
Keywords
Sequence: | 79613814 | Sequence: | 79613815 | Sequence: | 79613816 | Sequence: | 79613817 | Sequence: | 79613818 |
Name | mitral valve surgery | Name | mitral valve stenosis | Name | mitral valve insufficiency | Name | minimal invasive mitral valve surgery | Name | neurological outcome |
Downcase Name | mitral valve surgery | Downcase Name | mitral valve stenosis | Downcase Name | mitral valve insufficiency | Downcase Name | minimal invasive mitral valve surgery | Downcase Name | neurological outcome |
Design Outcomes
Sequence: | 176823858 |
Outcome Type | primary |
Measure | occurence of stroke (yes/ no) subsequent to mitral valve surgery |
Time Frame | post surgical from day of surgery until day of discharge from hospital (approx. 2 weeks) |
Description | assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery |
Sponsors
Sequence: | 48170886 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University Hospital, Basel, Switzerland |
Overall Officials
Sequence: | 29193996 |
Role | Principal Investigator |
Name | Martin Grapow, Prof. Dr. MD |
Affiliation | Klinik für Herzchirurgie, Universitätsspital Basel |
Design Group Interventions
Sequence: | 67936194 |
Design Group Id | 55418113 |
Intervention Id | 52324665 |
Eligibilities
Sequence: | 30672192 |
Sampling Method | Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | patients undergoing a surgical mitral valve reconstruction or replacement at the University Hospital Basel from 2009 until today |
Criteria | Inclusion Criteria:
surgery for mitral valve (reconstruction or replacement) (maybe combined with surgery for tricuspid valve and/ or surgery for atrial septal defects and/or patent foramen ovale) Exclusion Criteria: other surgical interventions then the surgical interventions mentioned in the inclusion criteria |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254302744 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 156 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30418962 |
Observational Model | Cohort |
Time Perspective | Retrospective |
Responsible Parties
Sequence: | 28785479 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03798002
2019-01-15
https://zephyrnet.com/?p=NCT03798002
NCT03798002https://www.clinicaltrials.gov/study/NCT03798002?tab=tableNANANAA randomized controlled trial in which Neuro-muscular exercise training and Isolated quadriceps training program would be applied on patients with symptomatic knee Osteoarthritis by using different tools and changes would be examined pre and post intervention .The participants fulfilling inclusion criteria would be randomly allocated to two groups. Both groups received different protocols and will be assessed on data collection tool on their first and last visit by using Numeric Pain Rating Scale (NPRS), The Western Ontario and McMaster Osteoarthritis Index (WOMAC), Timed Up and Go test (TUG test), 30sec chair stand test,6min walk test (6MWT).Participants of both groups will be pre-tested before the application of interventional programs and post-tested after the application of respective intervention.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-05 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-08-08 |
Start Month Year | January 15, 2019 |
Primary Completion Month Year | April 30, 2019 |
Verification Month Year | August 2019 |
Verification Date | 2019-08-31 |
Last Update Posted Date | 2019-08-08 |
Detailed Descriptions
Sequence: | 20716289 |
Description | The knee joint is a complex modified hinge joint with the greatest range of movement. Three bones come together to form the joint, which are the femur, tibia, and patella. Osteoarthritis, commonly known as wear-and-tear arthritis, is a condition in which the natural cushioning between joints, cartilage wears away. The bones of the joints rub more closely against one another with less of the shock-absorbing benefits of cartilage. The rubbing results in pain, swelling, stiffness, decreased ability to move and, sometimes, the formation of bone spurs.
Osteoarthritis is widespread among physically active individuals . The quadriceps weakness commonly associated with osteoarthritis of the knee is widely believed to result from disuse atrophy secondary to pain in the involved joint. However, quadriceps weakness may be an etiologic factor in the development of osteoarthritis. Several studies have indicated that Physical modalities for the treatment of knee pain in patients with osteoarthritis include physical therapy, exercise, weight loss, and the use of braces or heel wedges. High- and low-intensity aerobic exercises are equally effective in improving functional status, gait, pain, and aerobic capacity in persons with knee osteoarthritis water-based and land-based exercises reduce knee pain and physical disability and aerobic walking, quadriceps strengthening, resistance exercise reduce pain and disability.Several proptocols are available for management of knee joint osteoarthritis. These protocols include Neuro motor training exercise and isolated quadriceps training program. Neuromotor training is basically combination of three parts warming up, a circuit program, and cooling down. Main principle of Neuro-motor training is to improve sensorimotor control and compensatory functional stability.[3]Patients with symptomatic osteoarthritis pain, stiffness, flexibility and decreases range of motion is a common clinical finding. Flexibility is an important component of fitness needed for most desirable musculoskeletal functioning and maximizing the performance of physical activities. Flexibility is a biomechanical property of the body tissues and it determines the range of motion possible without injury at a joint or group of joints. Decrease range of motion has been shown to predispose a person to several musculoskeletal overuse injuries and considerably affect a person level of function.Changes in joint appearance/ joint deformities be one of the more commonly established causes of osteoarthritis. The target in treating patients with OA should be the safest possible intervention, with the best pain relief and prevention of further functional disability. Neuromotor training is also one of the treatment option related to physical therapy in reducing knee pain with home plane exercises to gain required ROM and resume function. Time up and go test (TUG test).the tug is internationally accepted functional dynamic test of balance with known reliability and validity as well as being low cost and easy to apply. The tug test measures the time in seconds that takes a subject to stand up from chair and sit down. Subject will score less than 10 seconds are consider normal, less than 15 sec are at risk of fall ,less than 20 sec are independent in ambulation and able to climb the stairs, and greater than 30 seconds need help with chair. The 30 Second Chair Stand Test, in conjunction with other measures such as the 4-Stage Balance Test, Timed Up and Go (TUG) Test and an assessment of postural hypotension can help to indicate if a patient is at risk of falling. Purpose is to test leg strength and endurance Equipment: A chair with a straight back, without arm rests, placed against a wall to prevent it moving. Sit in the middle of the chair. Place each hand on the opposite shoulder crossed at the wrists. Place your feet flat on the floor. Keep your back straight and keep your arms against your chest. On "Go", rise to a full standing position and then sit back down again. Repeat this for 30 seconds. On "Go" begin timing. Do not continue if you feel the patient may fall during the test. Count the number of times the patient comes to a full standing position in 30 seconds and record it in the box below. If the patient is over halfway to a standing position when 30 seconds have elapsed, count it as a stand. If the patient must use his or her arms to stand then stop the test and record "0" for the number below.The western Ontario and McMaster universities osteoarthritis (womac) is a widely used by health professionals to evaluate the condition of patient with osteoarthritis of knee . womac measures 5 items for pain score 0-20. 2 for stiffness score 0-8 and 17 for functional limitation score 0-68. Physical functioning question of daily activities such as siting standing walking lying on bed taking of socks getting in or out of bath. Numeric pain rating scale (NPRs) is used for measure of pain intensity. In NPRS 0-10 integers that best reflects the intensity of pain. 0 represent no pain. Previous studies were more focused on hydrotherapeutic exercises, muscle stretching strengthening, aerobics. There is still a challenge to explore best type of exercise therapy for improving sensorimotor function, alleviating symptoms and showing the disease process in different sub groups of patients with degenerative knee disease |
Facilities
Sequence: | 200053274 | Sequence: | 200053275 |
Name | Imran Amjad | Name | Riphah International University |
City | Islamabad | City | Islamabad |
State | Punjab | ||
Zip | 46000 | Zip | 46000 |
Country | Pakistan | Country | Pakistan |
Conditions
Sequence: | 52156483 |
Name | Knee Osteoarthritis |
Downcase Name | knee osteoarthritis |
Id Information
Sequence: | 40148199 |
Id Source | org_study_id |
Id Value | RiphahI Maryam Khan |
Countries
Sequence: | 42557722 |
Name | Pakistan |
Removed | False |
Design Groups
Sequence: | 55577890 | Sequence: | 55577891 |
Group Type | Experimental | Group Type | Active Comparator |
Title | Neuro-muscular exercise training Group | Title | quadriceps training program |
Description | Neuro-muscular exercise training will be administer to Knee OA patients. | Description | quadriceps stretching and strengthening exercises will be administer to Knee OA patients. |
Interventions
Sequence: | 52471996 | Sequence: | 52471997 |
Intervention Type | Other | Intervention Type | Other |
Name | Neuro-muscular exercise training Group | Name | quadriceps training program |
Description | Training takes place 3 days a week for 8 weeks follow up, under the supervision of physical therapist A training session lasts for 40 minutes, and consists of three parts.
PART 1:Warming up: warm-up period consists of ergometer cycling for 10 minutes PART 2: Circuit program: comprises four exercises, core stability/postural function; postural orientation; lower extremity muscle strength; and functional exercises. Each exercise is performed 2-3 sets 10-15 repetitions. PART 3:Cooling down: The cooling down part consists of walking exercises forward and backwards, about 10 meters in each direction, in front of mirror (mobility exercises for the lower extremity muscles for a total of about 10 minutes. Changes in patient's symptom assessed by structural questionnaire |
Description | Apply Tens (10min+ hot pack 7-10min) Before excercise ROM,Quadriceps and hamstring stretching exercise's and strengthening exercises.
4th-6th week (in addition): Straight leg raise, Quads over a roll, Hamstring curls. 7th and 8th week (in addition): Elastic band exercise, Hamstring curls, Quads chair, isometric strengthening All exercises are performed in set of 10 repetitions. 1 set of all exercises was twice a day for first 3 week, and 2 sets twice a day until 6th week and then 3 sets twice a day until 8th week |
Keywords
Sequence: | 79848067 | Sequence: | 79848068 | Sequence: | 79848069 |
Name | isolated quadriceps training | Name | Neuro-muscular exercise training | Name | knee Osteoarthritis |
Downcase Name | isolated quadriceps training | Downcase Name | neuro-muscular exercise training | Downcase Name | knee osteoarthritis |
Design Outcomes
Sequence: | 177327866 | Sequence: | 177327867 |
Outcome Type | primary | Outcome Type | secondary |
Measure | WOMAC Scale | Measure | Numeric pain rating scale(NPRS) |
Time Frame | From baseline to 8th week | Time Frame | From baseline to 8th week |
Description | WOMAC is western Onterio and McMaster Osteoarthritis Index. Its scores are from 0-100 | Description | Numeric pain rating scale is used to measure pain. Its score is from 0-10, with 0 means no pain and10 means worst pain. |
Browse Conditions
Sequence: | 193432017 | Sequence: | 193432018 | Sequence: | 193432019 | Sequence: | 193432020 | Sequence: | 193432021 | Sequence: | 193432022 |
Mesh Term | Osteoarthritis | Mesh Term | Osteoarthritis, Knee | Mesh Term | Arthritis | Mesh Term | Joint Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Rheumatic Diseases |
Downcase Mesh Term | osteoarthritis | Downcase Mesh Term | osteoarthritis, knee | Downcase Mesh Term | arthritis | Downcase Mesh Term | joint diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | rheumatic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306061 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Riphah International University |
Overall Officials
Sequence: | 29277922 |
Role | Principal Investigator |
Name | imran Amjad, Phd* |
Affiliation | Associate Professor |
Design Group Interventions
Sequence: | 68130859 | Sequence: | 68130860 |
Design Group Id | 55577890 | Design Group Id | 55577891 |
Intervention Id | 52471996 | Intervention Id | 52471997 |
Eligibilities
Sequence: | 30757344 |
Gender | All |
Minimum Age | 40 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
UL/BL knee OA, Exclusion Criteria: Knee surgery |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254227709 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2019 |
Actual Duration | 3 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 40 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30503569 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | Single |
Subject Masked | True |
Responsible Parties
Sequence: | 28869847 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52049388 | Sequence: | 52049389 | Sequence: | 52049390 | Sequence: | 52049391 | Sequence: | 52049392 | Sequence: | 52049393 | Sequence: | 52049394 | Sequence: | 52049395 |
Pmid | 19560995 | Pmid | 9230035 | Pmid | 23559821 | Pmid | 23461090 | Pmid | 27836677 | Pmid | 24931956 | Pmid | 23924144 | Pmid | 22141334 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Weng MC, Lee CL, Chen CH, Hsu JJ, Lee WD, Huang MH, Chen TW. Effects of different stretching techniques on the outcomes of isokinetic exercise in patients with knee osteoarthritis. Kaohsiung J Med Sci. 2009 Jun;25(6):306-15. doi: 10.1016/S1607-551X(09)70521-2. | Citation | Slemenda C, Brandt KD, Heilman DK, Mazzuca S, Braunstein EM, Katz BP, Wolinsky FD. Quadriceps weakness and osteoarthritis of the knee. Ann Intern Med. 1997 Jul 15;127(2):97-104. doi: 10.7326/0003-4819-127-2-199707150-00001. | Citation | Bhatia D, Bejarano T, Novo M. Current interventions in the management of knee osteoarthritis. J Pharm Bioallied Sci. 2013 Jan;5(1):30-8. doi: 10.4103/0975-7406.106561. | Citation | Merashly M, Uthman I. Management of knee osteoarthritis: an evidence-based review of treatment options. J Med Liban. 2012 Oct-Dec;60(4):237-42. | Citation | Holsgaard-Larsen A, Clausen B, Sondergaard J, Christensen R, Andriacchi TP, Roos EM. The effect of instruction in analgesic use compared with neuromuscular exercise on knee-joint load in patients with knee osteoarthritis: a randomized, single-blind, controlled trial. Osteoarthritis Cartilage. 2017 Apr;25(4):470-480. doi: 10.1016/j.joca.2016.10.022. Epub 2016 Nov 9. | Citation | Villadsen A, Overgaard S, Holsgaard-Larsen A, Christensen R, Roos EM. Immediate efficacy of neuromuscular exercise in patients with severe osteoarthritis of the hip or knee: a secondary analysis from a randomized controlled trial. J Rheumatol. 2014 Jul;41(7):1385-94. doi: 10.3899/jrheum.130642. Epub 2014 Jun 15. | Citation | Ageberg E, Nilsdotter A, Kosek E, Roos EM. Effects of neuromuscular training (NEMEX-TJR) on patient-reported outcomes and physical function in severe primary hip or knee osteoarthritis: a controlled before-and-after study. BMC Musculoskelet Disord. 2013 Aug 8;14:232. doi: 10.1186/1471-2474-14-232. | Citation | Bennell KL, Egerton T, Wrigley TV, Hodges PW, Hunt M, Roos EM, Kyriakides M, Metcalf B, Forbes A, Ageberg E, Hinman RS. Comparison of neuromuscular and quadriceps strengthening exercise in the treatment of varus malaligned knees with medial knee osteoarthritis: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2011 Dec 5;12:276. doi: 10.1186/1471-2474-12-276. |
]]>
https://zephyrnet.com/NCT03797989
2019-01-10
https://zephyrnet.com/?p=NCT03797989
NCT03797989https://www.clinicaltrials.gov/study/NCT03797989?tab=tableNANANAThis is a clinical study to assess the safety and feasibility of Plasmodium vivax (P. vivax) controlled blood-stage human malaria infection (CHMI), by inoculation using a newly created source of P. vivax malaria-infected blood.
25 healthy malaria-naïve UK volunteers, aged 18 – 50, will be recruited through the five phases of the study at the CCVTM, Oxford. Volunteers will undergo primary, secondary and tertiary P. vivax blood-stage challenges, which will be induced by injection of P. vivax infected blood. After the first challenge, the optimal dose for blood-stage CHMI will be selected and used for the second and third challenges. Through each challenge period, volunteers will have blood taken at regular intervals to measure the parasite growth, quantify the sexual parasite forms and assess the immune response to P. vivax infection. Transmission of P. vivax from volunteers to the Anopheline mosquito vectors will also be assessed.
In each challenge, following diagnosis, volunteers will be treated with a standard antimalarial course of oral artemether-lumefantrine (Riamet), given over 60 hours. Volunteers who take part in this study will be involved in the trial for approximately 2 years, receiving each of the three challenges at intervals of approximately 5 (and up to 9) months. Volunteers will be followed for 3 months after their last challenge.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-29 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-08-17 |
Start Month Year | January 10, 2019 |
Primary Completion Month Year | December 31, 2022 |
Verification Month Year | August 2022 |
Verification Date | 2022-08-31 |
Last Update Posted Date | 2022-08-17 |
Detailed Descriptions
Sequence: | 20838459 |
Description | This study aims primarily to assess the safety and feasibility of controlled blood-stage human P. vivax malaria infection. This will be the first time that this source of P. vivax infected blood will be utilised and the first P. vivax bloodstage CHMI in Europe. If demonstrated to be safe, it is intended that this parasitised blood bank be used in future CHMI studies to evaluate candidate vaccines.
This study will also assess parasite growth, including quantifying the sexual-stage parasites in the blood, as well as the transmission of P. vivax from volunteers to the Anopheline mosquito vectors and the immune responses in primary, secondary and tertiary P. vivax blood-stage challenge, as further secondary aims. Natural immunity to P. vivax is acquired over time, following repeated exposure. Repeated blood-stage challenge would improve understanding of how the human immune response to P. vivax infected is acquired, and how parasite growth changes in a second or third exposure. Repeated challenges can also be used to test if potential vaccine candidates can protect against repeated malaria infection. If proven to be safe and feasible in this study, this will provide a basis for conducting P. vivax blood-stage re-challenge studies for evaluation of new vaccine candidates. The study is funded through The Wellcome Trust and MultiViVax, a European Commission Horizon 2020 funded project. |
Facilities
Sequence: | 201180557 |
Name | Centre for Clinical Vaccinology & Tropical Medicine |
City | Oxford |
State | Oxfordshire |
Zip | OX3 7LE |
Country | United Kingdom |
Conditions
Sequence: | 52470523 |
Name | Malaria, Vivax |
Downcase Name | malaria, vivax |
Id Information
Sequence: | 40373226 |
Id Source | org_study_id |
Id Value | VAC069 |
Countries
Sequence: | 42808786 |
Name | United Kingdom |
Removed | False |
Design Groups
Sequence: | 55925841 | Sequence: | 55925842 | Sequence: | 55925843 | Sequence: | 55925844 | Sequence: | 55925845 | Sequence: | 55925846 | Sequence: | 55925847 | Sequence: | 55925848 | Sequence: | 55925849 | Sequence: | 55925850 | Sequence: | 55925851 | Sequence: | 55925852 | Sequence: | 55925853 | Sequence: | 55925854 | Sequence: | 55925855 | Sequence: | 55925856 |
Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
Title | Phase A: Group 1 | Title | Phase A: Group 2 | Title | Phase A: Group 3 | Title | Phase B: Group 4 | Title | Phase B: Group 6 | Title | Phase C: Group 5 | Title | Phase C: Group 7 | Title | Phase C: Group 9 | Title | Phase D: Group 8 | Title | Phase D: Group 10 | Title | Phase D: Group 12 | Title | Phase E: Group 11 | Title | Phase E: Group 13 | Title | Phase E: Group 15 | Title | Phase F: Group 14 | Title | Phase F: Group 16 |
Description | Each volunteer will receive one vial of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI. | Description | Each volunteer will receive a fifth of a vial (1:5 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI. | Description | Each volunteer will receive one twentieth of a vial (1:20 dilution) of P. vivax infected inoculum (parasitised red blood cells) at the first blood-stage controlled human malaria infection (CHMI). The optimal dose will be determined following the first CHMI and the selected dose will be administered to all volunteers (Groups 1-3) at both the second and third CHMI. | Description | The six volunteers from Groups 1, 2 and 3 in will undergo secondary challenge using the optimal inoculum, as determined in Phase A of the study. They will constitute 'Group 4' in Phase B. This will occur approximately eight months (and up to nine months) later after their primary challenge. | Description | Three new malaria naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls to Group 4. | Description | The six volunteers from Group 4 in Phase B will undergo tertiary challenge, again using the optimal inoculum as determined in Phase A, and will constitute Group 5 in Phase C. This will occur approximately sixteen months (and up to twenty months) later after their secondary challenge. | Description | The three volunteers from Group 6 who underwent primary challenge in Phase B undergo secondary challenge, again using the optimal inoculum as determined in Phase A, and will now form Group 7 in Phase C. This will occur approximately six months (and up to nine months) later after their primary challenge. | Description | Four to eight new malaria-naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls for Groups 5 and 7. | Description | The three volunteers from Group 7 in Phase C will undergo tertiary challenge, again using the optimal inoculum as determined in Phase A, and will constitute Group 8 in Phase D. This will occur approximately five months (and up to ten months) after their secondary challenge. | Description | The four to eight volunteers from Group 9 in Phase C will undergo secondary challenge, using the optimal inoculum as determined in Phase A, and form Group 10 in Phase D. This will occur approximately six months (and up to nine months) later after their primary challenge. | Description | Four to eight new malaria-naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls for Groups 8 and 10. | Description | The four to eight volunteers from Group 10 in Phase D will undergo tertiary challenge, again using the optimal inoculum as determined in Phase A, and will constitute Group 11 in Phase E. This will occur approximately five months (and up to ten months) after their secondary challenge. | Description | The four to eight volunteers from Group 12 in Phase D will undergo secondary challenge, again using the optimal inoculum as determined in Phase A, and will constitute Group 13 in Phase E. This will occur approximately five months (and up to ten months) after their secondary challenge. | Description | Two new malaria-naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls for Groups 11 and 13. | Description | The four to eight volunteers from Group 13 in Phase E will undergo tertiary challenge, again using the optimal inoculum as determined in Phase A, and will constitute Group 14 in Phase F. This will occur approximately five months (and up to ten months) after their secondary challenge. | Description | Two new malaria-naïve volunteers will be recruited to undergo primary challenge using the optimal inoculum, as determined in Phase A of the study. They will act as controls for Group 14. |
Interventions
Sequence: | 52780794 |
Intervention Type | Biological |
Name | P. vivax infected inoculum (parasitised red blood cells) |
Description | In the first controlled human malaria infection (CHMI, Phase A), inoculation of parasitised red blood cells will be at three different doses (1 vial, 1:5 dilution, 1:20 dilution). The optimal inoculation dose will then be selected and administered to all participants in each of the second and third CHMI. |
Design Outcomes
Sequence: | 178502132 | Sequence: | 178502133 | Sequence: | 178502134 | Sequence: | 178502135 | Sequence: | 178502136 | Sequence: | 178502137 | Sequence: | 178502138 | Sequence: | 178502139 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Safety of primary P. vivax blood-stage CHMI as measured by (S)AE occurrences | Measure | The optimal inoculation dose to take forward to future P. vivax CHMI studies | Measure | Feasibility of primary P. vivax blood-stage CHMI as measured by successful infection (development of detectable persistent parasitaemia by thick film and qPCR +/- clinical symptoms) | Measure | Safety of secondary and tertiary P. vivax controlled blood-stage CHMI as measured by (S)AE occurrences | Measure | Immune response to primary, secondary and tertiary P. vivax pre-treatment | Measure | Gametocytaemia | Measure | Feasibility of secondary and tertiary P. vivax controlled blood-stage CHMI as measured by successful infection (development of detectable persistent parasitaemia by thick film and qPCR +/- clinical symptoms) | Measure | Transmissibility of gametocytes from the infected volunteer to Anopheline mosquito vector, which will be assesed by Direct Membrane Feeding Assays (DMFA) |
Time Frame | 36 months | Time Frame | 3 months | Time Frame | 36 months | Time Frame | 36 months | Time Frame | 36 months | Time Frame | 36 months | Time Frame | 36 months | Time Frame | 36 months |
Description | Choosing the optimal inoculation dose to take forward to future P. vivax CHMI studies will be decided based on the following algorithm:
Ideal choice = the first group (2/2 volunteers) to reach diagnosis criteria (within 21 days). N.B. If both volunteers in Group 1 develop infection AND both volunteers in Group 2 (or 3) reliably develop infection within 5 days of Group 1 (and within the 21-day window) then the lowest dose group should be chosen. |
Description | As measured by antibody, B cell and T cell responses through experimental injection of P. vivax infected erythrocytes | Description | As measured by qPCR in primary, secondary and tertiary P. vivax blood-stage CHMI. |
Browse Conditions
Sequence: | 194630640 | Sequence: | 194630641 | Sequence: | 194630642 | Sequence: | 194630643 | Sequence: | 194630644 | Sequence: | 194630645 |
Mesh Term | Malaria | Mesh Term | Malaria, Vivax | Mesh Term | Infections | Mesh Term | Protozoan Infections | Mesh Term | Parasitic Diseases | Mesh Term | Vector Borne Diseases |
Downcase Mesh Term | malaria | Downcase Mesh Term | malaria, vivax | Downcase Mesh Term | infections | Downcase Mesh Term | protozoan infections | Downcase Mesh Term | parasitic diseases | Downcase Mesh Term | vector borne diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48597456 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Oxford |
Overall Officials
Sequence: | 29442268 |
Role | Principal Investigator |
Name | Angela M Minassian, MBBS MA DPhil MRCP FRCPath |
Affiliation | University of Oxford |
Design Group Interventions
Sequence: | 68559836 | Sequence: | 68559837 | Sequence: | 68559838 | Sequence: | 68559839 | Sequence: | 68559840 | Sequence: | 68559841 | Sequence: | 68559842 | Sequence: | 68559843 | Sequence: | 68559844 | Sequence: | 68559845 | Sequence: | 68559846 | Sequence: | 68559847 | Sequence: | 68559848 | Sequence: | 68559849 | Sequence: | 68559850 | Sequence: | 68559851 |
Design Group Id | 55925841 | Design Group Id | 55925842 | Design Group Id | 55925843 | Design Group Id | 55925844 | Design Group Id | 55925845 | Design Group Id | 55925846 | Design Group Id | 55925847 | Design Group Id | 55925848 | Design Group Id | 55925850 | Design Group Id | 55925851 | Design Group Id | 55925849 | Design Group Id | 55925852 | Design Group Id | 55925853 | Design Group Id | 55925854 | Design Group Id | 55925855 | Design Group Id | 55925856 |
Intervention Id | 52780794 | Intervention Id | 52780794 | Intervention Id | 52780794 | Intervention Id | 52780794 | Intervention Id | 52780794 | Intervention Id | 52780794 | Intervention Id | 52780794 | Intervention Id | 52780794 | Intervention Id | 52780794 | Intervention Id | 52780794 | Intervention Id | 52780794 | Intervention Id | 52780794 | Intervention Id | 52780794 | Intervention Id | 52780794 | Intervention Id | 52780794 | Intervention Id | 52780794 |
Eligibilities
Sequence: | 30937139 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 50 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Healthy adult aged 18 to 50 years. Exclusion Criteria: History of clinical malaria (any species). Exclusion criteria on day of CHMI: Acute disease, defined as moderate or severe illness with or without fever. |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254239523 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 50 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 3 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30682761 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Other |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29049488 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52380760 | Sequence: | 52380761 |
Pmid | 35664997 | Pmid | 34609964 |
Reference Type | derived | Reference Type | derived |
Citation | Hou MM, Barrett JR, Themistocleous Y, Rawlinson TA, Diouf A, Martinez FJ, Nielsen CM, Lias AM, King LDW, Edwards NJ, Greenwood NM, Kingham L, Poulton ID, Khozoee B, Goh C, Mac Lochlainn DJ, Salkeld J, Guilotte-Blisnick M, Huon C, Mohring F, Reimer JM, Chauhan VS, Mukherjee P, Biswas S, Taylor IJ, Lawrie AM, Cho JS, Nugent FL, Long CA, Moon RW, Miura K, Silk SE, Chitnis CE, Minassian AM, Draper SJ. Impact of a blood-stage vaccine on Plasmodium vivax malaria. medRxiv. 2022 May 30:2022.05.27.22275375. doi: 10.1101/2022.05.27.22275375. Preprint. | Citation | Minassian AM, Themistocleous Y, Silk SE, Barrett JR, Kemp A, Quinkert D, Nielsen CM, Edwards NJ, Rawlinson TA, Ramos Lopez F, Roobsoong W, Ellis KJ, Cho JS, Aunin E, Otto TD, Reid AJ, Bach FA, Labbe GM, Poulton ID, Marini A, Zaric M, Mulatier M, Lopez Ramon R, Baker M, Mitton CH, Sousa JC, Rachaphaew N, Kumpitak C, Maneechai N, Suansomjit C, Piteekan T, Hou MM, Khozoee B, McHugh K, Roberts DJ, Lawrie AM, Blagborough AM, Nugent FL, Taylor IJ, Johnson KJ, Spence PJ, Sattabongkot J, Biswas S, Rayner JC, Draper SJ. Controlled human malaria infection with a clone of Plasmodium vivax with high-quality genome assembly. JCI Insight. 2021 Dec 8;6(23):e152465. doi: 10.1172/jci.insight.152465. |
]]>
https://zephyrnet.com/NCT03797976
2018-01-01
https://zephyrnet.com/?p=NCT03797976
NCT03797976https://www.clinicaltrials.gov/study/NCT03797976?tab=tableBircan Yucekaya, MScbircanyucekaya@hotmail.com03262455516Parkinson’s disease is a progressive chronic neurodegenerative disease. In cases where drug treatment is insufficient and drug use is not possible due to drug side effects, highly effective and low-risk surgical treatment options could be used. In Parkinson’s Disease; findings such as chest wall rigidity and weakness of the respiratory muscle strength occur. The aim of this study was to determine the effect of preop and postop DBS surgery on respiratory muscle strength, respiratory function and physical performance in patients with Parkinson’s disease.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-18 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-03-15 |
Start Month Year | January 1, 2018 |
Primary Completion Month Year | September 30, 2019 |
Verification Month Year | March 2019 |
Verification Date | 2019-03-31 |
Last Update Posted Date | 2019-03-15 |
Detailed Descriptions
Sequence: | 20721661 |
Description | In the study, at least 10 patients with Parkinson's disease who had DBS surgery in Mustafa Kemal University Research and Practice Hospital, Department of Brain and Nerve Surgery will be evaluated. Demographic-physical features, pulmonary functions, respiratory muscle strength, exercise capacity, functionality, and muscle strength will be evaluated |
Facilities
Sequence: | 200108508 |
Status | Recruiting |
Name | Hatay Mustafa Kemal University |
City | Antakya |
State | Hatay |
Zip | 30100 |
Country | Turkey |
Facility Contacts
Sequence: | 28106439 | Sequence: | 28106440 |
Facility Id | 200108508 | Facility Id | 200108508 |
Contact Type | primary | Contact Type | backup |
Name | Bircan Yucekaya, MSc | Name | Deran Oskay, PhD |
bircanyucekaya@hotmail.com | deranoskay@yahoo.com | ||
Phone | +903262455516 | Phone | 312 2162600 |
Phone Extension | 15514 | Phone Extension | 2162627 |
Conditions
Sequence: | 52171329 | Sequence: | 52171328 | Sequence: | 52171330 | Sequence: | 52171331 |
Name | Surgery | Name | Parkinson Disease | Name | Respiration; Decreased | Name | Muscle Weakness |
Downcase Name | surgery | Downcase Name | parkinson disease | Downcase Name | respiration; decreased | Downcase Name | muscle weakness |
Id Information
Sequence: | 40158679 |
Id Source | org_study_id |
Id Value | Hatay Mustafa Kemal U 1 |
Countries
Sequence: | 42568978 |
Name | Turkey |
Removed | False |
Design Groups
Sequence: | 55593243 |
Group Type | Experimental |
Title | Parkinson's Disease Group |
Description | MIP and MEP Respiratory Function Test Strength Test |
Interventions
Sequence: | 52485553 |
Intervention Type | Device |
Name | MIP and MEP |
Description | Pre-op, Post-op of, 1 month after surgery, 3 months after surgery |
Design Outcomes
Sequence: | 177379100 | Sequence: | 177379101 | Sequence: | 177379102 | Sequence: | 177379103 | Sequence: | 177379104 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Functional exercise capacity | Measure | Pulmonary functions | Measure | Inspiratory and expiratory muscle strength (MIP, MEP) | Measure | Muscle strength | Measure | Grip Test (Peripheral muscle strength) |
Time Frame | Change from Baseline Functional exercise capacity at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months | Time Frame | Change from Pulmonary functions at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months | Time Frame | Change from Inspiratory and expiratory muscle strength (MIP, MEP) at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months | Time Frame | Change from Peripheral muscle strength at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months | Time Frame | Change from Peripheral muscle strength at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months |
Description | 6 minute walking test | Description | Spirometry | Description | Mouth pressure device | Description | Muscle Testing Device (N) | Description | Hand Held Dynamometer (kgf) |
Browse Conditions
Sequence: | 193487024 | Sequence: | 193487025 | Sequence: | 193487026 | Sequence: | 193487027 | Sequence: | 193487028 | Sequence: | 193487029 | Sequence: | 193487030 | Sequence: | 193487031 | Sequence: | 193487032 | Sequence: | 193487033 | Sequence: | 193487034 | Sequence: | 193487035 | Sequence: | 193487036 | Sequence: | 193487037 | Sequence: | 193487038 |
Mesh Term | Muscle Weakness | Mesh Term | Parkinson Disease | Mesh Term | Parkinsonian Disorders | Mesh Term | Basal Ganglia Diseases | Mesh Term | Brain Diseases | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Movement Disorders | Mesh Term | Synucleinopathies | Mesh Term | Neurodegenerative Diseases | Mesh Term | Muscular Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Neuromuscular Manifestations | Mesh Term | Neurologic Manifestations | Mesh Term | Pathologic Processes |
Downcase Mesh Term | muscle weakness | Downcase Mesh Term | parkinson disease | Downcase Mesh Term | parkinsonian disorders | Downcase Mesh Term | basal ganglia diseases | Downcase Mesh Term | brain diseases | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | movement disorders | Downcase Mesh Term | synucleinopathies | Downcase Mesh Term | neurodegenerative diseases | Downcase Mesh Term | muscular diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | neuromuscular manifestations | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | pathologic processes |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319344 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Mustafa Kemal University |
Overall Officials
Sequence: | 29285377 | Sequence: | 29285378 | Sequence: | 29285379 |
Role | Study Director | Role | Study Chair | Role | Principal Investigator |
Name | Deran Oskay, PhD | Name | Bircan Yucekaya, MSc | Name | Atilla Yılmaz, Med. Dr |
Affiliation | Gazi University Faculty of Health Science Department of Physical Therapy | Affiliation | Hatay Mustafa Kemal University School of Physical Therapy and Rehabilitation | Affiliation | Hatay Mustafa Kemal University Department of Neurosurgery |
Central Contacts
Sequence: | 12008898 | Sequence: | 12008899 |
Contact Type | primary | Contact Type | backup |
Name | Deran Oskay, PhD | Name | Bircan Yucekaya, MSc |
Phone | 0312 2162600 | Phone | 03262455516 |
deranoskay@yahoo.com | bircanyucekaya@hotmail.com | ||
Phone Extension | 2162627 | Phone Extension | 15514 |
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 68149218 |
Design Group Id | 55593243 |
Intervention Id | 52485553 |
Eligibilities
Sequence: | 30765390 |
Gender | All |
Minimum Age | 40 Years |
Maximum Age | 70 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Lack of any neurological disease other than Parkinson's Exclusion Criteria: Patients with advanced cognitive impairment |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253886010 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 40 |
Maximum Age Num | 70 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30511556 |
Allocation | N/A |
Intervention Model | Single Group Assignment |
Observational Model | |
Primary Purpose | Supportive Care |
Time Perspective | |
Masking | None (Open Label) |
Intervention Other Names
Sequence: | 26673768 | Sequence: | 26673769 |
Intervention Id | 52485553 | Intervention Id | 52485553 |
Name | Respiratory Function Test | Name | Muscle Test |
Responsible Parties
Sequence: | 28877851 |
Responsible Party Type | Principal Investigator |
Name | Bircan Yücekaya |
Title | Lecturer |
Affiliation | Mustafa Kemal University |
Study References
Sequence: | 52063431 | Sequence: | 52063432 | Sequence: | 52063433 |
Pmid | 17130410 | Pmid | 20022689 | Pmid | 21841525 |
Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Stemper B, Beric A, Welsch G, Haendl T, Sterio D, Hilz MJ. Deep brain stimulation improves orthostatic regulation of patients with Parkinson disease. Neurology. 2006 Nov 28;67(10):1781-5. doi: 10.1212/01.wnl.0000244416.30605.f1. | Citation | Trachani E, Constantoyannis C, Sirrou V, Kefalopoulou Z, Markaki E, Chroni E. Effects of subthalamic nucleus deep brain stimulation on sweating function in Parkinson's disease. Clin Neurol Neurosurg. 2010 Apr;112(3):213-7. doi: 10.1016/j.clineuro.2009.11.015. Epub 2009 Dec 22. | Citation | Hyam JA, Brittain JS, Paterson DJ, Davies RJ, Aziz TZ, Green AL. Controlling the lungs via the brain: a novel neurosurgical method to improve lung function in humans. Neurosurgery. 2012 Feb;70(2):469-77; discussion 477-8. doi: 10.1227/NEU.0b013e318231d789. |
]]>
https://zephyrnet.com/NCT03797963
2019-01-08
https://zephyrnet.com/?p=NCT03797963
NCT03797963https://www.clinicaltrials.gov/study/NCT03797963?tab=tableNANANAThe study aims to evaluate the clinical and radiological behavior, the histological and morphometrical components, the expression of proteins related to bone formation, and the analysis of markers of reparative mesenchymal stromal cells, after using two different xenogenic biomaterials in combination with autogenous cortical bone for maxillary sinus floor elevation.
A randomized split-mouth clinical study is designed to include patients in need of two-stage bilateral maxillary sinus floor elevation. Patients will be assigned to receive a mix of autogenous cortical bone (collected by a bone scraper from the access window to the maxillary sinus) and anorganic bovine bone (BioOss Xenograft) in one maxillary sinus or autogenous cortical bone and porcine bone mineral (Symbios Xenograft) in the other maxillary sinus. Cone-beam computerized tomography (CBCT) scans will be performed before and after sinus floor elevation and 6, 12 and 18 months after the procedure to assess the bone gain. Bone core biopsies will be obtained at the site of implant placement 6 months after the floor elevation. Histological sections will be subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-06 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-05-23 |
Start Month Year | January 8, 2019 |
Primary Completion Month Year | February 2, 2021 |
Verification Month Year | May 2023 |
Verification Date | 2023-05-31 |
Last Update Posted Date | 2023-05-23 |
Facilities
Sequence: | 200584875 |
Name | Universidad de Granada |
City | Granada |
Zip | 18071 |
Country | Spain |
Conditions
Sequence: | 52319484 |
Name | Sinus Floor Augmentation |
Downcase Name | sinus floor augmentation |
Id Information
Sequence: | 40264680 |
Id Source | org_study_id |
Id Value | 480CEIH2018 |
Countries
Sequence: | 42684031 |
Name | Spain |
Removed | False |
Design Groups
Sequence: | 55758277 | Sequence: | 55758278 |
Group Type | Active Comparator | Group Type | Experimental |
Title | PBM+ACB | Title | ABB+ACB |
Description | Porcine bone mineral (Symbios Xenograft) + autogenous cortical bone | Description | Anorganic bovine bone (BioOss Xenograft) + autogenous cortical bone |
Interventions
Sequence: | 52630545 | Sequence: | 52630546 |
Intervention Type | Device | Intervention Type | Device |
Name | PBM+ACB | Name | ABB+ACB |
Description | Maxillary sinus floor elevation and bone grafting with the use of porcine bone mineral biomaterial (Symbios Xenograft) combined with autogenous cortical bone | Description | Maxillary sinus floor elevation and bone grafting with the use of anorganic bovine bone biomaterial (BioOss Xenograft) combined with autogenous cortical bone |
Keywords
Sequence: | 80073482 | Sequence: | 80073483 | Sequence: | 80073484 | Sequence: | 80073485 | Sequence: | 80073486 | Sequence: | 80073487 |
Name | Maxillary sinus augmentation | Name | Sinus lift | Name | Biomaterial | Name | Anorganic bovine bone | Name | Porcine bone mineral | Name | Implant dentistry |
Downcase Name | maxillary sinus augmentation | Downcase Name | sinus lift | Downcase Name | biomaterial | Downcase Name | anorganic bovine bone | Downcase Name | porcine bone mineral | Downcase Name | implant dentistry |
Design Outcomes
Sequence: | 177927064 | Sequence: | 177927065 | Sequence: | 177927066 | Sequence: | 177927067 | Sequence: | 177927068 | Sequence: | 177927069 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Sinus floor height change | Measure | Sinus floor height change after 12 months | Measure | Sinus floor height change after 18 months | Measure | Area of new mineralized tissue | Measure | Area of non-mineralized tissue | Measure | Area of remaining graft particles |
Time Frame | From surgery to 6 months | Time Frame | From surgery to 12 months | Time Frame | From surgery to 18 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months |
Description | CBCT scans will be performed after the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change | Description | CBCT scans will be performed after the sinus floor elevation and 12 months later to calculate vertical bone height change | Description | CBCT scans will be performed after the sinus floor elevation and 18 months later to calculate vertical bone height change | Description | Histomorphometric quantification of new mineralized tissue in a bone biopsy collected 6 months after the grafting procedure | Description | Histomorphometric quantification of non-mineralized tissue in a bone biopsy collected 6 months after the grafting procedure | Description | Histomorphometric quantification of remaining graft particles in a bone biopsy collected 6 months after the grafting procedure |
Sponsors
Sequence: | 48458176 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Universidad de Granada |
Overall Officials
Sequence: | 29364318 |
Role | Principal Investigator |
Name | Pablo Galindo-Moreno, DDS, MS, PhD |
Affiliation | Universidad de Granada |
Design Group Interventions
Sequence: | 68349130 | Sequence: | 68349131 |
Design Group Id | 55758277 | Design Group Id | 55758278 |
Intervention Id | 52630545 | Intervention Id | 52630546 |
Eligibilities
Sequence: | 30851235 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Partially edentulous patients. Exclusion Criteria: Sinus pathology (sinusitis, mucocele, cysts). |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254267857 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 25 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 5 |
Designs
Sequence: | 30597092 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Outcomes Assessor Masked | True |
Responsible Parties
Sequence: | 28963575 |
Responsible Party Type | Principal Investigator |
Name | Pablo Galindo-Moreno |
Title | Full Professor |
Affiliation | Universidad de Granada |
Study References
Sequence: | 52223815 | Sequence: | 52223816 | Sequence: | 52223817 |
Pmid | 29071736 | Pmid | 17355356 | Pmid | 35224778 |
Reference Type | background | Reference Type | background | Reference Type | result |
Citation | Galindo-Moreno P, de Buitrago JG, Padial-Molina M, Fernandez-Barbero JE, Ata-Ali J, O Valle F. Histopathological comparison of healing after maxillary sinus augmentation using xenograft mixed with autogenous bone versus allograft mixed with autogenous bone. Clin Oral Implants Res. 2018 Feb;29(2):192-201. doi: 10.1111/clr.13098. Epub 2017 Oct 26. | Citation | Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Aguilar M, Sanchez-Fernandez E, Cutando A, Wang HL. Evaluation of sinus floor elevation using a composite bone graft mixture. Clin Oral Implants Res. 2007 Jun;18(3):376-82. doi: 10.1111/j.1600-0501.2007.01337.x. Epub 2007 Mar 12. | Citation | Galindo-Moreno P, Abril-Garcia D, Carrillo-Galvez AB, Zurita F, Martin-Morales N, O'Valle F, Padial-Molina M. Maxillary sinus floor augmentation comparing bovine versus porcine bone xenografts mixed with autogenous bone graft. A split-mouth randomized controlled trial. Clin Oral Implants Res. 2022 May;33(5):524-536. doi: 10.1111/clr.13912. Epub 2022 Mar 3. |
]]>
https://zephyrnet.com/NCT03797950
2018-11-01
https://zephyrnet.com/?p=NCT03797950
NCT03797950https://www.clinicaltrials.gov/study/NCT03797950?tab=tableNANANADespite major progress made in vaccination coverage overall, timeliness of vaccines remains a key concern in many settings. At the same time, access to mobile phones has increased rapidly, offering new opportunities to track and deliver health services. This research project uses these newly available mobile phone networks to simultaneously address two of the biggest bottlenecks in vaccine delivery: timely documentation of births, and lack of maternal effort or access to get essential vaccines. To increase documentation, investigators will train volunteers in each community to report new births via mobile phone to a central coordinator, and send small monetary rewards via mobile phone to volunteers for this reporting. To increase vaccination coverage, investigators will send reminder messages directly to mothers, and will also test small monetary rewards to volunteers and to mothers as an incentive to complete recommended vaccinations. The designs to provide vaccination encouragement will be tested through a small community randomized controlled trial in 15 selected villages in Ghana’s Northern region. The primary outcome for the pilot study will be the percentage of children who received both the polio birth dose (OPV0) vaccination within two weeks of life (14 days) and the BCG vaccination within the first four weeks (28 days) of life.
<![CDATA[
Studies
Study First Submitted Date | 2018-11-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2020-03-03 |
Start Month Year | November 1, 2018 |
Primary Completion Month Year | July 9, 2019 |
Verification Month Year | March 2020 |
Verification Date | 2020-03-31 |
Last Update Posted Date | 2020-03-03 |
Detailed Descriptions
Sequence: | 20710006 |
Description | Despite major progress made in vaccination coverage overall, timeliness of vaccines remains a key concern in many settings. Early vaccination coverage is particularly low in settings where a large share of women deliver at home, as it is the case in Ghana's Northern region, where only a minority of women seek out facilities for delivery. In Ghana, 95% of children receive BCG vaccination within the first two years of life, but only about half of these children receive the vaccine within the first 30 days after delivery. Less than 50% of children in Ghana's Northern region receive Bacillus Calmette-Guérin (BCG) vaccines within the first three months of their life, and less than 40% get polio vaccination, exposing a large number of infants to these diseases.
Recent research conducted in this region shows that the large majority of households have access to mobile phones, even in the most rural areas. this project uses mobile phone networks to simultaneously address two of the biggest bottlenecks in vaccine delivery: timely documentation of births, and lack of maternal effort or access to essential vaccines. Evidence from other low resource settings suggests that even small rewards can often result in substantial increases in vaccine uptake – investigators will test this hypothesis using mobile networks in rural areas of Northern Ghana. The main objective of this study is to assess the extent to which mobile-phone based reminder or reward systems can increase early vaccination coverage. Investigators will assess two specific interventions through the pilot study: a mobile-phone based call and text system which will be used to contact mothers to highlight the importance of early vaccinations, provide reminders (nudges) to mothers encouraging them to get their newborn vaccinated and providing information on where and when vaccinations are available in their community. Research Hypotheses (H1-3) H1: Nudging mothers through voice and text messages will increase early vaccination coverage. H2: Nudging mothers through community volunteers and small rewards will increase early vaccination coverage. Given that birth documentation remains low in many parts of Ghana, investigators will also test a new community-based reporting model, under which volunteers appointed by the community will receive small rewards for reporting births that occur in their communities. Investigators will test the extent to which such a program results in successful reporting of births: H3: Providing small mobile-phone based incentives to volunteers selected by communities for reporting births will result in accurate and timely reporting of births in rural areas. The study is an open label cluster-randomized controlled trial with three arms: a control arm, a voice reminder arm (group A), and a cash incentive arm (group B). During the intervention phase community volunteers will be appointed to document all births in 10 randomly selected treatment communities (group A and group B), and will receive small cash rewards delivered via "mobile money" for all documented births. In each of two active treatment arms, women across five villages will be enrolled in a proactive program over a period of six months. In intervention group A, participating women will receive reminders about vaccinations recommended at birth delivered via mobile phones. In intervention group B, participating women will receive encouragement from a community-appointed volunteer to complete recommended vaccinations and community volunteers and woman will receive small cash rewards delivered via "mobile money" for completing the recommended birth dose vaccinations on time. No volunteer will be appointed to documents births in the 5 control-arm villages and no women in the 5 control-arm villages will be actively enrolled nor receive a pro-active program intervention during the intervention phase. After the intervention phase is complete, an endline population-based household survey will be conducted in the 15 study villages (5 control, 5 treatment group A, 5 treatment group B) to evaluate the effect of the intervention programs on vaccine coverage. |
Facilities
Sequence: | 199965114 |
Name | Innovations for Poverty Action |
City | Tamale |
State | Karaga |
Country | Ghana |
Conditions
Sequence: | 52139050 |
Name | Immunization Coverage |
Downcase Name | immunization coverage |
Id Information
Sequence: | 40135100 |
Id Source | org_study_id |
Id Value | GHS-ERC008/07/18 |
Countries
Sequence: | 42542716 |
Name | Ghana |
Removed | False |
Design Groups
Sequence: | 55559405 | Sequence: | 55559406 | Sequence: | 55559407 |
Group Type | No Intervention | Group Type | Experimental | Group Type | Experimental |
Title | Control | Title | Voice Reminder (Group A) | Title | Cash Incentive (Group B) |
Description | No active intervention | Description | Community-appointed volunteers will document births in the community and will receive small monetary rewards via "mobile money" for all documented births. Enrolled women will receive reminders via mobile phone to highlight the importance of early vaccinations for newborns. Messages will recommend that women take their newborns to get the BCG and Polio0 vaccine as soon as possible after birth (within the first two weeks of life for Polio0 and within the first month for BCG). Information on where and when these vaccines will be available in the woman's community will be provided. | Description | Community-appointed volunteers will document births in the community and will receive small monetary rewards via "mobile money" for all documented births. Volunteers will encourage enrolled women to seek early vaccination for their newborns. Messages will recommend that women take their newborns to get the BCG and Polio0 vaccine as soon as possible after birth (within the first two weeks of life for Polio0 and within the first month for BCG). Volunteers will provide information on where and when these vaccines will be available in the woman's community. Volunteers and enrolled women will receive small monetary rewards via "mobile money" for receiving OPV0 and BCG vaccinations on time. |
Interventions
Sequence: | 52454962 | Sequence: | 52454963 |
Intervention Type | Behavioral | Intervention Type | Behavioral |
Name | Voice Reminder (Group A) | Name | Cash Incentive (Group B) |
Description | Woman with a recent delivery will be contacted via mobile phone by a central study staff member to encourage them to vaccinate their newborn with OPV0 and BCG, and information on where and when vaccines are available in this community will be provided. Community volunteers will receive small incentives for documenting births in the community. | Description | Mobile phone based monetary incentives will be provided to community volunteers and to women with a recent delivery who vaccinate newborns with OPV0 and BCG on time. Community volunteers will receive small incentives for documenting births in the community. |
Keywords
Sequence: | 79822883 | Sequence: | 79822884 | Sequence: | 79822885 | Sequence: | 79822886 | Sequence: | 79822887 |
Name | OPV | Name | BCG | Name | vaccine delivery | Name | mhealth | Name | incentives |
Downcase Name | opv | Downcase Name | bcg | Downcase Name | vaccine delivery | Downcase Name | mhealth | Downcase Name | incentives |
Design Outcomes
Sequence: | 177264009 | Sequence: | 177264010 | Sequence: | 177264011 | Sequence: | 177264012 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | other |
Measure | Full on time early vaccination coverage (OPV0 and BCG) | Measure | On time BCG coverage | Measure | On time OPV coverage | Measure | Birth documentation and reporting coverage |
Time Frame | First month of life | Time Frame | First month of life | Time Frame | First two weeks of life (14 days) | Time Frame | First month of life |
Description | Percentage of infants born during study who received both BCG and OPV0 vaccinations on time (OPV0 within first 2 weeks of life and BCG within first month of life) | Description | Percentage of infants who received BCG vaccination on time (within first month of life) | Description | Percentage of infants born during study who received OPV0 on time (within first two weeks of life) | Description | Percentage of live births in the community during the study which are documented and reported by community health volunteers |
Sponsors
Sequence: | 48290751 | Sequence: | 48290752 |
Agency Class | OTHER | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Swiss Tropical & Public Health Institute | Name | Innovations for Poverty Action |
Overall Officials
Sequence: | 29268554 |
Role | Principal Investigator |
Name | Guenther Fink, PhD |
Affiliation | Swiss Institute for Tropical and Public Health |
Design Group Interventions
Sequence: | 68107524 | Sequence: | 68107525 |
Design Group Id | 55559406 | Design Group Id | 55559407 |
Intervention Id | 52454962 | Intervention Id | 52454963 |
Eligibilities
Sequence: | 30747752 |
Gender | Female |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
Women who have given birth to a live-born, surviving infant in the last two weeks (14 days) and reside in the community. Exclusion Criteria: Women who do not reside in the community. |
Gender Description | Woman who have recently given birth |
Gender Based | True |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254122018 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 8 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Number Of Other Outcomes To Measure | 1 |
Designs
Sequence: | 30494035 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Health Services Research |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28860315 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52032785 | Sequence: | 52032786 |
Pmid | 34010312 | Pmid | 32813276 |
Reference Type | derived | Reference Type | derived |
Citation | Levine G, Salifu A, Mohammed I, Fink G. Mobile nudges and financial incentives to improve coverage of timely neonatal vaccination in rural areas (GEVaP trial): A 3-armed cluster randomized controlled trial in Northern Ghana. PLoS One. 2021 May 19;16(5):e0247485. doi: 10.1371/journal.pone.0247485. eCollection 2021. | Citation | Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679. |
]]>
https://zephyrnet.com/NCT03797937
2018-11-01
https://zephyrnet.com/?p=NCT03797937
NCT03797937https://www.clinicaltrials.gov/study/NCT03797937?tab=tableNANANAThe goal of this longitudinal study is to (1) explore the association between the gut microbiota and inflammatory disease activity in early onset multiple sclerosis, (2) investigate whether/how gut microbial composition vary when patients experience a relapse, and (3) to assess whether the gut microbiota shows increased similarities between affected pairs of first-degree relatives within the same family when compared with discordant pairs of first-degree relatives.
<![CDATA[
Studies
Study First Submitted Date | 2018-03-05 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-05-11 |
Start Month Year | November 1, 2018 |
Primary Completion Month Year | November 1, 2021 |
Verification Month Year | May 2022 |
Verification Date | 2022-05-31 |
Last Update Posted Date | 2022-05-11 |
Detailed Descriptions
Sequence: | 20812465 |
Description | Using metagenomics, as well as clinical, immunological, and radiological observations, the investigators will investigate if active relapsing-remitting multiple sclerosis patients have a more pro-inflammatory gut microbiota signature than multiple sclerosis patients with less active disease and matched healthy controls.
More specifically, the investigators will investigate whether temporal variability of the gut microbiota is related to inflammatory disease activity in multiple sclerosis, whether changes in the gut microbiota are predictive of future inflammatory disease activity in multiple sclerosis, and whether gut microbiota characteristics are predictive of the disease course after 2 years. |
Facilities
Sequence: | 200869503 | Sequence: | 200869504 |
Name | Universitair Ziekenhuis Brussel | Name | Nationaal Multiple Sclerose Centrum Melsbroek |
City | Jette | City | Melsbroek |
State | Brussel | State | Vlaams-Brabant |
Zip | 1090 | Zip | 1820 |
Country | Belgium | Country | Belgium |
Conditions
Sequence: | 52402790 |
Name | Multiple Sclerosis |
Downcase Name | multiple sclerosis |
Id Information
Sequence: | 40322741 |
Id Source | org_study_id |
Id Value | 2018BDM2 |
Countries
Sequence: | 42745775 |
Name | Belgium |
Removed | False |
Design Groups
Sequence: | 55849953 | Sequence: | 55849954 | Sequence: | 55849955 | Sequence: | 55849956 |
Group Type | Experimental | Group Type | No Intervention | Group Type | No Intervention | Group Type | No Intervention |
Title | Multiple sclerosis (MS) patients | Title | Healthy controls | Title | Multiple sclerosis (MS) patients undergoing a relapse | Title | Multiple sclerosis (MS) patients from multiplex MS families |
Description | Patients will undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected. | Description | Healthy controls will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected. | Description | Multiple sclerosis (MS) patients undergoing a relapse will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected. | Description | Multiple sclerosis (MS) patients from multiplex MS families will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected. |
Interventions
Sequence: | 52711568 |
Intervention Type | Other |
Name | Magnetic resonance imaging (MRI) |
Description | MRI scanner |
Design Outcomes
Sequence: | 178234742 | Sequence: | 178234743 |
Outcome Type | primary | Outcome Type | secondary |
Measure | Clinical evidence for active disease | Measure | Radiological evidence for active disease |
Time Frame | 3 years | Time Frame | 3 years |
Description | Time to first relapse (after baseline) will be reported for all patients. | Description | Occurrence of new contrast-enhancing T1 hyper intense lesions, or changes in white matter lesion volume (i.e. new or enlarging T2 hyper intense lesions) |
Browse Conditions
Sequence: | 194366338 | Sequence: | 194366339 | Sequence: | 194366340 | Sequence: | 194366341 | Sequence: | 194366342 | Sequence: | 194366343 | Sequence: | 194366344 | Sequence: | 194366345 | Sequence: | 194366346 |
Mesh Term | Multiple Sclerosis | Mesh Term | Sclerosis | Mesh Term | Pathologic Processes | Mesh Term | Demyelinating Autoimmune Diseases, CNS | Mesh Term | Autoimmune Diseases of the Nervous System | Mesh Term | Nervous System Diseases | Mesh Term | Demyelinating Diseases | Mesh Term | Autoimmune Diseases | Mesh Term | Immune System Diseases |
Downcase Mesh Term | multiple sclerosis | Downcase Mesh Term | sclerosis | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | demyelinating autoimmune diseases, cns | Downcase Mesh Term | autoimmune diseases of the nervous system | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | demyelinating diseases | Downcase Mesh Term | autoimmune diseases | Downcase Mesh Term | immune system diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48534970 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | National MS Center Melsbroek |
Overall Officials
Sequence: | 29406024 |
Role | Principal Investigator |
Name | Marie D'hooghe, M.D. |
Affiliation | National MS Center Melsbroek |
Design Group Interventions
Sequence: | 68462979 |
Design Group Id | 55849953 |
Intervention Id | 52711568 |
Eligibilities
Sequence: | 30898806 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 55 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria patients:
Diagnosis of MS (as defined by the 2010 McDonald criteria). Exclusion Criteria patients: Treatment with high doses of systemic steroids 2 months before baseline. Additional inclusion criteria for MS patients undergoing a relapse: • Ability to provide a faecal sample within 4 weeks from onset of the first symptoms suggestive of a relapse, before cortisone treatment. A relapse is defined by a new clinical sign or clinical worsening of a previous sign/symptom persisting for >=24 hours in the absence of fever. Additional exclusion criteria for MS patients undergoing a relapse: Treatment with cortisone before collection of baseline faecal sample. Inclusion criteria healthy controls: Willingness to participate to the study and to sign the informed consent. Exclusion criteria healthy controls: Neurodegenerative disorders. |
Adult | True |
Child | False |
Older Adult | False |
Calculated Values
Sequence: | 254148383 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2018 |
Actual Duration | 36 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 55 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 1 |
Designs
Sequence: | 30644534 |
Allocation | Non-Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 29011158 |
Responsible Party Type | Principal Investigator |
Name | Marie D'hooghe |
Title | Prof. Dr. |
Affiliation | National MS Center Melsbroek |
]]>
https://zephyrnet.com/NCT03797924
2019-04-25
https://zephyrnet.com/?p=NCT03797924
NCT03797924https://www.clinicaltrials.gov/study/NCT03797924?tab=tableNANANAIn this study the investigators would like to show that when patients undergo upper limb surgery under supraclavicular brachial plexus block, additional blocking of the Intercostobrachial Nerve Block (ICBN) does not affect the incidence or course of tourniquet pain.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-01 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-05-24 |
Start Month Year | April 25, 2019 |
Primary Completion Month Year | December 20, 2020 |
Verification Month Year | May 2022 |
Verification Date | 2022-05-31 |
Last Update Posted Date | 2022-05-24 |
Detailed Descriptions
Sequence: | 20770231 |
Description | The ICBN is a cutaneous sensory nerve that supplies the medial aspect of the upper arm. Traditionally this nerve is blocked to alleviate tourniquet pain. The etiology of tourniquet pain is complex and the study team hypothesize that blocking the ICBN has no impact on tourniquet pain. Patients will receive a supraclavicular block and be divided into two groups; ICBN with local anesthetic or ICBN with saline. All patients in this study will receive a supraclavicular block as their primary anesthetic and then be divided into two groups; those who receive ICBN and those who do not. Amount of intraoperative analgesics, conversion to deep sedation or general anesthesia, and onset of time to tourniquet pain will be the primary measures of this study. |
Facilities
Sequence: | 200512321 |
Name | University of Florida |
City | Gainesville |
State | Florida |
Zip | 32618 |
Country | United States |
Browse Interventions
Sequence: | 96248925 | Sequence: | 96248926 | Sequence: | 96248927 | Sequence: | 96248928 | Sequence: | 96248929 | Sequence: | 96248930 | Sequence: | 96248931 |
Mesh Term | Ropivacaine | Mesh Term | Anesthetics, Local | Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents |
Downcase Mesh Term | ropivacaine | Downcase Mesh Term | anesthetics, local | Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 52295908 | Sequence: | 52295909 |
Name | Nerve Block | Name | Pain |
Downcase Name | nerve block | Downcase Name | pain |
Id Information
Sequence: | 40248464 | Sequence: | 40248465 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | IRB201802525 | Id Value | OCR19802 |
Id Type | Other Identifier | ||
Id Type Description | OnCore | ||
Countries
Sequence: | 42666781 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55732569 | Sequence: | 55732570 |
Group Type | Active Comparator | Group Type | Placebo Comparator |
Title | ICBN with ropivacaine | Title | No ICBN block |
Description | Participants will receive ICBN with ropivacaine. In order to blind anesthesia providers in the room and nurses in PACU, the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients. | Description | Participants will have the site prepped, but no ICBN block given. In order to blind anesthesia providers in the room and nurses in PACU, the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients. |
Interventions
Sequence: | 52607737 | Sequence: | 52607738 |
Intervention Type | Drug | Intervention Type | Behavioral |
Name | Receive ICBN with ropivacaine | Name | No ICBN block |
Description | ICBN block will be performed using US guidance depositing 10 ml of 0.5% ropivacaine in the plane between pectoralis minor and serratus anterior over the 2nd and 3rd intercostal space. | Description | The site of injection will be prepped with tinted chlorhexidine |
Keywords
Sequence: | 80044123 | Sequence: | 80044124 | Sequence: | 80044125 |
Name | Intercostobrachial Nerve Block | Name | Tourniquet Pain | Name | Upper Limb Surgeries |
Downcase Name | intercostobrachial nerve block | Downcase Name | tourniquet pain | Downcase Name | upper limb surgeries |
Design Outcomes
Sequence: | 177837930 | Sequence: | 177837931 | Sequence: | 177837932 | Sequence: | 177837933 | Sequence: | 177837934 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change between the 2 groups assessed by the incidence of tourniquet pain reported by the patient on a Descriptor Differential Scale of Pain Intensity (DDSI) | Measure | Change between the 2 groups depth of anesthesia during surgery to alleviate tourniquet pain as assessed by the American Society of Anesthesiologist (ASA) Continuum of Depth of Sedation definition of general anesthesia and levels of sedation/analgesia. | Measure | Change between the 2 groups assessed by intraoperative opioid consumption | Measure | Change between the 2 groups assessed by time to onset of tourniquet pain | Measure | Change between the 2 groups in reported severity of tourniquet pain |
Time Frame | From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours) | Time Frame | From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours) | Time Frame | From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours) | Time Frame | From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours) | Time Frame | From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours) |
Description | Tourniquet pain defined by the presence of dull or aching pain underneath the tourniquet | Description | Determine required depth of anesthesia during surgery to alleviate tourniquet pain | Description | Determine amount of intraoperative opioid consumption due to tourniquet pain | Description | Determine the time to onset of tourniquet pain | Description | Determine if ICBN has an affect on the severity of tourniquet pain as assessed by Descriptor Differential Scale of Pain Intensity (DDSI) There are 10 points along which patients can rate their pain intensity to the right and left of each descriptor, so the pain is rated on a 21 point scale for each descriptor. Pain intensity is defined as a mean of the ratings and can range from 0 to 20. |
Sponsors
Sequence: | 48436237 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | University of Florida |
Overall Officials
Sequence: | 29352550 |
Role | Principal Investigator |
Name | Linda Le-Wendling, MD |
Affiliation | University of Florida |
Design Group Interventions
Sequence: | 68317268 | Sequence: | 68317269 |
Design Group Id | 55732569 | Design Group Id | 55732570 |
Intervention Id | 52607737 | Intervention Id | 52607738 |
Eligibilities
Sequence: | 30837863 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 80 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
American Society of Anesthesiologists (ASA) 1-3 Exclusion Criteria: ASA 4 or greater |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254143704 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 20 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | True |
Minimum Age Num | 18 |
Maximum Age Num | 80 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 4 |
Designs
Sequence: | 30583762 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | Double |
Masking Description | In order to blind anesthesia providers in the room and nurses in Post-op Anesthesia Care Unit (PACU), the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients. |
Intervention Model Description | Patients will be randomized to receive ICBN with ropivacaine or no ICBN or ropivacaine. |
Subject Masked | True |
Caregiver Masked | True |
Intervention Other Names
Sequence: | 26729420 |
Intervention Id | 52607737 |
Name | Naropin |
Responsible Parties
Sequence: | 28950179 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 52196400 | Sequence: | 52196401 | Sequence: | 52196402 | Sequence: | 52196403 | Sequence: | 52196404 | Sequence: | 52196405 |
Pmid | 23053464 | Pmid | 3767015 | Pmid | 3591250 | Pmid | 8092519 | Pmid | 1550287 | Pmid | 9613307 |
Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result |
Citation | Satsumae T, Yamaguchi H, Inomata S, Tanaka M. Magnesium sulfate attenuates tourniquet pain in healthy volunteers. J Anesth. 2013 Apr;27(2):231-5. doi: 10.1007/s00540-012-1493-4. Epub 2012 Oct 7. | Citation | Hagenouw RR, Bridenbaugh PO, van Egmond J, Stuebing R. Tourniquet pain: a volunteer study. Anesth Analg. 1986 Nov;65(11):1175-80. | Citation | Valli H, Rosenberg PH, Kytta J, Nurminen M. Arterial hypertension associated with the use of a tourniquet with either general or regional anaesthesia. Acta Anaesthesiol Scand. 1987 May;31(4):279-83. doi: 10.1111/j.1399-6576.1987.tb02566.x. | Citation | Crews JC, Cahall M, Behbehani MM. The neurophysiologic mechanisms of tourniquet pain. The activity of neurons in the rostroventral medulla in the rat. Anesthesiology. 1994 Sep;81(3):730-6. doi: 10.1097/00000542-199409000-00027. | Citation | MacIver MB, Tanelian DL. Activation of C fibers by metabolic perturbations associated with tourniquet ischemia. Anesthesiology. 1992 Apr;76(4):617-23. doi: 10.1097/00000542-199204000-00020. | Citation | Tschaikowsky K, Hemmerling T. Comparison of the effect of EMLA and semicircular subcutaneous anaesthesia in the prevention of tourniquet pain during plexus block anaesthesia of the arm. Anaesthesia. 1998 Apr;53(4):390-3. doi: 10.1046/j.1365-2044.1998.00301.x. |
]]>
https://zephyrnet.com/NCT03797911
2019-03-23
https://zephyrnet.com/?p=NCT03797911
NCT03797911https://www.clinicaltrials.gov/study/NCT03797911?tab=tableNANANAThis study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with physiotherapeutic techniques and pain education provides benefits with respect to physiotherapy and pain education techniques alone in the management of patients with chronic pelvic pain.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-12 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2021-12-28 |
Start Month Year | March 23, 2019 |
Primary Completion Month Year | April 16, 2021 |
Verification Month Year | December 2021 |
Verification Date | 2021-12-31 |
Last Update Posted Date | 2021-12-28 |
Detailed Descriptions
Sequence: | 20796477 |
Description | It is evident that physiotherapeutic techniques and pain education are a first-line treatment for patients suffering from chronic pelvic pain. But there is no scientific evidence that resistive capacitive monopolar radiofrequency can be another treatment option for these patients, although at the clinical level there is evidence of its beneficial effects. |
Facilities
Sequence: | 200765873 |
Name | Andrea Carralero Martinez |
City | Barcelona |
Zip | 08004 |
Country | Spain |
Conditions
Sequence: | 52363108 | Sequence: | 52363109 | Sequence: | 52363110 | Sequence: | 52363111 | Sequence: | 52363112 | Sequence: | 52363113 |
Name | Pelvic Pain | Name | Pelvic Pain Syndrome | Name | Chronic Pain | Name | Chronic Pain Syndrome | Name | Chronic Pelvic Inflammatory Disease | Name | Physical Therapy |
Downcase Name | pelvic pain | Downcase Name | pelvic pain syndrome | Downcase Name | chronic pain | Downcase Name | chronic pain syndrome | Downcase Name | chronic pelvic inflammatory disease | Downcase Name | physical therapy |
Id Information
Sequence: | 40295958 |
Id Source | org_study_id |
Id Value | RAP39426977 |
Countries
Sequence: | 42719126 |
Name | Spain |
Removed | False |
Design Groups
Sequence: | 55806575 | Sequence: | 55806576 |
Group Type | Experimental | Group Type | Placebo Comparator |
Title | active resistive capacitive monopolar radiofrequency | Title | Inactive resistive capacitive monopolar radiofrequency |
Description | Application of the technique in the intervention group (activated resistive capacitive monopolar radiofrequency therapy): The intervention group will receive the treatment with activated resistive capacitive monopolar radiofrequency system, with the resistive electrode at the minimum intensity, together with the techniques of conventional physiotherapy treatment (trigger point treatment and myofascial techniques according to the location of pain) and pain education.
The patient will be stretched on the stretcher and the session will last 45 minutes, once a week, for 10 sessions. Ass baseline, after half therapy and after 10 weeks therapy. |
Description | Application of the technique in the control group (inactivated resistive capacitive monopolar radiofrequency therapy): The control group will receive the treatment with inactivated resistive capacitive monopolar radiofrequency system (placebo), with the resistive electrode at the minimum intensity, together with the techniques of conventional physiotherapy treatment (trigger point treatment and myofascial techniques according to the location of pain) and pain education.
The patient will be stretched on the stretcher and the session will last 45 minutes, once a week, for 10 sessions. Ass baseline, after half therapy and after 10 weeks therapy. |
Interventions
Sequence: | 52673830 | Sequence: | 52673831 |
Intervention Type | Combination Product | Intervention Type | Combination Product |
Name | Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education | Name | Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education |
Description | Activated resistive capacitive monopolar radiofrequency is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education. | Description | Disactivated resistive capacitive monopolar radiofrequency inactived is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education. |
Design Outcomes
Sequence: | 178088331 | Sequence: | 178088332 | Sequence: | 178088333 | Sequence: | 178088334 | Sequence: | 178088335 | Sequence: | 178088336 | Sequence: | 178088337 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Efficacy of resistive capacitive monopolar radiofrequency in the modification of the perception of pain | Measure | Assess quality of life | Measure | Assess kinesiophobia | Measure | Assess catastrophism | Measure | Assess the degree of adherence to treatment | Measure | Assess number of participants with high adherence to treatment | Measure | Assess number of participants with adverse effects |
Time Frame | baseline and 10 weeks | Time Frame | baseline, 5 and 10 weeks | Time Frame | baseline, 5 and 10 weeks | Time Frame | baseline, 5 and 10 weeks | Time Frame | 10 weeks | Time Frame | 10 weeks | Time Frame | 10 weeks |
Description | The objective is to assess if there is a change in the perception of pain intensity according to VAS (Visual Analog Scale). Compare baseline and at the end of the intervention.
The Visual Analog Scale is a validated questionnaire that scores between 0 and 10 the perception of pain that the patient has. In a line of 10 cm the patient will mark his intensity of the pain taking into account that 0 means "I have no pain" and 10 means "I have an unbearable pain". The Visual Analog Scale (VAS) suitably collects the pain intensity perceived by the patient and allows to assess the severity of the disease, as well as the improvement obtained with the treatment. |
Description | Asess the perceived quality of life of patients in the study according to the SF-12 questionnaire.
The Short-Form 12 Health Survey was designed in 1994 with the aim that, through the self-completion of a brief questionnaire, the perception of physical and mental quality of life could be objectified in a simpler way than the original questionnaire SF -36. This simple questionnaire of 12 items representing the 8 dimensions of health was originally developed in English. It is a questionnaire that has proven to be valid and reliable to be used in clinical practice as an instrument to assess the quality of life. The 8 dimensions are the physical function (2 items), physical role (2 items), body pain (1 item), general health (1 item), vitality (1 item), social function (1 item), emotional role (2) items) and mental health (2 items). The result is two variables (physical and mental) that value quality in these two aspects. |
Description | Asess the kinesiophobia suffered by patients in the study according to the TSK-11 (Tampa Scale of Kinesiophobia) questionnaire.
The Tampa Scale of Kinesiophobia (TSK-11), validated in Spanish, adequately captures the patient's movement capacity taking into account the perceived pain intensity in 11 questions. It is a tool that allows assessing the severity of the disease, as well as the improvement that is obtained with the treatment. |
Description | Asess the catastrophism suffered by patients in the study according to the Catastrophism scale.
The Catastrophism Scale, also validated in Spanish, allows us to assess the catastrophic intensity of the disease, a more psychological aspect, but also very relevant in this chronic and disabling pathology. It is a tool that allows assessing the severity of the disease, as well as the improvement that is obtained with the treatment. It is a questionnaire of 20 questions. |
Description | Assess the degree of adherence to treatment (%) of the patients who are in this study. | Description | Assess the number of patients (n) with high adherence who are in this study. | Description | Evaluate and identify the number of participants (n) who have an adverse effect during the study intervention. |
Browse Conditions
Sequence: | 194216755 | Sequence: | 194216756 | Sequence: | 194216757 | Sequence: | 194216758 | Sequence: | 194216759 | Sequence: | 194216760 | Sequence: | 194216761 | Sequence: | 194216762 | Sequence: | 194216763 | Sequence: | 194216764 | Sequence: | 194216765 | Sequence: | 194216766 | Sequence: | 194216767 | Sequence: | 194216768 | Sequence: | 194216769 | Sequence: | 194216770 | Sequence: | 194216771 | Sequence: | 194216772 |
Mesh Term | Pelvic Inflammatory Disease | Mesh Term | Pelvic Infection | Mesh Term | Syndrome | Mesh Term | Chronic Pain | Mesh Term | Pelvic Pain | Mesh Term | Somatoform Disorders | Mesh Term | Disease | Mesh Term | Pathologic Processes | Mesh Term | Pain | Mesh Term | Neurologic Manifestations | Mesh Term | Mental Disorders | Mesh Term | Infections | Mesh Term | Adnexal Diseases | Mesh Term | Genital Diseases, Female | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Genital Diseases |
Downcase Mesh Term | pelvic inflammatory disease | Downcase Mesh Term | pelvic infection | Downcase Mesh Term | syndrome | Downcase Mesh Term | chronic pain | Downcase Mesh Term | pelvic pain | Downcase Mesh Term | somatoform disorders | Downcase Mesh Term | disease | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | pain | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | mental disorders | Downcase Mesh Term | infections | Downcase Mesh Term | adnexal diseases | Downcase Mesh Term | genital diseases, female | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | genital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48497976 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | RAPbarcelona |
Design Group Interventions
Sequence: | 68410887 | Sequence: | 68410888 |
Design Group Id | 55806575 | Design Group Id | 55806576 |
Intervention Id | 52673830 | Intervention Id | 52673831 |
Eligibilities
Sequence: | 30876064 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Have an age equal to or greater than 18 years Exclusion Criteria: Failure to grant informed consent. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254071410 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 25 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30621855 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Triple |
Masking Description | Triple blind |
Subject Masked | True |
Caregiver Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28988391 |
Responsible Party Type | Principal Investigator |
Name | Andrea Carralero Martínez |
Title | Physical therapist |
Affiliation | RAPbarcelona |
Study References
Sequence: | 52267526 |
Pmid | 34016168 |
Reference Type | derived |
Citation | Carralero-Martinez A, Munoz Perez MA, Pane-Alemany R, Blanco-Ratto L, Kauffmann S, Ramirez-Garcia I. Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: study protocol for a randomized controlled trial. Trials. 2021 May 20;22(1):356. doi: 10.1186/s13063-021-05321-6. |
]]>
https://zephyrnet.com/NCT03797898
2019-03-05
https://zephyrnet.com/?p=NCT03797898
NCT03797898https://www.clinicaltrials.gov/study/NCT03797898?tab=tableNANANAParent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care using a health educator (“Parent Coach”) to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. The Parent Coach provides anticipatory guidance, psychosocial and social needs screening/referral, and developmental and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by parent-focused pre-visit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical exam and any concerns that require a clinician’s attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines.
The investigators will conduct a cluster RCT of PARENT to determine its effects on quality, utilization, and clinician efficiency, and its cost/cost-offset.
<![CDATA[
Studies
Study First Submitted Date | 2018-12-20 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2023-06-26 |
Start Month Year | March 5, 2019 |
Primary Completion Month Year | July 14, 2022 |
Verification Month Year | June 2023 |
Verification Date | 2023-06-30 |
Last Update Posted Date | 2023-06-26 |
Results First Posted Date | 2023-06-26 |
Detailed Descriptions
Sequence: | 20699473 |
Description | Well-Child Care (WCC) visits for child preventive care during the first three years of life are critical because they may be the only opportunity before a child reaches preschool to identify and address important social, developmental, behavioral, and health issues that could have significant impact and long-lasting effects on children's lives as adults. Despite its potential, multiple studies have demonstrated that pediatric providers fail to provide all recommended preventive and developmental services at these visits and that most parents leave the visit with unaddressed psychosocial, developmental, and behavioral concerns. Further, these missed opportunities are more pronounced for children in low-income families.
A critical problem is that the structure of WCC in the U.S. cannot support the vast array of WCC needs of families. Key structural problems include (a) reliance on clinicians (pediatricians, family physicians, or nurse practitioners) for basic, routine WCC services, (b) limitation to a 15-minute face-to-face clinician-directed WCC visit for the wide array of education and guidance services in WCC, and (c) lack of a systematic, patient-driven method for visit customization to meet families' needs. These structural problems contribute to the wide variations in processes of care and preventive care outcomes, resulting in poorer quality of WCC and perhaps worse health outcomes, particularly for children in low-income communities. To address the gaps in current WCC this study introduces a new model of care to meet the needs of children in low-income communities: Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT). PARENT is a team-based approach to care using a health educator ("Parent Coach") to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. The Parent Coach provides anticipatory guidance, psychosocial screening/referral, and developmental and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by parent-focused pre-visit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical exam and any concerns that require a clinician's attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines. To assess the efficacy of PARENT, the investigators will conduct a cluster randomized controlled trial (RCT). The study will be conducted in partnership with 10 clinics. In preparation for the trial, investigators will use a Community Engagement & Intervention Implementation process that has been successful in previous studies to guide the intervention adaptation process, Parent Coach training, practice workflow, and intervention implementation in the practices. For the study trial, the investigators will conduct a cluster RCT of PARENT to determine its effects on quality, utilization, and clinician efficiency, and its cost/cost-offset. The project's community partners include two federally-qualified health centers (FQHC). FQHC #1 has 4 clinics participating in the study and FQHC #2 has 6 clinics participating in the study. The total number of clinics participating in the study is 10 clinics randomized at the clinic level to intervention or control condition. The intervention clinics will implement PARENT for all well-visits through age 2 years at their clinical site, and the control clinics will continue usual care (clinician directed well-visit). 1,000 families will be enrolled at infant age ≤12 months and remain in the study for a period of 12 months. Parents will complete a survey at baseline and at 6 and 12-months post enrollment. |
Facilities
Sequence: | 199814740 | Sequence: | 199814741 |
Name | University of California, Los Angeles | Name | Seattle Children's Research Institute |
City | Los Angeles | City | Seattle |
State | California | State | Washington |
Zip | 90095 | Zip | 98121 |
Country | United States | Country | United States |
Conditions
Sequence: | 52110905 | Sequence: | 52110906 |
Name | Preventive Health Services | Name | Health Promotion |
Downcase Name | preventive health services | Downcase Name | health promotion |
Id Information
Sequence: | 40111874 | Sequence: | 40111875 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | STUDY00000413 | Id Value | 5R01HD088586 |
Id Type | U.S. NIH Grant/Contract | ||
Id Link | https://reporter.nih.gov/quickSearch/5R01HD088586 |
Countries
Sequence: | 42514950 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55527987 | Sequence: | 55527988 |
Group Type | Experimental | Group Type | No Intervention |
Title | Intervention | Title | Control |
Description | Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt). | Description | usual care well child care |
Interventions
Sequence: | 52425311 |
Intervention Type | Other |
Name | Parent Coach |
Description | The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits. |
Design Outcomes
Sequence: | 177168195 | Sequence: | 177168196 | Sequence: | 177168197 | Sequence: | 177168198 | Sequence: | 177168199 | Sequence: | 177168200 | Sequence: | 177168201 | Sequence: | 177168202 | Sequence: | 177168203 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits | Measure | Healthcare Utilization: Emergency Department Utilization | Measure | Clinician Time With Parent During the Well-Child Care (WCC) Visit, From Observations of Well Child Care Visit | Measure | Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits | Measure | Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. | Measure | Healthcare Utilization: Hospitalizations | Measure | Healthcare Utilization: Well Child Care Visits Up to Date | Measure | Experiences of Care: Helpfulness of Care Assessment by Parent Report | Measure | Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report |
Time Frame | 12 months post enrollment | Time Frame | 12 months post enrollment | Time Frame | Data not collected due to COVID Pandemic restrictions on in clinic observations. | Time Frame | 12 months post enrollment | Time Frame | 12 months post enrollment | Time Frame | 12 months post enrollment | Time Frame | 12 months post enrollment | Time Frame | 12 months post enrollment | Time Frame | 12 months post enrollment |
Description | Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics.
scale, 0-100, higher is better |
Description | any emergency department care visit for the index child in past 12 months (parent report) | Description | time spent in parent-provider visit during the well child care visit. these data were not collected for trial participants at baseline. At follow-up, we did not collect data due to pandemic restrictions in doing observations. | Description | Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents received psychosocial assessment on all 7 items | Description | Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed. | Description | any hospitalizations for index child in past 12 months by parent report | Description | up to date on well child care by clinic electronic medical record review at 12 months post enrollment | Description | parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey scale is 0-100, higher is better | Description | receipt of family centeredness of care using items adapted from National Survey of Children's Health scale 0-100, higher is better |
Sponsors
Sequence: | 48264432 | Sequence: | 48264433 |
Agency Class | OTHER | Agency Class | NIH |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | Seattle Children's Hospital | Name | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Overall Officials
Sequence: | 29251161 |
Role | Principal Investigator |
Name | Tumaini R Coker, MD/MBA |
Affiliation | Seattle Children's |
Design Group Interventions
Sequence: | 68069128 |
Design Group Id | 55527987 |
Intervention Id | 52425311 |
Eligibilities
Sequence: | 30731156 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Parent/legal guardian-Child dyad attending well child check-up visits for a 2-week to 12- month WCC visit. Exclusion Criteria: More than one child attending Well-Child Care |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253996239 |
Number Of Facilities | 2 |
Number Of Sae Subjects | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 40 |
Were Results Reported | True |
Months To Report Results | 6 |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 7 |
Designs
Sequence: | 30477548 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Health Services Research |
Time Perspective | |
Masking | None (Open Label) |
Drop Withdrawals
Sequence: | 28924406 | Sequence: | 28924407 | Sequence: | 28924408 | Sequence: | 28924409 | Sequence: | 28924410 | Sequence: | 28924411 |
Result Group Id | 56032938 | Result Group Id | 56032939 | Result Group Id | 56032938 | Result Group Id | 56032939 | Result Group Id | 56032938 | Result Group Id | 56032939 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Reason | Lost to Follow-up | Reason | Lost to Follow-up | Reason | Withdrawal by Subject | Reason | Withdrawal by Subject | Reason | Became ineligible | Reason | Became ineligible |
Count | 60 | Count | 69 | Count | 9 | Count | 7 | Count | 5 | Count | 2 |
Milestones
Sequence: | 40948211 | Sequence: | 40948212 | Sequence: | 40948213 | Sequence: | 40948214 | Sequence: | 40948215 | Sequence: | 40948216 |
Result Group Id | 56032938 | Result Group Id | 56032939 | Result Group Id | 56032938 | Result Group Id | 56032939 | Result Group Id | 56032938 | Result Group Id | 56032939 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Description | 452 parent participants with a child ≤12 months arriving for a well child visit | Description | 485 parent participants with a child ≤12 months arriving for a well child visit | ||||||||
Count | 452 | Count | 485 | Count | 378 | Count | 407 | Count | 74 | Count | 78 |
Count Units | 5 | Count Units | 5 | Count Units | 5 | Count Units | 5 | Count Units | 0 | Count Units | 0 |
Participant Flows
Sequence: | 3916057 |
Recruitment Details | Participants were recruited from two multi-site federally qualified health centers (FQHCs) in California and Washington State, with 6 and 4 participating practices each. The first participant was enrolled March 5, 2019 and the last participant was enrolled July 1, 2021. **PLEASE NOTE that there were not multiple phases to the trial. this study was a cluster RCT that did not have multiple phases to the trial. |
Pre Assignment Details | Of 937 enrolled participants, 914 remained enrolled and were eligible to complete 12-month follow-up.
Participants are unique parent/child dyads. The parents were enrolled and each parent had an index child that they provided data on. This was the child for who they were coming to the clinic for a well child visit, and the child had to be 12 months of age or younger. |
Units Analyzed | clinics |
Outcome Counts
Sequence: | 73882865 | Sequence: | 73882866 | Sequence: | 73882867 | Sequence: | 73882868 | Sequence: | 73882869 | Sequence: | 73882870 | Sequence: | 73882871 | Sequence: | 73882872 | Sequence: | 73882873 | Sequence: | 73882874 | Sequence: | 73882875 | Sequence: | 73882876 | Sequence: | 73882877 | Sequence: | 73882878 | Sequence: | 73882879 | Sequence: | 73882880 | Sequence: | 73882881 | Sequence: | 73882882 |
Outcome Id | 30755253 | Outcome Id | 30755253 | Outcome Id | 30755254 | Outcome Id | 30755254 | Outcome Id | 30755255 | Outcome Id | 30755255 | Outcome Id | 30755256 | Outcome Id | 30755256 | Outcome Id | 30755257 | Outcome Id | 30755257 | Outcome Id | 30755258 | Outcome Id | 30755258 | Outcome Id | 30755259 | Outcome Id | 30755259 | Outcome Id | 30755260 | Outcome Id | 30755260 | Outcome Id | 30755261 | Outcome Id | 30755261 |
Result Group Id | 56032940 | Result Group Id | 56032941 | Result Group Id | 56032940 | Result Group Id | 56032941 | Result Group Id | 56032942 | Result Group Id | 56032943 | Result Group Id | 56032940 | Result Group Id | 56032941 | Result Group Id | 56032940 | Result Group Id | 56032941 | Result Group Id | 56032940 | Result Group Id | 56032941 | Result Group Id | 56032940 | Result Group Id | 56032941 | Result Group Id | 56032940 | Result Group Id | 56032941 | Result Group Id | 56032940 | Result Group Id | 56032941 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 375 | Count | 407 | Count | 376 | Count | 407 | Count | 0 | Count | 0 | Count | 378 | Count | 407 | Count | 378 | Count | 407 | Count | 376 | Count | 406 | Count | 419 | Count | 465 | Count | 378 | Count | 407 | Count | 378 | Count | 407 |
Provided Documents
Sequence: | 2576077 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2021-01-14 |
Url | https://ClinicalTrials.gov/ProvidedDocs/98/NCT03797898/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27904510 | Sequence: | 27904511 | Sequence: | 27904512 | Sequence: | 27904513 | Sequence: | 27904514 | Sequence: | 27904515 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 1 | Subjects Affected | 0 | Subjects Affected | 1 |
Subjects At Risk | 452 | Subjects At Risk | 452 | Subjects At Risk | 452 | Subjects At Risk | 485 | Subjects At Risk | 485 | Subjects At Risk | 485 |
Created At | 2023-08-08 16:04:57.635433 | Created At | 2023-08-08 16:04:57.635433 | Created At | 2023-08-08 16:04:57.635433 | Created At | 2023-08-08 16:04:57.635433 | Created At | 2023-08-08 16:04:57.635433 | Created At | 2023-08-08 16:04:57.635433 |
Updated At | 2023-08-08 16:04:57.635433 | Updated At | 2023-08-08 16:04:57.635433 | Updated At | 2023-08-08 16:04:57.635433 | Updated At | 2023-08-08 16:04:57.635433 | Updated At | 2023-08-08 16:04:57.635433 | Updated At | 2023-08-08 16:04:57.635433 |
Reported Events
Sequence: | 527140373 | Sequence: | 527140374 |
Result Group Id | 56032944 | Result Group Id | 56032945 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Time Frame | 12 months | Time Frame | 12 months |
Event Type | serious | Event Type | serious |
Subjects Affected | 0 | Subjects Affected | 1 |
Subjects At Risk | 452 | Subjects At Risk | 485 |
Description | As there were no risk of harm to participant dyads, we did not conduct a systematic approach to collecting data on harms. However, if in the course of the 12-month data collection, we gained information on participant harm to either the parent or child of the dyad, we report those as "adverse events". The only such information we received was on one parent of the parent/child dyads enrolled, and this event (parent death) is reported both in the serious adverse event and in all cause mortality. | Description | As there were no risk of harm to participant dyads, we did not conduct a systematic approach to collecting data on harms. However, if in the course of the 12-month data collection, we gained information on participant harm to either the parent or child of the dyad, we report those as "adverse events". The only such information we received was on one parent of the parent/child dyads enrolled, and this event (parent death) is reported both in the serious adverse event and in all cause mortality. |
Event Count | 0 | Event Count | 1 |
Organ System | General disorders | Organ System | General disorders |
Adverse Event Term | death | Adverse Event Term | death |
Frequency Threshold | 0 | Frequency Threshold | 0 |
Assessment | Non-systematic Assessment | Assessment | Non-systematic Assessment |
Responsible Parties
Sequence: | 28843938 |
Responsible Party Type | Principal Investigator |
Name | Tumaini Coker |
Title | Associate Professor |
Affiliation | Seattle Children's Hospital |
Result Agreements
Sequence: | 3846801 |
Pi Employee | No |
Result Contacts
Sequence: | 3846766 |
Organization | Seattle Children's |
Name | Tumaini R. Coker, MD, MBA |
Phone | 206-884-0559 |
Tumaini.Coker@seattlechildrens.org | |
Outcomes
Sequence: | 30755253 | Sequence: | 30755254 | Sequence: | 30755255 | Sequence: | 30755256 | Sequence: | 30755257 | Sequence: | 30755258 | Sequence: | 30755259 | Sequence: | 30755260 | Sequence: | 30755261 |
Outcome Type | Primary | Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits | Title | Healthcare Utilization: Emergency Department Utilization | Title | Clinician Time With Parent During the Well-Child Care (WCC) Visit, From Observations of Well Child Care Visit | Title | Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits | Title | Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. | Title | Healthcare Utilization: Hospitalizations | Title | Healthcare Utilization: Well Child Care Visits Up to Date | Title | Experiences of Care: Helpfulness of Care Assessment by Parent Report | Title | Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report |
Description | Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics.
scale, 0-100, higher is better |
Description | any emergency department care visit for the index child in past 12 months (parent report) | Description | time spent in parent-provider visit during the well child care visit. these data were not collected for trial participants at baseline. At follow-up, we did not collect data due to pandemic restrictions in doing observations. | Description | Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents received psychosocial assessment on all 7 items | Description | Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed. | Description | any hospitalizations for index child in past 12 months by parent report | Description | up to date on well child care by clinic electronic medical record review at 12 months post enrollment | Description | parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey scale is 0-100, higher is better | Description | receipt of family centeredness of care using items adapted from National Survey of Children's Health scale 0-100, higher is better |
Time Frame | 12 months post enrollment | Time Frame | 12 months post enrollment | Time Frame | Data not collected due to COVID Pandemic restrictions on in clinic observations. | Time Frame | 12 months post enrollment | Time Frame | 12 months post enrollment | Time Frame | 12 months post enrollment | Time Frame | 12 months post enrollment | Time Frame | 12 months post enrollment | Time Frame | 12 months post enrollment |
Population | all participants completing 12 month survey | Population | Data were not collected due to COVID 19 pandemic restrictions on in clinic observations | Population | all participants completing 12 month survey | Population | Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population | all participants completing 12 month survey | Population | all enrolled participants who remained eligible, and consented to chart review by the 12-month post intervention assessment | Population | all participants completing 12 month survey | Population | all participants completing 12 month survey | ||
Units | score on a scale | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | score on a scale | Units | score on a scale | ||
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||
Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean |
Outcome Measurements
Sequence: | 235255591 | Sequence: | 235255592 | Sequence: | 235255593 | Sequence: | 235255594 | Sequence: | 235255584 | Sequence: | 235255585 | Sequence: | 235255586 | Sequence: | 235255587 | Sequence: | 235255588 | Sequence: | 235255589 | Sequence: | 235255577 | Sequence: | 235255578 | Sequence: | 235255579 | Sequence: | 235255580 | Sequence: | 235255581 | Sequence: | 235255582 | Sequence: | 235255583 | Sequence: | 235255590 |
Outcome Id | 30755260 | Outcome Id | 30755260 | Outcome Id | 30755261 | Outcome Id | 30755261 | Outcome Id | 30755257 | Outcome Id | 30755257 | Outcome Id | 30755257 | Outcome Id | 30755258 | Outcome Id | 30755258 | Outcome Id | 30755259 | Outcome Id | 30755253 | Outcome Id | 30755253 | Outcome Id | 30755254 | Outcome Id | 30755254 | Outcome Id | 30755256 | Outcome Id | 30755256 | Outcome Id | 30755257 | Outcome Id | 30755259 |
Result Group Id | 56032940 | Result Group Id | 56032941 | Result Group Id | 56032940 | Result Group Id | 56032941 | Result Group Id | 56032941 | Result Group Id | 56032940 | Result Group Id | 56032941 | Result Group Id | 56032940 | Result Group Id | 56032941 | Result Group Id | 56032940 | Result Group Id | 56032940 | Result Group Id | 56032941 | Result Group Id | 56032940 | Result Group Id | 56032941 | Result Group Id | 56032940 | Result Group Id | 56032941 | Result Group Id | 56032940 | Result Group Id | 56032941 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Classification | Behavioral Concerns Elicited & Addressed | Classification | Developmental Screening | Classification | Developmental Screening | Classification | Behavioral Concerns Elicited & Addressed | ||||||||||||||||||||||||||||
Title | Experiences of Care: Helpfulness of Care Assessment by Parent Report | Title | Experiences of Care: Helpfulness of Care Assessment by Parent Report | Title | Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report | Title | Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report | Title | Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. | Title | Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. | Title | Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. | Title | Healthcare Utilization: Hospitalizations | Title | Healthcare Utilization: Hospitalizations | Title | Healthcare Utilization: Well Child Care Visits Up to Date | Title | Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits | Title | Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits | Title | Healthcare Utilization: Emergency Department Utilization | Title | Healthcare Utilization: Emergency Department Utilization | Title | Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits | Title | Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits | Title | Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. | Title | Healthcare Utilization: Well Child Care Visits Up to Date |
Description | parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey scale is 0-100, higher is better | Description | parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey scale is 0-100, higher is better | Description | receipt of family centeredness of care using items adapted from National Survey of Children's Health scale 0-100, higher is better | Description | receipt of family centeredness of care using items adapted from National Survey of Children's Health scale 0-100, higher is better | Description | Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed. | Description | Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed. | Description | Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed. | Description | any hospitalizations for index child in past 12 months by parent report | Description | any hospitalizations for index child in past 12 months by parent report | Description | up to date on well child care by clinic electronic medical record review at 12 months post enrollment | Description | Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics.
scale, 0-100, higher is better |
Description | Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics.
scale, 0-100, higher is better |
Description | any emergency department care visit for the index child in past 12 months (parent report) | Description | any emergency department care visit for the index child in past 12 months (parent report) | Description | Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents received psychosocial assessment on all 7 items | Description | Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents received psychosocial assessment on all 7 items | Description | Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed. | Description | up to date on well child care by clinic electronic medical record review at 12 months post enrollment |
Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | score on a scale | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | score on a scale | Units | score on a scale | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants |
Param Value | 77.8 | Param Value | 69.8 | Param Value | 89.0 | Param Value | 85.5 | Param Value | 292 | Param Value | 310 | Param Value | 332 | Param Value | 12 | Param Value | 9 | Param Value | 309 | Param Value | 73.9 | Param Value | 63.3 | Param Value | 140 | Param Value | 147 | Param Value | 253 | Param Value | 203 | Param Value | 305 | Param Value | 295 |
Param Value Num | 77.8 | Param Value Num | 69.8 | Param Value Num | 89.0 | Param Value Num | 85.5 | Param Value Num | 292.0 | Param Value Num | 310.0 | Param Value Num | 332.0 | Param Value Num | 12.0 | Param Value Num | 9.0 | Param Value Num | 309.0 | Param Value Num | 73.9 | Param Value Num | 63.3 | Param Value Num | 140.0 | Param Value Num | 147.0 | Param Value Num | 253.0 | Param Value Num | 203.0 | Param Value Num | 305.0 | Param Value Num | 295.0 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||
Dispersion Value | 25.2 | Dispersion Value | 30.7 | Dispersion Value | 22.5 | Dispersion Value | 27.1 | Dispersion Value | 23.4 | Dispersion Value | 27.8 | ||||||||||||||||||||||||
Dispersion Value Num | 25.2 | Dispersion Value Num | 30.7 | Dispersion Value Num | 22.5 | Dispersion Value Num | 27.1 | Dispersion Value Num | 23.4 | Dispersion Value Num | 27.8 | ||||||||||||||||||||||||
Study References
Sequence: | 52005445 | Sequence: | 52005446 | Sequence: | 52005447 | Sequence: | 52005448 | Sequence: | 52005449 |
Pmid | 28232142 | Pmid | 26908675 | Pmid | 23457149 | Pmid | 24936004 | Pmid | 34842563 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | derived |
Citation | Mimila NA, Chung PJ, Elliott MN, Bethell CD, Chacon S, Biely C, Contreras S, Chavis T, Bruno Y, Moss T, Coker TR. Well-Child Care Redesign: A Mixed Methods Analysis of Parent Experiences in the PARENT Trial. Acad Pediatr. 2017 Sep-Oct;17(7):747-754. doi: 10.1016/j.acap.2017.02.004. Epub 2017 Feb 14. | Citation | Coker TR, Chacon S, Elliott MN, Bruno Y, Chavis T, Biely C, Bethell CD, Contreras S, Mimila NA, Mercado J, Chung PJ. A Parent Coach Model for Well-Child Care Among Low-Income Children: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20153013. doi: 10.1542/peds.2015-3013. Epub 2016 Feb 10. | Citation | Coker TR, Windon A, Moreno C, Schuster MA, Chung PJ. Well-child care clinical practice redesign for young children: a systematic review of strategies and tools. Pediatrics. 2013 Mar;131 Suppl 1(Suppl 1):S5-25. doi: 10.1542/peds.2012-1427c. | Citation | Coker TR, Moreno C, Shekelle PG, Schuster MA, Chung PJ. Well-child care clinical practice redesign for serving low-income children. Pediatrics. 2014 Jul;134(1):e229-39. doi: 10.1542/peds.2013-3775. Epub 2014 Jun 16. | Citation | Hurst R, Liljenquist K, Lowry SJ, Szilagyi PG, Fiscella KA, Weaver MR, Porras-Javier L, Ortiz J, Sotelo Guerra LJ, Coker TR. A Parent Coach-Led Model of Well-Child Care for Young Children in Low-Income Communities: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 25;10(11):e27054. doi: 10.2196/27054. |
Baseline Counts
Sequence: | 11367863 | Sequence: | 11367864 | Sequence: | 11367865 |
Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 438 | Count | 476 | Count | 914 |
Result Groups
Sequence: | 56032935 | Sequence: | 56032936 | Sequence: | 56032937 | Sequence: | 56032938 | Sequence: | 56032939 | Sequence: | 56032940 | Sequence: | 56032941 | Sequence: | 56032942 | Sequence: | 56032943 | Sequence: | 56032944 | Sequence: | 56032945 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Intervention | Title | Control | Title | Total | Title | Intervention | Title | Control | Title | Intervention | Title | Control | Title | Intervention | Title | Control | Title | Intervention | Title | Control |
Description | Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits. |
Description | usual care well child care | Description | Total of all reporting groups | Description | Clinics assigned to the intervention arm will use the Parent Coach model for well child care visits, for children ages 0-2. Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits. |
Description | Clinics assigned to control group use usual well child care. They do not have a parent coach as part of the visit. | Description | Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits. |
Description | usual care well child care | Description | Clinics assigned to the intervention arm will use the Parent Coach model for well child care visits, for children ages 0-2. Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits. |
Description | Clinics assigned to control group use usual well child care. They do not have a parent coach as part of the visit. | Description | Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits. |
Description | usual care well child care |
Baseline Measurements
Sequence: | 125413943 | Sequence: | 125413944 | Sequence: | 125413945 | Sequence: | 125413946 | Sequence: | 125413947 | Sequence: | 125413948 | Sequence: | 125413949 | Sequence: | 125413950 | Sequence: | 125413951 | Sequence: | 125413952 | Sequence: | 125413953 | Sequence: | 125413954 | Sequence: | 125413955 | Sequence: | 125413956 | Sequence: | 125413957 | Sequence: | 125413958 | Sequence: | 125413959 | Sequence: | 125413960 | Sequence: | 125413961 | Sequence: | 125413962 | Sequence: | 125413963 | Sequence: | 125413964 | Sequence: | 125413965 | Sequence: | 125413966 | Sequence: | 125413967 | Sequence: | 125413968 | Sequence: | 125413971 | Sequence: | 125413969 | Sequence: | 125413970 | Sequence: | 125413972 | Sequence: | 125413973 | Sequence: | 125413974 | Sequence: | 125413975 | Sequence: | 125413976 | Sequence: | 125413977 | Sequence: | 125413978 | Sequence: | 125413979 | Sequence: | 125413980 | Sequence: | 125413981 | Sequence: | 125413982 | Sequence: | 125413983 | Sequence: | 125413984 | Sequence: | 125413985 | Sequence: | 125413986 | Sequence: | 125413987 | Sequence: | 125413988 | Sequence: | 125413989 | Sequence: | 125413990 | Sequence: | 125413991 | Sequence: | 125413992 | Sequence: | 125413993 | Sequence: | 125413994 | Sequence: | 125413995 | Sequence: | 125413996 | Sequence: | 125413997 | Sequence: | 125413998 | Sequence: | 125413999 | Sequence: | 125414000 | Sequence: | 125414001 | Sequence: | 125414002 | Sequence: | 125414003 | Sequence: | 125414004 | Sequence: | 125414005 | Sequence: | 125414006 | Sequence: | 125414007 | Sequence: | 125414008 | Sequence: | 125414009 | Sequence: | 125414010 | Sequence: | 125414011 | Sequence: | 125414012 | Sequence: | 125414013 | Sequence: | 125414014 | Sequence: | 125414015 | Sequence: | 125414016 | Sequence: | 125414017 | Sequence: | 125414018 | Sequence: | 125414019 | Sequence: | 125414020 | Sequence: | 125414021 | Sequence: | 125414022 | Sequence: | 125414023 | Sequence: | 125414024 | Sequence: | 125414025 | Sequence: | 125414026 | Sequence: | 125414027 | Sequence: | 125414028 | Sequence: | 125414029 | Sequence: | 125414030 | Sequence: | 125414031 | Sequence: | 125414032 | Sequence: | 125414033 | Sequence: | 125414034 | Sequence: | 125414035 | Sequence: | 125414036 | Sequence: | 125414037 | Sequence: | 125414038 | Sequence: | 125414039 | Sequence: | 125414040 | Sequence: | 125414041 | Sequence: | 125414042 | Sequence: | 125414043 | Sequence: | 125414044 | Sequence: | 125414045 | Sequence: | 125414046 | Sequence: | 125414047 | Sequence: | 125414048 | Sequence: | 125414049 | Sequence: | 125414050 | Sequence: | 125414051 | Sequence: | 125414052 | Sequence: | 125414053 | Sequence: | 125414054 | Sequence: | 125414055 | Sequence: | 125414056 | Sequence: | 125414057 | Sequence: | 125414058 | Sequence: | 125414059 | Sequence: | 125414060 | Sequence: | 125414061 | Sequence: | 125414062 | Sequence: | 125414063 | Sequence: | 125414064 | Sequence: | 125414065 | Sequence: | 125414066 | Sequence: | 125414067 | Sequence: | 125414068 | Sequence: | 125414069 | Sequence: | 125414070 | Sequence: | 125414071 | Sequence: | 125414072 | Sequence: | 125414073 | Sequence: | 125414074 | Sequence: | 125414075 | Sequence: | 125414076 | Sequence: | 125414077 | Sequence: | 125414078 | Sequence: | 125414079 | Sequence: | 125414080 | Sequence: | 125414081 | Sequence: | 125414082 | Sequence: | 125414083 | Sequence: | 125414084 | Sequence: | 125414085 | Sequence: | 125414086 | Sequence: | 125414087 | Sequence: | 125414088 | Sequence: | 125414089 | Sequence: | 125414090 | Sequence: | 125414091 | Sequence: | 125414092 | Sequence: | 125414093 | Sequence: | 125414094 | Sequence: | 125414095 | Sequence: | 125414096 | Sequence: | 125414097 | Sequence: | 125414098 | Sequence: | 125414099 | Sequence: | 125414100 | Sequence: | 125414101 |
Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 | Result Group Id | 56032935 | Result Group Id | 56032936 | Result Group Id | 56032937 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Classification | Mother | Classification | Mother | Classification | Mother | Classification | Father | Classification | Father | Classification | Father | Classification | Grandmother | Classification | Grandmother | Classification | Grandmother | Classification | Latino | Classification | Latino | Classification | Latino | Classification | Non-Latino Black | Classification | Non-Latino Black | Classification | Non-Latino Black | Classification | Non-Latino Asian | Classification | Non-Latino Asian | Classification | Non-Latino Asian | Classification | Non-Latino White | Classification | Non-Latino White | Classification | Non-Latino White | Classification | Non-Latino Multi-Racial | Classification | Non-Latino Multi-Racial | Classification | Non-Latino Other | Classification | Non-Latino Multi-Racial | Classification | Non-Latino Other | Classification | Non-Latino Other | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Category | English | Category | English | Category | English | Category | Spanish | Category | Spanish | Category | Spanish | Category | Other | Category | Other | Category | Other | Category | United States | Category | United States | Category | United States | Category | Country other than U.S. | Category | Country other than U.S. | Category | Country other than U.S. | Category | Married | Category | Married | Category | Married | Category | Divorced | Category | Divorced | Category | Divorced | Category | Living with a partner | Category | Living with a partner | Category | Living with a partner | Category | Separated | Category | Separated | Category | Separated | Category | Single (never married & currently not living with a partner) | Category | Single (never married & currently not living with a partner) | Category | Single (never married & currently not living with a partner) | Category | 1 adult | Category | 1 adult | Category | 1 adult | Category | 2 adults | Category | 2 adults | Category | 2 adults | Category | 3 adults | Category | 3 adults | Category | 3 adults | Category | 4 or more adults | Category | 4 or more adults | Category | 4 or more adults | Category | 1 child | Category | 1 child | Category | 1 child | Category | 2 children | Category | 2 children | Category | 2 children | Category | 3 children | Category | 3 children | Category | 3 children | Category | 4 or more children | Category | 4 or more children | Category | 4 or more children | Category | Medicaid (Medi-Cal/Apple Health) | Category | Medicaid (Medi-Cal/Apple Health) | Category | Medicaid (Medi-Cal/Apple Health) | Category | Private Insurance Plan | Category | Private Insurance Plan | Category | Private Insurance Plan | Category | Military | Category | Military | Category | Military | Category | Uninsured | Category | Uninsured | Category | Uninsured | Category | More than one | Category | More than one | Category | More than one | Category | Unknown | Category | Unknown | Category | Unknown | Category | Chronic medical problems | Category | Chronic medical problems | Category | Chronic medical problems | Category | No chronic medical problems | Category | No chronic medical problems | Category | No chronic medical problems | Category | Trouble paying for any household expenses in past 12 months | Category | Trouble paying for any household expenses in past 12 months | Category | Trouble paying for any household expenses in past 12 months | Category | No trouble paying for any household expenses in past 12 months | Category | No trouble paying for any household expenses in past 12 months | Category | No trouble paying for any household expenses in past 12 months | Category | Less than high school | Category | Less than high school | Category | Less than high school | Category | High school graduate or GED | Category | High school graduate or GED | Category | High school graduate or GED | Category | 2-Year college or some college | Category | 2-Year college or some college | Category | 2-Year college or some college | Category | 4-Year college degree or greater | Category | 4-Year college degree or greater | Category | 4-Year college degree or greater | Category | < $29,999 per year | Category | < $29,999 per year | Category | < $29,999 per year | Category | $30,000 to $49,999 per year | Category | $30,000 to $49,999 per year | Category | $30,000 to $49,999 per year | Category | $50,000 to $69,999 per year | Category | $50,000 to $69,999 per year | Category | $50,000 to $69,999 per year | Category | $70,000 or more | Category | $70,000 or more | Category | $70,000 or more | Category | Excellent | Category | Excellent | Category | Excellent | Category | Very good | Category | Very good | Category | Very good | Category | Good | Category | Good | Category | Good | Category | Fair/poor | Category | Fair/poor | Category | Fair/poor | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Title | Age, Continuous | Title | Age, Continuous | Title | Age, Continuous | Title | Sex/Gender, Customized | Title | Sex/Gender, Customized | Title | Sex/Gender, Customized | Title | Sex/Gender, Customized | Title | Sex/Gender, Customized | Title | Sex/Gender, Customized | Title | Sex/Gender, Customized | Title | Sex/Gender, Customized | Title | Sex/Gender, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Race/Ethnicity, Customized | Title | Primary language spoken at home | Title | Primary language spoken at home | Title | Primary language spoken at home | Title | Primary language spoken at home | Title | Primary language spoken at home | Title | Primary language spoken at home | Title | Primary language spoken at home | Title | Primary language spoken at home | Title | Primary language spoken at home | Title | Respondent country of birth | Title | Respondent country of birth | Title | Respondent country of birth | Title | Respondent country of birth | Title | Respondent country of birth | Title | Respondent country of birth | Title | Respondent marital status | Title | Respondent marital status | Title | Respondent marital status | Title | Respondent marital status | Title | Respondent marital status | Title | Respondent marital status | Title | Respondent marital status | Title | Respondent marital status | Title | Respondent marital status | Title | Respondent marital status | Title | Respondent marital status | Title | Respondent marital status | Title | Respondent marital status | Title | Respondent marital status | Title | Respondent marital status | Title | Number of adults in the home | Title | Number of adults in the home | Title | Number of adults in the home | Title | Number of adults in the home | Title | Number of adults in the home | Title | Number of adults in the home | Title | Number of adults in the home | Title | Number of adults in the home | Title | Number of adults in the home | Title | Number of adults in the home | Title | Number of adults in the home | Title | Number of adults in the home | Title | Number of children that parent has | Title | Number of children that parent has | Title | Number of children that parent has | Title | Number of children that parent has | Title | Number of children that parent has | Title | Number of children that parent has | Title | Number of children that parent has | Title | Number of children that parent has | Title | Number of children that parent has | Title | Number of children that parent has | Title | Number of children that parent has | Title | Number of children that parent has | Title | Child health insurance | Title | Child health insurance | Title | Child health insurance | Title | Child health insurance | Title | Child health insurance | Title | Child health insurance | Title | Child health insurance | Title | Child health insurance | Title | Child health insurance | Title | Child health insurance | Title | Child health insurance | Title | Child health insurance | Title | Child health insurance | Title | Child health insurance | Title | Child health insurance | Title | Child health insurance | Title | Child health insurance | Title | Child health insurance | Title | Child chronic medical problems | Title | Child chronic medical problems | Title | Child chronic medical problems | Title | Child chronic medical problems | Title | Child chronic medical problems | Title | Child chronic medical problems | Title | Trouble paying for any household expenses | Title | Trouble paying for any household expenses | Title | Trouble paying for any household expenses | Title | Trouble paying for any household expenses | Title | Trouble paying for any household expenses | Title | Trouble paying for any household expenses | Title | Highest level of education completed | Title | Highest level of education completed | Title | Highest level of education completed | Title | Highest level of education completed | Title | Highest level of education completed | Title | Highest level of education completed | Title | Highest level of education completed | Title | Highest level of education completed | Title | Highest level of education completed | Title | Highest level of education completed | Title | Highest level of education completed | Title | Highest level of education completed | Title | Household Annual Income | Title | Household Annual Income | Title | Household Annual Income | Title | Household Annual Income | Title | Household Annual Income | Title | Household Annual Income | Title | Household Annual Income | Title | Household Annual Income | Title | Household Annual Income | Title | Household Annual Income | Title | Household Annual Income | Title | Household Annual Income | Title | Child's current overall health | Title | Child's current overall health | Title | Child's current overall health | Title | Child's current overall health | Title | Child's current overall health | Title | Child's current overall health | Title | Child's current overall health | Title | Child's current overall health | Title | Child's current overall health | Title | Child's current overall health | Title | Child's current overall health | Title | Child's current overall health | Title | PROMIS (Patient-Reported Outcomes Measurement Information System) 2-item Global Mental Health | Title | PROMIS (Patient-Reported Outcomes Measurement Information System) 2-item Global Mental Health | Title | PROMIS (Patient-Reported Outcomes Measurement Information System) 2-item Global Mental Health | Title | PROMIS (Patient-Reported Outcomes Measurement Information System) 2-item Global Physical Health | Title | PROMIS (Patient-Reported Outcomes Measurement Information System) 2-item Global Physical Health | Title | PROMIS (Patient-Reported Outcomes Measurement Information System) 2-item Global Physical Health | Title | PROMIS (Patient-Reported Outcomes Measurement Information System) 4-item Emotional Support Score | Title | PROMIS (Patient-Reported Outcomes Measurement Information System) 4-item Emotional Support Score | Title | PROMIS (Patient-Reported Outcomes Measurement Information System) 4-item Emotional Support Score |
Description | Child Age (months). Parents reported on age of child. We did not collect data on parent age | Description | Child Age (months). Parents reported on age of child. We did not collect data on parent age | Description | Child Age (months). Parents reported on age of child. We did not collect data on parent age | Description | Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. | Description | Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. | Description | Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. | Description | Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. | Description | Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. | Description | Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. | Description | Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. | Description | Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. | Description | Participant (parent/caregiver) relationship to child. Child sex/gender was not collected. | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent race/ethnicity (child race/ethnicity not collected) | Description | Parent reported parent primary language spoken at home | Description | Parent reported parent primary language spoken at home | Description | Parent reported parent primary language spoken at home | Description | Parent reported parent primary language spoken at home | Description | Parent reported parent primary language spoken at home | Description | Parent reported parent primary language spoken at home | Description | Parent reported parent primary language spoken at home | Description | Parent reported parent primary language spoken at home | Description | Parent reported parent primary language spoken at home | Description | Parent reported parent country of birth | Description | Parent reported parent country of birth | Description | Parent reported parent country of birth | Description | Parent reported parent country of birth | Description | Parent reported parent country of birth | Description | Parent reported parent country of birth | Description | Parent reported parent marital status | Description | Parent reported parent marital status | Description | Parent reported parent marital status | Description | Parent reported parent marital status | Description | Parent reported parent marital status | Description | Parent reported parent marital status | Description | Parent reported parent marital status | Description | Parent reported parent marital status | Description | Parent reported parent marital status | Description | Parent reported parent marital status | Description | Parent reported parent marital status | Description | Parent reported parent marital status | Description | Parent reported parent marital status | Description | Parent reported parent marital status | Description | Parent reported parent marital status | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent reported insurance type for enrolled child | Description | Parent report of enrolled child chronic medical problems | Description | Parent report of enrolled child chronic medical problems | Description | Parent report of enrolled child chronic medical problems | Description | Parent report of enrolled child chronic medical problems | Description | Parent report of enrolled child chronic medical problems | Description | Parent report of enrolled child chronic medical problems | Description | Parent report of "some" or "a lot" of trouble paying for any household expenses in the past 12 months | Description | Parent report of "some" or "a lot" of trouble paying for any household expenses in the past 12 months | Description | Parent report of "some" or "a lot" of trouble paying for any household expenses in the past 12 months | Description | Parent report of "some" or "a lot" of trouble paying for any household expenses in the past 12 months | Description | Parent report of "some" or "a lot" of trouble paying for any household expenses in the past 12 months | Description | Parent report of "some" or "a lot" of trouble paying for any household expenses in the past 12 months | Description | Parent highest level of education | Description | Parent highest level of education | Description | Parent highest level of education | Description | Parent highest level of education | Description | Parent highest level of education | Description | Parent highest level of education | Description | Parent highest level of education | Description | Parent highest level of education | Description | Parent highest level of education | Description | Parent highest level of education | Description | Parent highest level of education | Description | Parent highest level of education | Description | Parent reported household annual income | Description | Parent reported household annual income | Description | Parent reported household annual income | Description | Parent reported household annual income | Description | Parent reported household annual income | Description | Parent reported household annual income | Description | Parent reported household annual income | Description | Parent reported household annual income | Description | Parent reported household annual income | Description | Parent reported household annual income | Description | Parent reported household annual income | Description | Parent reported household annual income | Description | Parent reported child's current overall health | Description | Parent reported child's current overall health | Description | Parent reported child's current overall health | Description | Parent reported child's current overall health | Description | Parent reported child's current overall health | Description | Parent reported child's current overall health | Description | Parent reported child's current overall health | Description | Parent reported child's current overall health | Description | Parent reported child's current overall health | Description | Parent reported child's current overall health | Description | Parent reported child's current overall health | Description | Parent reported child's current overall health | Description | PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Mental Health was calculated by summing two 5-point Likert scale questions for a total possible of 2-10 (9 values), then converting those sums to corresponding PROMIS T-scores, for 9 T-score values ranging from 25.8-64.6. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals | Description | PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Mental Health was calculated by summing two 5-point Likert scale questions for a total possible of 2-10 (9 values), then converting those sums to corresponding PROMIS T-scores, for 9 T-score values ranging from 25.8-64.6. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals | Description | PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Mental Health was calculated by summing two 5-point Likert scale questions for a total possible of 2-10 (9 values), then converting those sums to corresponding PROMIS T-scores, for 9 T-score values ranging from 25.8-64.6. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals | Description | PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Physical Health was calculated by summing 2 5-point Likert scale questions for a total possible of 2-10 (9 values), then converting those sums to corresponding PROMIS T-scores, for 9 T-score values ranging from 23.4-63.3. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals | Description | PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Physical Health was calculated by summing 2 5-point Likert scale questions for a total possible of 2-10 (9 values), then converting those sums to corresponding PROMIS T-scores, for 9 T-score values ranging from 23.4-63.3. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals | Description | PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Physical Health was calculated by summing 2 5-point Likert scale questions for a total possible of 2-10 (9 values), then converting those sums to corresponding PROMIS T-scores, for 9 T-score values ranging from 23.4-63.3. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals | Description | PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Emotional Support was calculated by summing 4 5-point Likert scale questions for a total possible of 4-20 (17 values), then converting those sums to corresponding PROMIS T-scores, for T-score values ranging from 25.7-62.0. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals | Description | PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Emotional Support was calculated by summing 4 5-point Likert scale questions for a total possible of 4-20 (17 values), then converting those sums to corresponding PROMIS T-scores, for T-score values ranging from 25.7-62.0. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals | Description | PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Emotional Support was calculated by summing 4 5-point Likert scale questions for a total possible of 4-20 (17 values), then converting those sums to corresponding PROMIS T-scores, for T-score values ranging from 25.7-62.0. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals | ||||||||||||||||||||||||||||||||||||||||||||||||
Units | months | Units | months | Units | months | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | T-Score | Units | T-Score | Units | T-Score | Units | T-Score | Units | T-Score | Units | T-Score | Units | T-Score | Units | T-Score | Units | T-Score |
Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Number | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean | Param Type | Mean |
Param Value | 4.0 | Param Value | 4.7 | Param Value | 4.4 | Param Value | 414 | Param Value | 454 | Param Value | 868 | Param Value | 20 | Param Value | 22 | Param Value | 42 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 321 | Param Value | 343 | Param Value | 664 | Param Value | 24 | Param Value | 22 | Param Value | 46 | Param Value | 14 | Param Value | 13 | Param Value | 27 | Param Value | 52 | Param Value | 56 | Param Value | 108 | Param Value | 16 | Param Value | 15 | Param Value | 25 | Param Value | 31 | Param Value | 10 | Param Value | 35 | Param Value | 212 | Param Value | 243 | Param Value | 455 | Param Value | 197 | Param Value | 199 | Param Value | 396 | Param Value | 28 | Param Value | 34 | Param Value | 62 | Param Value | 218 | Param Value | 249 | Param Value | 467 | Param Value | 218 | Param Value | 227 | Param Value | 445 | Param Value | 164 | Param Value | 181 | Param Value | 345 | Param Value | 6 | Param Value | 8 | Param Value | 14 | Param Value | 165 | Param Value | 189 | Param Value | 354 | Param Value | 13 | Param Value | 12 | Param Value | 25 | Param Value | 89 | Param Value | 86 | Param Value | 175 | Param Value | 21 | Param Value | 23 | Param Value | 44 | Param Value | 232 | Param Value | 257 | Param Value | 489 | Param Value | 67 | Param Value | 82 | Param Value | 149 | Param Value | 117 | Param Value | 114 | Param Value | 231 | Param Value | 144 | Param Value | 169 | Param Value | 313 | Param Value | 130 | Param Value | 126 | Param Value | 256 | Param Value | 82 | Param Value | 105 | Param Value | 187 | Param Value | 81 | Param Value | 76 | Param Value | 157 | Param Value | 405 | Param Value | 450 | Param Value | 855 | Param Value | 7 | Param Value | 7 | Param Value | 14 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 17 | Param Value | 15 | Param Value | 32 | Param Value | 4 | Param Value | 3 | Param Value | 7 | Param Value | 2 | Param Value | 1 | Param Value | 3 | Param Value | 10 | Param Value | 6 | Param Value | 16 | Param Value | 426 | Param Value | 470 | Param Value | 896 | Param Value | 238 | Param Value | 289 | Param Value | 527 | Param Value | 194 | Param Value | 186 | Param Value | 380 | Param Value | 111 | Param Value | 120 | Param Value | 231 | Param Value | 159 | Param Value | 166 | Param Value | 325 | Param Value | 127 | Param Value | 152 | Param Value | 279 | Param Value | 39 | Param Value | 38 | Param Value | 77 | Param Value | 246 | Param Value | 236 | Param Value | 482 | Param Value | 83 | Param Value | 111 | Param Value | 194 | Param Value | 25 | Param Value | 29 | Param Value | 54 | Param Value | 16 | Param Value | 22 | Param Value | 38 | Param Value | 293 | Param Value | 325 | Param Value | 618 | Param Value | 89 | Param Value | 105 | Param Value | 194 | Param Value | 43 | Param Value | 44 | Param Value | 87 | Param Value | 8 | Param Value | 1 | Param Value | 9 | Param Value | 54.7 | Param Value | 53.9 | Param Value | 54.3 | Param Value | 51.1 | Param Value | 50.6 | Param Value | 50.9 | Param Value | 57.6 | Param Value | 57.2 | Param Value | 57.4 |
Param Value Num | 4.0 | Param Value Num | 4.7 | Param Value Num | 4.4 | Param Value Num | 414.0 | Param Value Num | 454.0 | Param Value Num | 868.0 | Param Value Num | 20.0 | Param Value Num | 22.0 | Param Value Num | 42.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 321.0 | Param Value Num | 343.0 | Param Value Num | 664.0 | Param Value Num | 24.0 | Param Value Num | 22.0 | Param Value Num | 46.0 | Param Value Num | 14.0 | Param Value Num | 13.0 | Param Value Num | 27.0 | Param Value Num | 52.0 | Param Value Num | 56.0 | Param Value Num | 108.0 | Param Value Num | 16.0 | Param Value Num | 15.0 | Param Value Num | 25.0 | Param Value Num | 31.0 | Param Value Num | 10.0 | Param Value Num | 35.0 | Param Value Num | 212.0 | Param Value Num | 243.0 | Param Value Num | 455.0 | Param Value Num | 197.0 | Param Value Num | 199.0 | Param Value Num | 396.0 | Param Value Num | 28.0 | Param Value Num | 34.0 | Param Value Num | 62.0 | Param Value Num | 218.0 | Param Value Num | 249.0 | Param Value Num | 467.0 | Param Value Num | 218.0 | Param Value Num | 227.0 | Param Value Num | 445.0 | Param Value Num | 164.0 | Param Value Num | 181.0 | Param Value Num | 345.0 | Param Value Num | 6.0 | Param Value Num | 8.0 | Param Value Num | 14.0 | Param Value Num | 165.0 | Param Value Num | 189.0 | Param Value Num | 354.0 | Param Value Num | 13.0 | Param Value Num | 12.0 | Param Value Num | 25.0 | Param Value Num | 89.0 | Param Value Num | 86.0 | Param Value Num | 175.0 | Param Value Num | 21.0 | Param Value Num | 23.0 | Param Value Num | 44.0 | Param Value Num | 232.0 | Param Value Num | 257.0 | Param Value Num | 489.0 | Param Value Num | 67.0 | Param Value Num | 82.0 | Param Value Num | 149.0 | Param Value Num | 117.0 | Param Value Num | 114.0 | Param Value Num | 231.0 | Param Value Num | 144.0 | Param Value Num | 169.0 | Param Value Num | 313.0 | Param Value Num | 130.0 | Param Value Num | 126.0 | Param Value Num | 256.0 | Param Value Num | 82.0 | Param Value Num | 105.0 | Param Value Num | 187.0 | Param Value Num | 81.0 | Param Value Num | 76.0 | Param Value Num | 157.0 | Param Value Num | 405.0 | Param Value Num | 450.0 | Param Value Num | 855.0 | Param Value Num | 7.0 | Param Value Num | 7.0 | Param Value Num | 14.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 17.0 | Param Value Num | 15.0 | Param Value Num | 32.0 | Param Value Num | 4.0 | Param Value Num | 3.0 | Param Value Num | 7.0 | Param Value Num | 2.0 | Param Value Num | 1.0 | Param Value Num | 3.0 | Param Value Num | 10.0 | Param Value Num | 6.0 | Param Value Num | 16.0 | Param Value Num | 426.0 | Param Value Num | 470.0 | Param Value Num | 896.0 | Param Value Num | 238.0 | Param Value Num | 289.0 | Param Value Num | 527.0 | Param Value Num | 194.0 | Param Value Num | 186.0 | Param Value Num | 380.0 | Param Value Num | 111.0 | Param Value Num | 120.0 | Param Value Num | 231.0 | Param Value Num | 159.0 | Param Value Num | 166.0 | Param Value Num | 325.0 | Param Value Num | 127.0 | Param Value Num | 152.0 | Param Value Num | 279.0 | Param Value Num | 39.0 | Param Value Num | 38.0 | Param Value Num | 77.0 | Param Value Num | 246.0 | Param Value Num | 236.0 | Param Value Num | 482.0 | Param Value Num | 83.0 | Param Value Num | 111.0 | Param Value Num | 194.0 | Param Value Num | 25.0 | Param Value Num | 29.0 | Param Value Num | 54.0 | Param Value Num | 16.0 | Param Value Num | 22.0 | Param Value Num | 38.0 | Param Value Num | 293.0 | Param Value Num | 325.0 | Param Value Num | 618.0 | Param Value Num | 89.0 | Param Value Num | 105.0 | Param Value Num | 194.0 | Param Value Num | 43.0 | Param Value Num | 44.0 | Param Value Num | 87.0 | Param Value Num | 8.0 | Param Value Num | 1.0 | Param Value Num | 9.0 | Param Value Num | 54.7 | Param Value Num | 53.9 | Param Value Num | 54.3 | Param Value Num | 51.1 | Param Value Num | 50.6 | Param Value Num | 50.9 | Param Value Num | 57.6 | Param Value Num | 57.2 | Param Value Num | 57.4 |
Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | Dispersion Type | Standard Deviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value | 4.0 | Dispersion Value | 4.0 | Dispersion Value | 4.0 | Dispersion Value | 8.5 | Dispersion Value | 8.2 | Dispersion Value | 8.3 | Dispersion Value | 8.4 | Dispersion Value | 7.9 | Dispersion Value | 8.2 | Dispersion Value | 7.0 | Dispersion Value | 7.6 | Dispersion Value | 7.3 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dispersion Value Num | 4.0 | Dispersion Value Num | 4.0 | Dispersion Value Num | 4.0 | Dispersion Value Num | 8.5 | Dispersion Value Num | 8.2 | Dispersion Value Num | 8.3 | Dispersion Value Num | 8.4 | Dispersion Value Num | 7.9 | Dispersion Value Num | 8.2 | Dispersion Value Num | 7.0 | Dispersion Value Num | 7.6 | Dispersion Value Num | 7.3 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 | Number Analyzed | 438 | Number Analyzed | 476 | Number Analyzed | 914 |
Population Description | 911 participants responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 participants responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 participants responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 907 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 907 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 907 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 907 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 907 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 907 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 906 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 906 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 906 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 907 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 907 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 907 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 905 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 905 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) | Population Description | 905 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question) |
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https://zephyrnet.com/NCT03797885
2019-01-15
https://zephyrnet.com/?p=NCT03797885
NCT03797885https://www.clinicaltrials.gov/study/NCT03797885?tab=tableNANANAThis study aims to estimate the number of patients with cardiovascular disease and risk factors in patients who had been diagnosed with type 2 diabetes mellitus. Simultaneously, this study also intends to obtain more information about the management of type 2 diabetes mellitus patients with established cardiovascular disease. This study is non-interventional, which means that will not require participant’s further related visits or procedures. The study will collect the participant’s clinical data from the current visit and, when applicable, within the last 3 years.
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Studies
Study First Submitted Date | 2019-01-02 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2020-11-20 |
Start Month Year | January 15, 2019 |
Primary Completion Month Year | October 15, 2019 |
Verification Month Year | November 2020 |
Verification Date | 2020-11-30 |
Last Update Posted Date | 2020-11-20 |
Facilities
Sequence: | 200280835 | Sequence: | 200280836 | Sequence: | 200280837 | Sequence: | 200280838 | Sequence: | 200280839 | Sequence: | 200280840 | Sequence: | 200280841 | Sequence: | 200280842 | Sequence: | 200280843 | Sequence: | 200280844 | Sequence: | 200280845 | Sequence: | 200280846 | Sequence: | 200280847 | Sequence: | 200280848 |
Name | Novo Nordisk Investigational Site | Name | Novo Nordisk Investigational Site | Name | Novo Nordisk Investigational Site | Name | Novo Nordisk Investigational Site | Name | Novo Nordisk Investigational Site | Name | Novo Nordisk Investigational Site | Name | Novo Nordisk Investigational Site | Name | Novo Nordisk Investigational Site | Name | Novo Nordisk Investigational Site | Name | Novo Nordisk Investigational Site | Name | Novo Nordisk Investigational Site | Name | Novo Nordisk Investigational Site | Name | Novo Nordisk Investigational Site | Name | Novo Nordisk Investigational Site |
City | Almada | City | Caldas da Rainha | City | Leiria | City | Lisboa | City | Lisboa | City | Lisboa | City | Matosinhos | City | Portimão | City | Porto | City | Porto | City | Viana do Castelo | City | Vila Nova de Gaia | City | Vila Real | City | Viseu |
Zip | 2805-267 | Zip | 2500-176 | Zip | 2410-197 | Zip | 1349-019 | Zip | 1500-650 | Zip | 1600-777 | Zip | 4464-513 | Zip | 8500-338 | Zip | 4099-001 | Zip | 4200-319 | Zip | 4901-858 | Zip | 4434-502 | Zip | 5000-508 | Zip | 3504-509 |
Country | Portugal | Country | Portugal | Country | Portugal | Country | Portugal | Country | Portugal | Country | Portugal | Country | Portugal | Country | Portugal | Country | Portugal | Country | Portugal | Country | Portugal | Country | Portugal | Country | Portugal | Country | Portugal |
Conditions
Sequence: | 52221752 |
Name | Diabetes Mellitus, Type 2 |
Downcase Name | diabetes mellitus, type 2 |
Id Information
Sequence: | 40195787 | Sequence: | 40195788 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | NN2211-4435 | Id Value | U1111-1207-2878 |
Id Type | Other Identifier | ||
Id Type Description | World Health Organization (WHO) | ||
Countries
Sequence: | 42609770 |
Name | Portugal |
Removed | False |
Design Groups
Sequence: | 55650041 | Sequence: | 55650042 |
Title | Patients with type 2 diabetes mellitus (T2DM) | Title | Patients with T2DM and established cardiovascular disease |
Description | Patients with type 2 diabetes, at the hospital setting. | Description | Subgroup of patients with type 2 diabetes and established cardiovascular disease |
Interventions
Sequence: | 52535556 |
Intervention Type | Other |
Name | No treatment given |
Description | No treatment is administered to the participants for this study |
Design Outcomes
Sequence: | 177562205 | Sequence: | 177562206 | Sequence: | 177562202 | Sequence: | 177562203 | Sequence: | 177562197 | Sequence: | 177562198 | Sequence: | 177562199 | Sequence: | 177562200 | Sequence: | 177562201 | Sequence: | 177562204 | Sequence: | 177562207 | Sequence: | 177562208 | Sequence: | 177562209 | Sequence: | 177562210 | Sequence: | 177562211 | Sequence: | 177562212 | Sequence: | 177562213 | Sequence: | 177562214 | Sequence: | 177562215 | Sequence: | 177562216 | Sequence: | 177562217 |
Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Change in waist circumference | Measure | Change in body mass index | Measure | Hospital appointments | Measure | Hospitalisation episodes | Measure | Proportion of type 2 diabetes mellitus (T2DM) patients with cardiovascular risk factors (CVRFs) and/or established cardiovascular disease (CVD), regardless the date of diagnosis | Measure | Hypoglycaemic episodes | Measure | Hyperglycaemic episodes | Measure | Presence of T2DM complications (yes/no) | Measure | Types of T2DM complications | Measure | Emergency visits | Measure | Change in blood pressure | Measure | Change in urine albumin | Measure | Change in urine albumin | Measure | Change in glycosylated hemoglobin (HbA1c) | Measure | Change in HbA1c | Measure | Change in Estimated Glomerular Filtration Rate (eGFR) | Measure | Change in total cholesterol | Measure | Change in low-density lipoprotein cholesterol | Measure | Change in high-density lipoprotein cholesterol | Measure | Change in triglyceride | Measure | Type of pharmacological treatment |
Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | Baseline (month 0) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) | Time Frame | During 3 years before baseline (0 to -36 months) |
Description | Measured in cm | Description | Measured in kg/m^2 | Description | Number of cardiology, ophthalmology, nephrology, and vascular surgery appointments | Description | Number of episodes | Description | Proportion of subjects.
CVRFs are defined as a history of one or more of the following criteria: Overweight or obese CVD is defined as a history of one or more of the following events: Stroke |
Description | Number of episodes | Description | Number of episodes | Description | Number of patients for whom 'presence of T2DM complications' has been answered yes/no respectively | Description | Types of T2DM complications: Retinopathy, Diabetic neuropathy (peripheral, autonomic), Diabetic nephropathy, Amputation. | Description | Number of visits | Description | Measured in mmHg | Description | Measured in mg/24 hours | Description | Measured in microgram/minute | Description | Measured in mmol/mol | Description | Measured in % | Description | Measured in mL/min/1.73 m^2 | Description | measured in mg/dl | Description | measured in mg/dl | Description | measured in mg/dl | Description | measured in mg/dl | Description | Types of pharmacological treatment: Antidiabetics Antihypertensive Lipid lowering therapy Antiplatelet/anticoagulant therapy |
Browse Conditions
Sequence: | 193679338 | Sequence: | 193679339 | Sequence: | 193679335 | Sequence: | 193679336 | Sequence: | 193679337 |
Mesh Term | Metabolic Diseases | Mesh Term | Endocrine System Diseases | Mesh Term | Diabetes Mellitus, Type 2 | Mesh Term | Diabetes Mellitus | Mesh Term | Glucose Metabolism Disorders |
Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | endocrine system diseases | Downcase Mesh Term | diabetes mellitus, type 2 | Downcase Mesh Term | diabetes mellitus | Downcase Mesh Term | glucose metabolism disorders |
Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48366626 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Novo Nordisk A/S |
Overall Officials
Sequence: | 29313015 |
Role | Study Director |
Name | Clinical Reporting Anchor and Disclosure (1452) |
Affiliation | Novo Nordisk A/S |
Design Group Interventions
Sequence: | 68217673 | Sequence: | 68217674 |
Design Group Id | 55650042 | Design Group Id | 55650041 |
Intervention Id | 52535556 | Intervention Id | 52535556 |
Eligibilities
Sequence: | 30794839 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Patients with type 2 diabetes mellitus |
Criteria | Inclusion Criteria:
Main study population (Data collection – Prevalence): Signed Informed Consent Form (ICF) obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol) Subgroup (Data collection – Patient management): Patients followed at the hospital setting by the endocrinologist or internal medicine specialist (ambulatory diabetes management) and with available medical records, retrospectively within the last three years Exclusion Criteria: Previous participation in this study. Participation is defined as signed ICF |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254004522 |
Number Of Facilities | 14 |
Registered In Calendar Year | 2019 |
Actual Duration | 9 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 20 |
Designs
Sequence: | 30540879 |
Observational Model | Cohort |
Time Perspective | Cross-Sectional |
Responsible Parties
Sequence: | 28907199 |
Responsible Party Type | Sponsor |
]]>
https://zephyrnet.com/NCT03797872
2019-04-17
https://zephyrnet.com/?p=NCT03797872
NCT03797872https://www.clinicaltrials.gov/study/NCT03797872?tab=tableNANANAPOISE is a two arm interventional trial nested within a cohort (Trials Within Cohorts or TWiCs design). This tests less aggressive early therapy in patients newly diagnosed with low impact oligoarticular PsA. Arm 1 will receive standard step up therapy in the cohort and act as the control group. Arm 2 will receive local steroid injections to active joints and will be able to use non-steroidal anti-inflammatory drugs (NSAIDs) only
<![CDATA[
Studies
Study First Submitted Date | 2018-12-18 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2021-05-10 |
Start Month Year | April 17, 2019 |
Primary Completion Month Year | July 16, 2020 |
Verification Month Year | March 2020 |
Verification Date | 2020-03-31 |
Last Update Posted Date | 2021-05-10 |
Results First Posted Date | 2021-05-10 |
Detailed Descriptions
Sequence: | 20543846 |
Description | Arm 1: Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard practice in these PsA clinics following current international recommendations and National requirements for the prescription of biologic therapy. Whilst physician discretion is used, most commonly Initial therapy will be with methotrexate alone (15mg/week rising to 25mg/week as tolerated by week 8 of therapy) unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (most commonly sulfasalazine or leflunomide) added or switched to at the discretion of the rheumatologist. In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations usually with a TNF inhibitor as first line. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Further details are available in the PsA clinic treatment protocol which is Appendix D in the MONITOR-PsA protocol.
Arm 2: Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local glucocorticoid injections to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication as indicated for individuals. Local glucocorticoid injections will include injections with methylprednisolone or triamcinolone. All active joints will be treated with glucocorticoid injections. Glucocorticoid injections can be either be given as an intra-articular injection to an inflamed joint or as an intra-muscular injection if multiple joints are involved. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). If Participants require DMARD therapy, they will be offered rescue therapy as per usual clinical care but will be asked to continue with data collection for the trial. This is to ensure that sufficient data is collected for the trial but risks in delaying treatment to the individual are mitigated. |
Facilities
Sequence: | 198363087 |
Name | Oxford University Hospitals NHS Trust |
City | Oxford |
State | Oxfordshire |
Zip | OX3 7LD |
Country | United Kingdom |
Browse Interventions
Sequence: | 95148125 | Sequence: | 95148126 | Sequence: | 95148127 | Sequence: | 95148128 | Sequence: | 95148129 | Sequence: | 95148130 | Sequence: | 95148131 | Sequence: | 95148132 | Sequence: | 95148133 | Sequence: | 95148134 | Sequence: | 95148135 | Sequence: | 95148136 | Sequence: | 95148137 | Sequence: | 95148138 | Sequence: | 95148139 | Sequence: | 95148140 | Sequence: | 95148141 | Sequence: | 95148142 | Sequence: | 95148143 | Sequence: | 95148144 | Sequence: | 95148145 | Sequence: | 95148146 | Sequence: | 95148147 | Sequence: | 95148148 | Sequence: | 95148149 | Sequence: | 95148150 | Sequence: | 95148151 | Sequence: | 95148152 | Sequence: | 95148153 | Sequence: | 95148154 | Sequence: | 95148155 | Sequence: | 95148156 | Sequence: | 95148157 | Sequence: | 95148158 | Sequence: | 95148159 | Sequence: | 95148160 | Sequence: | 95148161 | Sequence: | 95148162 | Sequence: | 95148163 | Sequence: | 95148164 | Sequence: | 95148165 | Sequence: | 95148166 | Sequence: | 95148167 | Sequence: | 95148168 | Sequence: | 95148169 |
Mesh Term | Sulfasalazine | Mesh Term | Methylprednisolone | Mesh Term | Methylprednisolone Acetate | Mesh Term | Methylprednisolone Hemisuccinate | Mesh Term | Prednisolone | Mesh Term | Prednisolone acetate | Mesh Term | Triamcinolone | Mesh Term | Triamcinolone Acetonide | Mesh Term | Triamcinolone hexacetonide | Mesh Term | Methotrexate | Mesh Term | Triamcinolone diacetate | Mesh Term | Leflunomide | Mesh Term | Prednisolone hemisuccinate | Mesh Term | Prednisolone phosphate | Mesh Term | Abortifacient Agents, Nonsteroidal | Mesh Term | Abortifacient Agents | Mesh Term | Reproductive Control Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Antimetabolites, Antineoplastic | Mesh Term | Antimetabolites | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antineoplastic Agents | Mesh Term | Dermatologic Agents | Mesh Term | Enzyme Inhibitors | Mesh Term | Folic Acid Antagonists | Mesh Term | Immunosuppressive Agents | Mesh Term | Immunologic Factors | Mesh Term | Antirheumatic Agents | Mesh Term | Nucleic Acid Synthesis Inhibitors | Mesh Term | Anti-Inflammatory Agents | Mesh Term | Antiemetics | Mesh Term | Autonomic Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Gastrointestinal Agents | Mesh Term | Glucocorticoids | Mesh Term | Hormones | Mesh Term | Hormones, Hormone Substitutes, and Hormone Antagonists | Mesh Term | Neuroprotective Agents | Mesh Term | Protective Agents | Mesh Term | Antineoplastic Agents, Hormonal | Mesh Term | Anti-Infective Agents | Mesh Term | Anti-Inflammatory Agents, Non-Steroidal | Mesh Term | Analgesics, Non-Narcotic | Mesh Term | Analgesics | Mesh Term | Sensory System Agents |
Downcase Mesh Term | sulfasalazine | Downcase Mesh Term | methylprednisolone | Downcase Mesh Term | methylprednisolone acetate | Downcase Mesh Term | methylprednisolone hemisuccinate | Downcase Mesh Term | prednisolone | Downcase Mesh Term | prednisolone acetate | Downcase Mesh Term | triamcinolone | Downcase Mesh Term | triamcinolone acetonide | Downcase Mesh Term | triamcinolone hexacetonide | Downcase Mesh Term | methotrexate | Downcase Mesh Term | triamcinolone diacetate | Downcase Mesh Term | leflunomide | Downcase Mesh Term | prednisolone hemisuccinate | Downcase Mesh Term | prednisolone phosphate | Downcase Mesh Term | abortifacient agents, nonsteroidal | Downcase Mesh Term | abortifacient agents | Downcase Mesh Term | reproductive control agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | antimetabolites, antineoplastic | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | dermatologic agents | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | folic acid antagonists | Downcase Mesh Term | immunosuppressive agents | Downcase Mesh Term | immunologic factors | Downcase Mesh Term | antirheumatic agents | Downcase Mesh Term | nucleic acid synthesis inhibitors | Downcase Mesh Term | anti-inflammatory agents | Downcase Mesh Term | antiemetics | Downcase Mesh Term | autonomic agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | gastrointestinal agents | Downcase Mesh Term | glucocorticoids | Downcase Mesh Term | hormones | Downcase Mesh Term | hormones, hormone substitutes, and hormone antagonists | Downcase Mesh Term | neuroprotective agents | Downcase Mesh Term | protective agents | Downcase Mesh Term | antineoplastic agents, hormonal | Downcase Mesh Term | anti-infective agents | Downcase Mesh Term | anti-inflammatory agents, non-steroidal | Downcase Mesh Term | analgesics, non-narcotic | Downcase Mesh Term | analgesics | Downcase Mesh Term | sensory system agents |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51714173 |
Name | Psoriatic Arthritis |
Downcase Name | psoriatic arthritis |
Id Information
Sequence: | 39795366 |
Id Source | org_study_id |
Id Value | 18/SC/0261 |
Countries
Sequence: | 42195324 |
Name | United Kingdom |
Removed | False |
Design Groups
Sequence: | 55135056 | Sequence: | 55135057 |
Group Type | Active Comparator | Group Type | Experimental |
Title | Standard care | Title | Local/IM steroid injections |
Description | Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. | Description | Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). |
Interventions
Sequence: | 52036214 | Sequence: | 52036215 | Sequence: | 52036216 | Sequence: | 52036217 | Sequence: | 52036218 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | Methotrexate | Name | Sulfasalazine | Name | Leflunomide | Name | Methylprednisolone | Name | Triamcinolone |
Description | Methotrexate up to 25mg/week as tolerated po or sc | Description | Sulfasalazine up to 3g daily po | Description | Leflunomide 10-20mg daily po | Description | For IA or IM injection 20-120mg | Description | For IA or IM injection 20-120mg |
Design Outcomes
Sequence: | 175894300 | Sequence: | 175894301 | Sequence: | 175894302 | Sequence: | 175894303 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study | Measure | Psoriatic Arthritis Disease Activity Score (PASDAS) | Measure | Ultrasound Score of Synovitis | Measure | Ultrasound Score of Enthesitis |
Time Frame | 48 weeks | Time Frame | 48 weeks | Time Frame | 0 weeks | Time Frame | 0 weeks |
Description | To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48). | Description | A composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as <3.2. | Description | A summary score of synovitis measured at baseline. The score will comprise of 23 joints bilaterally. Grey scale synovitis is scored at each site 0-3 and power doppler is also scored 0-3 at each site where higher scores indicate more severe disease. These scores are then summed to give a final score. Score range is 0-276 | Description | A summary score of enthesitis measured at baseline. The score will comprise of 5 entheses bilaterally. Power doppler is scored 0-3 at each site where higher scores indicate more severe disease activity. Calcifications, enthesophytes and grey scale abnormalities will each be score 0 (absent) or 1 (present) at each site. These scores are then summed to give a final score. Score range is 0-30 |
Browse Conditions
Sequence: | 191649731 | Sequence: | 191649732 | Sequence: | 191649733 | Sequence: | 191649734 | Sequence: | 191649735 | Sequence: | 191649736 | Sequence: | 191649737 | Sequence: | 191649738 | Sequence: | 191649739 | Sequence: | 191649740 | Sequence: | 191649741 | Sequence: | 191649742 |
Mesh Term | Arthritis | Mesh Term | Arthritis, Psoriatic | Mesh Term | Joint Diseases | Mesh Term | Musculoskeletal Diseases | Mesh Term | Spondylarthropathies | Mesh Term | Spondylarthritis | Mesh Term | Spondylitis | Mesh Term | Spinal Diseases | Mesh Term | Bone Diseases | Mesh Term | Psoriasis | Mesh Term | Skin Diseases, Papulosquamous | Mesh Term | Skin Diseases |
Downcase Mesh Term | arthritis | Downcase Mesh Term | arthritis, psoriatic | Downcase Mesh Term | joint diseases | Downcase Mesh Term | musculoskeletal diseases | Downcase Mesh Term | spondylarthropathies | Downcase Mesh Term | spondylarthritis | Downcase Mesh Term | spondylitis | Downcase Mesh Term | spinal diseases | Downcase Mesh Term | bone diseases | Downcase Mesh Term | psoriasis | Downcase Mesh Term | skin diseases, papulosquamous | Downcase Mesh Term | skin diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47895883 | Sequence: | 47895884 |
Agency Class | OTHER | Agency Class | OTHER_GOV |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
Name | University of Oxford | Name | National Institute for Health Research, United Kingdom |
Design Group Interventions
Sequence: | 67592148 | Sequence: | 67592149 | Sequence: | 67592150 | Sequence: | 67592151 | Sequence: | 67592152 |
Design Group Id | 55135056 | Design Group Id | 55135056 | Design Group Id | 55135056 | Design Group Id | 55135057 | Design Group Id | 55135057 |
Intervention Id | 52036214 | Intervention Id | 52036215 | Intervention Id | 52036216 | Intervention Id | 52036217 | Intervention Id | 52036218 |
Eligibilities
Sequence: | 30499693 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Participants consented to the PsA inception cohort (MONITOR-PsA) and to be approached for alternate interventional therapies. Participants with mild disease as defined by: Oligoarticular disease with <5 active joints at baseline assessment. Participant has clinically acceptable laboratory results within 6 weeks of enrolment: Haemoglobin count > 8.5 g/dL Exclusion Criteria: ≥1 poor prognostic factors for psoriatic arthritis, from raised C reactive protein (CRP) defined as > 4g/dl for standard non-hsCRP |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254040581 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Actual Duration | 15 |
Were Results Reported | True |
Months To Report Results | 7 |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30248907 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | Single |
Masking Description | Blinded assessor will perform clinical evaluations |
Outcomes Assessor Masked | True |
Intervention Other Names
Sequence: | 26449144 | Sequence: | 26449145 | Sequence: | 26449146 | Sequence: | 26449147 | Sequence: | 26449148 |
Intervention Id | 52036214 | Intervention Id | 52036215 | Intervention Id | 52036216 | Intervention Id | 52036217 | Intervention Id | 52036218 |
Name | methotrexate sodium | Name | sulfasalazine pill | Name | leflunomide pill | Name | methylprednisolone acetate | Name | triamcinolone acetonide |
Milestones
Sequence: | 40675576 | Sequence: | 40675577 | Sequence: | 40675578 | Sequence: | 40675579 | Sequence: | 40675580 | Sequence: | 40675581 |
Result Group Id | 55732955 | Result Group Id | 55732956 | Result Group Id | 55732955 | Result Group Id | 55732956 | Result Group Id | 55732955 | Result Group Id | 55732956 |
Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 |
Title | STARTED | Title | STARTED | Title | COMPLETED | Title | COMPLETED | Title | NOT COMPLETED | Title | NOT COMPLETED |
Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study | Period | Overall Study |
Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 1 | Count | 0 |
Participant Flows
Sequence: | 3888691 |
Recruitment Details | The POISE trial opened on 17 April 2019 in Oxford and 19 September 2019 in Bath.
The study remained open until 16 July 2020 as planned. |
Outcome Counts
Sequence: | 73393043 | Sequence: | 73393044 | Sequence: | 73393045 | Sequence: | 73393046 | Sequence: | 73393047 | Sequence: | 73393048 | Sequence: | 73393049 | Sequence: | 73393050 |
Outcome Id | 30547991 | Outcome Id | 30547991 | Outcome Id | 30547992 | Outcome Id | 30547992 | Outcome Id | 30547993 | Outcome Id | 30547993 | Outcome Id | 30547994 | Outcome Id | 30547994 |
Result Group Id | 55732957 | Result Group Id | 55732958 | Result Group Id | 55732957 | Result Group Id | 55732958 | Result Group Id | 55732957 | Result Group Id | 55732958 | Result Group Id | 55732957 | Result Group Id | 55732958 |
Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 |
Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure | Scope | Measure |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants |
Count | 1 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 | Count | 0 |
Provided Documents
Sequence: | 2560043 |
Document Type | Study Protocol and Statistical Analysis Plan |
Has Protocol | True |
Has Icf | False |
Has Sap | True |
Document Date | 2019-08-27 |
Url | https://ClinicalTrials.gov/ProvidedDocs/72/NCT03797872/Prot_SAP_000.pdf |
Reported Event Totals
Sequence: | 27710638 | Sequence: | 27710639 | Sequence: | 27710640 | Sequence: | 27710641 | Sequence: | 27710642 | Sequence: | 27710643 |
Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 | Ctgov Group Code | EG001 |
Event Type | serious | Event Type | other | Event Type | deaths | Event Type | serious | Event Type | other | Event Type | deaths |
Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality | Classification | Total, serious adverse events | Classification | Total, other adverse events | Classification | Total, all-cause mortality |
Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 | Subjects Affected | 0 |
Subjects At Risk | 1 | Subjects At Risk | 1 | Subjects At Risk | 1 | Subjects At Risk | 0 | Subjects At Risk | 0 | Subjects At Risk | 0 |
Created At | 2023-08-06 07:44:58.127991 | Created At | 2023-08-06 07:44:58.127991 | Created At | 2023-08-06 07:44:58.127991 | Created At | 2023-08-06 07:44:58.127991 | Created At | 2023-08-06 07:44:58.127991 | Created At | 2023-08-06 07:44:58.127991 |
Updated At | 2023-08-06 07:44:58.127991 | Updated At | 2023-08-06 07:44:58.127991 | Updated At | 2023-08-06 07:44:58.127991 | Updated At | 2023-08-06 07:44:58.127991 | Updated At | 2023-08-06 07:44:58.127991 | Updated At | 2023-08-06 07:44:58.127991 |
Responsible Parties
Sequence: | 28629715 |
Responsible Party Type | Sponsor |
Result Agreements
Sequence: | 3819435 |
Pi Employee | No |
Result Contacts
Sequence: | 3819400 |
Organization | University of Oxford |
Name | Professor Laura Coates |
Phone | +447870257823 |
laura.coates@ndorms.ox.ac.uk | |
Outcomes
Sequence: | 30547991 | Sequence: | 30547992 | Sequence: | 30547993 | Sequence: | 30547994 |
Outcome Type | Primary | Outcome Type | Secondary | Outcome Type | Secondary | Outcome Type | Secondary |
Title | Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study | Title | Psoriatic Arthritis Disease Activity Score (PASDAS) | Title | Ultrasound Score of Synovitis | Title | Ultrasound Score of Enthesitis |
Description | To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48). | Description | A composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as <3.2. | Description | A summary score of synovitis measured at baseline. The score will comprise of 23 joints bilaterally. Grey scale synovitis is scored at each site 0-3 and power doppler is also scored 0-3 at each site where higher scores indicate more severe disease. These scores are then summed to give a final score. Score range is 0-276 | Description | A summary score of enthesitis measured at baseline. The score will comprise of 5 entheses bilaterally. Power doppler is scored 0-3 at each site where higher scores indicate more severe disease activity. Calcifications, enthesophytes and grey scale abnormalities will each be score 0 (absent) or 1 (present) at each site. These scores are then summed to give a final score. Score range is 0-30 |
Time Frame | 48 weeks | Time Frame | 48 weeks | Time Frame | 0 weeks | Time Frame | 0 weeks |
Population | All participants included | Population | Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis | Population | Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis | Population | Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis. The US was not performed as this was only for participants in the intervention group. |
Units | Participants | ||||||
Param Type | Count of Participants |
Outcome Measurements
Sequence: | 233726597 |
Outcome Id | 30547991 |
Result Group Id | 55732957 |
Ctgov Group Code | OG000 |
Title | Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study |
Description | To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48). |
Units | Participants |
Param Type | Count of Participants |
Param Value | 0 |
Param Value Num | 0.0 |
Study References
Sequence: | 51604931 |
Pmid | 35035537 |
Reference Type | derived |
Citation | Rombach I, Tucker L, Tillett W, Jadon D, Watson M, Francis A, Sinomati Y, Dutton SJ, Coates LC. Clinical effectiveness of symptomatic therapy compared with standard step-up care for the treatment of low-impact psoriatic oligoarthritis: the two-arm parallel group randomised POISE feasibility study. Ther Adv Musculoskelet Dis. 2022 Jan 10;13:1759720X211057668. doi: 10.1177/1759720X211057668. eCollection 2021. Erratum In: Ther Adv Musculoskelet Dis. 2022 Feb 9;14:1759720X221077827. |
Baseline Counts
Sequence: | 11289985 | Sequence: | 11289986 | Sequence: | 11289987 |
Result Group Id | 55732952 | Result Group Id | 55732953 | Result Group Id | 55732954 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 |
Units | Participants | Units | Participants | Units | Participants |
Scope | overall | Scope | overall | Scope | overall |
Count | 1 | Count | 0 | Count | 1 |
Result Groups
Sequence: | 55732952 | Sequence: | 55732953 | Sequence: | 55732954 | Sequence: | 55732955 | Sequence: | 55732956 | Sequence: | 55732957 | Sequence: | 55732958 | Sequence: | 55732959 | Sequence: | 55732960 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | FG000 | Ctgov Group Code | FG001 | Ctgov Group Code | OG000 | Ctgov Group Code | OG001 | Ctgov Group Code | EG000 | Ctgov Group Code | EG001 |
Result Type | Baseline | Result Type | Baseline | Result Type | Baseline | Result Type | Participant Flow | Result Type | Participant Flow | Result Type | Outcome | Result Type | Outcome | Result Type | Reported Event | Result Type | Reported Event |
Title | Standard Care | Title | Local/IM Steroid Injections | Title | Total | Title | Standard Care | Title | Local/IM Steroid Injections | Title | Standard Care | Title | Local/IM Steroid Injections | Title | Standard Care | Title | Local/IM Steroid Injections |
Description | Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.
Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily po |
Description | Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).
Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg |
Description | Total of all reporting groups | Description | Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.
Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily po |
Description | Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).
Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg |
Description | Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.
Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily po |
Description | Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).
Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg |
Description | Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.
Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily po |
Description | Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).
Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg |
Baseline Measurements
Sequence: | 124593395 | Sequence: | 124593396 | Sequence: | 124593397 | Sequence: | 124593398 | Sequence: | 124593399 | Sequence: | 124593400 | Sequence: | 124593401 | Sequence: | 124593402 | Sequence: | 124593403 | Sequence: | 124593404 | Sequence: | 124593405 | Sequence: | 124593406 | Sequence: | 124593407 | Sequence: | 124593408 | Sequence: | 124593409 | Sequence: | 124593410 | Sequence: | 124593411 | Sequence: | 124593412 |
Result Group Id | 55732952 | Result Group Id | 55732953 | Result Group Id | 55732954 | Result Group Id | 55732952 | Result Group Id | 55732953 | Result Group Id | 55732954 | Result Group Id | 55732952 | Result Group Id | 55732953 | Result Group Id | 55732954 | Result Group Id | 55732952 | Result Group Id | 55732953 | Result Group Id | 55732954 | Result Group Id | 55732952 | Result Group Id | 55732953 | Result Group Id | 55732954 | Result Group Id | 55732954 | Result Group Id | 55732952 | Result Group Id | 55732954 |
Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG001 | Ctgov Group Code | BG002 | Ctgov Group Code | BG002 | Ctgov Group Code | BG000 | Ctgov Group Code | BG002 |
Classification | United Kingdom | Classification | United Kingdom | ||||||||||||||||||||||||||||||||
Category | <=18 years | Category | <=18 years | Category | <=18 years | Category | Between 18 and 65 years | Category | Between 18 and 65 years | Category | Between 18 and 65 years | Category | >=65 years | Category | >=65 years | Category | >=65 years | Category | Female | Category | Female | Category | Female | Category | Male | Category | Male | Category | Male | ||||||
Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Age, Categorical | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Sex: Female, Male | Title | Race and Ethnicity Not Collected | Title | Region of Enrollment | Title | Region of Enrollment |
Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | Participants | Units | participants | Units | participants |
Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Count of Participants | Param Type | Number | Param Type | Number |
Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 0 | Param Value | 1 | Param Value | 1 |
Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 0.0 | Param Value Num | 1.0 | Param Value Num | 1.0 |
Number Analyzed | 1 | Number Analyzed | 0 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 0 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 0 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 0 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 0 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 | Number Analyzed | 1 |
Population Description | Race and Ethnicity were not collected from any participant. | ||||||||||||||||||||||||||||||||||
]]>
https://zephyrnet.com/NCT03797859
2019-01-08
https://zephyrnet.com/?p=NCT03797859
NCT03797859https://www.clinicaltrials.gov/study/NCT03797859?tab=tableNANANATransnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) denotes the use of high-flow humidified nasal oxygen system (for example Optiflow®) as an alternative ventilation modality for an anesthetized patient without spontaneous respiration. This method requires only basic airway management manoeuvres to keep the airway open and provides both stable longterm oxygenation as well as apneic ventialtion.
We plan to evaluate this methods physiological performance under standardized conditions of airway management by frequent, repeated arterial blood gas analyses.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2019-01-23 |
Start Month Year | January 8, 2019 |
Primary Completion Month Year | May 1, 2019 |
Verification Month Year | January 2019 |
Verification Date | 2019-01-31 |
Last Update Posted Date | 2019-01-23 |
Detailed Descriptions
Sequence: | 20762931 |
Description | THRIVE is previously shown feasible as sole mode of ventilation in selected patients during general anaesthesia for minor laryngeal surgery for a limited time up to 30 minutes, where direct laryngoscopy was required and applied throughout the procedure. A stable oxygenation and a degree of ventilation was observed. However, a slowly developed respiratory acidosis was also observed over time.
Existing physiologic studies on high flow humidified nasal oxygen suggest that closed mouth breathing enhance the effects of the high flows of oxygen levels applied by increasing the airway pressures and thereby enhance gas exchange in the lungs. Currently, it is unclear whether the efficiency of THRIVE depends on the particular circumstances of airway management. Physiologic characterization of THRIVE performance under standardized conditions of airway management and under close monitoring by systematic analysis of blood gas dynamics over time during general anesthesia is needed. We plan to study the blood gas dynamics during THRIVE apnea ventilation during general anesthesia, where the airway is managed only by jaw-thrust for up to 60 minutes. The patients will be closely monitored by repetitive arterial blood gasses to evaluate blood gas dynamics and development of respiratory acidosis. Desaturation or respiratory acidosis with pH under 7.15 and/or PaCO2-rise > 12 kPa will lead to cessation of THRIVE. |
Facilities
Sequence: | 200458204 | Sequence: | 200458205 |
Name | Rigshospitalet | Name | Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071 |
City | Copenhagen | City | Copenhagen |
State | Hoevdstaden | ||
Zip | 2100 | Zip | 2100 |
Country | Denmark | Country | Denmark |
Conditions
Sequence: | 52277464 | Sequence: | 52277465 | Sequence: | 52277466 |
Name | Apnea | Name | Ventilation Therapy; Complications | Name | Respiratory Acidosis |
Downcase Name | apnea | Downcase Name | ventilation therapy; complications | Downcase Name | respiratory acidosis |
Id Information
Sequence: | 40235469 |
Id Source | org_study_id |
Id Value | H-18017844 |
Countries
Sequence: | 42653066 |
Name | Denmark |
Removed | False |
Interventions
Sequence: | 52589530 |
Intervention Type | Procedure |
Name | Apneic ventilation |
Description | Ventilation by THRIVE |
Design Outcomes
Sequence: | 177770698 |
Outcome Type | primary |
Measure | Respiratory acidosis |
Time Frame | Max. 60 minutes |
Description | Development of respiratory acidosis (pH < 7.15 or paCO2 > 12) over time on study |
Browse Conditions
Sequence: | 193892782 | Sequence: | 193892783 | Sequence: | 193892784 | Sequence: | 193892785 | Sequence: | 193892786 | Sequence: | 193892787 | Sequence: | 193892788 |
Mesh Term | Acidosis, Respiratory | Mesh Term | Acidosis | Mesh Term | Acid-Base Imbalance | Mesh Term | Metabolic Diseases | Mesh Term | Respiratory Insufficiency | Mesh Term | Respiration Disorders | Mesh Term | Respiratory Tract Diseases |
Downcase Mesh Term | acidosis, respiratory | Downcase Mesh Term | acidosis | Downcase Mesh Term | acid-base imbalance | Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | respiratory insufficiency | Downcase Mesh Term | respiration disorders | Downcase Mesh Term | respiratory tract diseases |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48418649 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Rigshospitalet, Denmark |
Overall Officials
Sequence: | 29342619 |
Role | Principal Investigator |
Name | Michael S Kristensen, MD |
Affiliation | Senior consultant, Rigshospitalet |
Eligibilities
Sequence: | 30827037 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Population | Patients presenting for non-laryngeal surgery in general anesthesia, where intubation is not mandatory. |
Criteria | Inclusion Criteria:
Adult (age over 18 years) Exclusion Criteria: ASA (American Society of Anaesthesiologists class) > 3 |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254123732 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Designs
Sequence: | 30572967 |
Observational Model | Case-Only |
Time Perspective | Prospective |
Responsible Parties
Sequence: | 28939389 |
Responsible Party Type | Principal Investigator |
Name | Michael Seltz Kristensen |
Title | SENIOR CONSULTANT |
Affiliation | Rigshospitalet, Denmark |
]]>
https://zephyrnet.com/NCT03797846
2018-01-01
https://zephyrnet.com/?p=NCT03797846
NCT03797846https://www.clinicaltrials.gov/study/NCT03797846?tab=tableNANANAThe aim of the study is to compare the effectiveness and safety of two types of intraoperative eye fixation: for the superior rectus muscle and traction suture in the peripheral cornea.
This is a prospective randomized trial with a 6 month follow-up period, which covers patients with open angle glaucoma qualified for combined glaucoma procedure (phacotrabeculectomy). In I group, the intraoperatively fixation in the peripheral part of the cornea is used, in II group the bridle suture for the superior rectus muscle is performed.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-03 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2020-07-14 |
Start Month Year | January 1, 2018 |
Primary Completion Month Year | January 1, 2019 |
Verification Month Year | July 2020 |
Verification Date | 2020-07-31 |
Last Update Posted Date | 2020-07-14 |
Detailed Descriptions
Sequence: | 20716296 |
Description | The way of the intraoperatively fixation may have some impact for postoperative results of the level of intraocular pressure (IOP), visual acuity (BCVA) and the incidence of upper eyelid ptosis was determined as a post-operative MRD (margin reflex distance) ≥2mm. |
Facilities
Sequence: | 200053300 |
Name | Medical University |
City | Białystok |
Zip | 15-089 |
Country | Poland |
Conditions
Sequence: | 52156500 | Sequence: | 52156501 |
Name | Glaucoma Eye | Name | Glaucoma |
Downcase Name | glaucoma eye | Downcase Name | glaucoma |
Id Information
Sequence: | 40148214 |
Id Source | org_study_id |
Id Value | 1771 |
Countries
Sequence: | 42557735 |
Name | Poland |
Removed | False |
Design Groups
Sequence: | 55577910 | Sequence: | 55577911 |
Group Type | Active Comparator | Group Type | Active Comparator |
Title | Corneal Suture | Title | Muscle Suture |
Description | intraoperative fixation with the suture in clear cornea qualified to the combined glaucoma surgery | Description | intraoperative fixation with the bridle suture for superior rectus muscle qualified to the combined glaucoma surgery |
Interventions
Sequence: | 52472012 |
Intervention Type | Procedure |
Name | combined glaucoma surgery |
Description | combined procedure with trabeculectomy and cataract removal |
Keywords
Sequence: | 79848096 | Sequence: | 79848097 | Sequence: | 79848098 | Sequence: | 79848099 |
Name | ptosis | Name | combined procedures | Name | glaucoma | Name | post-surgery complication |
Downcase Name | ptosis | Downcase Name | combined procedures | Downcase Name | glaucoma | Downcase Name | post-surgery complication |
Design Outcomes
Sequence: | 177328009 | Sequence: | 177328010 | Sequence: | 177328011 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | IOP | Measure | BCVA | Measure | MRD |
Time Frame | baseline and twelve months after surgery | Time Frame | baseline and twelve months after surgery | Time Frame | baseline and twelve months after surgery |
Description | the change in the level of intraocular pressure | Description | the change in the best corrected visual acuity | Description | the incidence of upper eyelid ptosis determined as a post-operative MRD (margin reflex distance) ≥2mm |
Browse Conditions
Sequence: | 193432080 | Sequence: | 193432078 | Sequence: | 193432079 |
Mesh Term | Eye Diseases | Mesh Term | Glaucoma | Mesh Term | Ocular Hypertension |
Downcase Mesh Term | eye diseases | Downcase Mesh Term | glaucoma | Downcase Mesh Term | ocular hypertension |
Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48306087 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Medical University of Bialystok |
Overall Officials
Sequence: | 29277931 |
Role | Study Chair |
Name | Zofia Mariak, Prof |
Affiliation | Medical University of Bialystok |
Design Group Interventions
Sequence: | 68130877 | Sequence: | 68130878 |
Design Group Id | 55577910 | Design Group Id | 55577911 |
Intervention Id | 52472012 | Intervention Id | 52472012 |
Eligibilities
Sequence: | 30757357 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria:
co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale (Lens Opacities Classification System III) Exclusion Criteria: no consent to participation in the study |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254227935 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2019 |
Actual Duration | 12 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 2 |
Designs
Sequence: | 30503582 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Intervention Model Description | A prospective randomized trial with a 6 month follow-up period |
Responsible Parties
Sequence: | 28869860 |
Responsible Party Type | Principal Investigator |
Name | Joanna Konopińska |
Title | MD, PhD |
Affiliation | Medical University of Bialystok |
Study References
Sequence: | 52049407 |
Pmid | 25803293 |
Reference Type | background |
Citation | Li B, Zhang M, Liu W, Wang J. Comparison of Superior Rectus and Peripheral Lamellar Corneal Traction Suture during Trabeculectomy. Curr Eye Res. 2016;41(2):215-21. doi: 10.3109/02713683.2015.1009635. Epub 2015 Sep 15. |
Ipd Information Types
Sequence: | 3332718 |
Name | Study Protocol |
]]>
https://zephyrnet.com/NCT03797833
2019-01-07
https://zephyrnet.com/?p=NCT03797833
NCT03797833https://www.clinicaltrials.gov/study/NCT03797833?tab=tableNANANAThis study evaluates the potential benefits of spinal anaesthesia for nulliparous mothers scheduled for external version of babies in breech position.
<![CDATA[
Studies
Study First Submitted Date | 2019-01-07 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2022-10-27 |
Start Month Year | January 7, 2019 |
Primary Completion Month Year | January 31, 2029 |
Verification Month Year | October 2022 |
Verification Date | 2022-10-31 |
Last Update Posted Date | 2022-10-27 |
Detailed Descriptions
Sequence: | 20587369 |
Description | Fetuses in breech position are almost always delivered by Caesarian section (CS). If the fetus is in breech position by the end of pregnancy, attempts for external cephalic version (ECV) are usually made. The success rate of ECV in nulliparous women is lower than in multiparous women. There are studies showing a higher rate of successful ECV's if the mother received a low dose spinal anaesthesia (SA). Overall maternal satisfaction was higher with SA. These studies, however, did not take parity into account.
The primary aim of this study is to see if SA can increase the rate of successful ECV's in nulliparous women. The secondary aims are to evaluate if maternal satisfaction increases and if the rate of CS is decreasing using SA during ECV. |
Facilities
Sequence: | 198728093 | Sequence: | 198728094 |
Name | Skåne University Hospital | Name | Skåne University Hospital |
City | Lund | City | Malmö |
Country | Sweden | Country | Sweden |
Browse Interventions
Sequence: | 95372136 | Sequence: | 95372137 | Sequence: | 95372138 |
Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs |
Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
Sequence: | 51825421 |
Name | Breech Presentation; Before Labor |
Downcase Name | breech presentation; before labor |
Id Information
Sequence: | 39882881 |
Id Source | org_study_id |
Id Value | 2018/634 |
Countries
Sequence: | 42281325 |
Name | Sweden |
Removed | False |
Design Groups
Sequence: | 55248203 | Sequence: | 55248204 |
Group Type | No Intervention | Group Type | Active Comparator |
Title | Standard treatment | Title | Spinal anaesthesia |
Description | ECV according to standard practice. | Description | ECV after low dose spinal anaesthesia (Bupivacain 2,5 mg plus Sufentanil 5 micrograms (µg) |
Interventions
Sequence: | 52146766 |
Intervention Type | Procedure |
Name | Spinal Anaesthesia |
Description | Spinal anaesthesia with Bupivacain 2.5 mg and Sufentanil 5 µg |
Keywords
Sequence: | 79304278 |
Name | breech presentation, external version, spinal anaesthesia |
Downcase Name | breech presentation, external version, spinal anaesthesia |
Design Outcomes
Sequence: | 176258167 | Sequence: | 176258165 | Sequence: | 176258166 | Sequence: | 176258168 |
Outcome Type | secondary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Overall maternal satisfaction post partum | Measure | External version success rate | Measure | Overall maternal satisfaction post external version attempt | Measure | Caesarian section rate |
Time Frame | 3 months | Time Frame | 1 hour | Time Frame | 1 hour | Time Frame | 1 months |
Description | Evaluation of overall participant satisfaction using an online assessment questionnaire within 3 months from the external version attempts (within 2 months post partum) | Description | Rate of successful version as assessed by gynaecologist after maximum three attempts. | Description | Evaluation of overall participant satisfaction using an online assessment questionnaire within an hour from the external version attempts. | Description | The mode of delivery, assessed from the medical charts after delivery. |
Browse Conditions
Sequence: | 192092730 | Sequence: | 192092731 | Sequence: | 192092732 | Sequence: | 192092733 | Sequence: | 192092734 |
Mesh Term | Breech Presentation | Mesh Term | Obstetric Labor Complications | Mesh Term | Pregnancy Complications | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases |
Downcase Mesh Term | breech presentation | Downcase Mesh Term | obstetric labor complications | Downcase Mesh Term | pregnancy complications | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47997671 |
Agency Class | OTHER |
Lead Or Collaborator | lead |
Name | Region Skane |
Overall Officials
Sequence: | 29082516 |
Role | Principal Investigator |
Name | Andreas Herbst, MD PhD |
Affiliation | Lund University, IKVL gyn/ob . Skåne University Hospital, Lund Sweden |
Design Group Interventions
Sequence: | 67731683 |
Design Group Id | 55248204 |
Intervention Id | 52146766 |
Eligibilities
Sequence: | 30562564 |
Gender | Female |
Minimum Age | 18 Years |
Maximum Age | N/A |
Healthy Volunteers | No |
Criteria | Inclusion Criteria:
Pregnant nulliparous women. Exclusion Criteria: Unwilling to participate. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254249532 |
Number Of Facilities | 2 |
Registered In Calendar Year | 2019 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | False |
Minimum Age Num | 18 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30310848 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Treatment |
Time Perspective | |
Masking | None (Open Label) |
Responsible Parties
Sequence: | 28689480 |
Responsible Party Type | Sponsor |
Study References
Sequence: | 51719082 | Sequence: | 51719083 | Sequence: | 51719084 | Sequence: | 51719085 |
Pmid | 25962611 | Pmid | 27131581 | Pmid | 25674710 | Pmid | 28723831 |
Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
Citation | Khaw KS, Lee SW, Ngan Kee WD, Law LW, Lau TK, Ng FF, Leung TY. Randomized trial of anaesthetic interventions in external cephalic version for breech presentation. Br J Anaesth. 2015 Jun;114(6):944-50. doi: 10.1093/bja/aev107. Epub 2015 May 10. | Citation | Magro-Malosso ER, Saccone G, Di Tommaso M, Mele M, Berghella V. Neuraxial analgesia to increase the success rate of external cephalic version: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2016 Sep;215(3):276-86. doi: 10.1016/j.ajog.2016.04.036. Epub 2016 Apr 27. Erratum In: Am J Obstet Gynecol. 2017 Mar;216(3):315. | Citation | Cluver C, Gyte GM, Sinclair M, Dowswell T, Hofmeyr GJ. Interventions for helping to turn term breech babies to head first presentation when using external cephalic version. Cochrane Database Syst Rev. 2015 Feb 9;(2):CD000184. doi: 10.1002/14651858.CD000184.pub4. | Citation | Chalifoux LA, Bauchat JR, Higgins N, Toledo P, Peralta FM, Farrer J, Gerber SE, McCarthy RJ, Sullivan JT. Effect of Intrathecal Bupivacaine Dose on the Success of External Cephalic Version for Breech Presentation: A Prospective, Randomized, Blinded Clinical Trial. Anesthesiology. 2017 Oct;127(4):625-632. doi: 10.1097/ALN.0000000000001796. |
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https://zephyrnet.com/NCT03797820
2018-10-01
https://zephyrnet.com/?p=NCT03797820
NCT03797820https://www.clinicaltrials.gov/study/NCT03797820?tab=tableNANANAAortic valve stenosis (AVS) is becoming more and more frequent with the aging, which has brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart disease are not so clear, especially in the developing countries such as China etc. Because of the slow and progressive nature of AVS, symptoms might not be too severe to be diagnosed on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe aortic valve stenosis are very common in China. Hence, we design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification,cost-effective ,treatments and prognosis of Chinese elderly patients with aortic valve stenosis.
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Studies
Study First Submitted Date | 2018-12-24 |
Study First Posted Date | 2019-01-09 |
Last Update Posted Date | 2021-07-15 |
Start Month Year | October 1, 2018 |
Primary Completion Month Year | September 30, 2023 |
Verification Month Year | July 2021 |
Verification Date | 2021-07-31 |
Last Update Posted Date | 2021-07-15 |
Facilities
Sequence: | 200108545 |
Status | Recruiting |
Name | Second Affiliated Hospital Zhejiang University School of Medicine |
City | Hangzhou |
State | Zhejiang |
Zip | 310000 |
Country | China |
Facility Contacts
Sequence: | 28106461 |
Facility Id | 200108545 |
Contact Type | primary |
Name | Xianbao Liu, MD |
liuxb2009@hotmail.com | |
Phone | +86-13857173887 |
Conditions
Sequence: | 52171335 |
Name | Valvular Heart Disease |
Downcase Name | valvular heart disease |
Id Information
Sequence: | 40158684 |
Id Source | org_study_id |
Id Value | SAHZJU CT012 |
Countries
Sequence: | 42568997 |
Name | China |
Removed | False |
Interventions
Sequence: | 52485557 |
Intervention Type | Other |
Name | Our study type is observational |
Description | Our study type is observational |
Design Outcomes
Sequence: | 177379132 | Sequence: | 177379133 | Sequence: | 177379134 | Sequence: | 177379135 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | All-cause mortality,disabling strokes and Surgical or transcatheter aortic valve replacement | Measure | Hospitalization for heart failure | Measure | Surgical or transcatheter aortic valve replacement | Measure | Cardiovascular death |
Time Frame | one year | Time Frame | one year | Time Frame | one year | Time Frame | one year |
Description | time from enrolled to first occurrence of any of the components of the composite outcome | Description | time from enrolled to first occurrence of the outcome | Description | time from enrolled to first occurrence of the outcome | Description | time from enrolled to first occurrence of the outcome |
Browse Conditions
Sequence: | 193487064 | Sequence: | 193487065 | Sequence: | 193487066 | Sequence: | 193487067 | Sequence: | 193487068 | Sequence: | 193487069 |
Mesh Term | Heart Diseases | Mesh Term | Aortic Valve Stenosis | Mesh Term | Heart Valve Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Aortic Valve Disease | Mesh Term | Ventricular Outflow Obstruction |
Downcase Mesh Term | heart diseases | Downcase Mesh Term | aortic valve stenosis | Downcase Mesh Term | heart valve diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | aortic valve disease | Downcase Mesh Term | ventricular outflow obstruction |
Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48319349 | Sequence: | 48319350 | Sequence: | 48319351 | Sequence: | 48319352 | Sequence: | 48319353 | Sequence: | 48319354 | Sequence: | 48319355 | Sequence: | 48319356 | Sequence: | 48319357 | Sequence: | 48319358 |
Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER_GOV | Agency Class | OTHER |
Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
Name | Second Affiliated Hospital, School of Medicine, Zhejiang University | Name | First Affiliated Hospital of Wenzhou Medical University | Name | Second Affiliated Hospital of Wenzhou Medical University | Name | Jinhua Central Hospital | Name | The Second Affiliated Hospital of Jiaxing University | Name | The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Name | The Central Hospital of Lishui City | Name | Sir Run Run Shaw Hospital | Name | Ningbo Medical Center Lihuili Hospital | Name | Ningbo No. 1 Hospital |
Eligibilities
Sequence: | 30765394 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | 60 Years |
Maximum Age | 90 Years |
Healthy Volunteers | No |
Population | Patients over 60 years old and moderate or above aortic stenosis |
Criteria | Inclusion Criteria:
1. Patients over 60 years old meet the following condition moderate or above aortic stenosis as defined by echocardiography: Aortic stenosis, moderate or above, or valve area≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient≥20mmHg Exclusion Criteria: Patients cannot be followed up for any reasons. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 253886099 |
Number Of Facilities | 1 |
Registered In Calendar Year | 2018 |
Were Results Reported | False |
Has Us Facility | False |
Has Single Facility | True |
Minimum Age Num | 60 |
Maximum Age Num | 90 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 3 |
Designs
Sequence: | 30511560 |
Observational Model | Cohort |
Time Perspective | Prospective |
Links
Sequence: | 4388089 |
Url | http://www.ncbi.nlm.nih.gov/pubmed/27908608 |
Description | A hospital-based survey of patients with severe valvular heart disease in China |
Responsible Parties
Sequence: | 28877855 |
Responsible Party Type | Principal Investigator |
Name | Jian'an Wang,MD,PhD |
Title | President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology |
Affiliation | Second Affiliated Hospital, School of Medicine, Zhejiang University |
Study References
Sequence: | 52063435 |
Pmid | 27908608 |
Reference Type | background |
Citation | Hu P, Liu XB, Liang J, Zhu QF, Pu CX, Tang MY, Wang JA. A hospital-based survey of patients with severe valvular heart disease in China. Int J Cardiol. 2017 Mar 15;231:244-247. doi: 10.1016/j.ijcard.2016.11.301. Epub 2016 Nov 25. |
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