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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< |